Source
February 22, 2012
VIDEO NBC News: New worry for baby boomers: Hepatitis C
Half of the 3 million Americans infected with Hepatitis C don’t even know it. NBC’s Nancy Snyderman reports.
Source
Source
New Hepatitis C Treatment
Reported February 22, 2012
(Ivanhoe Newswire) – Nearly four million people in the United States are infected with genotype-1 hepatitis C — a virus that attacks the liver, causing swelling, scarring, cancers and the need for transplants. And unlike hepatitis B, there is no vaccine for hepatitis C, until now.
Up until last summer, treating people with hepatitis C was a gamble, with many side effects, including anemia, vomiting, hair loss and depression.
"These treatments are very uncomfortable and long — up to 48 weeks," Jeremy Goldhaber-Fiebert, PhD, assistant professor at the Sanford University School of Medicine, was quoted as saying.
"Many people likened the experience to cancer chemotherapy: hard to undergo if the chance of treatment success is not that high."
With an impending spike in illnesses among the hepatitis-C-infected population in the United States, researchers and physicians have been developing new tests and treatments. The latest in a series of improved therapies — and the focus of the study — are two new virus-targeting drugs called protease inhibitors, boceprevir (trade name Victrelis) and telaprevir (trade name Incivek).
The drugs, which came out in the summer of 2011, were designed to be taken in conjunction with the standard treatment, which itself is a combination of two drugs, an interferon and an antiviral called ribavirin.
While the new triple therapies increase the chances of kicking the virus, they have more severe side effects — such as full body rash and rectal bleeding — and boost costs. Boceprevir adds $1,100 per week to the cost of treatment, and telaprevir adds $4,100 per week.
"At the outset, it was not at all clear to me that drugs as expensive as these, which are added onto the standard therapy, would result in sufficient benefits and reduced costs from averted liver cancers and transplants to make them cost-effective," said Goldhaber-Fiebert.
To find the answers, Goldhaber-Fiebert and his colleagues created a computer model of the hepatitis C disease. They compared the pros and the cons of three treatment strategies. And after intense statistical and simulation analysis, they found that the new triple therapies were indeed cost-effective for chronic hepatitis C patients with advanced liver disease. Despite the large price tag and side effects, the new treatments help these patients avoid costly cancers and liver transplants — as well as allowing them to live longer, higher-quality lives.
The closer the threat of severe disease, the more justified treatment costs and risks become, said Goldhaber-Fiebert. "That would be the bottom line."
"As more and better treatments become available, the decision will continue to evolve, requiring further analysis," added Shan Liu, a graduate student in management science and engineering in the School of Engineering and lead author of the study. "Patients and health systems could also benefit from price competition with multiple treatment options available."
"But ultimately, treatment decisions will remain a private conversation between a doctor and a patient," Liu was also quoted as saying.
SOURCE: Stanford University Medical Center, February, 2012
Also See: New Protease Inhibitors for the Treatment of Chronic Hepatitis C
Top Liver Cancer Specialists Gather in Denver, Colorado for TheraSphere® Summit
PRESS RELEASE
Feb. 22, 2012, 8:00 a.m. EST
OTTAWA, Feb. 22, 2012 /PRNewswire via COMTEX/ -- Nordion providing training, discussion forum for advanced users of radioactive glass microsphere treatment
Nordion Inc. a leading provider of products and services for the prevention, diagnosis and treatment of disease, is pleased to present the fourth TheraSphere Summit for Advanced Users, taking place February 24 in Denver, Colorado.
Nordion has invited over 100 interdisciplinary liver cancer specialists from hospitals and universities across the U.S. and Canada to attend the Summit. Moderated by Dr. Riad Salem, a world-renowned expert in interventional radiology and liver cancer treatment, the full-day program is a master class for experienced users of the innovative TheraSphere device, a radioactive glass microsphere treatment for hepatocellular carcinoma (HCC), a form of primary liver cancer.
"The TheraSphere Summit is for physicians who are already familiar with the device but want to improve their knowledge and hone their skills to better serve their patients," said Dr. Salem, Professor of Radiology, Medicine and Surgery and Director, Interventional Oncology at Northwestern University in Chicago. "It's an opportunity for them to gain insight from highly respected specialists representing a wide range of disciplines and experience."
Attendees will hear presentations about the latest techniques, research findings and case studies. The user community will also have a chance to share their feedback on every aspect of TheraSphere, from training programs to clinical support services, with senior members of the Nordion team.
"Hosting these sessions for our advanced users demonstrates Nordion's commitment to driving excellence within the TheraSphere brand," said Kevin Brooks, Nordion's Senior Vice President of Sales and Marketing. "These physicians are on the front lines of the fight against liver cancer, and we want to make sure they are armed with the best training and most up to date information available."
About TheraSphere TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.
TheraSphere is used to treat patients with unresectable hepatocellular carcinoma (HCC) and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with portal vein thrombosis (PVT). Patients will typically receive 1.8 treatments over their lifetime. TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.
Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert at www.nordion.com/therasphere .
About Nordion Inc. Nordion Inc. is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .
SOURCE Nordion Inc.
February 21, 2012
The Scientist Who Discovered Hepatitis C Says He’s Now Discovered the Vaccine
By Kristen Philipkoski Feb 21, 2012 5:11 PM
In a poetic turn of virology, the scientist who discovered hepatitis C in 1989 has now also discovered a vaccine that will hopefully cure the now-incurable disease.
Not only is it poetic, it's an accomplishment that many thought was impossible. Because hepatitis C is more virulent than HIV, no one was confident a vaccine against all the various strains around the world could be developed. But Michael Houghton, the University of Alberta researcher who announced his work today at the Canada Excellence Research Chairs Summit in Vancouver, says his vaccine works against every known strain of the virus.
It could still be up to seven years before the vaccine goes through the necessary phases of clinical trials and receives FDA approval, but it's amazing news for people who thought they'd be living with hepatitis C for the rest of their lives. It also remains to be seen how much impact the vaccine will have in people who already have the disease—it will be most effective as a preventive against acquiring the disease. Hundreds of thousands of people get hepatitis C every year, and 20 to 30 per cent of them develop liver disease.
Researchers at Oxford have also made progress towards a vaccine. With news out earlier today that hepatitis C now kills more Americans than HIV, a vaccine can't come soon enough.
Does This Patient With Liver Disease Have Cirrhosis?
The Rational Clinical Examination
CLINICIAN'S CORNER
JAMA. 2012;307(8):832-842. doi: 10.1001/jama.2012.186
Jacob A. Udell, MD, MPH, FRCPC; Charlie S. Wang, MD, MSc, FRCPC; Jill Tinmouth, MD, PhD, FRCPC; J. Mark FitzGerald, MB, FRCPC; Najib T. Ayas, MD, MPH, FRCPC; David L. Simel, MD, MHS; Michael Schulzer, MD, PhD; Edwin Mak, BASc; Eric M. Yoshida, MD, MHSc, FRCPC
[+] Author Affiliations
Abstract
Context Among adult patients with liver disease, the ability to identify those most likely to have cirrhosis noninvasively is challenging.
Objective To identify simple clinical indicators that can exclude or detect cirrhosis in adults with known or suspected liver disease.
Data Sources We searched MEDLINE and EMBASE (1966 to December 2011) and reference lists from retrieved articles, previous reviews, and physical examination textbooks.
Study Selection We retained 86 studies of adequate quality that evaluated the accuracy of clinical findings for identifying histologically proven cirrhosis.
Data Extraction Two authors independently abstracted data (sensitivity, specificity, and likelihood ratios [LRs]) and assessed methodological quality. Random-effects meta-analyses were used to calculate summary LRs across studies.
