GREG HALES North Country HealthCare
Posted: Sunday, July 4, 2010 5:00 am
Telemedicine is allowing North Country HealthCare to expand its primary care services across a very large service area from Lake Havasu City on Arizona's California border to Springerville on the New Mexico border.
The technology makes it possible for patients to visit medical providers miles away via direct video conference links coupled with high tech instruments such as hand-held examination cameras or digital stethoscopes.
The telemedicine technology is saving time and money for patients as well as their medical providers. Steve McCrosky is a family nurse practitioner at North Country HealthCare, who lives in Flagstaff and practices two days a week in Winslow and two days a week in Flagstaff. Thanks to telemedicine, he has been able to open up his schedule so he can see patients from Winslow on the days he is in Flagstaff. The patients can get care delivered to them where they are when they need it, and Steve McCrosky can provide the service without getting in the car.
During a telemedicine visit a "telepresenter" such as a medical assistant or nurse sits in the exam room with the patient and acts as the doctor's hands and eyes. The telepresenter can use a camera with a close-up lens to look at a rash or a video otoscope to look inside the patient's ears, and the doctor can examine the patient in real time from miles away while carrying on a conversation with the patient. Patients and providers can establish positive relationships, which makes acceptance of the process high, especially if the patients are able to save time or gain access to services that would be otherwise hard to receive.
North Country HealthCare has registered with the FDA to do a formal research study to evaluate digital stethoscopes in telemedicine applications. Littmann Stethoscopes, marketed by the 3M Company, are among the world's oldest and most respected stethoscopes. Littman is now manufacturing FDA-approved digital stethoscopes that are able to amplify and record heart and lung sounds. The company has created software that allows these sounds to be heard over the internet in a telemedicine encounter. The research is designed to find out if the quality of the sound is equal or comparable to the sound you would hear if you were in the same room with the patient. Positive study results would support FDA approval of the telemedicine software.
North Country HealthCare is developing a telemedicine program that will allow a provider to see HIV patients across the system without driving hours to a remote location. Another program will bring specialists from Banner Health System to Flagstaff one or two days a month where they can see Hepatitis C patients by telemedicine at several North Country sites on the same day. North Country is already providing behavioral health care to remote sites through telemedicine and its pharmacy is gearing up to launch a "telepharmacy" program. In the future, North Country would like to use telemedicine to monitor frail elderly patients at home and reduce the frequency of readmissions to the hospital.
At a time when the health care system needs to provide better access to care at a lower cost, telemedicine has a great deal of potential to be part of the solution, especially in rural and undeserved areas.
Greg Hales is the program coordinator for telehealth at North Country HealthCare.
Posted in Columnists on Sunday, July 4, 2010 5:00 am Updated: 8:48 pm.
Source
July 4, 2010
‘Bad blood’ victim takes campaign to Number 10
9:28am Sunday 4th July 2010
A VICTIM of the “bad blood” scandal has taken his fight for financial redress to Downing Street.
David Fielding, from Farnworth, was among some 4,500 haemophiliacs affected by the scandal in the 1970s and 1980s and needed a liver transplant after being given infected blood.
He joined other members of the national Haemophilia Society to deliver a letter to Prime Minister David Cameron.
The campaigners have spent the past two decades fighting for compensation for victims.
In April, Labour announced it would look at the Skipton Fund, which compensates those who contracted Hepatitis C and the Haemophilia Society wants the Government to make the same commitment.
Mr Fielding said: “We had about 250 victims and their families down in London with us and six of us went to Downing Street with our MPs to deliver the letter and a wreath in memory of the 2,000 victims.
“It was important for us to do that and I will continue to fight, as I have done for the past 17 years.”
The 54-year-old, whose brother, Brian, died in 1990 at the age of 46 after being infected with HIV, also met up with Bolton South East MP Yasmin Qureshi, who Mr Fielding hopes will continue the fight taken up by her predecessor Dr Brian Iddon.
The brothers were among 4,500 people affected by the scandal in the 1970s and 1980s. About 2,000 have now died as a result.
Mr Fielding said: “A lot of people are dying. At one time we were losing one a week, now it is about one a month. It is important that people who are still alive are coping with this infection.
“This Government and the past Government have had the money to put this to bed and compensate us, but it has still not happened.
“I don’t want to go to my grave and this not have been sorted out. I have been fighting for 17 years now and I am getting tired, worn out and angry.
“We have to start all over again with the new MPs to educate them about what happened.”
Following the scandal, a public inquiry by Lord Archer recommended better compensation for all victims and a committee to advise on haemophilia.
Attempts to get a Contaminated Blood Bill through Parliament, to implement all the recommendations, have so far failed.
Source
A VICTIM of the “bad blood” scandal has taken his fight for financial redress to Downing Street.
David Fielding, from Farnworth, was among some 4,500 haemophiliacs affected by the scandal in the 1970s and 1980s and needed a liver transplant after being given infected blood.
He joined other members of the national Haemophilia Society to deliver a letter to Prime Minister David Cameron.
The campaigners have spent the past two decades fighting for compensation for victims.
In April, Labour announced it would look at the Skipton Fund, which compensates those who contracted Hepatitis C and the Haemophilia Society wants the Government to make the same commitment.
Mr Fielding said: “We had about 250 victims and their families down in London with us and six of us went to Downing Street with our MPs to deliver the letter and a wreath in memory of the 2,000 victims.
“It was important for us to do that and I will continue to fight, as I have done for the past 17 years.”
The 54-year-old, whose brother, Brian, died in 1990 at the age of 46 after being infected with HIV, also met up with Bolton South East MP Yasmin Qureshi, who Mr Fielding hopes will continue the fight taken up by her predecessor Dr Brian Iddon.
The brothers were among 4,500 people affected by the scandal in the 1970s and 1980s. About 2,000 have now died as a result.
Mr Fielding said: “A lot of people are dying. At one time we were losing one a week, now it is about one a month. It is important that people who are still alive are coping with this infection.
“This Government and the past Government have had the money to put this to bed and compensate us, but it has still not happened.
“I don’t want to go to my grave and this not have been sorted out. I have been fighting for 17 years now and I am getting tired, worn out and angry.
“We have to start all over again with the new MPs to educate them about what happened.”
Following the scandal, a public inquiry by Lord Archer recommended better compensation for all victims and a committee to advise on haemophilia.
Attempts to get a Contaminated Blood Bill through Parliament, to implement all the recommendations, have so far failed.
Source
July 3, 2010
Self-Management Program for Veterans with Hepatitis C Virus Improves Health
July 1, 2010
This study looked at the effects of being involved in a self-management program on the quality of life of Veterans with Hepatitis C virus (HCV). Self-management programs are more complete or thorough than traditional patient education, and they focus on teaching problem-solving skills and helping patients manage their illness. In this study, 132 VA patients with HCV infection were randomly assigned to either a 6-week self-management workshop or an information-only program between 5/07 and 11/08. Researchers then looked at what, if any, changes occurred in health-related quality of life, knowledge of HCV, the ability to manage one's health condition, depression, energy, and health distress at the beginning of the study and, again, six weeks later.
Findings show that when compared to the information-only group, Veterans who attended the self-management workshop knew more about their disease and were better able to manage their condition, and they had more energy and vitality. Increased energy and vitality is important because fatigue is the most commonly reported symptom of chronic HCV infection. The study researchers suggest that this intervention can improve the health of Veterans with HCV infection, independent of medication therapy.
Groessl E, Weingart K, Stepnowsky C, Gifford A, Asch S, and Ho S. The Hepatitis C Self-Management Program: A randomized controlled trial. Journal of Viral Hepatitis May 31, 2010;e-pub ahead of print.
This study was funded by HSR&D (IAC 05-067). Drs. Groessl, Weingart, and Stepnowsky are part of the VA San Diego Healthcare System. Drs. Gifford and Asch are part of VA/HSR&D's HIV/Hepatitis Quality Enhancement Research Initiative (QUERI).
Source
This study looked at the effects of being involved in a self-management program on the quality of life of Veterans with Hepatitis C virus (HCV). Self-management programs are more complete or thorough than traditional patient education, and they focus on teaching problem-solving skills and helping patients manage their illness. In this study, 132 VA patients with HCV infection were randomly assigned to either a 6-week self-management workshop or an information-only program between 5/07 and 11/08. Researchers then looked at what, if any, changes occurred in health-related quality of life, knowledge of HCV, the ability to manage one's health condition, depression, energy, and health distress at the beginning of the study and, again, six weeks later.
Findings show that when compared to the information-only group, Veterans who attended the self-management workshop knew more about their disease and were better able to manage their condition, and they had more energy and vitality. Increased energy and vitality is important because fatigue is the most commonly reported symptom of chronic HCV infection. The study researchers suggest that this intervention can improve the health of Veterans with HCV infection, independent of medication therapy.
Groessl E, Weingart K, Stepnowsky C, Gifford A, Asch S, and Ho S. The Hepatitis C Self-Management Program: A randomized controlled trial. Journal of Viral Hepatitis May 31, 2010;e-pub ahead of print.
This study was funded by HSR&D (IAC 05-067). Drs. Groessl, Weingart, and Stepnowsky are part of the VA San Diego Healthcare System. Drs. Gifford and Asch are part of VA/HSR&D's HIV/Hepatitis Quality Enhancement Research Initiative (QUERI).
Source
For Family and Friends: Caring for Someone with Hepatitis C
• Introduction
In a presentation to the American Association for the Study of Liver Diseases (AASLD), Brian Edlin from Cornell University’s Weill Medical College reported that 5 million people in the United States have chronic hepatitis C virus infection (HCV). HCV primarily affects the liver. Usually it takes a long time to do any damage, especially if the person who has it does not drink alcohol and lives a healthy lifestyle. Sometimes the damage is so minimal that people will go through their entire lives without knowing they have HCV. However, HCV may cause extensive damage to the liver and health of an individual. A small percentage of people will experience liver cancer, liver failure and death resulting from HCV.
Important note: Most people will die with HCV and not of HCV. Unfortunately, it is not known who will and who will not have serious disease progression. Also, the number of patients expected to have HCV-related cirrhosis will dramatically increase between 2010 and 2030. For this reason, everyone with hepatitis C needs to be regularly monitored by a medical provider.
HCV symptoms are vague because they are similar to many other medical conditions. Some people have little or no symptoms. The most commonly reported one is fatigue. Body aches, flu-like symptoms, depression, and abdominal discomfort are also symptoms of HCV. Some patients report difficulty concentrating or that their thinking feels cloudy. Although not an official medical term, many refer to this as “brain fog.”
You may have a loved one or friend who tested positive for the hepatitis C virus (HCV). Whether this person is asymptomatic or struggling with multiple HCV symptoms, their disease may affect you. Since HCV is not passed casually, it is unlikely that you will acquire HCV.
Caregivers are at high risk for health problems. According to the Family Caregiver Alliance, caregivers have a higher risk of mental and physical health problems than non-caregivers do. They experience depression, pain, loneliness, isolation, abandonment, loss, and grief. They experience fear – of the unknown, of death and of change. Caregivers may feel insecure about their ability to give adequate support. They may worry about the security of their future, the risk of acquiring HCV, or of being a single parent or sole financial provider. The likelihood of any of this happening is low. However, it is normal to feel and think about these possibilities.
Lucinda K. Porter, RN
Writer, Hepatitis C Support Project and HCV Advocate
Common Reactions of Caregivers
Guilt is a common feeling among caregivers. If you find yourself saying the word “should,” this is associated with guilt. Examples are “I should do more,” “be more understanding,” “be more loving.” Guilt helps no one. It robs us of our self-esteem. Try to let go of guilt.
Anger is another emotion reported by caregivers. The HCV patient may be getting sympathy and attention, while you are striving to keep your family afloat. You may feel resentful that no one notices how overworked and exhausted you are.
Many caregivers feel afraid. You may fear what the future holds for you and your loved one. You may wonder if you are going to be strong enough to handle the future.
Grief is common. Your life has changed. You may feel that your dreams are gone. Your loved one may be wrapped up in his or her illness and you may feel lonely because of this. You may need to mourn the loss of the person you once knew and the dreams you once held.
How to Cope
The best way you can help your loved one is to take care of yourself first. In the event of a pressure drop on an airplane, we are advised to put on our own oxygen mask first before assisting others. This concept applies to caregivers. If you put the needs of your loved one before your own, you serve no one.
• Make a commitment to your own health. Do not neglect your sleep, diet, exercise and other health-promoting habits. Get a flu shot and regular health care.
• Do not throw away inner peace by reacting to everything you hear. Get the facts first. That way, if you are going to be upset about something, at least it is about something accurate.
• Take time to process new information. You may hear “bad news” or be bombarded by data. This is not a good position from which to make decisions. Take a break. Give yourself time to digest new details.
• Accept your feelings and talk about them.
• Get support. Find out if there is a caregiver’s support group in your community.
• Every day, do something you enjoy.
• Maintain social contacts. Ask a friend out for coffee, a movie or a walk. Use the phone or email to stay in touch.
• Ask for help. You aren’t Superman or Superwoman. Be specific about the help you need.
• Take a break from care giving. See a friend, go for a walk, read, go to a movie, take a nap – anything that revitalizes you. It is all right to go away for a day, a weekend, or longer if this is what you need.
• Set limits for yourself. Remember the word “no” is a complete sentence.
• Focus on the positive.
• Find ways to laugh. Laughter can relieve all sorts of complaints and has no side effects.
Caregiver Stress Danger Signs
Caregiver stress must be taken seriously. If left unmanaged, caregiver stress can be life threatening. Some danger signs are:
• Uncontrollable anger or resentment
• Depression or suicidal thoughts
• Thoughts of harming another or physical abuse
• Misuse of alcohol or drugs
• Sleep problems
• Overeating or loss of appetite
• Physical complaints, such as headaches or stomach problems. Some of these may be serious and may affect your blood pressure or heart.
Protect Yourself from HCV Infection
HCV transmission between household members is rare. HCV is contagious, but mostly only through blood-to-blood contact. HCV is not transmitted by hugging, kissing, sneezing, coughing, sharing eating utensils or glasses, or by casual contact. Although the risks are low, it is recommended that family members be tested, especially children of women who may have had HCV at the same time they were pregnant.
In the August 2006 issue of Hepatology, Hwang and associates reported findings of a large study indicating no increased risk of HCV transmission based solely on history of body piercing, tattooing, or intranasal drug use. Although the risk of acquiring HCV is low, we recommend that you do not share razors, toothbrushes and other tools that may be exposed to blood. A common source of infection is through the sharing of contaminated injection drug utensils. If you use drugs with an HCV-positive person, learn how to do this safely.
Sexual Transmission
The risk of sexual transmission between monogamous heterosexual partners is low. The Centers for Disease Control (CDC) does not recommend any changes in sexual practices between monogamous, long-term partners. Sexual transmission rates increase with multiple sexual partners. It is important to get accurate information about sexual transmission of HCV.
Sex is a basic part of life. If your partner is HCV-positive and you have any concerns about transmission, talk to your partner about this. Honesty and openness are important. Be honest with yourself and your partner(s). If you are uncomfortable with the current sexual practices in your relationship, it is your right to express and change this. If you want to practice safer sex, it is your right to do so.
The HCV Patient during Treatment
The HCV patient in your life may be symptom-free or have symptoms of the disease. The decision to undergo treatment is a complicated one and not based solely on the presence of symptoms. Current HCV treatment uses a combination of medications. Peginterferon is an injection, usually given once weekly. Ribavirin is a pill, usually taken twice daily.
HCV medications may cause many side effects. Some common ones are fatigue, irritability, depression, anxiety, difficulty concentrating, insomnia, itching, rashes, stomach upsets, headaches, fevers, and body aches. Patients sometimes report decreased sex drive (libido) during treatment. The social and psychological side effects are usually harder to deal with than the physical ones, especially for family and friends of HCV patients. These side effects are temporary and they will reverse with time after HCV treatment is stopped.
Patients often “look good” during treatment. This can create problems, especially if the patient feels awful and assumes everyone around her can see this. Open communication is the best way to find out how your loved one feels. However, do not expect too much from the person undergoing HCV therapy, especially if he was not a good communicaton before treatment. Some patients do not want to talk about their experiences. Others want to talk about them a great deal. The two best things you can do for your loved one are to encourage him or her to join a support group and to take care of your own health.
Depression, Anxiety, Iritability and Mania
Psychiatric problems commonly occur during HCV treatment. Watching a loved one experience these may leave you feeling frightened and helpless. Encourage him or her to speak to a doctor. Appropriate diagnosis and treatment are essential. Treatment for depression may take anywhere from two to eight weeks to become fully effective. Encourage your friend or family member to stick with it until the medications start to work, or to talk to his or her doctor about alternatives if there seems to be no improvement. If there are any hepatitis C support groups available in your area, encourage your loved one to attend. You may offer to drive her to the group. If the group is open to everyone, perhaps volunteer to attend together. Respect the wishes of your loved one if he does not want you to attend.