Results Among the 86 studies, 19 533 patients were included in this meta-analysis, among whom 4725 had biopsy-proven cirrhosis (prevalence rate, 24%; 95% CI, 20%-28%). Many physical examination and simple laboratory tests increase the likelihood of cirrhosis, though the presence of ascites (LR, 7.2; 95% CI, 2.9-12), a platelet count <160 × 103/μL (LR, 6.3; 95% CI, 4.3-8.3), spider nevi (LR, 4.3; 95% CI 2.4-6.2), or a combination of simple laboratory tests with the Bonacini cirrhosis discriminant score >7 (LR, 9.4; 95% CI, 2.6-37) are the most frequently studied, reliable, and informative results. For lowering the likelihood of cirrhosis, the most useful findings are a Lok index <0.2 (a score created from the platelet count, serum aspartate aminotransferase and alanine aminotransferase, and prothrombin international normalized ratio; LR, 0.09; 95% CI, 0.03-0.31); a platelet count ≥160 × 103/μL (LR, 0.29; 95% CI, 0.20-0.39); or the absence of hepatomegaly (LR, 0.37; 95% CI, 0.24-0.51). The overall impression of the clinician was not as informative as the individual findings or laboratory combinations.
Conclusions For identifying cirrhosis, the presence of a variety of clinical findings or abnormalities in a combination of simple laboratory tests that reflect the underlying pathophysiology increase its likelihood. To exclude cirrhosis, combinations of normal laboratory findings are most useful
Related article
JAMA Patient Page
Cirrhosis
Ann R. Punnoose, MD, Writer; Cassio Lynm, MA, Illustrator; Robert M. Golub, MD, Editor
JAMA. 2012;307(8):874.doi:10.1001/jama.2012.82
Cirrhosis is the end stage of any condition in which the liver progressively becomes scarred. It is diagnosed based on physical findings as well as a microscopic examination of liver tissue from a biopsy (tissue sample) or evidence from other diagnostic tests such as ultrasound. Under the microscope, cirrhosis appears as widespread bands of fibrous (made up of fibers) tissue that divide the liver into nodules (small knots or collections of tissue). Eventually, cirrhosis interferes with the function of the liver and can lead to liver failure or liver cancer. The February 22/29, 2012, issue of JAMA includes an article on diagnosing cirrhosis.
COMMON RISK FACTORS
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Hepatitis B or C infection
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Autoimmune liver diseases, which include autoimmune hepatitis, primary biliary cirrhosis, and primary sclerosing cholangitis
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Nonalcoholic fatty liver disease, often found in obese individuals who do not drink alcohol. Although it can have a benign course, it can sometimes progress to cirrhosis.
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Hereditary metabolic liver diseases, such as hemochromatosis (iron overload), Wilson disease (copper overload), and α1-antitrypsin deficiency (inability to make a type of protein)
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Long-term exposure to excess amounts of alcohol can lead to inflammation in the liver, which eventually causes cirrhosis.
PHYSICAL FINDINGS
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Because the liver does not appropriately process bile (a fluid that helps absorb digested fats) and bilirubin (a waste product), jaundice or yellowing of the skin may occur.
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Palmar erythema (redness of the palms), spider angiomas (blood vessels that spread out in a spider shape), gynecomastia (breast enlargement in men), decreased body hair, and shrinking of the testicles may occur.
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Patients can experience spontaneous bleeding because the liver is unable to make factors in the blood that form normal clots.
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As cirrhosis progresses, it becomes increasingly difficult for blood to travel through the vessels in the liver. This causes increased pressure (portal hypertension) in the portal vein (the major vein in the liver). This results in the formation of esophageal varices (enlarged veins in the esophagus) that can bleed easily.
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The liver is responsible for making several proteins, like albumin. Portal hypertension and low albumin levels cause ascites (accumulation of fluid in the abdominal space) and edema (water retention leading to swelling in dependent areas).
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As the liver fails, it becomes unable to remove toxins from the body. This buildup can affect a person's level of awareness, called hepatic encephalopathy.
TREATMENT
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If possible, treat the illness that led to cirrhosis to prevent progression or worsening of cirrhosis before liver failure or cancer develops.
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Control complications that cirrhosis causes by supplementing nutrition, transfusing clotting factors to prevent bleeding, and using medications to reduce ascites, edema, and the buildup of toxins.
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Avoid alcohol and any medications that could affect the liver.
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When cirrhosis progresses and the complications can no longer be controlled, physicians and their patients may discuss liver transplantation.
FOR MORE INFORMATION
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Mayo Clinic
www.mayoclinic.com/health/cirrhosis/DS00373 -
National Digestive Diseases Information Clearinghouse
digestive.niddk.nih.gov/ddiseases/pubs/cirrhosis/index.aspx
INFORM YOURSELF
To find this and previous JAMA Patient Pages, go to the Patient Page link on JAMA's website at www.jama.com. Many are available in English and Spanish. A Patient Page on liver transplantation was published in the January 18, 2012, issue.
From the laboratory to the patient: First Canadian Symposium on Hepatitis C to be held in Montreal
February 21, 2012 10:49 AM
MONTREAL, Feb. 21, 2012 /CNW Telbec/ - Montreal will host the first ever Canadian Symposium on the Hepatitis C Virus (HCV) on February 23 at the Hotel Hilton Bonaventure. Chaired by Dr. Naglaa Shoukry of the University of Montreal Hospital Research Centre (CRCHUM), this symposium will bring together around 200 researchers and clinicians from across Canada and around the world. The goal is to increase interactions and exchanges between researchers, healthcare professionals and community organizations to develop more effective strategies to meet the challenges of preventing and treating Hepatitis C.
CRCHUM researchers at the forefront of HCV research
CRCHUM researchers have spearheaded the development of many important discoveries in this area:
- The effectiveness of early treatment in restoring the immune response against HCV (Drs. Naglaa Shoukry and Julie Bruneau)
- Development of guidelines for HCV screening and treatment in injection drug users (Dr. Bruneau)
- Clinical trials for novel HCV antiviral therapies (Drs. Bernard Willems and Marc Bilodeau)
- Care and management of HCV infected patient post liver transplant (Dr. Denis Marleau).
"However," notes Dr. Shoukry, "these important breakthroughs remain all too often in the laboratory and only rarely make their way into the healthcare care community."
New drugs and resistance: a debate in the scientific community
Panellists will also address the recent approval and introduction of new drugs to fight this disease. While the advent of these pharmacological developments represents a significant treatment breakthrough, it also raises issues related to drug resistance and access to these drugs by vulnerable and marginalized populations. These two themes will figure prominently in discussions at the symposium. "Our expectation is that this meeting will set the agenda for research and community outreach for the coming years," notes Shoukry.
Internationally renowned speakers
The symposium is organized by the National CIHR Research Training Program in Hepatitis C. It, which will feature speakers from throughout North America and Europe, will be held at the Hilton Bonaventure Hotel in Montreal. Topics will include a broad range of issues ranging from the virology of HCV, immunity and vaccine development against HCV to socially-based approaches to HCV prevention, psychological issues in the care of people living with hepatitis C and potential problems associated with the new treatments for HCV.
The keynote speaker at the conference is Dr. Jean-Michel Pawlotsky from the University of Paris-Est and the Henri Mondor University Hospital in Créteil, France, a leading authority on treatment of hepatitis C. "This symposium is a major first step in ensuring that basic and clinical research findings reach those who matter the most—patients," notes Dr. Shoukry.
Hepatitis C
- The hepatitis C virus (HCV) infects 170 million individuals worldwide.
- In Canada, approximately 240,000 people are infected
- In Canada, there are 4,000 new infections each year.
- The majority of HCV exposed individuals develop a life-long persistent infection that can lead to irreversible liver damage and cancer.
About the CRCHUM: www.crchum.qc.ca
About Dr Naglaa Shoukry:
http://www.chumtl.qc.ca/userfiles/Image/CENTRE_RECHERCHE/CRCHUM/Documentaions/Recherche20CRCHUM/RechercheCRCHUM_vol1no1_fr_.pdf
About the National CIHR Research Training Program in Hepatitis C: http://www.ncrtp-hepc.ca/
For further information:
Source : CRCHUM
Information:
Richard Ashby
Associate Director, Information and Development
CRCHUM
(514) 890-8000 / 14090
Richard.ashby.chum@ssss.gouv.qc.ca
Patients’ Expectations About New HCV Direct-Acting Antivirals Often Unrealistic
Gatroenterology & Endoscopy News ISSUE: FEBRUARY 2012 | VOLUME: 63:2
Careful Patient Selection, Education Is Key for Success
by Christina Frangou
San Francisco—Soon after the FDA approved two direct-acting antiviral agents (DAAs) last spring for treating infection with hepatitis C virus (HCV), a 57-year-old black man came to see gastroenterologist Andrew Muir, MD.
The man had been diagnosed with hepatitis C in 2001. A liver biopsy one year later revealed he had stage II fibrosis. At the time, the patient declined treatment, saying the duration was too long and offered too few benefits.
But recently, he came back to Dr. Muir wanting to try a new protease inhibitor. Based on his reading, the man believed he could avoid interferon (IFN) and ribavirin (RBV), take a protease inhibitor as monotherapy for 24 weeks and expect a 75% chance of achieving a sustained virologic response (SVR).
Unfortunately, the patient’s expectations were unrealistic on all counts. The new protease inhibitor can only be given in conjunction with IFN and RBV, and the treatment duration varies. For blacks, therapy usually lasts a full 48 weeks, and in clinical trials, only 30% of black patients achieved an SVR with 28 weeks of therapy. Moreover, among black patients in the Phase III trials, SVR rates fell short of the 75% that the patient expected, and in treatment-naive blacks, only 62% receiving telaprevir and 53% on boceprevir achieved an SVR.
Educate To Encourage Adherence
Unrealistic expectations are common among patients with HCV infection who, after years of waiting for better therapies, are eager to try treatment with the new DAAs, said Dr. Muir. The DAAs on the market today are complex, with varied stoppage rules, monitoring points and some serious adverse events and drug–drug interactions.
“This is a real problem for clinicians. There’s tremendous excitement about these new therapies, but oftentimes, patients’ expectations are not in line with what these drugs can deliver,” said Dr. Muir, clinical director of hepatology at Duke University Medical Center, Durham, N.C.
In a presentation at The Liver Meeting 2011, Dr. Muir stressed that clinicians need to take time to carefully prepare patients for DAA therapy. Physicians must have clear, detailed discussions with their patients before and throughout treatment to optimize the benefits of DAA therapy, he said.
“The major challenges are preparing patients for the rigors of therapy, checking in frequently to make decisions about the duration of treatment and managing any issues as the patient goes along,” said Dr. Muir.
When patients come into the office considering treatment with DAAs, the first step is to clarify their expectations, said Dr. Muir. Patients need to learn the reality about DAAs if they want treatment to succeed.
Dr. Muir outlines for patients the complex prescribing rules, the contraindications, the lifestyle changes and duration of treatment with DAAs. The lifestyle changes can be significant, he cautions patients. Both telaprevir and boceprevir must be taken three times a day, or once every eight hours, and always with a meal. Dr. Muir then asks if the patient still wants treatment when these things are taken into account.
“That’s no small feat. Patients must adhere to that regimen because lapses in the concentration of telaprevir and boceprevir have historically been the risk period for breakthrough variants on therapy,” said Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital, Boston. Many of Dr. Chung’s patients limit or reschedule their work hours while on DAA therapy to help with adherence.
The key to getting patients through DAA treatment successfully is to select patients carefully and prepare them assiduously, said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Dallas. “This means that any issues that might impact compliance, tolerance and drug access should be dealt with before treatment starts. Educating the patient is essential. Patients and their support person need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points.”
The treatment care team then needs to remain in close contact with the patient throughout treatment to reinforce adherence and offer feedback on their process, he added. At Dr. Chung’s office at Massachusetts General Hospital, one nurse practitioner has been assigned full-time to managing patients on DAAs. She works with them on everything from managing possible reactions like rash and anemia to helping them set up a daily schedule for taking the medications.
“We have 50 to 100 patients in varying stages of DAA treatment,” said Dr. Chung. “Every one of these patients is coming in for frequent visits—weekly in the beginning—and they are very much in need of monitoring, not just for adverse events like rash but also for fatigue and their ability to carry out work.”
Begin With a Thorough History
Before patients start the new therapies, gastroenterologists and hepatologists should consider getting a liver biopsy to help guide treatment, said Dr. Muir. Physicians also should confirm a patient’s history of treatment for HCV. If patients were previously on antiviral therapies, physicians need to find out as much as they can about that experience.
“You must ask whether we can improve upon previous treatment,” said Dr. Muir. “Were there adverse events with treatments? Were there dose reductions? If so, were they appropriate? How was patient adherence to medications? Did they use alcohol?”
Based on that information, physicians should outline the likelihood of each individual patient achieving an SVR, he said. The key predictors of SVR are whether patients are treatment-naive or treatment-experienced, whether they have cirrhosis and their race. Another important issue for patients is treatment duration. Duration will vary depending on each patient’s characteristics. “It’s important to speak with every patient about their likelihood of a shorter duration of treatment,” said Dr. Muir.
The American Association for the Study of Liver Diseases recommends 48 weeks of treatment for all patients with cirrhosis, as fewer patients with cirrhosis were included in the clinical trials that led to approval of the new drugs. Among those included, virologic response levels were lower than for patients without cirrhosis. For treatment-naive patients, 46% of non-black and 29% of black patients in the boceprevir SPRINT-2 (Serine Protease Inhibitor Therapy 2) trial achieved undetectable levels of HCV by 28 weeks, making them eligible for the shortened course of treatment (Poordad F et al. N Engl J Med 2011;364:1195-1206). In the telaprevir trial, 58% of patients had an early rapid virologic response (Jacobson IM et al. N Engl J Med 2011;364:2405-2416).
Patients’ interleukin-28B (IL28B) genotype also affects the expected duration of treatment. For both boceprevir and telaprevir, patients with the IL28B CC genotype are most likely to attain an early virologic response, more likely to receive a shortened course of therapy and more likely to have an SVR, according to studies presented at last year’s annual meeting of the European Association for the Study of the Liver.
Follow Through: Monitor for Response, Resistance, Reactions, Interactions
When the new HCV drugs were first approved, physicians’ offices reported some trouble getting approval from third-party payers for the full course of treatment, said Dr. Chung. His office had to provide documentation of successful early virologic response to get the go-ahead from payers to approve continuation of treatment with a protease inhibitor.
“You can imagine that if any gaps occur in the virologic tests or their reporting, this could lead to interruption of protease inhibitor therapy. It’s been a real challenge,” he said.
Experts recommend following patients very carefully over the course of treatment, monitoring any virologic breakthroughs or adverse reactions to the medications, particularly rash and anemia. Dr. Chung sees patients after the first, second and fourth week of therapy, and every four weeks thereafter if patients are having an uneventful course. Treatment monitoring is essential to prevent unwarranted continuation of treatment in patients when a breakthrough has occurred, he said.
“That would signal the emergence of resistant variants. Upon discovery, it would be paramount to discontinue the entire regimen to prevent selection of additional resistance mutations,” he said.
Equally important is the need to monitor patients closely for adverse reactions and drug–drug interactions. As IFN and RBV remain the backbone of this HCV regimen, the same contraindications exist as with standard dual therapy: decompensated cirrhosis, renal insufficiency, advanced cardiac/pulmonary disease, active depression, severe mental illness, anemia/neutropenia/thrombocytopenia and noncompliance.