Encourage the depressed person to go for a walk, go to the movies, or engage in other activities that previously gave pleasure. However, if the offer is refused, do not push it. It may be enough to just sit and listen to the radio or watch TV together. Some patients have difficulty reading during treatment, so perhaps listening to an audio book might interest you both.
People with hepatitis C are sometimes irritable during treatment. Try not to take this personally. Keep your expectations to a minimum. Do not expect a depressed HCV patient to “snap out of it” or to be able to turn his or her mood around through positive thinking. Medication-induced depression is influenced by physical factors, and all the willpower in the world won’t make it go away.
Important Note: Do not ignore remarks about suicide or hurting oneself or others. Report these immediately to the patient’s doctor or other professional. If a suicide attempt is imminent, call 911. If you feel the patient could physically harm you, get immediate help. Do not put yourself in harm’s way.
HCV affects many people besides patients. Educating yourself about the disease and the side effects of HCV therapy may help you understand some of the issues your loved one is confronting. Above all else, get support for yourself. Remember the advice given on airplanes – put your oxygen mask on first before assisting others.
Resources
• Hepatitis C Support Project http://www.hcvadvocate.org/
• Caring.com http://www.caring.com/
Source
In a presentation to the American Association for the Study of Liver Diseases (AASLD), Brian Edlin from Cornell University’s Weill Medical College reported that 5 million people in the United States have chronic hepatitis C virus infection (HCV). HCV primarily affects the liver. Usually it takes a long time to do any damage, especially if the person who has it does not drink alcohol and lives a healthy lifestyle. Sometimes the damage is so minimal that people will go through their entire lives without knowing they have HCV. However, HCV may cause extensive damage to the liver and health of an individual. A small percentage of people will experience liver cancer, liver failure and death resulting from HCV.
Important note: Most people will die with HCV and not of HCV. Unfortunately, it is not known who will and who will not have serious disease progression. Also, the number of patients expected to have HCV-related cirrhosis will dramatically increase between 2010 and 2030. For this reason, everyone with hepatitis C needs to be regularly monitored by a medical provider.
HCV symptoms are vague because they are similar to many other medical conditions. Some people have little or no symptoms. The most commonly reported one is fatigue. Body aches, flu-like symptoms, depression, and abdominal discomfort are also symptoms of HCV. Some patients report difficulty concentrating or that their thinking feels cloudy. Although not an official medical term, many refer to this as “brain fog.”
You may have a loved one or friend who tested positive for the hepatitis C virus (HCV). Whether this person is asymptomatic or struggling with multiple HCV symptoms, their disease may affect you. Since HCV is not passed casually, it is unlikely that you will acquire HCV.
Caregivers are at high risk for health problems. According to the Family Caregiver Alliance, caregivers have a higher risk of mental and physical health problems than non-caregivers do. They experience depression, pain, loneliness, isolation, abandonment, loss, and grief. They experience fear – of the unknown, of death and of change. Caregivers may feel insecure about their ability to give adequate support. They may worry about the security of their future, the risk of acquiring HCV, or of being a single parent or sole financial provider. The likelihood of any of this happening is low. However, it is normal to feel and think about these possibilities.
Lucinda K. Porter, RN
Writer, Hepatitis C Support Project and HCV Advocate
Common Reactions of Caregivers
Guilt is a common feeling among caregivers. If you find yourself saying the word “should,” this is associated with guilt. Examples are “I should do more,” “be more understanding,” “be more loving.” Guilt helps no one. It robs us of our self-esteem. Try to let go of guilt.
Anger is another emotion reported by caregivers. The HCV patient may be getting sympathy and attention, while you are striving to keep your family afloat. You may feel resentful that no one notices how overworked and exhausted you are.
Many caregivers feel afraid. You may fear what the future holds for you and your loved one. You may wonder if you are going to be strong enough to handle the future.
Grief is common. Your life has changed. You may feel that your dreams are gone. Your loved one may be wrapped up in his or her illness and you may feel lonely because of this. You may need to mourn the loss of the person you once knew and the dreams you once held.
How to Cope
The best way you can help your loved one is to take care of yourself first. In the event of a pressure drop on an airplane, we are advised to put on our own oxygen mask first before assisting others. This concept applies to caregivers. If you put the needs of your loved one before your own, you serve no one.
• Make a commitment to your own health. Do not neglect your sleep, diet, exercise and other health-promoting habits. Get a flu shot and regular health care.
• Do not throw away inner peace by reacting to everything you hear. Get the facts first. That way, if you are going to be upset about something, at least it is about something accurate.
• Take time to process new information. You may hear “bad news” or be bombarded by data. This is not a good position from which to make decisions. Take a break. Give yourself time to digest new details.
• Accept your feelings and talk about them.
• Get support. Find out if there is a caregiver’s support group in your community.
• Every day, do something you enjoy.
• Maintain social contacts. Ask a friend out for coffee, a movie or a walk. Use the phone or email to stay in touch.
• Ask for help. You aren’t Superman or Superwoman. Be specific about the help you need.
• Take a break from care giving. See a friend, go for a walk, read, go to a movie, take a nap – anything that revitalizes you. It is all right to go away for a day, a weekend, or longer if this is what you need.
• Set limits for yourself. Remember the word “no” is a complete sentence.
• Focus on the positive.
• Find ways to laugh. Laughter can relieve all sorts of complaints and has no side effects.
Caregiver Stress Danger Signs
Caregiver stress must be taken seriously. If left unmanaged, caregiver stress can be life threatening. Some danger signs are:
• Uncontrollable anger or resentment
• Depression or suicidal thoughts
• Thoughts of harming another or physical abuse
• Misuse of alcohol or drugs
• Sleep problems
• Overeating or loss of appetite
• Physical complaints, such as headaches or stomach problems. Some of these may be serious and may affect your blood pressure or heart.
Protect Yourself from HCV Infection
HCV transmission between household members is rare. HCV is contagious, but mostly only through blood-to-blood contact. HCV is not transmitted by hugging, kissing, sneezing, coughing, sharing eating utensils or glasses, or by casual contact. Although the risks are low, it is recommended that family members be tested, especially children of women who may have had HCV at the same time they were pregnant.
In the August 2006 issue of Hepatology, Hwang and associates reported findings of a large study indicating no increased risk of HCV transmission based solely on history of body piercing, tattooing, or intranasal drug use. Although the risk of acquiring HCV is low, we recommend that you do not share razors, toothbrushes and other tools that may be exposed to blood. A common source of infection is through the sharing of contaminated injection drug utensils. If you use drugs with an HCV-positive person, learn how to do this safely.
Sexual Transmission
The risk of sexual transmission between monogamous heterosexual partners is low. The Centers for Disease Control (CDC) does not recommend any changes in sexual practices between monogamous, long-term partners. Sexual transmission rates increase with multiple sexual partners. It is important to get accurate information about sexual transmission of HCV.
Sex is a basic part of life. If your partner is HCV-positive and you have any concerns about transmission, talk to your partner about this. Honesty and openness are important. Be honest with yourself and your partner(s). If you are uncomfortable with the current sexual practices in your relationship, it is your right to express and change this. If you want to practice safer sex, it is your right to do so.
The HCV Patient during Treatment
The HCV patient in your life may be symptom-free or have symptoms of the disease. The decision to undergo treatment is a complicated one and not based solely on the presence of symptoms. Current HCV treatment uses a combination of medications. Peginterferon is an injection, usually given once weekly. Ribavirin is a pill, usually taken twice daily.
HCV medications may cause many side effects. Some common ones are fatigue, irritability, depression, anxiety, difficulty concentrating, insomnia, itching, rashes, stomach upsets, headaches, fevers, and body aches. Patients sometimes report decreased sex drive (libido) during treatment. The social and psychological side effects are usually harder to deal with than the physical ones, especially for family and friends of HCV patients. These side effects are temporary and they will reverse with time after HCV treatment is stopped.
Patients often “look good” during treatment. This can create problems, especially if the patient feels awful and assumes everyone around her can see this. Open communication is the best way to find out how your loved one feels. However, do not expect too much from the person undergoing HCV therapy, especially if he was not a good communicaton before treatment. Some patients do not want to talk about their experiences. Others want to talk about them a great deal. The two best things you can do for your loved one are to encourage him or her to join a support group and to take care of your own health.
Depression, Anxiety, Iritability and Mania
Psychiatric problems commonly occur during HCV treatment. Watching a loved one experience these may leave you feeling frightened and helpless. Encourage him or her to speak to a doctor. Appropriate diagnosis and treatment are essential. Treatment for depression may take anywhere from two to eight weeks to become fully effective. Encourage your friend or family member to stick with it until the medications start to work, or to talk to his or her doctor about alternatives if there seems to be no improvement. If there are any hepatitis C support groups available in your area, encourage your loved one to attend. You may offer to drive her to the group. If the group is open to everyone, perhaps volunteer to attend together. Respect the wishes of your loved one if he does not want you to attend.
Encourage the depressed person to go for a walk, go to the movies, or engage in other activities that previously gave pleasure. However, if the offer is refused, do not push it. It may be enough to just sit and listen to the radio or watch TV together. Some patients have difficulty reading during treatment, so perhaps listening to an audio book might interest you both.
People with hepatitis C are sometimes irritable during treatment. Try not to take this personally. Keep your expectations to a minimum. Do not expect a depressed HCV patient to “snap out of it” or to be able to turn his or her mood around through positive thinking. Medication-induced depression is influenced by physical factors, and all the willpower in the world won’t make it go away.
Important Note: Do not ignore remarks about suicide or hurting oneself or others. Report these immediately to the patient’s doctor or other professional. If a suicide attempt is imminent, call 911. If you feel the patient could physically harm you, get immediate help. Do not put yourself in harm’s way.
HCV affects many people besides patients. Educating yourself about the disease and the side effects of HCV therapy may help you understand some of the issues your loved one is confronting. Above all else, get support for yourself. Remember the advice given on airplanes – put your oxygen mask on first before assisting others.
Resources
• Hepatitis C Support Project http://www.hcvadvocate.org/
• Caring.com http://www.caring.com/
Source
Harold Amos Scholar Finds Many HCV-Infected Children Don’t Receive Treatment
Publication Date: Jun 21, 2010
If at first you don’t succeed, try, try again.
Physician scientist Aymin Delgado-Borrego re-learned this fundamental lesson while researching the Hepatitis C virus (HCV).
Four years ago, Delgado-Borrego, M.D., M.P.H., moved to Miami to begin research into insulin resistance in adults and children, a project that was funded by the Harold Amos Medical Faculty Development Program. Supported by the Robert Wood Johnson Foundation (RWJF), the Harold Amos Program aims to enhance the diversity of faculty at the nation’s medical schools. Delgado-Borrego became a Harold Amos Program scholar in 2006 and will complete the program in 2011.
Based on national survey data, Delgado-Borrego expected to find hundreds of children in the city and the surrounding areas who were infected with Hepatitis C. But, to her surprise, she could only identify a handful of HCV-infected children at local health clinics.
The lack of HCV-infected children was so puzzling that she decided to look into the matter further. While continuing her research into insulin resistance, she also began a search for the children infected with HCV who she had expected to find at local clinics.
Delgado-Borrego conducted a detailed review of the health data for all of Miami-Dade County and sent an online survey to all licensed pediatric gastroenterologists in the county inquiring about the number of pediatric HCV-infected patients. She then broadened her investigation to the state level.
What she found shocked her.
Of the 12,155 children estimated to have HCV in Florida, only 1,755—or 14.4 percent—had been identified. What’s more, only 1.2 percent of the estimated number of infected children were actually receiving medical care.
Delgado-Borrego says the proportion of children with HCV infection that have been identified is even lower in most other states. Florida, she notes, does a better job than most other states of keeping track of communicable diseases.
“There is a frightening lack of awareness among both the public and clinicians about Hepatitis C virus infection in pediatric patients,” she says.
Delgado-Borrego Asked to Present Findings at Conference of Physician Scientists
Her findings have since become the basis of a new study about the lack of awareness of HCV-infected children. Delgado-Borrego was one of four researchers—selected from a group of more than 5,000 physician scientists—who were asked to present their findings in a special telebriefing in advance of Digestive Disease Week, the world’s largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The conference was held in New Orleans.
The news garnered nationwide media coverage in publications ranging from regional newspapers and health trade publications to U.S. News & World Report and the Discovery Channel online. It also sparked a discussion among health authorities about steps that can be taken to identify more HCV-infected children.
“We have identified a significant problem that needed attention,” she says. “Hopefully that means we can focus our energy on identifying barriers that are preventing children from being identified and treated for HCV infection and then do something about it.”
Early identification and treatment of HCV could save countless lives, she says.
HCV infection, she said, is like a time bomb: There are often no discernable symptoms until the very late stages of the disease. At that point, patients may begin to experience enlarged abdomens, profuse bleeding and bruising. But when patients are diagnosed at this late stage, the virus is often too advanced to treat. Patients who cannot get a liver transplant are faced with death.
Early treatment, however, can prevent liver failure, liver cancer and death, especially among children, she says.
More than half of the children who are currently infected with the virus could be cured, Delgado-Borrego says. Advances in antiviral therapy could boost that rate and save even more lives in the future, she notes. Treatment and prevention programs could also ease the social and financial burdens of the disease and prevent its spread.
Children are excellent candidates for medical treatment because most have had the disease for a shorter period of time than adults, they are less likely to have co-existing conditions that could complicate treatment, and they are less likely to have extensive liver damage. Early identification and treatment would have a disproportionate benefit for Blacks and Latinos, who are more likely than other groups to carry the virus.
The good news is that the solutions to the problem are simple, Delgado-Borrego says.
To start, physicians should screen all children born to women who are infected with the virus, Delgado-Borrego says. Physicians should also screen all pregnant women at risk for the infection, because children are most likely to acquire the infection in the womb. Physicians should also screen teenagers who use drugs or other illegal substances.
“If we started with these simple steps, we would be much better off,” she says.
Source
If at first you don’t succeed, try, try again.
Physician scientist Aymin Delgado-Borrego re-learned this fundamental lesson while researching the Hepatitis C virus (HCV).
Four years ago, Delgado-Borrego, M.D., M.P.H., moved to Miami to begin research into insulin resistance in adults and children, a project that was funded by the Harold Amos Medical Faculty Development Program. Supported by the Robert Wood Johnson Foundation (RWJF), the Harold Amos Program aims to enhance the diversity of faculty at the nation’s medical schools. Delgado-Borrego became a Harold Amos Program scholar in 2006 and will complete the program in 2011.
Based on national survey data, Delgado-Borrego expected to find hundreds of children in the city and the surrounding areas who were infected with Hepatitis C. But, to her surprise, she could only identify a handful of HCV-infected children at local health clinics.
The lack of HCV-infected children was so puzzling that she decided to look into the matter further. While continuing her research into insulin resistance, she also began a search for the children infected with HCV who she had expected to find at local clinics.
Delgado-Borrego conducted a detailed review of the health data for all of Miami-Dade County and sent an online survey to all licensed pediatric gastroenterologists in the county inquiring about the number of pediatric HCV-infected patients. She then broadened her investigation to the state level.
What she found shocked her.
Of the 12,155 children estimated to have HCV in Florida, only 1,755—or 14.4 percent—had been identified. What’s more, only 1.2 percent of the estimated number of infected children were actually receiving medical care.
Delgado-Borrego says the proportion of children with HCV infection that have been identified is even lower in most other states. Florida, she notes, does a better job than most other states of keeping track of communicable diseases.
“There is a frightening lack of awareness among both the public and clinicians about Hepatitis C virus infection in pediatric patients,” she says.
Delgado-Borrego Asked to Present Findings at Conference of Physician Scientists
Her findings have since become the basis of a new study about the lack of awareness of HCV-infected children. Delgado-Borrego was one of four researchers—selected from a group of more than 5,000 physician scientists—who were asked to present their findings in a special telebriefing in advance of Digestive Disease Week, the world’s largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The conference was held in New Orleans.
The news garnered nationwide media coverage in publications ranging from regional newspapers and health trade publications to U.S. News & World Report and the Discovery Channel online. It also sparked a discussion among health authorities about steps that can be taken to identify more HCV-infected children.
“We have identified a significant problem that needed attention,” she says. “Hopefully that means we can focus our energy on identifying barriers that are preventing children from being identified and treated for HCV infection and then do something about it.”
Early identification and treatment of HCV could save countless lives, she says.
HCV infection, she said, is like a time bomb: There are often no discernable symptoms until the very late stages of the disease. At that point, patients may begin to experience enlarged abdomens, profuse bleeding and bruising. But when patients are diagnosed at this late stage, the virus is often too advanced to treat. Patients who cannot get a liver transplant are faced with death.
Early treatment, however, can prevent liver failure, liver cancer and death, especially among children, she says.
More than half of the children who are currently infected with the virus could be cured, Delgado-Borrego says. Advances in antiviral therapy could boost that rate and save even more lives in the future, she notes. Treatment and prevention programs could also ease the social and financial burdens of the disease and prevent its spread.