Additionally, there are important drug–drug interactions with boceprevir and telaprevir. Both DAAs inhibit the CYP3A4/5 enzyme. Drugs metabolized by CYP3A4/5 may have increased effect in the presence of boceprevir or telaprevir. The DAAs themselves are metabolized by this cytochrome. As a result, other drugs that induce or inhibit CYP3A4/5 could affect HCV levels.
“Planning is key to deal with drug–drug interactions,” said Dr. Muir. It’s very important to do a risk–benefit analysis of treatment with boceprevir and telaprevir, taking into account patients’ comorbidities, he added.
It is important to review all drugs that the patient is taking, including over-the-counter and herbal medications. Check with the patient’s primary care provider, cardiologist and psychiatrist about medication use, Dr. Muir said. “It’s a good time to revisit the need for all medications. Ask if the antidepressant can be changed, the blood pressure medicines. Can the patient hold their statin for 12 weeks?” he said.
Women taking oral contraceptives should be advised to try other methods of contraception, such as an intrauterine device or barrier methods. Additionally, pregnant women should not take either drug, as both are considered pregnancy category X, meaning the risks “clearly outweigh potential benefits,” according to the FDA.
Anemia and rashes are the two most common adverse events associated with the new therapies. Experts suggest physicians be proactive about managing both.
Before a patient starts therapy, do a pretreatment evaluation for anemia and consider the impact on comorbidities, such as cardiac and pulmonary disorders. Weigh the benefits of reducing the dose versus increasing or starting erythropoietin.
For rashes, patients should be proactive by moisturizing twice a day, limiting sun exposure and wearing loose-fitting clothing. Dr. Chung recommends including a dermatologist on the treatment team.
Keep an Eye on the ‘Holy Grail of Therapy’
One other important element that needs to be taken into account when considering patients for DAA therapy is whether patients should wait for something else to be approved, said Dr. Chung. Recent results from Phase II studies of second-generation DAAs suggest that some combination of these could be approved in the next three years (see “New Polymerase Inhibitor Could Become Cornerstone of Interferon-free HCV Treatment Regimen,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:16 and “Second Study of New Hep C Drug Is Promising for Difficult-to-Treat HCV Genotype 1 Patients,” by Christina Frangou. Gastroenterology & Endoscopy News 2012;63[2]:17-19). These therapies omit IFN from the treatment regimen and can generally be taken orally once a day, with or without food.
“That’s something critical to consider. With all the complexities of therapy—the issues of tolerability, adherence, drug–drug interactions, quality of life—there’s another equally important set of events going on, and that’s the emerging data on all-oral, interferon-free treatments,” said Dr. Chung. “It’s clear that the promise of interferon-sparing therapy is very real. For all of us, that would be the holy grail of therapy.”
Dr. Chung currently recommends that all patients with HCV infection who have advanced-stage disease, regardless of whether they are treatment-naive or experienced, should be considered for boceprevir or telaprevir, provided the benefits outweigh the risks. Patients who can reasonably defer treatment because of early-stage disease or who cannot tolerate IFN may be able to wait for investigational therapies to be approved. These patients also may be eligible for investigational studies, which are ongoing.
Dr. Muir disclosed that he is on advisory committees or review panels for Merck & Co., and Vertex Pharmaceuticals; is a consultant for Inhibitex, Merck & Co., and Vertex Pharmaceuticals; and receives grant/research support from Abbott Laboratories, Anadys, Bristol-Myers Squibb, Gilead, Medtronic, Merck & Co., Pfizer, Roche, Santaris, Scynexis and Vertex Pharmaceuticals. Dr. Chung receives grant/research support from Gilead, Merck & Co., Pfizer and Romark. Dr. Davis is a consultant for Vertex Pharmaceuticals and receives grant/research support from Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, Novartis, Pharmasset, Tibotec and Vertex Pharmaceuticals.
Hepatitis C Bigger Killer than HIV
By Michael Smith, North American Correspondent, MedPage Today
Published: February 20, 2012
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.
More Americans now die from hepatitis C infection than from HIV, researchers from the Centers for Disease Control and Prevention reported.
The rate of HIV deaths has been falling while the rate for hepatitis C has been rising and the two curves crossed each other in 2007, according to Kathleen Ly, MPH, and colleagues.
In that year, they wrote in the Feb. 21 issue of Annals of Internal Medicine, 12,734 deaths were blamed on HIV, compared with 15,106 attributed to hepatitis C.
The analysis, based on death certificates from 1999 through 2007, also showed that the death rate for hepatitis B has been falling slightly, although it was the underlying or contributing cause of 1,815 deaths in 2007.
The figures probably represent "only a fraction of a larger burden of morbidity and mortality from viral hepatitis," Ly and colleagues argued, noting that chronic hepatitis infection -- both B and C -- is most prevalent among people born from 1945 through 1965.
Most of those with the disease do not know they are infected and they are now reaching the age where they are at risk for hepatitis-related diseases and death, they noted.
Indeed, in 2007, 73.4% of hepatitis C-related deaths were among people ages 45 through 64, while 59.4% of hepatitis B-related deaths occurred in that age group, they found.
Ly and colleagues cautioned that someone other than the primary physician often completes death certificates, so that they may not be completely accurate. But the effect of that bias, they noted, should be roughly the same over time and so should not affect the trends.
Also, they noted, viral hepatitis was often not detected and thus not reported as a cause of death.
The findings come at a time when the treatment picture for hepatitis C is changing rapidly, as a range of new direct-acting agents is approved and comes to the clinic.
Before 1990, HCV infection had only a 10% cure rate with early interferon monotherapy. In 2011, HCV-specific protease inhibitors combined with pegylated interferon and ribavirin, achieved close to 70% sustained virologic response rates for patients with genotype 1 infections.
Within five years, it may be possible to achieve 90% cure rates using combinations of the new agents, according to Harvey Alter, MD, and Jake Liang, MD, both of the National Institutes of Health in Bethesda, Md.
"What is currently lacking in this optimistic perspective is a national 'find-and-treat' policy" to reduce the burden of the disease, they argued in an accompanying editorial.
Preventing the long-term consequences of hepatitis C – liver disease and cancer – "is now achievable if our collective will can evolve as rapidly as our pharmacologic skill."
One possible step forward would be a change in screening policy for hepatitis C, according to David Rein, PhD, of the social science research organization NORC at the University of Chicago in Atlanta, and colleagues.
Currently, the CDC recommends antibody screening for people with such risk factors or indicators as a history of injection-drug use or elevated alanine aminotransferase levels.
But one-time screening and then treating people based on birth cohort – specifically those born from 1945 through 1965 – would be cost-effective, Rein and colleagues argued in a companion study in the journal.
Their analysis showed that birth-cohort screening identified an extra 808,580 cases of chronic infection, compared with the status quo, at a cost of $2,874 per case.
Depending on the form of subsequent treatment, the screening would prevent between 82,300 and 121,000 deaths, with an incremental cost-effectiveness ratio per quality-adjusted life year gained ranged from $15,700 to $35,700, Rein and colleagues calculated.
The analysis of hepatitis C burden was supported by the CDC. The authors are employees of the agency.
The analysis of birth-cohort screening was supported by the CDC. Rein did not report any financial links with industry. Several authors are employees of the CDC.
The journal said the editorial authors made no disclosures.
Primary source: Annals of Internal Medicine
Source reference:
Ly KN, et al "The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007" Ann Intern Med 2012; 156: 271-278.
Additional source: Annals of Internal Medicine
Source reference:
Rein DB, et al "The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings" Ann Intern Med 2012; 156: 263-270.
Additional source: Annals of Internal Medicine
Source reference:
Alter HJ, Liang TJ "Hepatitis C: The end of the beginning and possibly the beginning of the end" Ann Intern Med 2012; 156: 317-319.
Also See:
Enanta Enters Into Strategic Collaboration to Advance NS5A Inhibitor Candidate for HCV
WATERTOWN, Mass., Feb. 21, 2012 /PRNewswire/ -- Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced today that it has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. Enanta has received IND approval for EDP-239 from the FDA.
NS5A, a clinically validated target, is a non-structural viral protein that is essential to viral replication. Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development. Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts. EDP-239, Enanta's lead candidate targeting NS5A was most recently recognized on Windhover's list of the "Top Most Interesting Infectious Disease Projects to Watch".
Under the terms of the agreement, Enanta will receive an upfront payment of $34 million and is eligible to receive up to $406 million if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains co-detail rights in the United States. Novartis will be responsible for all costs associated with the development, manufacture and commercialization of EDP-239 and will fund Enanta's drug discovery efforts on certain additional compounds targeting NS5A.
"Novartis is a recognized leader in the field of HCV, and access to its global expertise combined with our shared vision for commercializing HCV therapies will support the successful development and commercialization of products targeting NS5A," said Jay R. Luly, PhD, President & CEO, Enanta Pharmaceuticals. "We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans."
About the Hepatitis C Virus
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
About Enanta
Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field. Enanta is developing novel protease, NS5A, nucleoside(tide) polymerase, and cyclophilin-based inhibitors targeted against the Hepatitis C virus (HCV). Additionally, the Company has created a new class of antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include overcoming resistance to superbugs, treating respiratory tract infections, and developing intravenous and oral treatments for hospital and community MRSA infections. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at www.enanta.com.
For Enanta Investor Relations, please contact:
Paul Mellett
617-607-0761
For Enanta Public Relations, please contact MacDougall Biomedical Communications:
Kari Watson
781-235-3060 or kwatson@macbiocom.com
SOURCE Enanta Pharmaceuticals, Inc.
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February 20, 2012
Model Explains Efficacy of HIV Drugs
By Michael Smith, North American Correspondent, MedPage Today
Published: February 19, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.
Any HIV therapy that reduces the risk of an immune cell being infected by a factor of at least 100,000 is enough to keep the virus in check, researchers reported.
The finding, from a detailed mathematical model of antiviral activity, suggests why some drugs and drug combinations do better than others, according to Robert Siliciano, MD, PhD, of Johns Hopkins University in Baltimore and colleagues.
And the model also demonstrated that the complexity and cost of HIV treatment might be reduced -- and access to treatment improved -- by choosing drugs based on their ability to inhibit infection, Siliciano and colleagues reported online in Nature Medicine.
In principle, it might even be possible to move to dual therapy or even monotherapy, if the inhibition remained high enough, Siliciano told MedPage Today. "There are trials of (protease inhibitor) monotherapy already, with reasonably good results," he wrote in an email.
The key to the model, the researcher said, is understanding how well individual drugs block the infection of immune cells in a single round of replication and then calculating what happens to the inhibition when drugs are combined.
In some combinations, the individual effects are nearly independent of each other, increasing the power of the regimen as a whole, the researchers reported.
In others, the drugs share a common target and their effects add up, but not as much as might be expected, they found.
For this analysis, the researchers calculated the instantaneous inhibitory potential (IIP) of a range of commonly used drugs and combinations. IIP is a useful and intuitive measure of antiviral activity, the authors explained.
They defined the IIP as the log reduction in infected cells caused by a drug or combination.
Among the surprises, Siliciano said, was the fact that the IIP varied widely among drugs.
For instance, one of the earliest anti-retrovirals -- the nucleoside analogue reverse transcriptase inhibitor stavudine (or d4T) -- had an IIP of less than one log.
In contrast, the boosted protease inhibitor darunavir (Prezista) had an IIP of about 10 logs by itself, while the combination of darunavir and efavirenz (Sustiva), had an IIP of about 12 logs.
Overall, the researchers reported, a drug or regimen can be effective if its IIP is between five and eight logs.
But of 31 regimens evaluated, only one with an IIP of less than eight was able to reduce the viral load to undetectable in 70% of patients after 48 weeks.
"Overall, the results fit well with clinical results," Siliciano said.
The work could help refine anti-HIV strategy, which for years has focused in attacking different aspects of the viral life cycle. In most cases, the approach worked but it wasn't clear why come combinations worked and others did not.
"What this work does is explain why some combinations work and others don't," Siliciano said.
There no immediate clinical application of the work, but it will help in "shaping future clinical research questions," Siliciano said.
The study was supported by the NIH and the Howard Hughes Medical Institute.
The journal said the authors declared no competing financial interests.
Primary source: Nature Medicine
Source reference:
Jilek BJ, et al. "A quantitative basis for antiretroviral therapy for HIV-1 infection" Nature Medicine 2012; DOI: 10.1038/nm.2649.
New Protease Inhibitors for the Treatment of Chronic Hepatitis C
A Cost-Effectiveness Analysis
Shan Liu, SM; Lauren E. Cipriano, BSc, BA; Mark Holodniy, MD; Douglas K. Owens, MD, MS; and Jeremy D. Goldhaber-Fiebert, PhD
Abstract
Background: Chronic hepatitis C virus is difficult to treat and affects approximately 3 million Americans. Protease inhibitors increase the effectiveness of standard therapy, but they are costly. A genetic assay may identify patients most likely to benefit from this treatment advance.
Objective: To assess the cost-effectiveness of new protease inhibitors and an interleukin (IL)–28B genotyping assay for treating chronic hepatitis C virus.
Design: Decision-analytic Markov model.
Data Sources: Published literature and expert opinion.
Target Population: Treatment-naive patients with chronic, genotype 1 hepatitis C virus monoinfection.
Time Horizon: Lifetime.
Perspective: Societal.
Intervention: Strategies are defined by the use of IL-28B genotyping and type of treatment (standard therapy [pegylated interferon with ribavirin]; triple therapy [standard therapy and a protease inhibitor]). Interleukin-28B–guided triple therapy stratifies patients with CC genotypes to standard therapy and those with non-CC types to triple therapy.
Outcome Measures: Discounted costs (in 2010 U.S. dollars) and quality-adjusted life-years (QALYs); incremental cost-effectiveness ratios.
Results of Base-Case Analysis: For patients with mild and advanced fibrosis, universal triple therapy reduced the lifetime risk for hepatocellular carcinoma by 38% and 28%, respectively, and increased quality-adjusted life expectancy by 3% and 8%, respectively, compared with standard therapy. Gains from IL-28B–guided triple therapy were smaller. If the protease inhibitor costs $1100 per week, universal triple therapy costs $102 600 per QALY (mild fibrosis) or $51 500 per QALY (advanced fibrosis) compared with IL-28B–guided triple therapy and $70 100 per QALY (mild fibrosis) and $36 300 per QALY (advanced fibrosis) compared with standard therapy.
Results of Sensitivity Analysis: Results were sensitive to the cost of protease inhibitors and treatment adherence rates.
Limitation: Data on the long-term comparative effectiveness of the new protease inhibitors are lacking.
Conclusion: Both universal triple therapy and IL-28B–guided triple therapy are cost-effective when the least-expensive protease inhibitor are used for patients with advanced fibrosis.
Primary Funding Source: Stanford University.
Boomers' Drug Use Pushes Hepatitis Deaths Past HIV, Study Finds
February 20, 2012 10:00 PM
Feb. 20 (Bloomberg) -- Deaths attributed to hepatitis in the U.S. rose during the past decade to surpass those from HIV, posing a future public health burden as most people aren't aware they are infected.
The baby boom generation, those born from 1946 to 1964, are the most at risk to the bloodborne virus, said John Ward, director of the Centers for Disease Control and Prevention's hepatitis division, and an author of the study.
“Injection drug use was frequent in this age group, and even one-time exposure to injection drug use carries a high risk,” Ward said in an interview. “Seventy-five percent of the mortality is in this age group, and that mortality is increasing. That's the sobering facts for the baby boom generation.”
Hepatitis is a viral infection that can cause swelling and inflammation of the liver and can lead to damage of the organ, cancer and death, according to the National Institutes of Health. The virus has different forms -- A, B and C -- which are further broken down into subgroups called genotypes.