Children are excellent candidates for medical treatment because most have had the disease for a shorter period of time than adults, they are less likely to have co-existing conditions that could complicate treatment, and they are less likely to have extensive liver damage. Early identification and treatment would have a disproportionate benefit for Blacks and Latinos, who are more likely than other groups to carry the virus.
The good news is that the solutions to the problem are simple, Delgado-Borrego says.
To start, physicians should screen all children born to women who are infected with the virus, Delgado-Borrego says. Physicians should also screen all pregnant women at risk for the infection, because children are most likely to acquire the infection in the womb. Physicians should also screen teenagers who use drugs or other illegal substances.
“If we started with these simple steps, we would be much better off,” she says.
Source
Hepatitis C Virus Infections from Unsafe Injection Practices at an Endoscopy Clinic in Las Vegas, Nevada, 2007–2008
Clinical Infectious Diseases 2010;51:267–273
© 2010 by the Infectious Diseases Society of America.
All rights reserved.
1058-4838/2010/5103-0003$15.00
DOI: 10.1086/653937
Gayle E. Fischer, Melissa K. Schaefer, Brian J. Labus, Lawrence Sands, Patricia Rowley, Ihsan A. Azzam, Patricia Armour, Yury E. Khudyakov, Yulin Lin, Guoliang Xia, Priti R. Patel, Joseph F. Perz, and Scott D. Holmberg
Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, and Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and Southern Nevada Health District and Southern Nevada Public Health Laboratory, Las Vegas, and Nevada State Health Division, Carson City
Background. In January 2008, 3 persons with acute hepatitis C who all underwent endoscopy at a single facility in Nevada were identified.
Method. We reviewed clinical and laboratory data from initially detected cases of acute hepatitis C and reviewed infection control practices at the clinic where case patients underwent endoscopy. Persons who underwent procedures on days when the case patients underwent endoscopy were tested for hepatitis C virus (HCV) infection and other bloodborne pathogens. Quasispecies analysis determined the relatedness of HCV in persons infected.
Results. In addition to the 3 initial cases, 5 additional cases of clinic‐acquired HCV infection were identified from 2 procedure dates included in this initial field investigation. Quasispecies analysis revealed 2 distinct clusters of clinic‐acquired HCV infections and a source patient related to each cluster, suggesting separate transmission events. Of 49 HCV‐susceptible persons whose procedures followed that of the source patient on 25 July 2007, 1 (2%) was HCV infected. Among 38 HCV‐susceptible persons whose procedures followed that of another source patient on 21 September 2007, 7 (18%) were HCV infected. Reuse of syringes on single patients in conjunction with use of single‐use propofol vials for multiple patients was observed during normal clinic operations.
Conclusions. Patient–to‐patient transmission of HCV likely resulted from contamination of single‐use medication vials that were used for multiple patients during anesthesia administration. The resulting public health notification of 50,000 persons was the largest of its kind in United States health care. This investigation highlighted breaches in aseptic technique, deficiencies in oversight of outpatient settings, and difficulties in detecting and investigating such outbreaks.
Received 17 December 2009; accepted 31 March 2010; electronically published 24 June 2010.
Reprints or correspondence: Dr Gayle E. Fischer, Div of Viral Diseases, Mailstop A34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333 (fez7@cdc.gov).
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
http://www.journals.uchicago.edu/doi/abs/10.1086/653937
© 2010 by the Infectious Diseases Society of America.
All rights reserved.
1058-4838/2010/5103-0003$15.00
DOI: 10.1086/653937
Gayle E. Fischer, Melissa K. Schaefer, Brian J. Labus, Lawrence Sands, Patricia Rowley, Ihsan A. Azzam, Patricia Armour, Yury E. Khudyakov, Yulin Lin, Guoliang Xia, Priti R. Patel, Joseph F. Perz, and Scott D. Holmberg
Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, and Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and Southern Nevada Health District and Southern Nevada Public Health Laboratory, Las Vegas, and Nevada State Health Division, Carson City
Background. In January 2008, 3 persons with acute hepatitis C who all underwent endoscopy at a single facility in Nevada were identified.
Method. We reviewed clinical and laboratory data from initially detected cases of acute hepatitis C and reviewed infection control practices at the clinic where case patients underwent endoscopy. Persons who underwent procedures on days when the case patients underwent endoscopy were tested for hepatitis C virus (HCV) infection and other bloodborne pathogens. Quasispecies analysis determined the relatedness of HCV in persons infected.
Results. In addition to the 3 initial cases, 5 additional cases of clinic‐acquired HCV infection were identified from 2 procedure dates included in this initial field investigation. Quasispecies analysis revealed 2 distinct clusters of clinic‐acquired HCV infections and a source patient related to each cluster, suggesting separate transmission events. Of 49 HCV‐susceptible persons whose procedures followed that of the source patient on 25 July 2007, 1 (2%) was HCV infected. Among 38 HCV‐susceptible persons whose procedures followed that of another source patient on 21 September 2007, 7 (18%) were HCV infected. Reuse of syringes on single patients in conjunction with use of single‐use propofol vials for multiple patients was observed during normal clinic operations.
Conclusions. Patient–to‐patient transmission of HCV likely resulted from contamination of single‐use medication vials that were used for multiple patients during anesthesia administration. The resulting public health notification of 50,000 persons was the largest of its kind in United States health care. This investigation highlighted breaches in aseptic technique, deficiencies in oversight of outpatient settings, and difficulties in detecting and investigating such outbreaks.
Received 17 December 2009; accepted 31 March 2010; electronically published 24 June 2010.
Reprints or correspondence: Dr Gayle E. Fischer, Div of Viral Diseases, Mailstop A34, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30333 (fez7@cdc.gov).
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
http://www.journals.uchicago.edu/doi/abs/10.1086/653937
Hepatitis C virus enters human peripheral neuroblastoma cells – evidence for extra-hepatic cells sustaining hepatitis C virus penetration
Journal of Viral Hepatitis
B. Bürgel , M. Friesland 1 , A. Koch , M. P. Manns , H. Wedemeyer , K. Weissenborn , W. J. Schulz-Schaeffer , T. Pietschmann 1 , E. Steinmann and S. Ciesek
Division of Experimental Virology, TWINCORE, Centre for Experimental and Clinical Infection Research; a joint venture between the Medical School Hannover (MHH) and the Helmholtz Centre for Infection Research (HZI), Hannover, Germany ; Department of Neuropathology, Charité– Universitätsmedizin Berlin, Berlin, Germany ; Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany ; Department of Neurology, Hannover Medical School, Hannover, Germany ; and Department of Neuropathology, Prion and Dementia Research Unit, University Medical Center, Göttingen, Germany
Correspondence to Dr. rer. nat. Thomas Pietschmann, Division of Experimental Virology, Twincore Center for Experimental and Clinical Infection Research, Feodor-Lynen-Straße 7-9, 30625 Hannover, Germany. E-mail: thomas.pietschmann@twincore.de
*These authors contributed equally to this work.
Copyright © 2010 Blackwell Publishing Ltd
KEYWORDS
extrahepatic reservoir • HCV • hepatitis C Virus • neuroblastoma • SKNMC
ABSTRACT
Summary. Patients with chronic hepatitis C virus (HCV) infection show an increased incidence of nervous system disorders such as chronic fatigue syndrome, depression and cognitive dysfunction. It is unclear whether this is because of HCV replication in the brain and in peripheral neuronal cells or to more indirect effects of HCV infection on the central or peripheral nervous system. The aim of this study was to investigate whether cells originating from these tissues are permissive for HCV cell entry, RNA replication and virus assembly. Among eight cell lines analysed, the human peripheral neuroblastoma cell line SKNMC expressed all HCV entry factors and was efficiently infected with HCV pseudoparticles (HCVpp) independent of the HCV genotype. All remaining cell types including human neuroblastoma and glioblastoma cell lines and microglial cells lacked expression of at least one host factor essential for HCV entry. When transfected with HCV luciferase reporter virus RNA, inoculated with HCV reporter viruses or challenged with high-titre cell culture–derived HCV, none of these cells supported detectable HCV RNA replication. Thus, in conclusion, this comprehensive screening did not reveal evidence directly strengthening the notion that HCV enters and replicates in the central nervous system. However, productive viral entry into the peripheral neuroblastoma cell line SKNMC indicates that HCV may penetrate into certain nonhepatic cell types which may serve as viral reservoirs and could modulate viral pathogenesis.
Received February 2010; accepted for publication March 2010
DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1365-2893.2010.01339.x About DOI
B. Bürgel , M. Friesland 1 , A. Koch , M. P. Manns , H. Wedemeyer , K. Weissenborn , W. J. Schulz-Schaeffer , T. Pietschmann 1 , E. Steinmann and S. Ciesek
Division of Experimental Virology, TWINCORE, Centre for Experimental and Clinical Infection Research; a joint venture between the Medical School Hannover (MHH) and the Helmholtz Centre for Infection Research (HZI), Hannover, Germany ; Department of Neuropathology, Charité– Universitätsmedizin Berlin, Berlin, Germany ; Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany ; Department of Neurology, Hannover Medical School, Hannover, Germany ; and Department of Neuropathology, Prion and Dementia Research Unit, University Medical Center, Göttingen, Germany
Correspondence to Dr. rer. nat. Thomas Pietschmann, Division of Experimental Virology, Twincore Center for Experimental and Clinical Infection Research, Feodor-Lynen-Straße 7-9, 30625 Hannover, Germany. E-mail: thomas.pietschmann@twincore.de
*These authors contributed equally to this work.
Copyright © 2010 Blackwell Publishing Ltd
KEYWORDS
extrahepatic reservoir • HCV • hepatitis C Virus • neuroblastoma • SKNMC
ABSTRACT
Summary. Patients with chronic hepatitis C virus (HCV) infection show an increased incidence of nervous system disorders such as chronic fatigue syndrome, depression and cognitive dysfunction. It is unclear whether this is because of HCV replication in the brain and in peripheral neuronal cells or to more indirect effects of HCV infection on the central or peripheral nervous system. The aim of this study was to investigate whether cells originating from these tissues are permissive for HCV cell entry, RNA replication and virus assembly. Among eight cell lines analysed, the human peripheral neuroblastoma cell line SKNMC expressed all HCV entry factors and was efficiently infected with HCV pseudoparticles (HCVpp) independent of the HCV genotype. All remaining cell types including human neuroblastoma and glioblastoma cell lines and microglial cells lacked expression of at least one host factor essential for HCV entry. When transfected with HCV luciferase reporter virus RNA, inoculated with HCV reporter viruses or challenged with high-titre cell culture–derived HCV, none of these cells supported detectable HCV RNA replication. Thus, in conclusion, this comprehensive screening did not reveal evidence directly strengthening the notion that HCV enters and replicates in the central nervous system. However, productive viral entry into the peripheral neuroblastoma cell line SKNMC indicates that HCV may penetrate into certain nonhepatic cell types which may serve as viral reservoirs and could modulate viral pathogenesis.
Received February 2010; accepted for publication March 2010
DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1365-2893.2010.01339.x About DOI
Patient preferences and assessment of likely adherence to hepatitis C virus treatment.
J Viral Hepat. 2010 Jun 22. [Epub ahead of print]
Brett Hauber A, Mohamed AF, Beam C, Medjedovic J, Mauskopf J.
RTI International, RTP, NC.
Abstract
Summary. To estimate patient preferences for attributes of hepatitis C virus (HCV) treatment and patients' assessment of the likely effect of treatment attributes on treatment adherence, HCV patients >/=18 years old completed an online survey that included nine 2-alternative choice questions. Each choice question was defined by the probability of sustained viral response (Efficacy), injection frequency (Frequency), duration of flu-like symptoms after every injection (Flu), injection device (Device), average number of days of work missed each week (Lost Work Days), probability of reversible hair thinning while on treatment (Alopecia) and probability of developing clinical depression while on treatment (Depression). We estimated a mean relative importance weight for each attribute. Patients also answered three rating questions to assess the extent to which treatment attributes might affect adherence. Hundred and fifty patients completed the survey. Efficacy was the most important attribute with a mean relative importance weight of 10 [95% CI: 7.9-12.1]. The remaining attributes were ranked in order of importance as follows: Depression (4.4 [95% CI: 3.6-5.1]), Flu Days (Frequency x Flu) (3.7 [95% CI: 2.2-5.3]), Lost Work Days (2.9 [95% CI: 2.3-3.5]), Alopecia (1.3 [95% CI: 0.7-1.9]) and Device (1.2 [95% CI: 0.4-2.0]). Patients with prior treatment experience were less likely to indicate that treatment attributes would affect adherence. Patients also indicated that increases in the number of flu days would increase the likelihood of nonadherence to treatment. Sustained viral response is the most important treatment attribute to patients but treatment side effects might affect treatment adherence.
PMID: 20579276 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20579276
Brett Hauber A, Mohamed AF, Beam C, Medjedovic J, Mauskopf J.
RTI International, RTP, NC.
Abstract
Summary. To estimate patient preferences for attributes of hepatitis C virus (HCV) treatment and patients' assessment of the likely effect of treatment attributes on treatment adherence, HCV patients >/=18 years old completed an online survey that included nine 2-alternative choice questions. Each choice question was defined by the probability of sustained viral response (Efficacy), injection frequency (Frequency), duration of flu-like symptoms after every injection (Flu), injection device (Device), average number of days of work missed each week (Lost Work Days), probability of reversible hair thinning while on treatment (Alopecia) and probability of developing clinical depression while on treatment (Depression). We estimated a mean relative importance weight for each attribute. Patients also answered three rating questions to assess the extent to which treatment attributes might affect adherence. Hundred and fifty patients completed the survey. Efficacy was the most important attribute with a mean relative importance weight of 10 [95% CI: 7.9-12.1]. The remaining attributes were ranked in order of importance as follows: Depression (4.4 [95% CI: 3.6-5.1]), Flu Days (Frequency x Flu) (3.7 [95% CI: 2.2-5.3]), Lost Work Days (2.9 [95% CI: 2.3-3.5]), Alopecia (1.3 [95% CI: 0.7-1.9]) and Device (1.2 [95% CI: 0.4-2.0]). Patients with prior treatment experience were less likely to indicate that treatment attributes would affect adherence. Patients also indicated that increases in the number of flu days would increase the likelihood of nonadherence to treatment. Sustained viral response is the most important treatment attribute to patients but treatment side effects might affect treatment adherence.
PMID: 20579276 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20579276
July 2, 2010
NewYork-Presbyterian Performs Lifesaving Liver Transplant On Premature Infant
30 Jun 2010
A 5-month-old New York infant received a lifesaving liver transplant for advanced liver failure diagnosed following her birth 10 weeks premature. One of the smallest babies ever to successfully receive a liver transplant, she weighed 4 pounds at the time of the surgery.
The surgery was performed in February and was led by Dr. Tomoaki Kato, surgical director of liver and intestine transplant programs at NewYork-Presbyterian Hospital/Columbia University Medical Center, and chief of abdominal organ transplantation and professor of surgery at Columbia University College of Physicians and Surgeons.
"Performing a transplant in a premature infant this size is a major challenge where any technical issue would have been fatal, but it was the only option," says Dr. Kato. "Most babies born with her condition would not have the chance to grow up. This surgery shows that transplantation is possible -- although only at an academic medical center with appropriate resources and only with focused teamwork and dedication."
In the weeks after being born on Dec. 3, the patient was referred to NewYork-Presbyterian/Morgan Stanley Children's Hospital where she was diagnosed with an irreversible liver injury of unknown origin. Cared for in the neonatal intensive care unit, she was on a ventilator and had dangerous fluid buildup in her abdomen and difficulty feeding. After being on the organ waitlist for two weeks, a replacement liver became available in Florida.
"The donor organ wasn't a matching blood type and it was substantially larger than her diseased organ, but it was critical that we proceed. To accommodate its size we created an artificial abdominal wall using a Gore-Tex mesh," explains Dr. Kato. "Unlike other organs, the liver has the unique ability to adapt itself to the patient's body. In this case the organ is making itself smaller. As she grows, her new liver will grow with her."
In the weeks following the surgery, the patient started recognizing her mother and responding to her by smiling. The child has also gained the ability to get nutrition through a feeding tube rather than intravenously. Her liver function normalized, and soon after the Gore-Tex mesh was removed and her abdomen closed.
Her medical care has been overseen by Dr. Steven Lobritto, medical director of pediatric liver transplantation at NewYork-Presbyterian/Morgan Stanley Children's Hospital and associate clinical professor of pediatrics and medicine at Columbia University College of Physicians and Surgeons.
"While she is on immunosuppressant medication and received a blood-type mismatched organ, rejection is usually not a major issue in babies, whose bodies can more easily accept an organ than someone who is full grown," says Dr. Lobritto.
Collaboration With the Neonatal Intensive Care Unit
According to Drs. Kato and Lobritto, the success of this transplant was a direct result of a novel transplant collaboration with the neonatal intensive care unit.
The patient's tiny size and medical issues related to prematurity meant that she may not have received optimal treatment in the pediatric intensive care unit, where childhood transplant patients are normally treated. "Accommodating the patient in a NICU setting required thorough on-the-spot training for clinicians and caregivers at every level," says Dr. Lobritto.
Dr. Ulana Sanocka, the neonatologist in charge of caring for this transplanted child at NewYork-Presbyterian/Morgan Stanley Children's Hospital and an associate clinical professor of pediatrics at Columbia University College of Physicians and Surgeons, says: "It was a very rewarding collaborative experience. Everyone worked around the clock to ensure she received the best care possible."
Special Note to the Media: NewYork-Presbyterian physicians and surgeons are available for interviews about the surgical procedure. At the parents' request, the patient is not available for media interviews.
Organ Transplantation at NewYork-Presbyterian Hospital
The organ transplantation program at NewYork-Presbyterian Hospital -- which includes NewYork-Presbyterian Hospital/Weill Cornell, NewYork-Presbyterian Hospital/Columbia and The Rogosin Institute -- is the most active program of its kind in the nation, offering comprehensive and personalized care for the heart, liver, pancreas, kidney and lung. With outcomes ranked among the nation's best, the Hospital is dedicated to improving quality of life for its patients. NewYork-Presbyterian's dedicated teams of surgeons and physicians are responsible for many significant advances made over the past several decades in transplant surgery and the maintenance of healthy organs. The Hospital has been on the forefront of developing and improving anti-rejection medications (immunosuppressants), minimally invasive surgery for living donors, genetic methods to detect transplant rejection, strategies to increase opportunities for donor matching, islet cell transplantation, and the FDA-approved Left Ventricle Assist Device (LVAD) that functions as a bridge to transplantation for those waiting for a new heart.
NewYork-Presbyterian/Morgan Stanley Children's Hospital
NewYork-Presbyterian/Morgan Stanley Children's Hospital, located in New York City, offers the best available care in every area of pediatrics -- including the most complex neonatal and critical care, and all areas of pediatric subspecialties -- in a family-friendly and technologically advanced setting. Building a reputation for more than a century as one of the nation's premier children's hospitals, Morgan Stanley Children's Hospital is affiliated with the Department of Pediatrics at Columbia University College of Physicians and Surgeons, and is Manhattan's only hospital dedicated solely to the care of children and one of the largest providers of children's health services in the tri-state area with a long-standing commitment to its community. It is also a major international referral center, meeting the special needs of children from infancy through adolescence worldwide. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report.
Source: NewYork-Presbyterian Hospital
Article URL: http://www.medicalnewstoday.com/articles/193333.php
A 5-month-old New York infant received a lifesaving liver transplant for advanced liver failure diagnosed following her birth 10 weeks premature. One of the smallest babies ever to successfully receive a liver transplant, she weighed 4 pounds at the time of the surgery.
The surgery was performed in February and was led by Dr. Tomoaki Kato, surgical director of liver and intestine transplant programs at NewYork-Presbyterian Hospital/Columbia University Medical Center, and chief of abdominal organ transplantation and professor of surgery at Columbia University College of Physicians and Surgeons.
"Performing a transplant in a premature infant this size is a major challenge where any technical issue would have been fatal, but it was the only option," says Dr. Kato. "Most babies born with her condition would not have the chance to grow up. This surgery shows that transplantation is possible -- although only at an academic medical center with appropriate resources and only with focused teamwork and dedication."
In the weeks after being born on Dec. 3, the patient was referred to NewYork-Presbyterian/Morgan Stanley Children's Hospital where she was diagnosed with an irreversible liver injury of unknown origin. Cared for in the neonatal intensive care unit, she was on a ventilator and had dangerous fluid buildup in her abdomen and difficulty feeding. After being on the organ waitlist for two weeks, a replacement liver became available in Florida.
"The donor organ wasn't a matching blood type and it was substantially larger than her diseased organ, but it was critical that we proceed. To accommodate its size we created an artificial abdominal wall using a Gore-Tex mesh," explains Dr. Kato. "Unlike other organs, the liver has the unique ability to adapt itself to the patient's body. In this case the organ is making itself smaller. As she grows, her new liver will grow with her."
In the weeks following the surgery, the patient started recognizing her mother and responding to her by smiling. The child has also gained the ability to get nutrition through a feeding tube rather than intravenously. Her liver function normalized, and soon after the Gore-Tex mesh was removed and her abdomen closed.
Her medical care has been overseen by Dr. Steven Lobritto, medical director of pediatric liver transplantation at NewYork-Presbyterian/Morgan Stanley Children's Hospital and associate clinical professor of pediatrics and medicine at Columbia University College of Physicians and Surgeons.
"While she is on immunosuppressant medication and received a blood-type mismatched organ, rejection is usually not a major issue in babies, whose bodies can more easily accept an organ than someone who is full grown," says Dr. Lobritto.
Collaboration With the Neonatal Intensive Care Unit
According to Drs. Kato and Lobritto, the success of this transplant was a direct result of a novel transplant collaboration with the neonatal intensive care unit.
The patient's tiny size and medical issues related to prematurity meant that she may not have received optimal treatment in the pediatric intensive care unit, where childhood transplant patients are normally treated. "Accommodating the patient in a NICU setting required thorough on-the-spot training for clinicians and caregivers at every level," says Dr. Lobritto.
Dr. Ulana Sanocka, the neonatologist in charge of caring for this transplanted child at NewYork-Presbyterian/Morgan Stanley Children's Hospital and an associate clinical professor of pediatrics at Columbia University College of Physicians and Surgeons, says: "It was a very rewarding collaborative experience. Everyone worked around the clock to ensure she received the best care possible."
Special Note to the Media: NewYork-Presbyterian physicians and surgeons are available for interviews about the surgical procedure. At the parents' request, the patient is not available for media interviews.
Organ Transplantation at NewYork-Presbyterian Hospital
The organ transplantation program at NewYork-Presbyterian Hospital -- which includes NewYork-Presbyterian Hospital/Weill Cornell, NewYork-Presbyterian Hospital/Columbia and The Rogosin Institute -- is the most active program of its kind in the nation, offering comprehensive and personalized care for the heart, liver, pancreas, kidney and lung. With outcomes ranked among the nation's best, the Hospital is dedicated to improving quality of life for its patients. NewYork-Presbyterian's dedicated teams of surgeons and physicians are responsible for many significant advances made over the past several decades in transplant surgery and the maintenance of healthy organs. The Hospital has been on the forefront of developing and improving anti-rejection medications (immunosuppressants), minimally invasive surgery for living donors, genetic methods to detect transplant rejection, strategies to increase opportunities for donor matching, islet cell transplantation, and the FDA-approved Left Ventricle Assist Device (LVAD) that functions as a bridge to transplantation for those waiting for a new heart.
NewYork-Presbyterian/Morgan Stanley Children's Hospital
NewYork-Presbyterian/Morgan Stanley Children's Hospital, located in New York City, offers the best available care in every area of pediatrics -- including the most complex neonatal and critical care, and all areas of pediatric subspecialties -- in a family-friendly and technologically advanced setting. Building a reputation for more than a century as one of the nation's premier children's hospitals, Morgan Stanley Children's Hospital is affiliated with the Department of Pediatrics at Columbia University College of Physicians and Surgeons, and is Manhattan's only hospital dedicated solely to the care of children and one of the largest providers of children's health services in the tri-state area with a long-standing commitment to its community. It is also a major international referral center, meeting the special needs of children from infancy through adolescence worldwide. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report.
Source: NewYork-Presbyterian Hospital
Article URL: http://www.medicalnewstoday.com/articles/193333.php
Four Rules to Help HCV Sufferers Sleep Well
July 1, 2010
By making sure these four rules are practiced daily, those with Hepatitis C will benefit from the resulting improvement in their sleep.
by Nicole Cutler, L.Ac.
An estimated three quarters of those with Hepatitis C wage an ongoing battle against chronic fatigue. Although it seems ridiculously simple, getting a deep, restful, complete night's sleep is one of the most effective solutions for this fatigue. Unfortunately, obtaining said sleep is not always an easy feat.
For those with Hepatitis C, sleep disturbances typically accompany their illness. In the January 2010 Journal of Clinical Gastroenterology, S. Sockalingam and colleagues presented a review of sleep disturbances in people with Hepatitis C. They reported that up to 60 percent of patients with chronic Hepatitis C experience sleep problems. Some of the proposed mechanisms responsible for sleeping troubles in those with Hepatitis C, include:
· Depression - Troubled sleep is considered by experts to be a hallmark sign of depression. It is estimated that between 24 and 70 percent of those with chronic Hepatitis C experience a major depressive disorder.
· Side effect of interferon/ribavirin treatment - Up to 30 percent of interferon-treated Hepatitis C patients has newly diagnosed sleep disturbances.
· Cirrhosis - For those with an advanced case of Hepatitis C, cirrhosis typically interferes with the sleep-wake cycle.
Sleep's Importance
Variations on sleeplessness include problems falling asleep, maintaining sleep or experiencing non-restorative sleep. Because sleep rejuvenates the psyche and immune system, sleeplessness affects energy level, mood and overall health. The result of poor sleep is fatigue, which always perpetuates chronic illness. Long-term sleep deprivation is practically guaranteed to worsen the severity of chronic Hepatitis C.
A good night's sleep is more important to the immune system's response to Hepatitis C than most people realize. The immune system is activated during the deepest stage of sleep to fight disease. This is why people tend to sleep longer when they're sick. Loss of sleep, even for a few short hours during the night, can prompt one's immune system to turn against healthy tissue and organs.
As published in a September 2008 issue of Biological Psychiatry, California researchers reported that losing sleep for even part of one night could trigger the key cellular pathway that produces tissue-damaging inflammation. Obviously, inviting such inflammation in the face of the Hepatitis C virus is a surefire way to fan the flames of liver damage.
Four Sleep Tips
Those with Hepatitis C need deep, restful sleep to maintain their health. Thus, the following tips should be regarded as a strict set of rules - rather than just mere suggestions:
1. Coffee Cut-Off - While several studies have demonstrated coffee's benefits to people with Hepatitis C, it should not be consumed after 4pm; restricting caffeine intake to the morning hours is even better. Even if you can fall asleep easily after an evening espresso, your body will not get the same kind of deep, restful sleep with caffeine circulating in your system.
2. Take Control of Your Sleep/Wake Cycle - You don't need to be an infant to benefit from an established bedtime. A stringent routine of retiring and rising at the same time every day can influence the body's sleep hormones to normalize.
3. Modify Your Environment - Coinciding with the absence of activity and light, people naturally sleep at nighttime. Because we are designed to slumber during the darkest, quietest part of the day, our sleep environment should reflect that, with sounds minimized, lights low and the television (and other illuminated and noisy electronics) turned off.
4. Relax Before Bed - It's hard to fall asleep when your mind and body are racing from an active day. Take some time to unwind before your allocated bedtime by purposefully relaxing. Some ways to do this could be meditating, taking a warm bath, drinking some herbal tea or doing some deep abdominal breathing.
While severe and/or recurring insomnia certainly warrants getting help from a physician, many people's sleep problems can be corrected by heeding the four rules described above. Individuals with Hepatitis C are especially prone to sleeping difficulties. Not surprisingly, those with this liver disease have a lot to gain from a good night's rest. Thus, cutting off coffee early in the day, setting a sleep/wake cycle, controlling the sleep environment and relaxing before bed should be considered standard practices for living healthfully with Hepatitis C.
References:
http://www.hcvadvocate.org/news/newsRev/2010/HJR-7.1.html#5, HCV and Sleep Disorders, Retrieved January 26, 2010, Hepatitis C Support Project, 2010.
http://www.hepatitis-central.com/mt/archives/2009/01/why_depression.html, Why Depression is Likely With Hepatitis C, Nicole Cutler, L.Ac., Retrieved January 29, 2010, Natural Wellness, 2010.
http://www.hepatitis-central.com/mt/archives/2009/07/back_to_basics.html, Back to Basics: Helping Your Body Fight Hepatitis C, Nicole Cutler, L.Ac., Retrieved January 29, 2010, Natural Wellness, 2010.
http://www.huffingtonpost.com/dr-michael-j-breus/sleep-hygiene-101-how-to_b_412965.html, Sleep Hygiene 101: How to Ensure a Better Night's Rest, Dr. Michael J. Breus, HuffingtonPost.com, Inc., 2010.
http://www.liverdisease.com/fatigue_hepatitis.html, Fatigue and Liver Disease/Hepatitis, Retrieved January 26, 2010, Melissa Palmer, MD, 2010.
http://www.ncbi.nlm.nih.gov/pubmed/19730115?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2, A review of sleep disturbance in hepatitis C, Sockalingam S, et al, Retrieved January 26, 2010, Journal of Clinical Gastroenterology, January 2010.
http://www.psychologytoday.com/articles/200307/bedfellows-insomnia-and-depression, Bedfellows: Insomnia and Depression, Hara Estroff Marano, Retrieved January 29, 2010, Psychology Today, July 2003.
http://www.webmd.com/hepatitis/hepc-guide/managing-hepatitis-c , Managing Hepatitis C, Retrieved January 26, 2010, WebMD, LLC, 2010.
Source
By making sure these four rules are practiced daily, those with Hepatitis C will benefit from the resulting improvement in their sleep.
by Nicole Cutler, L.Ac.
An estimated three quarters of those with Hepatitis C wage an ongoing battle against chronic fatigue. Although it seems ridiculously simple, getting a deep, restful, complete night's sleep is one of the most effective solutions for this fatigue. Unfortunately, obtaining said sleep is not always an easy feat.
For those with Hepatitis C, sleep disturbances typically accompany their illness. In the January 2010 Journal of Clinical Gastroenterology, S. Sockalingam and colleagues presented a review of sleep disturbances in people with Hepatitis C. They reported that up to 60 percent of patients with chronic Hepatitis C experience sleep problems. Some of the proposed mechanisms responsible for sleeping troubles in those with Hepatitis C, include:
· Depression - Troubled sleep is considered by experts to be a hallmark sign of depression. It is estimated that between 24 and 70 percent of those with chronic Hepatitis C experience a major depressive disorder.
· Side effect of interferon/ribavirin treatment - Up to 30 percent of interferon-treated Hepatitis C patients has newly diagnosed sleep disturbances.
· Cirrhosis - For those with an advanced case of Hepatitis C, cirrhosis typically interferes with the sleep-wake cycle.
Sleep's Importance
Variations on sleeplessness include problems falling asleep, maintaining sleep or experiencing non-restorative sleep. Because sleep rejuvenates the psyche and immune system, sleeplessness affects energy level, mood and overall health. The result of poor sleep is fatigue, which always perpetuates chronic illness. Long-term sleep deprivation is practically guaranteed to worsen the severity of chronic Hepatitis C.
A good night's sleep is more important to the immune system's response to Hepatitis C than most people realize. The immune system is activated during the deepest stage of sleep to fight disease. This is why people tend to sleep longer when they're sick. Loss of sleep, even for a few short hours during the night, can prompt one's immune system to turn against healthy tissue and organs.
As published in a September 2008 issue of Biological Psychiatry, California researchers reported that losing sleep for even part of one night could trigger the key cellular pathway that produces tissue-damaging inflammation. Obviously, inviting such inflammation in the face of the Hepatitis C virus is a surefire way to fan the flames of liver damage.
Four Sleep Tips
Those with Hepatitis C need deep, restful sleep to maintain their health. Thus, the following tips should be regarded as a strict set of rules - rather than just mere suggestions:
1. Coffee Cut-Off - While several studies have demonstrated coffee's benefits to people with Hepatitis C, it should not be consumed after 4pm; restricting caffeine intake to the morning hours is even better. Even if you can fall asleep easily after an evening espresso, your body will not get the same kind of deep, restful sleep with caffeine circulating in your system.
2. Take Control of Your Sleep/Wake Cycle - You don't need to be an infant to benefit from an established bedtime. A stringent routine of retiring and rising at the same time every day can influence the body's sleep hormones to normalize.
3. Modify Your Environment - Coinciding with the absence of activity and light, people naturally sleep at nighttime. Because we are designed to slumber during the darkest, quietest part of the day, our sleep environment should reflect that, with sounds minimized, lights low and the television (and other illuminated and noisy electronics) turned off.
4. Relax Before Bed - It's hard to fall asleep when your mind and body are racing from an active day. Take some time to unwind before your allocated bedtime by purposefully relaxing. Some ways to do this could be meditating, taking a warm bath, drinking some herbal tea or doing some deep abdominal breathing.
While severe and/or recurring insomnia certainly warrants getting help from a physician, many people's sleep problems can be corrected by heeding the four rules described above. Individuals with Hepatitis C are especially prone to sleeping difficulties. Not surprisingly, those with this liver disease have a lot to gain from a good night's rest. Thus, cutting off coffee early in the day, setting a sleep/wake cycle, controlling the sleep environment and relaxing before bed should be considered standard practices for living healthfully with Hepatitis C.