Researchers studied 22 million death records from 1999 to 2007, finding 15,000 died from hepatitis C alone, compared with 13,000 from HIV. As many as 1.4 million people are living with chronic hepatitis B, according to the study, and 3.2 million have hepatitis C, with two-thirds born from 1946 to 1964. The results were reported today in the Annals of Internal Medicine.
‘So Little Attention'
“Few diseases of such morbidity and mortality in the United States have received so little public attention and funding as chronic viral hepatitis,” the researchers wrote in the study.
A vaccine for hepatitis B was first approved by the U.S. Food and Drug Administration in 1981, and has been recommended for all infants since the early 1990s, Ward said, eliminating its prevalence among younger generations. Hepatitis C wasn't discovered until 1989 and has no vaccine, he said.
“It's an infection that doesn't always cause you to become ill when you become infected,” Ward said. “It progresses silently over decades, and many people do not become symptomatic or sick until their liver damage is quite advanced, or they develop liver cancer, and so for those reasons, the scope of the problem is underappreciated.”
As many as 170 million people worldwide are chronically infected with the hepatitis C virus, according to the World Health Organization.
HIV Cases
While the number of people infected with HIV rose to 34 million globally in 2009, the virus that leads to AIDS, once a death sentence, can be reduced to low levels in the blood with use of combination antiviral medicines. About 1.2 million Americans have HIV, with about 43,000 new cases reported in 2008, according to the CDC.
The standard treatment for hepatitis C for the past decade has been a combination of the antiviral drug ribavirin with interferon, an immune-boosting protein sold by Merck & Co. as PegIntron and by Roche Holding AG as Pegasys. Patients receive weekly shots of Interferon for as long as a year, which can cause side effects such as fatigue and flu-like symptoms.
A new class of drugs were introduced last year called protease inhibitors, including Victrelis from Whitehouse Station, New Jersey-based Merck and Incivek by Vertex Pharmaceuticals Inc. of Cambridge, Massachusetts. These medicines attack the virus itself, and have been shown to cure more patients in less time with fewer side effects, although they still must be combined with Interferon shots.
Potential Breakthrough
A further breakthrough in treatment may come this year with the development of the experimental drug class called nucleotide polymerase inhibitors, which bind to a different part of the virus than the protease inhibitors. These drugs are pan- genotypic -- meaning they are effective across the different types of hepatitis C. They could become the backbone for an Interferon-free combination.
Abbott Laboratories, Bristol-Myers Squibb Co., Gilead Sciences Inc., Johnson & Johnson, Merck and Vertex are among the drugmakers acquiring and developing these new therapies as they seek a potential combination that may lead to a cocktail pill to control the disease, similar to the approach taken with HIV drugs.
--Editors: Andrew Pollack, Stephen West
Benefits of hepatitis C treatment outweigh costs for patients with advanced disease
A towering $60,000 bill, a year of fierce, flu-like symptoms and a running risk of depression are among the possible costs of two new hepatitis C treatments. But according to Stanford University health policy researchers, they might be worth it.
Using a computer model of hepatitis C disease — which accounts for different treatments, outcomes, disease stages and genetics — a research team led by Jeremy Goldhaber-Fiebert, PhD, found that new triple-therapies for genotype-1 hepatitis C are cost-effective for patients with advanced disease. Their results will be published Feb. 21 in the Annals of Internal Medicine.
"With so many simultaneous factors, it's very hard to know what to do," said Shan Liu, a graduate student in management science and engineering in the School of Engineering and lead author of the study. "I think building models is a very eloquent and abstract way to inform difficult policy decisions."
Nearly 4 million people in the United States are infected with genotype-1 hepatitis C — a virus that attacks the liver, causing swelling, scarring, cancers and the need for transplants. Many of those infected are age 50 or older, meaning they may have long-term infections and could face serious hepatitis C-related diseases. Unlike hepatitis B, there is no vaccine for hepatitis C. Until last summer, hepatitis C treatments were a gamble with many side effects, including anemia, vomiting, hair loss and depression.
"These treatments are very uncomfortable and long — up to 48 weeks," said Goldhaber-Fiebert, assistant professor of medicine at the School of Medicine. "Many people likened the experience to cancer chemotherapy: hard to undergo if the chance of treatment success is not that high."
With an impending spike in illnesses among the hepatitis-C-infected population in the United States, researchers and physicians have been developing new tests and treatments. For instance, researchers recently identified a specific DNA sequence in the gene that codes an immune response regulator, called IL28b. Different IL28b sequences predict whether treatment will successfully clear the virus.
The latest in a series of improved therapies — and the focus of the study — are two new virus-targeting drugs called protease inhibitors, boceprevir (trade name Victrelis) and telaprevir (trade name Incivek).
The drugs, which came out in the summer of 2011, were designed to be taken in conjunction with the standard treatment, which itself is a combination of two drugs, an interferon and an antiviral called ribavirin. While the new triple therapies increase the chances of kicking the virus, they have more severe side effects — such as full body rash and rectal bleeding — and boost costs. Boceprevir adds $1,100 per week to the cost of treatment, and telaprevir adds $4,100 per week.
"At the outset, it was not at all clear to me that drugs as expensive as these, which are added onto the standard therapy, would result in sufficient benefits and reduced costs from averted liver cancers and transplants to make them cost-effective," said Goldhaber-Fiebert, who is also a faculty member of Stanford Health Policy at the university's Freeman Spogli Institute for International Studies.
Goldhaber-Fiebert, Liu and their colleagues wanted to know when or if doctors should prescribe the new treatments. Should doctors prescribe them to all hepatitis C patients? Or, should only patients with advanced disease be treated with the new drugs? With such high costs, the answers could have sweeping impacts on health-care budgets, particularly for public health systems such as the Department of Veterans Affairs hospitals where many hepatitis C patients receive care.
To find the answers, they used their model to compare the pros and cons of three treatment strategies: Giving all hepatitis C patients the standard treatment, giving all of them a triple therapy or giving triple therapy only to those patients less likely — based on their IL-28B gene — to respond to standard therapy. For each strategy, they examined both of the new triple therapies. They also considered patients with mild and advanced disease.
After intense statistical and simulation analysis, the model showed that the new triple therapies were indeed cost-effective for chronic hepatitis C patients with advanced liver disease. Despite the large price tag and side effects, the new treatments help these patients avoid costly cancers and liver transplants — as well as allowing them to live longer, higher-quality lives.
For those patients with mild disease, the model indicated that determining their IL-28B genotype is the best next step, before prescribing a treatment.
The closer the threat of severe disease, the more justified treatment costs and risks become, said Goldhaber-Fiebert. "That would be the bottom line."
Though these new drugs may offer relatively desirable options now, both Goldhaber-Fiebert and Liu noted that additional, and perhaps more effective, drugs are already in clinical trials.
"As more and better treatments become available, the decision will continue to evolve, requiring further analysis," Liu said. "Patients and health systems could also benefit from price competition with multiple treatment options available." But ultimately, she added, treatment decisions will remain a private conversation between a doctor and a patient.
Hepatitis C Now Killing More Americans than HIV
Image courtesy of iStockphoto/sjlocke
By Katherine Harmon | February 20, 2012|
The number of people who die from HIV-related causes each year in the U.S. is now down to about 12,700—from a peak of more than 50,000 in the mid-1990s—thanks to condom education and distribution campaigns, increased testing and improved treatments. But now a different infectious disease is quietly killing even more people than HIV is:
The majority of the 3.2 million people who are estimated to have chronic hepatitis C virus (HCV) in the U.S. are baby boomer adults.
And most of those infected with the virus do not know that they have it, which means they could easily be spreading it to others via exposure to blood—or, occasionally, sexual contact.