References:
http://www.hcvadvocate.org/news/newsRev/2010/HJR-7.1.html#5, HCV and Sleep Disorders, Retrieved January 26, 2010, Hepatitis C Support Project, 2010.
http://www.hepatitis-central.com/mt/archives/2009/01/why_depression.html, Why Depression is Likely With Hepatitis C, Nicole Cutler, L.Ac., Retrieved January 29, 2010, Natural Wellness, 2010.
http://www.hepatitis-central.com/mt/archives/2009/07/back_to_basics.html, Back to Basics: Helping Your Body Fight Hepatitis C, Nicole Cutler, L.Ac., Retrieved January 29, 2010, Natural Wellness, 2010.
http://www.huffingtonpost.com/dr-michael-j-breus/sleep-hygiene-101-how-to_b_412965.html, Sleep Hygiene 101: How to Ensure a Better Night's Rest, Dr. Michael J. Breus, HuffingtonPost.com, Inc., 2010.
http://www.liverdisease.com/fatigue_hepatitis.html, Fatigue and Liver Disease/Hepatitis, Retrieved January 26, 2010, Melissa Palmer, MD, 2010.
http://www.ncbi.nlm.nih.gov/pubmed/19730115?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2, A review of sleep disturbance in hepatitis C, Sockalingam S, et al, Retrieved January 26, 2010, Journal of Clinical Gastroenterology, January 2010.
http://www.psychologytoday.com/articles/200307/bedfellows-insomnia-and-depression, Bedfellows: Insomnia and Depression, Hara Estroff Marano, Retrieved January 29, 2010, Psychology Today, July 2003.
http://www.webmd.com/hepatitis/hepc-guide/managing-hepatitis-c , Managing Hepatitis C, Retrieved January 26, 2010, WebMD, LLC, 2010.
Source
Excitement grows for potential revolution in hepatitis C virus treatment
Nature Reviews Drug Discovery 9, 501-503 (July 2010) doi:10.1038/nrd3214
Alisa Opar
Data from a late-stage trial of the most advanced of a new class of drugs targeting the hepatitis C virus protease fuel hopes for major improvements in treatment outcomes.
In May this year, Vertex Pharmaceuticals announced the first set of highly anticipated data from Phase III trials of telaprevir, which is competing to be the first protease inhibitor for the treatment of hepatitis C virus (HCV) infection to reach the market. The findings did not disappoint: telaprevir in addition to the current standard therapy was shown to be considerably more efficacious than the standard therapy alone.
Merck is hot on Vertex's heels with its drug boceprevir, which, like telaprevir, targets the key role of the HCV protease in the viral life cycle. Merck plans to release Phase III data for boceprevir later this year and Vertex expects results from two additional Phase III trials of telaprevir in the third quarter. If all goes well, both companies could file for regulatory approval this year and launch their drugs in 2011.
Protease inhibitors could represent a “revolution” in HCV treatment, says Stefan Zeuzem, Professor and Chief of Medicine at the J. W. Goethe University Hospital in Frankfurt, Germany. “The addition of a protease inhibitor to standard therapy is a milestone,” he says. “It's increased the cure rate by more than 30%. That is almost unprecedented within internal medicine. It is really, really rare that you have these breakthroughs.”
"The addition of a protease inhibitor to standard therapy is a milestone."
One of the biggest challenges in HCV treatment is that only about half of the patients with the genotype 1 strain of the virus — HCV1, the most common form in the United States and in Europe, and typically considered the most difficult to treat — obtain a sustained viral response (SVR), or cure, after completing standard therapy. Current treatment is a 48-week course of injections of pegylated interferon combined with the generic antiviral pill ribavirin. The arduous side effects of interferon, which include anaemia, depression and flu-like symptoms, lead many patients to curtail their treatment. Experts are hoping that protease inhibitors and other novel agents in the pipeline (Table 1) will shorten treatment duration, have better tolerability and cure more people.
Table 1 Selected drugs in Phase II or III trials for the treatment of HCV*
In Vertex's recently reported Phase III study, known as ADVANCE, 75% of patients infected with HCV1 who had not been previously treated achieved an SVR after receiving 12 weeks of telaprevir, pegylated interferon and ribavirin, followed by a course of standard therapy for at least another 12 weeks. The ADVANCE trial was response-guided, meaning that if in the telaprevir group the virus was sufficiently suppressed after 4 weeks, patients received only 24 weeks of total treatment — half the standard treatment time. Notably, about 70% of those who achieved SVR only received 24 weeks of therapy. Patients in the control group underwent standard therapy for 48 weeks and 44% achieved an SVR.
Both telaprevir and boceprevir might halve treatment duration to 24 weeks, although telaprevir might have an edge over boceprevir as its side effects seem to be milder; telaprevir causes rash and increases anaemia, but not to the same extent as boceprevir. The picture will be clearer later this year after Vertex and Merck report results of Phase III studies for treatment-experienced and treatment-naive patients with HCV1.
In addition to offering patients who have failed standard therapy another option, better drugs for HCV could spur more people to seek treatment. In fact, because the novel therapies seem so promising, a growing number of patients are delaying treatment until they become available. This phenomenon, called warehousing, is widespread, says Ira Jacobson, Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, USA, and an investigator for the ADVANCE trial. For many people, waiting a year or so to start therapy makes sense because the illness progresses slowly, scarring the liver over years or even decades and eventually leading to cirrhosis, liver cancer or other conditions. “The idea is, why take therapy now if you have a 40–45% chance of success when you can wait and have something that might confer a 70% chance of success perhaps with the added advantage of shorter duration of therapy, as suggested by clinical trial data so far,” Jacobson explains.
Initially, telaprevir and boceprevir would be used in combination with interferon and ribavirin, but experts hope that new drugs will ultimately remove the need for interferon. However, it is unlikely that a protease inhibitor will be used alone because of problems with resistance. “The first monotherapy studies with telaprevir have shown that resistance develops within the first 2 weeks. The data have also shown that the [viral] mutants exist before treatment,” says Michael Manns, Head of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany. “As resistance is a problem, the FDA has restricted the use of monotherapy to 3 days in early studies, and then interferon plus ribavirin has to be added because the mutants for the protease are sensitive to interferon.”
To combat resistance, researchers are looking at using combinations of direct-acting antivirals. “This approach has been very successful at preventing resistance in HIV treatment,” says Robert Kauffman, Vertex's Chief Medical Officer. “If you have two drugs against two different viral targets for which there is no cross-resistance, to get a resistant variant, resistance needs to develop to both drugs, which is obviously much less likely than with just one drug.” Still, whether interferon-free regimens are possible, and, if they are, what will be the best combinations of direct-acting antivirals are “open questions,” says Manns.
Several companies are already tackling these questions. In addition to boceprevir and telaprevir, which are taken orally three times a day, second-generation protease inhibitors taken once a day are in Phase II trials (Table 1). “The big advantage we are hoping for from the second-wave protease inhibitors are improvements in the pharmacokinetic profile, dosing intervals, and perhaps some advances with respect to safety and tolerability,” says Zeuzem.
Although protease inhibitors are expected to reach the market first, investigational agents that block other HCV enzymes, such as non-nucleoside and nucleoside polymerase inhibitors, are also in development (Table 1). “Nucleoside polymerase inhibitors in particular appear to have a high genetic barrier to resistance, but the non-nucleosides also offer great promise in combination with other drugs,” says Jacobson. NS5A inhibitors are another novel class of agents that block a protein critical to viral replication; there is a “great deal of focus” on these compounds, Jacobson adds, because they show marked antiviral activity. In addition, trials of immunological therapies, new formulations of interferon, and antagonists to cyclophilins, which are human proteins used by the virus to augment its own replication, are all underway.
As yet, nobody knows what the most effective strategy might be. “We are now entering a phase where we have a large number of companies combining direct-acting antiviral drugs together, which have non-cross resistance patterns — a protease inhibitor with a NS5A inhibitor, a protease inhibitor with a non-nucleoside polymerase inhibitor, a protease inhibitor with a nucleoside inhibitor,” says Zeuzem. One of the key challenges in the clinical trials of such agents will be learning how to manage resistance and side effects related to the direct-acting antivirals, says Kaufmann, noting that these challenges will be compounded when the agents are combined.
“I think it will be a potentially breathtaking event when any of those trials gives us proof of concept that you can induce a sustained virologic response with combinations of pure antiviral drugs in the absence of interferon,” says Jacobson. “If such proof of concept materializes soon, I think it will further accelerate the development of interferon-free regimens.”
http://www.nature.com/nrd/journal/v9/n7/full/nrd3214.html
Alisa Opar
Data from a late-stage trial of the most advanced of a new class of drugs targeting the hepatitis C virus protease fuel hopes for major improvements in treatment outcomes.
In May this year, Vertex Pharmaceuticals announced the first set of highly anticipated data from Phase III trials of telaprevir, which is competing to be the first protease inhibitor for the treatment of hepatitis C virus (HCV) infection to reach the market. The findings did not disappoint: telaprevir in addition to the current standard therapy was shown to be considerably more efficacious than the standard therapy alone.
Merck is hot on Vertex's heels with its drug boceprevir, which, like telaprevir, targets the key role of the HCV protease in the viral life cycle. Merck plans to release Phase III data for boceprevir later this year and Vertex expects results from two additional Phase III trials of telaprevir in the third quarter. If all goes well, both companies could file for regulatory approval this year and launch their drugs in 2011.
Protease inhibitors could represent a “revolution” in HCV treatment, says Stefan Zeuzem, Professor and Chief of Medicine at the J. W. Goethe University Hospital in Frankfurt, Germany. “The addition of a protease inhibitor to standard therapy is a milestone,” he says. “It's increased the cure rate by more than 30%. That is almost unprecedented within internal medicine. It is really, really rare that you have these breakthroughs.”
"The addition of a protease inhibitor to standard therapy is a milestone."
One of the biggest challenges in HCV treatment is that only about half of the patients with the genotype 1 strain of the virus — HCV1, the most common form in the United States and in Europe, and typically considered the most difficult to treat — obtain a sustained viral response (SVR), or cure, after completing standard therapy. Current treatment is a 48-week course of injections of pegylated interferon combined with the generic antiviral pill ribavirin. The arduous side effects of interferon, which include anaemia, depression and flu-like symptoms, lead many patients to curtail their treatment. Experts are hoping that protease inhibitors and other novel agents in the pipeline (Table 1) will shorten treatment duration, have better tolerability and cure more people.
Table 1 Selected drugs in Phase II or III trials for the treatment of HCV*
In Vertex's recently reported Phase III study, known as ADVANCE, 75% of patients infected with HCV1 who had not been previously treated achieved an SVR after receiving 12 weeks of telaprevir, pegylated interferon and ribavirin, followed by a course of standard therapy for at least another 12 weeks. The ADVANCE trial was response-guided, meaning that if in the telaprevir group the virus was sufficiently suppressed after 4 weeks, patients received only 24 weeks of total treatment — half the standard treatment time. Notably, about 70% of those who achieved SVR only received 24 weeks of therapy. Patients in the control group underwent standard therapy for 48 weeks and 44% achieved an SVR.
Both telaprevir and boceprevir might halve treatment duration to 24 weeks, although telaprevir might have an edge over boceprevir as its side effects seem to be milder; telaprevir causes rash and increases anaemia, but not to the same extent as boceprevir. The picture will be clearer later this year after Vertex and Merck report results of Phase III studies for treatment-experienced and treatment-naive patients with HCV1.
In addition to offering patients who have failed standard therapy another option, better drugs for HCV could spur more people to seek treatment. In fact, because the novel therapies seem so promising, a growing number of patients are delaying treatment until they become available. This phenomenon, called warehousing, is widespread, says Ira Jacobson, Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, USA, and an investigator for the ADVANCE trial. For many people, waiting a year or so to start therapy makes sense because the illness progresses slowly, scarring the liver over years or even decades and eventually leading to cirrhosis, liver cancer or other conditions. “The idea is, why take therapy now if you have a 40–45% chance of success when you can wait and have something that might confer a 70% chance of success perhaps with the added advantage of shorter duration of therapy, as suggested by clinical trial data so far,” Jacobson explains.
Initially, telaprevir and boceprevir would be used in combination with interferon and ribavirin, but experts hope that new drugs will ultimately remove the need for interferon. However, it is unlikely that a protease inhibitor will be used alone because of problems with resistance. “The first monotherapy studies with telaprevir have shown that resistance develops within the first 2 weeks. The data have also shown that the [viral] mutants exist before treatment,” says Michael Manns, Head of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany. “As resistance is a problem, the FDA has restricted the use of monotherapy to 3 days in early studies, and then interferon plus ribavirin has to be added because the mutants for the protease are sensitive to interferon.”
To combat resistance, researchers are looking at using combinations of direct-acting antivirals. “This approach has been very successful at preventing resistance in HIV treatment,” says Robert Kauffman, Vertex's Chief Medical Officer. “If you have two drugs against two different viral targets for which there is no cross-resistance, to get a resistant variant, resistance needs to develop to both drugs, which is obviously much less likely than with just one drug.” Still, whether interferon-free regimens are possible, and, if they are, what will be the best combinations of direct-acting antivirals are “open questions,” says Manns.
Several companies are already tackling these questions. In addition to boceprevir and telaprevir, which are taken orally three times a day, second-generation protease inhibitors taken once a day are in Phase II trials (Table 1). “The big advantage we are hoping for from the second-wave protease inhibitors are improvements in the pharmacokinetic profile, dosing intervals, and perhaps some advances with respect to safety and tolerability,” says Zeuzem.
Although protease inhibitors are expected to reach the market first, investigational agents that block other HCV enzymes, such as non-nucleoside and nucleoside polymerase inhibitors, are also in development (Table 1). “Nucleoside polymerase inhibitors in particular appear to have a high genetic barrier to resistance, but the non-nucleosides also offer great promise in combination with other drugs,” says Jacobson. NS5A inhibitors are another novel class of agents that block a protein critical to viral replication; there is a “great deal of focus” on these compounds, Jacobson adds, because they show marked antiviral activity. In addition, trials of immunological therapies, new formulations of interferon, and antagonists to cyclophilins, which are human proteins used by the virus to augment its own replication, are all underway.
As yet, nobody knows what the most effective strategy might be. “We are now entering a phase where we have a large number of companies combining direct-acting antiviral drugs together, which have non-cross resistance patterns — a protease inhibitor with a NS5A inhibitor, a protease inhibitor with a non-nucleoside polymerase inhibitor, a protease inhibitor with a nucleoside inhibitor,” says Zeuzem. One of the key challenges in the clinical trials of such agents will be learning how to manage resistance and side effects related to the direct-acting antivirals, says Kaufmann, noting that these challenges will be compounded when the agents are combined.
“I think it will be a potentially breathtaking event when any of those trials gives us proof of concept that you can induce a sustained virologic response with combinations of pure antiviral drugs in the absence of interferon,” says Jacobson. “If such proof of concept materializes soon, I think it will further accelerate the development of interferon-free regimens.”
http://www.nature.com/nrd/journal/v9/n7/full/nrd3214.html
Safety of small-for-size grafts in adult-to-adult living donor liver transplantation using the right lobe
Liver Transpl. 2010 Jul;16(7):864-9.
Moon JI, Kwon CH, Joh JW, Jung GO, Choi GS, Park JB, Kim JM, Shin M, Kim SJ, Lee SK.
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Abstract
The problem of graft size is one of the critical factors limiting the expansion of adult-to-adult living donor liver transplantation (LDLT). We compared the outcome of LDLT recipients who received grafts with a graft-to-recipient weight ratio (GRWR) < 0.8% or a GRWR >/= 0.8%, and we analyzed the risk factors affecting graft survival after small-for-size grafts (SFSGs) were used. Between June 1997 and April 2008, 427 patients underwent LDLT with right lobe grafts at the Department of Surgery of Samsung Medical Center. Recipients were divided into 2 groups: group A with a GRWR < 0.8% (n = 35) and group B with a GRWR >/= 0.8% (n = 392). We retrospectively evaluated the recipient factors, donor factors, and operative factors through the medical records. Small-for-size dysfunction (SFSD) occurred in 2 of 35 patients (5.7%) in group A and in 14 of 392 patients (3.6%) in group B (P = 0.368). Graft survival rates at 1, 3, and 5 years were not different between the 2 groups (87.8%, 83.4%, and 74.1% versus 90.7%, 84.5%, and 79.4%, P = 0.852). However, when we analyzed risk factors within group A, donor age and middle hepatic vein tributary drainage were significant risk factors for graft survival according to univariate analysis (P = 0.042 and P = 0.038, respectively). Donor age was the only significant risk factor for poor graft survival according to multivariate analysis. The graft survival rates of recipients without SFSD tended to be higher than those of recipients with SFSD (85.3% versus 50.0%, P = 0.074). The graft survival rates of recipients with grafts from donors < 44 years old were significantly higher than those of recipients with grafts from donors >/= 44 years old (92.2% versus 53.6%, P = 0.005). In conclusion, an SFSG (GRWR < 0.8%) can be used safely in adult-to-adult right lobe LDLT when a recipient is receiving the graft from a donor younger than 44 years. Liver Transpl 16:864-869, 2010. (c) 2010 AASLD.
PMID: 20583075 [PubMed - in process]
Source
Moon JI, Kwon CH, Joh JW, Jung GO, Choi GS, Park JB, Kim JM, Shin M, Kim SJ, Lee SK.
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Abstract
The problem of graft size is one of the critical factors limiting the expansion of adult-to-adult living donor liver transplantation (LDLT). We compared the outcome of LDLT recipients who received grafts with a graft-to-recipient weight ratio (GRWR) < 0.8% or a GRWR >/= 0.8%, and we analyzed the risk factors affecting graft survival after small-for-size grafts (SFSGs) were used. Between June 1997 and April 2008, 427 patients underwent LDLT with right lobe grafts at the Department of Surgery of Samsung Medical Center. Recipients were divided into 2 groups: group A with a GRWR < 0.8% (n = 35) and group B with a GRWR >/= 0.8% (n = 392). We retrospectively evaluated the recipient factors, donor factors, and operative factors through the medical records. Small-for-size dysfunction (SFSD) occurred in 2 of 35 patients (5.7%) in group A and in 14 of 392 patients (3.6%) in group B (P = 0.368). Graft survival rates at 1, 3, and 5 years were not different between the 2 groups (87.8%, 83.4%, and 74.1% versus 90.7%, 84.5%, and 79.4%, P = 0.852). However, when we analyzed risk factors within group A, donor age and middle hepatic vein tributary drainage were significant risk factors for graft survival according to univariate analysis (P = 0.042 and P = 0.038, respectively). Donor age was the only significant risk factor for poor graft survival according to multivariate analysis. The graft survival rates of recipients without SFSD tended to be higher than those of recipients with SFSD (85.3% versus 50.0%, P = 0.074). The graft survival rates of recipients with grafts from donors < 44 years old were significantly higher than those of recipients with grafts from donors >/= 44 years old (92.2% versus 53.6%, P = 0.005). In conclusion, an SFSG (GRWR < 0.8%) can be used safely in adult-to-adult right lobe LDLT when a recipient is receiving the graft from a donor younger than 44 years. Liver Transpl 16:864-869, 2010. (c) 2010 AASLD.
PMID: 20583075 [PubMed - in process]
Source
Insulin resistance impairs response to hepatitis C therapy for patients co-infected with HIV
Michael Carter, Friday, July 02, 2010
Insulin resistance is associated with an impaired response to hepatitis C therapy for HIV-positive patients, Spanish investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.
“Our findings suggest that insulin resistance is an important determinant of poor response to anti-HCV [hepatitis C virus] therapy in HIV/HCV-coinfected patients”, comment the authors.
Recommended treatment for hepatitis C consists of pegylated interferon and weight-dosed ribavirin. The aim of therapy is an undetectable hepatitis C viral load 24 weeks after the completion of treatment. This is called a sustained virological response.
However, many patients do not achieve this outcome, and a poorer response to hepatitis C therapy is seen in HIV/hepatitis C-co-infected individuals.
Others factors associated with a lower chance of achieving a sustained virological response include hepatitis C genotype, hepatitis C viral load, fibrosis stage, and age.
Some research has suggested that the presence of insulin resistance also impairs responses to hepatitis C therapy. To gain a clear understanding of this issue, investigators from the HIV outpatient clinic of the Gregorio Maranon Hospital in Madrid performed a retrospective analysis involving 134 patients treated for hepatitis C between 2000 and 2007.
For each patient an insulin resistance score was calculated using the homeostatic model assessment (HOMA) method. An insulin resistance score was obtained using the following formula: fasting plasma glucose was multiplied by fasting serum insulin and divided by 22.5. Insulin resistance was diagnosed when a patient had a score of 3.8 of higher.
Most of the patients (77%) were men, and the median age was 40 years. The majority of patients (67%) were infected with the harder to treated hepatitis C genotypes – 1 and 4. In the majority of cases (81%) hepatitis C therapy included pegylated interferon.
The median HOMA-insulin resistance score was 2.5, and 31% of patients were diagnosed with insulin resistance.
Baseline insulin resistance scores were significantly lower for patients who achieved a sustained response to hepatitis C therapy than those who did not (1.9 vs. 3.3, p = 0.005).
Statistical analysis showed that the factors associated with achieving a sustained response to treatment included infection with the easier-to-treat genotypes 2 and 3 (OR = 6.7; 95% CI, 2.71-16.98, p < 0.001), and the absence of insulin resistance (OR = 3.3; 95% CI, 1.36-9.26, p = 0.008).
These findings were unaltered when the investigators controlled for age, gender, body mass index, type of interferon used in therapy, and fibrosis stage.
Moreover, the investigators found that even after controlling for potentially confounding factors, the presence of insulin resistance was associated with a poorer virologic response to hepatitis C therapy at weeks 4, 12, 24, 48, and 72.
“HOMA-insulin resistance should be included in the routine baseline evaluation of HIV/HCV-coinfected patients who are candidates for treatment with interferon and ribavirin”, conclude the investigators.
Reference
Ryan P et al. Insulin resistance impairs response to interferon plus ribavirin in patients coinfected with HIV and hepatitis C virus. J Acquire
http://www.aidsmap.com/en/news/93CBEFCF-9B51-48FA-94E9-18A3EA3335B5.asp
Insulin resistance is associated with an impaired response to hepatitis C therapy for HIV-positive patients, Spanish investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.
“Our findings suggest that insulin resistance is an important determinant of poor response to anti-HCV [hepatitis C virus] therapy in HIV/HCV-coinfected patients”, comment the authors.
Recommended treatment for hepatitis C consists of pegylated interferon and weight-dosed ribavirin. The aim of therapy is an undetectable hepatitis C viral load 24 weeks after the completion of treatment. This is called a sustained virological response.
However, many patients do not achieve this outcome, and a poorer response to hepatitis C therapy is seen in HIV/hepatitis C-co-infected individuals.
Others factors associated with a lower chance of achieving a sustained virological response include hepatitis C genotype, hepatitis C viral load, fibrosis stage, and age.
Some research has suggested that the presence of insulin resistance also impairs responses to hepatitis C therapy. To gain a clear understanding of this issue, investigators from the HIV outpatient clinic of the Gregorio Maranon Hospital in Madrid performed a retrospective analysis involving 134 patients treated for hepatitis C between 2000 and 2007.
For each patient an insulin resistance score was calculated using the homeostatic model assessment (HOMA) method. An insulin resistance score was obtained using the following formula: fasting plasma glucose was multiplied by fasting serum insulin and divided by 22.5. Insulin resistance was diagnosed when a patient had a score of 3.8 of higher.
Most of the patients (77%) were men, and the median age was 40 years. The majority of patients (67%) were infected with the harder to treated hepatitis C genotypes – 1 and 4. In the majority of cases (81%) hepatitis C therapy included pegylated interferon.
The median HOMA-insulin resistance score was 2.5, and 31% of patients were diagnosed with insulin resistance.
Baseline insulin resistance scores were significantly lower for patients who achieved a sustained response to hepatitis C therapy than those who did not (1.9 vs. 3.3, p = 0.005).
Statistical analysis showed that the factors associated with achieving a sustained response to treatment included infection with the easier-to-treat genotypes 2 and 3 (OR = 6.7; 95% CI, 2.71-16.98, p < 0.001), and the absence of insulin resistance (OR = 3.3; 95% CI, 1.36-9.26, p = 0.008).
These findings were unaltered when the investigators controlled for age, gender, body mass index, type of interferon used in therapy, and fibrosis stage.
Moreover, the investigators found that even after controlling for potentially confounding factors, the presence of insulin resistance was associated with a poorer virologic response to hepatitis C therapy at weeks 4, 12, 24, 48, and 72.
“HOMA-insulin resistance should be included in the routine baseline evaluation of HIV/HCV-coinfected patients who are candidates for treatment with interferon and ribavirin”, conclude the investigators.
Reference
Ryan P et al. Insulin resistance impairs response to interferon plus ribavirin in patients coinfected with HIV and hepatitis C virus. J Acquire
http://www.aidsmap.com/en/news/93CBEFCF-9B51-48FA-94E9-18A3EA3335B5.asp
July 1, 2010
Treating Hepatitis C in People with Compensated Cirrhosis Is Most Cost-effective Approach
SUMMARY: Interferon-based combination therapy for chronic hepatitis C virus (HCV) infection is most cost-effective -- saving more than $55,000 compared with no treatment -- when initiated in patients with compensated cirrhosis rather than waiting until progression to decompensated cirrhosis or HCV recurrence after a liver transplant, according to research from the University of California at Los Angeles reported in the June 2010 issue of Liver Transplantation.
By Liz Highleyman
Treatment with pegylated interferon plus ribavirin can cause difficult side effects and cures only about half of people with chronic hepatitis C. Furthermore, HCV leads to advanced liver disease such as cirrhosis (replacement of functional liver cells with scar tissue) or hepatocellular carcinoma (a type of liver cancer) in only a minority of patients. Therefore, clinicians attempt to wait long enough to be sure an individual is progressing and truly needs treatment, while not waiting too long, since interferon does not work as well and side effects can be worse in people with severe disease.
Experts have debated the best time to start treatment for people with advanced liver disease. Interferon and ribavirin are more likely to cause adverse events in people with cirrhosis, but these are also the patients who stand to benefit most if successful therapy can halt or slow disease progression.
Compensated cirrhosis means the liver is heavily scarred but can still carry out most if its vital functions. Decompensated cirrhosis means the liver is no longer working properly to filter blood, leading to conditions such as portal hypertension, bleeding varicose veins in the esophagus, ascites (abdominal fluid build-up), and hepatic encephalopathy (neurocognitive impairment).
Sammy Saab and colleagues sought to determine the most cost-effective timing for pegylated interferon plus ribavirin treatment (48 weeks) in patients with advanced liver disease related to genotype 1 HCV infection -- the most difficult type to treat.
The study included about 4000 participants followed over 17 years. The investigators used a Markov mathematical model to compare treatment 4 treatment strategies, with approximately equal numbers of patients in each group:
1 No treatment;
2 Antiviral therapy for patients with compensated cirrhosis;
3 Antiviral therapy for patients with decompensated cirrhosis;
4 Antiviral therapy for patients with progressive fibrosis due to recurrent HCV post-transplantation.
They looked at outcomes including total cost per patient, number of quality-adjusted life years (QALYs) saved, cost per QALY saved, number of deaths, number of cases of hepatocellular carcinoma, and number of liver transplants required.
Results
All 3 treatment strategies were cost-saving compared with no therapy, but treating patients with compensated cirrhosis was much more cost-effective and greatly improved survival:
"This study provides pharmacoeconomic evidence in support of treating HCV in patients with compensated cirrhosis before progression to more advanced liver disease," they added.
In an accompanying editorial, hepatology experts Angel Rubin and Marina Berenguer from Valencia, Spain, offered the caveat that models such as this do not take into account all the many variables that can affect disease progression and treatment response, recommending that "Physicians must decide whether the most cost-effective approach is the most appropriate one in each individual."
Investigator affiliations: Departments of Medicine, University of California at Los Angeles, Los Angeles, CA; Department of Surgery, University of California at Los Angeles, Los Angeles, CA; Harbor-UCLA Medical Center, Torrance, CA; Huntington Medical Research Institutes, Pasadena, CA.
7/2/10
References
S Saab, DR Hunt, MA Stone, and others. Timing of hepatitis C antiviral therapy in patients with advanced liver disease: a decision analysis model. Liver Transplantation 16(6): 748-759 (Abstract). June 2010.
A Rubin and M Berenguer. An economic analysis of antiviral therapy in patients with advanced hepatitis C virus disease: still not there! (Editorial). Liver Transplantation 16(6): 697-700. June 2010.
Other source
Wiley-Blackwell. Antiviral therapy during compensated cirrhosis most cost-effective approach. Media advisory. May 27, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0702_2010_b.html
By Liz Highleyman
Treatment with pegylated interferon plus ribavirin can cause difficult side effects and cures only about half of people with chronic hepatitis C. Furthermore, HCV leads to advanced liver disease such as cirrhosis (replacement of functional liver cells with scar tissue) or hepatocellular carcinoma (a type of liver cancer) in only a minority of patients. Therefore, clinicians attempt to wait long enough to be sure an individual is progressing and truly needs treatment, while not waiting too long, since interferon does not work as well and side effects can be worse in people with severe disease.
Experts have debated the best time to start treatment for people with advanced liver disease. Interferon and ribavirin are more likely to cause adverse events in people with cirrhosis, but these are also the patients who stand to benefit most if successful therapy can halt or slow disease progression.
Compensated cirrhosis means the liver is heavily scarred but can still carry out most if its vital functions. Decompensated cirrhosis means the liver is no longer working properly to filter blood, leading to conditions such as portal hypertension, bleeding varicose veins in the esophagus, ascites (abdominal fluid build-up), and hepatic encephalopathy (neurocognitive impairment).
Sammy Saab and colleagues sought to determine the most cost-effective timing for pegylated interferon plus ribavirin treatment (48 weeks) in patients with advanced liver disease related to genotype 1 HCV infection -- the most difficult type to treat.
The study included about 4000 participants followed over 17 years. The investigators used a Markov mathematical model to compare treatment 4 treatment strategies, with approximately equal numbers of patients in each group:
1 No treatment;
2 Antiviral therapy for patients with compensated cirrhosis;
3 Antiviral therapy for patients with decompensated cirrhosis;
4 Antiviral therapy for patients with progressive fibrosis due to recurrent HCV post-transplantation.
They looked at outcomes including total cost per patient, number of quality-adjusted life years (QALYs) saved, cost per QALY saved, number of deaths, number of cases of hepatocellular carcinoma, and number of liver transplants required.
Results
All 3 treatment strategies were cost-saving compared with no therapy, but treating patients with compensated cirrhosis was much more cost-effective and greatly improved survival:
- Treatment during compensated cirrhosis: increased QALYs by 0.950 and saved $55,31 compared with no treatment.
- Treatment during decompensated cirrhosis: increased QALYs by 0.044 and saved $5511.
- Treatment during HCV recurrence after transplantation: increased QALYs by 0.061 and saved $3223.
- 119 fewer deaths;
- 54 fewer cases of hepatocellular carcinoma;
- 66 fewer liver transplants.
"This study provides pharmacoeconomic evidence in support of treating HCV in patients with compensated cirrhosis before progression to more advanced liver disease," they added.
In an accompanying editorial, hepatology experts Angel Rubin and Marina Berenguer from Valencia, Spain, offered the caveat that models such as this do not take into account all the many variables that can affect disease progression and treatment response, recommending that "Physicians must decide whether the most cost-effective approach is the most appropriate one in each individual."
Investigator affiliations: Departments of Medicine, University of California at Los Angeles, Los Angeles, CA; Department of Surgery, University of California at Los Angeles, Los Angeles, CA; Harbor-UCLA Medical Center, Torrance, CA; Huntington Medical Research Institutes, Pasadena, CA.
7/2/10
References
S Saab, DR Hunt, MA Stone, and others. Timing of hepatitis C antiviral therapy in patients with advanced liver disease: a decision analysis model. Liver Transplantation 16(6): 748-759 (Abstract). June 2010.
A Rubin and M Berenguer. An economic analysis of antiviral therapy in patients with advanced hepatitis C virus disease: still not there! (Editorial). Liver Transplantation 16(6): 697-700. June 2010.
Other source
Wiley-Blackwell. Antiviral therapy during compensated cirrhosis most cost-effective approach. Media advisory. May 27, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0702_2010_b.html
Discovery of a hepatitis C-related virus in bats may reduce outbreaks in humans
Contact: Stephanie Berger
sb2247@columbia.edu
212-305-4372
Columbia University's Mailman School of Public Health
July 1, 2010 -- Viral hepatitis affects more than 500 million people worldwide and is a cause of liver failure and liver cancer. While vaccines are available for hepatitis A and B, this is not the case for hepatitis C, which affects as much as two percent of the population in the U.S. Scientists today are reporting discovery of a virus related to hepatitis C in Asian bats, which may provide insights into the origins of the hepatitis C virus and into the mechanisms by which infectious diseases move from other species to humans.
The full study findings are published online in the publication PLoS Pathogens.
Transmitted by blood transfusion or sexual intercourse, hepatitis C is a common cause of liver failure. Viruses related to hepatitis C, known as GB-viruses, have previously been found only in primates. Now, using cutting-edge molecular techniques, an international team of investigators has identified a GB-virus in Pteropus giganteus bats in Bangladesh. The work was completed at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health, led by W. Ian Lipkin, MD; the International Centre for Diarrheal Disease Research in Bangladesh; 454 Life Sciences, a Connecticut-based division of Roche Corporation; and the Wildlife Trust in New York City. Using gene sequencing methods, the investigators confirmed the viral genetic material in the serum of five of 98 bats, and in the saliva of one, to be related to GBV-A and –C viruses. Further analysis of the two identified strains, tentatively named GBV-D, suggests that P. giganteus bats are a natural reservoir for this virus. According to the research team, the fact that bat saliva can contain GBV-D nucleic acids provides a biologically plausible mechanism for this agent to be transmitted from infected bats to other hosts, including humans.