Although long-term intravenous drug users are at particular risk, so are “those who experimented with [such] drugs for a limited time in their youth,” Harvey Alter and T. Jake Liang, both of the National Institutes of Health, wrote in an essay published online Monday in Annals of Internal Medicine. “These bygone experiences do not often connote risk to the affected persons nor serve as a reason to seek testing,” they noted, making this slow-developing disease difficult to catch before it develops into cirrhosis or liver cancer (hepatocellular carcinoma). Their essay was part of a four-paper special series on hepatitis C.
More than 15,000 people died from hepatitis C-related issues in the U.S. in 2007—about three quarters of whom were people aged 45 to 64, according to Alter and Liang. And that number is expected to double as the bulk of the population with the disease get older. The cost of treating all of these people is likely to top $6.7 billion in the decade of 2010 to 2019.
Much of that growth is anticipated because those infected with hepatitis C often don’t seek treatment until the disease has caused serious damage, according to another paper published Monday in the same issue of Annals of Internal Medicine. “Hepatitis C virus infection is often asymptomatic or causes nonspecific symptoms (depression, arthralgia and fatigue) for decades,” Kathleen Ly, of the U.S. Centers for Disease Control and Prevention (CDC), and her colleagues wrote in their paper.
The good news for those who do get diagnosed is that new hepatitis C drugs are coming onto the market. But they are not cheap. One new promising one, a protease inhibitor called boceprevir, runs about $1,100 per week, which when added to the double-drug cocktail of interfearon and the antiviral ribavirin, makes for especially expensive treatment. Some researchers have proposed that testing patients for a genotype that has a cure rate of less than 40 percent with previous treatment might help make treatment the more cost effective.
A new analysis in the same issue of Annals of Internal Medicine, led by Shan Liu of the Center for Health Policy at Stanford University, found that giving HCV patients of all genotypes a triple-drug cocktail is, indeed, cost-effective for allowing patients to live longer, healthier lives. And as Alter and Liang pointed out, as opposed to HIV or even hepatitis B, HCV can often be effectively cured after six months to a year of antiviral treatment. “Every effectively treated high-risk individual diminishes the infectious pool and the likelihood of secondary transmission.”
With treatment options expanding, many researchers are turning their attention back to the question of locating patients. “As innovative treatments for hepatitis C follow their now-destined progression, the most burning question will not be whether to treat, but rather how to identify the many chronic HCV carriers who are unaware of their infection and are at risk for cirrhosis, end-stage liver disease, or hepatocellular carcinoma,” Alter and Liang wrote.
Knowing that those born between 1945 and 1964 are at the highest risk for HCV infection could help guide screening, according to another study published in the same issue of the journal, led by David Rein, of the CDC. “Because HCV progresses slowly, the risk for serious complications is increasing among infected Americans as time passes,” he and his colleagues wrote. “Without changes in current case identification and treatment, deaths from HCV are forecasted to increase to 35,000 annually by 2030.”
About the Author: Katherine Harmon is an associate editor for Scientific American covering health, medicine and life sciences. Follow on Twitter @katherineharmon.
The views expressed are those of the author and are not necessarily those of Scientific American.
Philippine govt. starts ‘Code Yellow’ Hepatitis B awareness program
The best way to prevent Hepatitis B is by getting vaccinated.
Credits: U.S. Navy photo by Photographer's Mate Airman Apprentice Christopher D. Blachly
February 19, 2012
Infectious Disease Examiner
The World Health Organization (WHO) reports that 60 percent of the Philippine’s population has been infected with HBV, while approximately 10 percent have chronic or active hepatitis B and are carriers.
According to Dr. Lemuel Delos Reyes, medical doctor and Hepatitis B Awareness Campaign advocate, “This means that there are already around eight to 10 million hepatitis B carriers in the country who might infect more people.”
To draw awareness on the hepatitis B issue in the Philippines, the Philippine Council for Health Research and Development of the Department of Science and Technology (PCHRD-DOST) conducted a seminar on “Code Yellow, Mission Against Hepatitis” to draw awareness on the dreadful disease.
In a report on the PCHRD-DOST web site Friday, Dr. Gerald Belimac, program manager of the Department of Health’s National AIDS STI Prevention and Control Program said, “Hepatitis B is 100 times more contagious than the AIDS virus. It is also the most common cause of liver infection leading to liver cancer - the principal cause of cancer death in many parts of Africa, Asia and the Pacific Region.”
According to the US CDC, Hepatitis B is a contagious liver disease that results from infection with the Hepatitis B virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis B is usually spread when blood, semen, or another body fluid from a person infected with the Hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact with an infected person or sharing needles, syringes, or other drug-injection equipment. Hepatitis B can also be passed from an infected mother to her baby at birth.
Hepatitis B can be either acute or chronic. Acute Hepatitis B virus infection is a short-term illness that occurs within the first 6 months after someone is exposed to the Hepatitis B virus. Acute infection can — but does not always — lead to chronic infection. Chronic Hepatitis B virus infection is a long-term illness that occurs when the Hepatitis B virus remains in a person’s body. Chronic Hepatitis B is a serious disease that can result in long-term health problems, and even death.
Although there is no cure for hepatitis B it is a preventable disease. The best way to prevent Hepatitis B is by getting vaccinated.
Dr Delos Reyes said, “Vaccination is the easiest and most logical means of preventing the disease. It is also recognized as the most effective and long term means of preventing hepatitis.”
The PCHRD-DOST conducted the seminar “Code Yellow, Mission Against Hepatitis” Jan 30.
Hope for liver cancer patients
ILLUSTRATION: CHOOPONG EAMORAPHAN
Support group and new drugs lessen the pressure on liver cancer patients
Published: 21/02/2012 at 03:13 AM
Once diagnosed with cancer, what a patient needs is morale support from friends and family to cope with their overwhelming grief, fear and confusion.
``But what they need most is self morale. It's very unfortunate that many of us died because they gave up too early,'' said cancer patient Somsak (not his real name).
After learning that he had advanced liver cancer, Somsak said he broke down, cried and cried.
Somsak knew he had the hepatitis B virus 10 years ago. After that, he noticed he began to experience chronic fatigue and unexplained weight loss. His dark orange-coloured urine also worried him.
In addition, he suffered acute abdominal pain. An ultrasound screening detected an abdominal mass in the upper right area of his body. A CT scan and biopsy later confirmed the diagnosis of liver cancer.
``I was shocked when my doctor told me that the cancer was in advanced stage. And that I might only be able to live six more months.''
Never saying die, Somsak decided to join ``the Advanced Liver Cancer Patient Assistance Programme'' following his doctor's suggestion. The programme gives patients cancer oral medicine support.
``I'm lucky because I have responded relatively well to the medication.'' he said.
After two years of medication, Somsak continues to fight bravely against the deadly disease despite some adverse side effects from the medication.
``It is as good as it gets,'' he said. ``Apart from medication, I believe that positive thinking and good emotional health is equally important to fight cancer. We need to be strong and brave if we want to live longer.''
The liver cancer that Somsak has is called hepatocellular carcinoma (HCC), explained Dr Thiravud Khuhaprema, chairman of the National Cancer Institute Foundation. This form of liver cancer is closely linked to chronic hepatitis B and C. It is the most common type of liver cancer that begins in the cells of the liver itself.
``These patients are often found to have a history of viral hepatitis B or C infection. HCC is one of the main cancers that causes death in Thailand and chronic hepatitis B is found in 80% of these cases,'' said Dr Thiravud. ``The infection can cause continual damage to the liver and develop into cirrhosis and cancer.''
He said the frequency of liver cancer is highest in developing countries and quite rare in developed countries. Each year, it is estimated that there are about 350,000 new cases of liver cancer. And two-thirds of the cases are found in countries in Asia. Mongolia is ranked first and Thailand fifth.