Bats are often important hosts for emerging infectious disease agents with significant impact on human health including rabies, ebola, Marburg, hendra, nipah, and SARS viruses. Opportunities for transmission to humans are particularly prominent in countries like Bangladesh, where people live in close association with bats.
"This discovery underscores the importance of international programs focused on microbe hunting in hot spots of emerging infectious diseases," said Dr. Ian Lipkin, John Snow Professor of Epidemiology and director of the CII. "Finding this novel flavivirus in bats significantly broadens the host range of GB-like agents and may provide insights into the origins of hepatitis C," added Thomas Briese, PhD, lead molecular biologist on the team and Mailman School associate professor and associate director of CII.
"The Indian subcontinent and South Asia are areas where we are ardently working to identify the next possible pandemic disease," stated Peter Daszak, President of Wildlife Trust. "Identification of the natural reservoir of a virus, even if it may not directly infect people, is critical to surveillance and reducing the risk of outbreaks of infectious disease," noted Jonathan Epstein, associate vice president of Conservation Medicine Programs at Wildlife Trust.
###
The Center for Infection and Immunity at the Mailman School is dedicated to global research and training programs focused on pathogen surveillance and discovery, and to understanding how gene-environment-timing interactions contribute to health and disease. http://www.cii.columbia.edu/
About the Mailman School of Public Health
The only accredited school of public health in New York City and among the first in the nation, Columbia University's Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting millions of people locally and globally. The Mailman School is the recipient of some of the largest government and private grants in Columbia University's history. Its more than 1000 graduate students pursue master's and doctoral degrees, and the School's 300 multi-disciplinary faculty members work in more than 100 countries around the world, addressing such issues as infectious and chronic diseases, health promotion and disease prevention, environmental health, maternal and child health, health over the life course, health policy, and public health preparedness. http://www.mailman.columbia.edu/
http://www.eurekalert.org/pub_releases/2010-07/cums-doa070110.php
sb2247@columbia.edu
212-305-4372
Columbia University's Mailman School of Public Health
July 1, 2010 -- Viral hepatitis affects more than 500 million people worldwide and is a cause of liver failure and liver cancer. While vaccines are available for hepatitis A and B, this is not the case for hepatitis C, which affects as much as two percent of the population in the U.S. Scientists today are reporting discovery of a virus related to hepatitis C in Asian bats, which may provide insights into the origins of the hepatitis C virus and into the mechanisms by which infectious diseases move from other species to humans.
The full study findings are published online in the publication PLoS Pathogens.
Transmitted by blood transfusion or sexual intercourse, hepatitis C is a common cause of liver failure. Viruses related to hepatitis C, known as GB-viruses, have previously been found only in primates. Now, using cutting-edge molecular techniques, an international team of investigators has identified a GB-virus in Pteropus giganteus bats in Bangladesh. The work was completed at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health, led by W. Ian Lipkin, MD; the International Centre for Diarrheal Disease Research in Bangladesh; 454 Life Sciences, a Connecticut-based division of Roche Corporation; and the Wildlife Trust in New York City. Using gene sequencing methods, the investigators confirmed the viral genetic material in the serum of five of 98 bats, and in the saliva of one, to be related to GBV-A and –C viruses. Further analysis of the two identified strains, tentatively named GBV-D, suggests that P. giganteus bats are a natural reservoir for this virus. According to the research team, the fact that bat saliva can contain GBV-D nucleic acids provides a biologically plausible mechanism for this agent to be transmitted from infected bats to other hosts, including humans.
Bats are often important hosts for emerging infectious disease agents with significant impact on human health including rabies, ebola, Marburg, hendra, nipah, and SARS viruses. Opportunities for transmission to humans are particularly prominent in countries like Bangladesh, where people live in close association with bats.
"This discovery underscores the importance of international programs focused on microbe hunting in hot spots of emerging infectious diseases," said Dr. Ian Lipkin, John Snow Professor of Epidemiology and director of the CII. "Finding this novel flavivirus in bats significantly broadens the host range of GB-like agents and may provide insights into the origins of hepatitis C," added Thomas Briese, PhD, lead molecular biologist on the team and Mailman School associate professor and associate director of CII.
"The Indian subcontinent and South Asia are areas where we are ardently working to identify the next possible pandemic disease," stated Peter Daszak, President of Wildlife Trust. "Identification of the natural reservoir of a virus, even if it may not directly infect people, is critical to surveillance and reducing the risk of outbreaks of infectious disease," noted Jonathan Epstein, associate vice president of Conservation Medicine Programs at Wildlife Trust.
###
The Center for Infection and Immunity at the Mailman School is dedicated to global research and training programs focused on pathogen surveillance and discovery, and to understanding how gene-environment-timing interactions contribute to health and disease. http://www.cii.columbia.edu/
About the Mailman School of Public Health
The only accredited school of public health in New York City and among the first in the nation, Columbia University's Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting millions of people locally and globally. The Mailman School is the recipient of some of the largest government and private grants in Columbia University's history. Its more than 1000 graduate students pursue master's and doctoral degrees, and the School's 300 multi-disciplinary faculty members work in more than 100 countries around the world, addressing such issues as infectious and chronic diseases, health promotion and disease prevention, environmental health, maternal and child health, health over the life course, health policy, and public health preparedness. http://www.mailman.columbia.edu/
http://www.eurekalert.org/pub_releases/2010-07/cums-doa070110.php
Nutrition in Hepatic Encephalopathy
Rajagopal Chadalavada, MD
Raja Shekhar Sappati Biyyani, MD
John Maxwell, MD
Kevin Mullen, MD
Division of Gastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.
Correspondence: Kevin D. Mullen, MD, 2500 MetroHealth Dr, Cleveland, OH 44109; e-mail: kdmullen@metrohealth.org.
Protein calorie malnutrition (PCM) is a well-known complication of chronic liver disease (CLD). A major contribution to PCM in CLD is restriction of dietary protein intake. After many decades of injudicious reduction in dietary protein, cirrhotic patients are now prescribed appropriate amounts of protein. PCM in CLD is known to be associated with life-threatening complications. In the general approach to these patients, the initial and most important step for the clinician is to recognize the extent of malnutrition. Most patients tolerate a normal amount of dietary protein without developing hepatic encephalopathy (HE). Oral branched-chain amino acids (BCAAs) have a limited role in HE. Patients who exhibit dietary protein intolerance originally were thought to be best treated with BCAA formulations. Mixed evidence has been reported in multiple studies. In keeping with other reports, this article shows that in animal protein–intolerant patients, even those with advanced cirrhosis, vegetable protein–based diets are well tolerated. Another approach to management of apparent dietary intolerance is to optimize HE treatment with available medications. This article reviews the causes of HE, minimal HE, and PCM; examines nutrition requirements and assessment; and discusses treatment options for malnutrition in HE.
Key Words: hepatic encephalopathy • nutrition assessment • nutrition therapy • malnutrition • liver diseases • liver cirrhosis
Nutrition in Clinical Practice, Vol. 25, No. 3, 257-264 (2010)
DOI: 10.1177/0884533610368712
http://ncp.sagepub.com/cgi/content/abstract/25/3/257
Raja Shekhar Sappati Biyyani, MD
John Maxwell, MD
Kevin Mullen, MD
Division of Gastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.
Correspondence: Kevin D. Mullen, MD, 2500 MetroHealth Dr, Cleveland, OH 44109; e-mail: kdmullen@metrohealth.org.
Protein calorie malnutrition (PCM) is a well-known complication of chronic liver disease (CLD). A major contribution to PCM in CLD is restriction of dietary protein intake. After many decades of injudicious reduction in dietary protein, cirrhotic patients are now prescribed appropriate amounts of protein. PCM in CLD is known to be associated with life-threatening complications. In the general approach to these patients, the initial and most important step for the clinician is to recognize the extent of malnutrition. Most patients tolerate a normal amount of dietary protein without developing hepatic encephalopathy (HE). Oral branched-chain amino acids (BCAAs) have a limited role in HE. Patients who exhibit dietary protein intolerance originally were thought to be best treated with BCAA formulations. Mixed evidence has been reported in multiple studies. In keeping with other reports, this article shows that in animal protein–intolerant patients, even those with advanced cirrhosis, vegetable protein–based diets are well tolerated. Another approach to management of apparent dietary intolerance is to optimize HE treatment with available medications. This article reviews the causes of HE, minimal HE, and PCM; examines nutrition requirements and assessment; and discusses treatment options for malnutrition in HE.
Key Words: hepatic encephalopathy • nutrition assessment • nutrition therapy • malnutrition • liver diseases • liver cirrhosis
Nutrition in Clinical Practice, Vol. 25, No. 3, 257-264 (2010)
DOI: 10.1177/0884533610368712
http://ncp.sagepub.com/cgi/content/abstract/25/3/257
The Use of Mind-Body Medicine and Prayer Among Adult Patients With Chronic Hepatitis C
Gastroenterology Nursing:
May/June 2010 - Volume 33 - Issue 3 - p 210–216
doi: 10.1097/SGA.0b013e3181e01a7b
Richmond, Jacqueline A. PhD, MPH, RN; Bailey, Donald E. Jr. PhD, RN; McHutchison, John G. MD; Muir, Andrew J. MD
AbstractThe use of mind–body medicine by patients with chronic hepatitis C has not been reported. The prevalence and reasons for using mind–body medicine and prayer among a cohort of patients with chronic hepatitis C are described. Use of mind–body medicine and prayer was investigated as a component of a larger exploratory, descriptive study of the use of complementary and alternative medicine by patients with hepatitis C attending a tertiary healthcare facility in the United States. An investigator-designed self-administered questionnaire (n = 149) and semistructured interview (n = 28) were completed by participants. Eighty-eight percent (n = 105) of participants had used mind–body medicine in the past 12 months. The most commonly used therapies were prayer for health reasons (90%), deep breathing (29%), and meditation (29%). Mind–body medicine was most commonly used to relieve tension and promote general well-being. The use of mind–body medicine was widespread among patients with chronic hepatitis C. To provide patient-centered healthcare, health providers need to be aware of the alternative support strategies, including mind–body medicine, used by patients.
Source
May/June 2010 - Volume 33 - Issue 3 - p 210–216
doi: 10.1097/SGA.0b013e3181e01a7b
Richmond, Jacqueline A. PhD, MPH, RN; Bailey, Donald E. Jr. PhD, RN; McHutchison, John G. MD; Muir, Andrew J. MD
AbstractThe use of mind–body medicine by patients with chronic hepatitis C has not been reported. The prevalence and reasons for using mind–body medicine and prayer among a cohort of patients with chronic hepatitis C are described. Use of mind–body medicine and prayer was investigated as a component of a larger exploratory, descriptive study of the use of complementary and alternative medicine by patients with hepatitis C attending a tertiary healthcare facility in the United States. An investigator-designed self-administered questionnaire (n = 149) and semistructured interview (n = 28) were completed by participants. Eighty-eight percent (n = 105) of participants had used mind–body medicine in the past 12 months. The most commonly used therapies were prayer for health reasons (90%), deep breathing (29%), and meditation (29%). Mind–body medicine was most commonly used to relieve tension and promote general well-being. The use of mind–body medicine was widespread among patients with chronic hepatitis C. To provide patient-centered healthcare, health providers need to be aware of the alternative support strategies, including mind–body medicine, used by patients.
Source
Increased risk of hospitalization for acute hepatitis in patients with previous exposure to NSAIDs.
Lee CH, Wang JD, Chen PC.
Pharmacoepidemiol Drug Saf. 2010 May 13;19(7):708-714. [Epub ahead of print]
Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health, Taipei, Taiwan.
Abstract
BACKGROUND: Epidemiological studies related to hospitalization due to the hepatotoxicity of traditional non-steroidal anti-inflammatory drugs (NSAIDs) are infrequent, and case reports of hepatotoxicity of nimesulide, celecoxib, and rofecoxib seem to be increasing. The reimbursement database of National Health Insurance (NHI) in Taiwan provided an opportunity for post-marketing surveillance. We conducted this study to determine the association between the use of hepatoxic NSAIDs and increased hospitalizations related to acute hepatitis. METHODS: We included hospitalized subjects with a major diagnosis of acute or sub-acute necrosis of liver or toxic hepatitis and excluded viral and other causes of hepatobiliary diseases from the NHI database from 1 April 2001 to 31 December 2004. We applied two kinds of models to analyze by uni-directional and bi-directional case-crossover designs during the 28 days exposure periods and performed conditional logistic regression models. RESULTS: There were 4519 cases of hospitalization relating to acute hepatitis, and the odds ratios of celecoxib, nimesulide, dicofenac, ibuprofen, and other hepatoxic NSAIDs were significantly increased. Compared with the adjusted odds ratios of other hepatoxic NSAIDs (OR = 2.13, 95%CI = 2.00, 2.28), celecoxib (OR =1.92, 95%CI = 1.38, 2.69) was similar during the 28 days by our uni-directional case-crossover design. CONCLUSIONS: Our results provide evidence for an increased risk of hospitalization with acute hepatitis among hepatoxic NSAIDs including celecoxib users. Further mechanistic research is warranted in order to document celecoxib's hepatotoxicity. Copyright (c) 2010 John Wiley & Sons, Ltd.
PMID: 20582911 [PubMed - as supplied by publisher]
Source
Pharmacoepidemiol Drug Saf. 2010 May 13;19(7):708-714. [Epub ahead of print]
Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health, Taipei, Taiwan.
Abstract
BACKGROUND: Epidemiological studies related to hospitalization due to the hepatotoxicity of traditional non-steroidal anti-inflammatory drugs (NSAIDs) are infrequent, and case reports of hepatotoxicity of nimesulide, celecoxib, and rofecoxib seem to be increasing. The reimbursement database of National Health Insurance (NHI) in Taiwan provided an opportunity for post-marketing surveillance. We conducted this study to determine the association between the use of hepatoxic NSAIDs and increased hospitalizations related to acute hepatitis. METHODS: We included hospitalized subjects with a major diagnosis of acute or sub-acute necrosis of liver or toxic hepatitis and excluded viral and other causes of hepatobiliary diseases from the NHI database from 1 April 2001 to 31 December 2004. We applied two kinds of models to analyze by uni-directional and bi-directional case-crossover designs during the 28 days exposure periods and performed conditional logistic regression models. RESULTS: There were 4519 cases of hospitalization relating to acute hepatitis, and the odds ratios of celecoxib, nimesulide, dicofenac, ibuprofen, and other hepatoxic NSAIDs were significantly increased. Compared with the adjusted odds ratios of other hepatoxic NSAIDs (OR = 2.13, 95%CI = 2.00, 2.28), celecoxib (OR =1.92, 95%CI = 1.38, 2.69) was similar during the 28 days by our uni-directional case-crossover design. CONCLUSIONS: Our results provide evidence for an increased risk of hospitalization with acute hepatitis among hepatoxic NSAIDs including celecoxib users. Further mechanistic research is warranted in order to document celecoxib's hepatotoxicity. Copyright (c) 2010 John Wiley & Sons, Ltd.
PMID: 20582911 [PubMed - as supplied by publisher]
Source
VA secretary: St. Louis mistakes 'unacceptable'
By JIM SALTER (AP) – 12 minutes ago
ST. LOUIS — The Veterans Administration said Thursday that the chief of dental services at a St. Louis VA Medical Center has been placed on administrative after the hospital urged nearly 2,000 veterans to return for blood tests because inadequately sterilized equipment may have exposed them to viral infections during dental procedures.
An independent board will also investigate how employees failed to properly sterilize the dental equipment that potentially exposed veterans to infections including hepatitis and HIV, the administration said.
"The mistakes made at the St. Louis VA Medical Center are unacceptable, and steps have been and continue to be taken to correct this situation and assure the safety of our veterans," VA Secretary Eric Shinseki said.
The VA sent letters out Monday to 1,812 veterans who had dental procedures at the St. Louis center from Feb. 1, 2009, through March 11 of this year, saying reviews determined that some sterilization steps in preparing dental instruments were not in compliance with standards.
Officials say the infection risk is extremely low, and no illnesses have been uncovered so far out of some 100 veterans who have come in for blood work that will screen for hepatitis B, hepatitis C and HIV.
Rep. Russ Carnahan, D-Mo., said the House Veterans' Affairs Committee also said they will investigate what happened at the center and planned to hold a hearing in St. Louis. The announced investigations follow demands for action by several lawmakers from Missouri and Illinois — the St. Louis region's five VA facilities serve veterans in both states.
VA Under Secretary for Health Dr. Robert Petzel said he found there was a need for an independent review by the national Administrative Investigation Board "to determine the reasons for failure to follow correct procedures."
No date has been set for the Veterans' Affairs Committee hearing in St. Louis. Two Missouri congressmen, Republican Blaine Luetkemeyer and Democrat William Lacy Clay, also asked the House Oversight and Government Reform Committee to investigate. Both serve on that committee.
Lawmakers also want to know why it took so long for the VA to inform the veterans about the mistakes. The problem was uncovered in March and letters went out Monday.
Marcena Gunter, a spokeswoman for the St. Louis center, said the delay was because officials were evaluating the risk posed to veterans.
The name of the suspended chief of dental services was not released. A VA spokeswoman did not respond to interview requests.
The VA said patients who have had dental procedures since March 11 are not at risk because procedures were corrected.
Shinseki said that over the past 18 months, VA has implemented more stringent safety oversight at its medical facilities, and that oversight led to the identification of problems at the St. Louis facility.
VA centers around the country have had problems in recent years. In 2007, Walter Reed Army Medical Center in Washington came under scrutiny over concerns about conditions at the hospital and treatment of veterans. At the time, St. Louis VA officials said they were working to fix similar problems.
That same year, a surgeon at the VA hospital in Marion, Ill., resigned after a patient bled to death following gall bladder surgery. All inpatient surgeries were suspended. The VA found at least nine deaths between October 2006 and March 2007 resulted from substandard care at the Marion hospital, and another 10 patients died after receiving questionable care that complicated their health.
Copyright © 2010 The Associated Press. All rights reserved.
Source
Text of the senators' letter
Wednesday, Jun. 30, 2010
General Eric Shinseki Secretary of Veterans Affairs
Department of Veterans Affairs
810 Vermont Avenue, Northwest
Washington, DC 20420
Dear Secretary Shinseki: Please note our deep disappointment and concern that 1,812 St. Louis area veterans were potentially exposed between February 2009 and March 2010 to dangerous blood-borne diseases, including Hepatitis B and C and HIV, through possible contact with improperly cleaned dental devices at the John Cochran VA Medical Center (VAMC) in St. Louis, Missouri. In light of other recent revelations by the VA Inspector General regarding problems with reprocessing of endoscopes at John Cochran and frequent customer service satisfaction problems reported at John Cochran, we are concerned about VA management of the facility. Veterans receiving care at John Cochran deserve the best quality care available, including absolute assuredness that the hospital is meeting the most basic and critical professional standards of cleanliness and conduct. We are also deeply concerned that the VA took four months to notify veterans who may have been endangered by the flawed procedures at the John Cochran VAMC, as well as to notify the area Congressional delegation so that we might assist our constituents. We appreciate that the VA acted quickly to remedy the flawed cleaning procedures but the failure to share information in a timely fashion about the situation is unacceptable. In addition, a follow up visit to John Cochran by VA Headquarters staff was not conducted until May, some two months after the initial inspection revealed problems with the cleaning of the dental devices. When a significant failure in procedures occurs, like that discovered at the John Cochran VAMC dental clinic, we would expect a more timely response and more aggressive oversight. The VA has decided to dedicate $5 million in funding to make infrastructure and other improvements at the John Cochran VAMC in light of this troubling incident. While we applaud the VA’s efforts to address aggressively underlying problems, including infrastructure problems that could have contributed to the failures in the dental clinic, we must be kept apprised of how the $5 million in renovations will be spent and prioritized. Please keep us informed about any follow up actions that the VA takes to train staff and improve standard operating procedures in the dental clinic and elsewhere in the hospital.
In closing, as you evaluate each of the 1,812 veterans who have received letters from the VA about potential exposure from improperly handled dental devices, we ask for an accounting of any health irregularities identified and attributed to the exposure. We know you value the health and safety of each and every veteran and strongly urge you to make sure that no veteran’s health goes unchecked in this case. We are committed to working with you, Mr. Secretary, to provide veterans with the resources they need to heal—resources they earned through their great service. The repeated failures to follow simple rules and regulations, however, is wholly unacceptable, and we want to know the measures you plan to implement in order to ensure this catastrophe never happens again. We thank you for your immediate attention to this matter and look forward to your reply. Should you have additional questions please feel free to contact us directly or to have your staff contact Tressa Guenov in Senator McCaskill’s office, Bo Prosch in Senator Bond’s office or Gabe Chavez in Senator Durbin’s office.
Sincerely,
Claire McCaskill UNITED STATES SENATOR
Christopher Bond UNITED STATES SENATOR
Richard Durbin UNITES STATES SENATOR
© 2007 Belleville News-Democrat and wire service sources.
All Rights Reserved. http://www.belleville.com/
Source
See Also:
Military men and women suffer abuse at the hands of their own doctors
VA hospital may have infected 1,800 veterans with HIV
ST. LOUIS — The Veterans Administration said Thursday that the chief of dental services at a St. Louis VA Medical Center has been placed on administrative after the hospital urged nearly 2,000 veterans to return for blood tests because inadequately sterilized equipment may have exposed them to viral infections during dental procedures.
An independent board will also investigate how employees failed to properly sterilize the dental equipment that potentially exposed veterans to infections including hepatitis and HIV, the administration said.
"The mistakes made at the St. Louis VA Medical Center are unacceptable, and steps have been and continue to be taken to correct this situation and assure the safety of our veterans," VA Secretary Eric Shinseki said.
The VA sent letters out Monday to 1,812 veterans who had dental procedures at the St. Louis center from Feb. 1, 2009, through March 11 of this year, saying reviews determined that some sterilization steps in preparing dental instruments were not in compliance with standards.
Officials say the infection risk is extremely low, and no illnesses have been uncovered so far out of some 100 veterans who have come in for blood work that will screen for hepatitis B, hepatitis C and HIV.
Rep. Russ Carnahan, D-Mo., said the House Veterans' Affairs Committee also said they will investigate what happened at the center and planned to hold a hearing in St. Louis. The announced investigations follow demands for action by several lawmakers from Missouri and Illinois — the St. Louis region's five VA facilities serve veterans in both states.
VA Under Secretary for Health Dr. Robert Petzel said he found there was a need for an independent review by the national Administrative Investigation Board "to determine the reasons for failure to follow correct procedures."
No date has been set for the Veterans' Affairs Committee hearing in St. Louis. Two Missouri congressmen, Republican Blaine Luetkemeyer and Democrat William Lacy Clay, also asked the House Oversight and Government Reform Committee to investigate. Both serve on that committee.
Lawmakers also want to know why it took so long for the VA to inform the veterans about the mistakes. The problem was uncovered in March and letters went out Monday.
Marcena Gunter, a spokeswoman for the St. Louis center, said the delay was because officials were evaluating the risk posed to veterans.
The name of the suspended chief of dental services was not released. A VA spokeswoman did not respond to interview requests.
The VA said patients who have had dental procedures since March 11 are not at risk because procedures were corrected.
Shinseki said that over the past 18 months, VA has implemented more stringent safety oversight at its medical facilities, and that oversight led to the identification of problems at the St. Louis facility.
VA centers around the country have had problems in recent years. In 2007, Walter Reed Army Medical Center in Washington came under scrutiny over concerns about conditions at the hospital and treatment of veterans. At the time, St. Louis VA officials said they were working to fix similar problems.
That same year, a surgeon at the VA hospital in Marion, Ill., resigned after a patient bled to death following gall bladder surgery. All inpatient surgeries were suspended. The VA found at least nine deaths between October 2006 and March 2007 resulted from substandard care at the Marion hospital, and another 10 patients died after receiving questionable care that complicated their health.
Copyright © 2010 The Associated Press. All rights reserved.
Source
Text of the senators' letter
Wednesday, Jun. 30, 2010
General Eric Shinseki Secretary of Veterans Affairs
Department of Veterans Affairs
810 Vermont Avenue, Northwest
Washington, DC 20420
Dear Secretary Shinseki: Please note our deep disappointment and concern that 1,812 St. Louis area veterans were potentially exposed between February 2009 and March 2010 to dangerous blood-borne diseases, including Hepatitis B and C and HIV, through possible contact with improperly cleaned dental devices at the John Cochran VA Medical Center (VAMC) in St. Louis, Missouri. In light of other recent revelations by the VA Inspector General regarding problems with reprocessing of endoscopes at John Cochran and frequent customer service satisfaction problems reported at John Cochran, we are concerned about VA management of the facility. Veterans receiving care at John Cochran deserve the best quality care available, including absolute assuredness that the hospital is meeting the most basic and critical professional standards of cleanliness and conduct. We are also deeply concerned that the VA took four months to notify veterans who may have been endangered by the flawed procedures at the John Cochran VAMC, as well as to notify the area Congressional delegation so that we might assist our constituents. We appreciate that the VA acted quickly to remedy the flawed cleaning procedures but the failure to share information in a timely fashion about the situation is unacceptable. In addition, a follow up visit to John Cochran by VA Headquarters staff was not conducted until May, some two months after the initial inspection revealed problems with the cleaning of the dental devices. When a significant failure in procedures occurs, like that discovered at the John Cochran VAMC dental clinic, we would expect a more timely response and more aggressive oversight. The VA has decided to dedicate $5 million in funding to make infrastructure and other improvements at the John Cochran VAMC in light of this troubling incident. While we applaud the VA’s efforts to address aggressively underlying problems, including infrastructure problems that could have contributed to the failures in the dental clinic, we must be kept apprised of how the $5 million in renovations will be spent and prioritized. Please keep us informed about any follow up actions that the VA takes to train staff and improve standard operating procedures in the dental clinic and elsewhere in the hospital.
In closing, as you evaluate each of the 1,812 veterans who have received letters from the VA about potential exposure from improperly handled dental devices, we ask for an accounting of any health irregularities identified and attributed to the exposure. We know you value the health and safety of each and every veteran and strongly urge you to make sure that no veteran’s health goes unchecked in this case. We are committed to working with you, Mr. Secretary, to provide veterans with the resources they need to heal—resources they earned through their great service. The repeated failures to follow simple rules and regulations, however, is wholly unacceptable, and we want to know the measures you plan to implement in order to ensure this catastrophe never happens again. We thank you for your immediate attention to this matter and look forward to your reply. Should you have additional questions please feel free to contact us directly or to have your staff contact Tressa Guenov in Senator McCaskill’s office, Bo Prosch in Senator Bond’s office or Gabe Chavez in Senator Durbin’s office.
Sincerely,
Claire McCaskill UNITED STATES SENATOR
Christopher Bond UNITED STATES SENATOR
Richard Durbin UNITES STATES SENATOR
© 2007 Belleville News-Democrat and wire service sources.
All Rights Reserved. http://www.belleville.com/
Source
See Also:
Military men and women suffer abuse at the hands of their own doctors
VA hospital may have infected 1,800 veterans with HIV
Eiger BioPharmaceuticals Announces New HCV Synergy Data
Publication describes high level of synergy of clemizole with protease inhibitor class
PALO ALTO, Calif., July 1, 2010 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today the publication of research from the lab of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues entitled, "The Hepatitis C Virus (HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors".
"This work demonstrates that clemizole can yield high-level synergy with the protease inhibitor class," said David Cory, President and CEO of Eiger. "Inclusion of clemizole in future anti-HCV cocktails represents an attractive paradigm for increasing virologic response rates and may minimize unwanted side effects and combat drug resistance to HCV protease inhibitors."
"Clemizole appears to be able to dramatically increase the in vitro efficacy of other agents such as the NS3 protease inhibitors in advanced clinical development," said Jeffrey Glenn, M.D., Ph.D., Founder of Eiger. "The addition of clemizole to regimens may allow protease inhibitors to be used at lower doses, thereby maintaining the desired antiviral efficacy while avoiding the toxicities associated with the protease inhibitors such as severe rash and anemia. Clemizole has the potential to be an ideal component of future anti-HCV cocktails."
About NS4B and Clemizole
Binding of the non-structural protein NS4B to the 3' terminus of the HCV negative RNA strand is a recently identified target for drug intervention. The requirement of this target for viral replication has been genetically validated. The two component nature of this target, involving interaction between NS4B and HCV-RNA, creates mutational constraints that should decrease resistance to pharmacologic inhibitors, compared to agents designed against a single component target such as the NS3 protease. Clemizole hydrochloride was identified as a specific inhibitor of NS4B-RNA binding. The anti-HCV activity of clemizole is currently being investigated across genotypes in multiple HCV clinical proof of concept trials as a cocktail component with standard of care medications.
About Eiger BioPharmaceuticals, Inc. http://www.eigerbio.com/
Eiger is focused on the discovery and development of new antiviral agents against novel targets for the treatment of hepatitis virus infections. Eiger's pipeline includes repurposed clinical stage therapeutic agents as well as preclinical NCEs from discovery that exhibit antiviral activity against Hepatitis C, Hepatitis D, and other viruses. Eiger investors include InterWest Partners http://www.interwest.com/ and Vivo Ventures http://www.vivoventures.com/.
SOURCE Eiger BioPharmaceuticals, Inc.
Source
PALO ALTO, Calif., July 1, 2010 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today the publication of research from the lab of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues entitled, "The Hepatitis C Virus (HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors".
"This work demonstrates that clemizole can yield high-level synergy with the protease inhibitor class," said David Cory, President and CEO of Eiger. "Inclusion of clemizole in future anti-HCV cocktails represents an attractive paradigm for increasing virologic response rates and may minimize unwanted side effects and combat drug resistance to HCV protease inhibitors."
"Clemizole appears to be able to dramatically increase the in vitro efficacy of other agents such as the NS3 protease inhibitors in advanced clinical development," said Jeffrey Glenn, M.D., Ph.D., Founder of Eiger. "The addition of clemizole to regimens may allow protease inhibitors to be used at lower doses, thereby maintaining the desired antiviral efficacy while avoiding the toxicities associated with the protease inhibitors such as severe rash and anemia. Clemizole has the potential to be an ideal component of future anti-HCV cocktails."
About NS4B and Clemizole
Binding of the non-structural protein NS4B to the 3' terminus of the HCV negative RNA strand is a recently identified target for drug intervention. The requirement of this target for viral replication has been genetically validated. The two component nature of this target, involving interaction between NS4B and HCV-RNA, creates mutational constraints that should decrease resistance to pharmacologic inhibitors, compared to agents designed against a single component target such as the NS3 protease. Clemizole hydrochloride was identified as a specific inhibitor of NS4B-RNA binding. The anti-HCV activity of clemizole is currently being investigated across genotypes in multiple HCV clinical proof of concept trials as a cocktail component with standard of care medications.
About Eiger BioPharmaceuticals, Inc. http://www.eigerbio.com/
Eiger is focused on the discovery and development of new antiviral agents against novel targets for the treatment of hepatitis virus infections. Eiger's pipeline includes repurposed clinical stage therapeutic agents as well as preclinical NCEs from discovery that exhibit antiviral activity against Hepatitis C, Hepatitis D, and other viruses. Eiger investors include InterWest Partners http://www.interwest.com/ and Vivo Ventures http://www.vivoventures.com/.
SOURCE Eiger BioPharmaceuticals, Inc.
Source
Military men and women suffer abuse at the hands of their own doctors
July 1, 8:51 AM
Fort Lauderdale Domestic Violence & Abuse Examiner
Cheryl Whittaker
It is not enough to drive down the streets of Ft. Lauderdale every single day and witness day after day our homeless military personnel out on the streets begging for food, money, and shelter because they are being abused by the military and society.
Oh how we forget that these men and women have suffered enough abuse going in to war, watching their own peers die in front of their faces, coming home with disabilities and mental problems, to go seek help and suffer abuse at the hands of their American doctors and hospital staff.
These men and women who fought for our country are now faced with being at risk of HIV infection from unsafe dental practices. 1800 soldiers being mailed letters stating they may have been exposed to HIV from unclean dental equipment.
Over 3800 soldiers exposed to HIV and Hepititis C from having unclean colonoscopy equipment used on them in procedures.
What would a U.S. government run health care system look like? Well, one big indication is to examine what is going on at places where the United States government is already running health care. One of those place is at VA hospitals, and the reality is that the level of care that our veterans receive can only be described as horrific, abuse, and neglect.
When ABC news ran their story about the VA hospitals they found horrible, unconceivable conditions that our Veterans are suffering at the hands of their own people.
Bathrooms filthy with what appeared to be human excrement
Dirty linens from some patients mixed in with clean supplies
Examining tables that had dried blood and medications still on them
Equipment used to sterilize surgical instruments that had broken down
Some patients were forced to beg for food and water
Vets neglected so badly that they developed horrific bedsores and dangerous infections
As July 4th is coming we must remember the reason we are a free country is because men and women risk their lives to keep it a free country. It is our independence day as a country and we are a free country not because of our government but because of brave men and women who fight for our country.
Help stop veteran abuse. If you know of veterans being abused contact the U.S. Department of Veterans Affairs - 810 Vermont Avenue, NW - Washington, DC 20420
In Miami and Broward County
The Bruce W. Carter Department of Veterans Affairs Medical Center Patient Advocate is Cynthia Korland. Available from 7:30 a.m. to 4:30 p.m., and may be reached at (305) 575-3392 (305) 575-3392 or at room number 1D165. The fax number is (305) 575-3385.
The Broward County VA Outpatient Clinic Patient Advocate, Sheila McClendon, is available from 8:00 a.m. to 4:30 p.m., and may be reached by calling (954) 475-6500 (954) 475-6500 extension 8729.
Source
Also See: VA hospital may have infected 1,800 veterans with HIV
Blood transfusion risks and reactions
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