In Thailand, liver cancer is the most common cancer in males. It is the third most frequent cancer in females, but it's the number one cause of death among female patients. The incidence rate and the mortality rate of liver cancer in Thailand are steadily rising.
Assoc Prof Narin Voravud, an expert in medical oncology from Chulalongkorn University Hospital pointed out that the relative high rates of HCC in Thailand is reflected in the high frequency of hepatitis B infection.
``One person in every 12 people suffers from hepatitis B infection in Thailand,'' he said. Meanwhile, the number of people with viral hepatitis C infection has been on the increase.
Heavy drinking is also another important cause of liver cancer in Thailand, he noted. The chance for liver cancer is even higher if the drinkers have snacks that contain alfatoxin, a dangerous mould in foodstuffs commonly found in peanuts, wheat and corns that are stored in a wet or humid environment. It's odourless, colourless and tasteless.
``Most Thai people drink alcohol paired with peanuts. These combined factors may trigger the development of HCC,'' said Dr Narin.
HCC liver cancer often does not show any symptoms in its early stage. Like Somsak, patients with advanced stage may experience fatigue, loss of appetite, weight loss, yellowing of the skin and the eyes, abdominal pain (particularly in the upper right area where the liver is present).
Primary liver cancer that affects just a small part of the liver is often treated with surgery to remove the cancerous tumour and the surrounding liver tissues to preserve the important areas of the liver for normal body function. It is possible for patients to suffer from the recurrence of the disease, however.
``Only 10-20% of HCC can be completely removed using surgery. And the recurrent rate is about 50-60%,'' Dr Narin said.
Another treatment option involves inserting particles into the liver artery to block the flow of blood to the tumour. Liver transplants to replace the diseased liver can cure the disease but a living donor graft and matching of organ donors is not easy to find.
It is unfortunate that patients with HCC often suffer from liver cancer, viral hepatitis B infection and cirrhosis of the liver at the same time, he said.
It is not uncommon that patients with liver cancer die shortly after the diagnosis. If the cancer cannot be completely removed, the decline is rapid. Patients may usually continue to live only three to six months.
``Treating patients with liver cancer can be very challenging as we have to deal with three conditions simultaneously,'' Dr Narin said.
Most chemotherapy drugs are not effective to liver cancer. And chemotherapy has not been shown to help patients live longer, he said. The liver often cannot tolerate radiation which harms healthy liver tissues.
``The good news is that the patients who cannot be treated with surgery can now resort to new liver cancer drugs,'' he said. This new medication tackles the cancerous cells and tumour blood vessels directly.
A liver tumour needs new blood vessels for it to grow. Since this medication blocks the growth of new blood vessels, the growth of the tumour is then stopped. The possible side effects include diarrhoea, skin rash and high blood pressure.
In clinical trials overseas, the drug succeeded in extending the lives of patients who cannot be treated with surgery and injection by 44 % one year when compared to 33% of those who received a placebo, said Dr Narin.
In Thailand, a clinical trial involving 140 Thai patients with advanced liver cancer showed that the patients continued to live up to 14 months.
``An improvement of survival probability of four months in Thai patients means that the drug is effective with Thai patients,'' said Dr Narin.
The bad news is that this new medication is extremely expensive. It costs about 250,000 baht a month for the drugs.
``This is why the patients with advanced liver cancer may consider joining the Advanced Liver Cancer Patient Assistance Programme,'' said Dr Thiravud.
The programme which requires participants to pay for the medicine for the first three months before they are accepted, is a collaboration between the National Cancer Institute Foundation and the country's leading pharmaceutical company. Since its inception in 2009, more than 170 patients have participated in the programme.
``But prevention is better than cure,'' stressed Dr Thiravut. To keep liver cancer at bay, people should be vaccinated for hepatitis B. Meanwhile, patients with viral hepatitis B should also be periodically monitored for HCC.''
For more on the Advanced Liver Cancer Patient Assistance Programme, call the National Cancer Institute Foundation at 02 354 7025 ext.1221.
Low-choline diet linked to liver damage in post-menopausal women
Updated: 2012-02-17 17:07:44 CST
Post-menopausal women who consume few foods containing the essential nutrient choline may benefit from liver panel testing. A new study indicates that these individuals may face a higher risk of liver scarring caused by non-alcoholic fatty liver disease.
Choline is found in dairy foods, eggs, broccoli, chicken, beef and legumes. The problem my be worse in post-menopausal women because low levels of estrogen may interfere with the body's ability to absorb and process dietary choline, the researchers said.
Therefore, even individuals who eat adequate amounts of these foods may be at risk.
For the study, researchers administered dietary surveys to more than 600 individuals of various ages and gender who were enrolled in a study of liver disease. The results showed that low choline intake was most strongly associated with liver scarring in post-menopausal women.
Consuming less of the nutrient did not mean that a woman was more likely to develop liver disease, However, it did predict the degree to which the condition would scar her liver and impair its function.
New measurement for hepatitis B unveiled
2012/02/19 21:17:21
Taipei, Feb. 19 (CNA) A Taiwanese liver disease research team introduced on Sunday a new measurement that helps to better diagnose hepatitis B infections, which affect roughly 2.5 million people in Taiwan, and gauge whether they are under control.
The REVEAL–HBV Study Group, led by Chen Chien-jen, unveiled the new measurement at an annual meeting of the Asian Pacific Association for the Study of the Liver (APASL) in Taipei.
The new measurement detects the amount of hepatitis B surface antigens (HBsAg) in a person's body. The antigens are proteins produced by the hepatitis B virus (HBV) that peak with the first appearance of clinical disease symptoms.
The new measurement reveals how a hepatitis B carrier's immune system responds to the virus and helps doctors evaluate the effectiveness of certain medications, according to Kao Jia-horng, APASL chief and a professor at National Taiwan University's College of Medicine.
Chen, an academician at Academia Sinica, Taiwan's top research institution, said that the new measurement complements existing gauges measuring the amount of hepatitis B virus DNA and will help doctors more accurately assess the risk of hepatitis B infections developing into liver cirrhosis and liver cancer.
Liaw Yun-fan, another academician at the meeting, said that a growing body of research shows the amount of HBsAg is indrectly related to how hepatitis B infections come under control.
Liaw said the lower the HBsAg level, the more the infection is under control.
Among the other existing measurements for hepatitis B infections are age, sex, and liver function index.
(By Chen Ching-fang and Scully Hsiao)
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Taiwan offers new model to predict hepatitis C cancer risk
2012/02/19 20:14:20
Taipei, Feb. 19 (CNA) A Taiwan-led research team has successfully devised a new prediction model to calculate the likelihood of hepatitis C patients developing liver cancer, the team leader said Sunday.
The model incorporates indicators such as age, the liver function indexes ALT and AST, hepatitis C virus RNA in serum, cirrhosis and the genotype of the virus, said Chen Chien-jen at a session of the Conference of the Asian Pacific Association for the Study of the Liver held in Taipei.
Chen, vice president of Taipei-based Academia Sinica, said the serum data was particularly important in predicting the chances of developing liver cancer.
The model, which can predict a result with 80 percent accuracy, assigns a score on 0-25 scale to analyze each case. The higher the score, the higher the risk of getting liver cancer, Chen said.
Hepatitis B and C viruses are the main causes of liver cancer in Taiwan, Chen said, with 20-25 percent of liver cancer cases triggered by the hepatitis C virus and 70-75 percent by the hepatitis B virus.
Close to 3 million people in Taiwan's 23-million population carry the hepatitis B virus, while some 600,000 carry the hepatitis C virus, according to the Department of Health.
With the model, "we hope to identify those facing higher risk of getting liver cancer and treat them as early as possible," Chen said.
Chen's team also launched a model in 2010 to calculate the chances of the hepatitis B virus developing into liver cancer.
In the future, the prediction models will be available on the Internet and in apps on smartphones to allow individuals to determine their own risk factor, Chen said.
(By Elaine Hou)
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