Integrated Health Care Model Shows Promise for Hepatitis C Patients in Durham

Posted by Anna Both on Apr 26, 2012 in Faculty, Rae Jean Proeschold Bell, Research

Reported by the Duke Global Health Institute:

Four in ten hepatitis C patients who drank alcohol refrained from it as part of a Duke pilot program that integrates alcohol and hepatitis C treatments. Led by DGHI researcher Rae Jean Proeschold-Bell and Duke physician Andrew Muir, the dual model of care may be a viable option for steering these patients away from alcohol, who may otherwise develop serious health complications that lead to liver failure or death.

The Duke study, featured in the April issue of Digestive Diseases and Sciences, involved hepatitis C patients from the Duke Liver Clinic who received both alcohol treatment and medical care over a six-month period. Of the 53 alcohol-drinking patients in the study, 44 percent had stopped drinking alcohol by the end of the six months. Patients who did not become abstinent by six months still reported a 30 percent drop in alcohol consumption, spending on alcohol and urges to drink.

“We were able to show that integrated hepatitis C-alcohol care is feasible,” said Proeschold-Bell, a DGHI faculty member at the Center for Health Policy and Inequalities Research. “More than that, the study shows that such integrated care results in alcohol reductions that benefit patient health.”

Researchers say the intervention worked in part because it focused on liver health, rather than simply reducing alcohol use. It involved weekly group therapy and bi-weekly individual sessions customized to each patient that address alcohol use, nutrition, stress and family support. Because knowledge alone does not change behavior, the addictions specialist taught patients practical ways to improve other aspects of their lives based on their individual circumstances. Study participants were also evaluated for mental illness and had access to a psychiatrist for care, if needed.

The research team also found ways to increase communication and collaboration between the patient’s hepatologist and addictions specialist, a critical part of the study.

“We didn’t know the extent to which we could get busy medical providers and addictions specialists to collaborate. We had to find ways to fit the collaboration into the clinic flow,” said Proeschold-Bell. “In some instances, we had the addictions specialist use a laptop outside the patient exam rooms so medical providers could easily access her and her knowledge about the patient’s alcohol use and behavior changes.”

To date, studies have shown that adults with hepatitis C are three times more likely to have at least one alcoholic drink a day and almost eight times more likely to have at least three drinks a day, compared to adults without hepatitis C. The combination of alcohol use and hepatitis C speeds the time to liver failure and increases rates of liver fibrosis and cancer.

As strong proponents of clinic-based alcohol treatment, Proeschold-Bell and Muir hope to pursue a larger study that recruits patients from the Duke Liver Clinic, the UNC Liver Clinic and the Durham Veterans Affairs Medical Center.

“Alcohol treatment needs to occur in a trusted and known setting,” said Muir. “This study shows that patients will attend alcohol treatment offered in the liver clinic setting and try to change their behaviors in the context of their lives beyond alcohol use.”

More information on this CHPIR project on the HEP ART page

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AHF Urges Swift Passage of Rep. Maxine Waters' "Routine HIV Screening Coverage Act"

PRESS RELEASE

April 26, 2012, 1:41 p.m. EDT

The new bill would require health insurance plans to cover routine HIV tests under the same terms as other routine health screenings. Legislation could spur nationwide compliance with CDC's 2006 HIV testing guidelines recommending HIV testing in routine health settings.

WASHINGTON, Apr 26, 2012 (BUSINESS WIRE) -- AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today urged Congress to pass Congresswoman Maxine Waters' (D, CA 35th) bill to require health insurance plans to cover routine HIV tests under the same terms and conditions as other routine health screenings. The bill, which is known as the Routine HIV Screening Coverage Act (HR 4470), had been previously introduced by Waters during the 110th and 111th Congress; however, it did not become law.

"The 'Routine HIV Screening Coverage Act' seeks to bring national health policy in line with the science that shows that HIV testing and linkage to treatment is the best way to prevent new infections" said Michael Weinstein, President of AIDS Healthcare Foundation. "By requiring insurer coverage of routine HIV screening, this bill should go a long way in helping to break the chain of new infections by making HIV testing -- and linkage to treatment, far more readily available. We applaud Congresswoman Waters for reintroducing and carrying this lifesaving public health measure."

According to the CDC, approximately 250,000 people with HIV in the United States are unaware of their infection. These so-called "unawares" are estimated to be the source of most new infections. Finding these "unawares" and linking them to AIDS treatment, which has shown to reduce HIV transmission by 96%, would drive down HIV infection rates nationwide.

In 2006, CDC issued guidelines recommending routine HIV testing of adults and adolescents in all health care settings. However, lack of coverage for the cost of providing HIV testing continues to be a key factor in preventing widespread adoption of the CDC guidelines.

"The 2006 CDC guidelines for HIV testing have been largely ignored nationwide because no one knows who will actually cover the costs of such routine screening," said Weinstein. "By requiring health insurance plans to cover routine HIV tests under the same terms as other routine health screenings, Congresswoman Waters' bill should help spur compliance with the CDC's guidelines. The only way to truly get control of HIV in this country is for people to know their status. This step will remove a significant barrier to HIV testing. It is necessary, it is way past time, and Congress should take up and pass this bill immediately."

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 164,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare

SOURCE: AIDS Healthcare Foundation

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NICE recommends Victrelis and Incivo for hepatitis C

Published: 26/04/2012

Janssen’s Incivo and MSD’s Victrelis have been recommended for reimbursement by the NHS when used in the treatment of hepatitis C.

The National Institute for Health and Clinical Excellence (NICE), which serves as a cost watchdog for England and Wales, has published guidance stating that both treatments should be available for the treatment of genotype 1 chronic hepatitis C, when used in combination with peginterferon alfa and ribavirin.

Professor Carole Longson, health technology evaluationcentre director at NICE, said: “The significant improvement in sustained virological response rates seen with boceprevir or telaprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone represents a major benefit for people with genotype 1 chronic hepatitis C.”

Genotype 1 is the most common subtype of hepatitis C in England and Wales affecting around half of the estimated 255,000 people with hepatitis in the region.

It is also the most resistant to treatment, with Longson describing how patients have declined treatment with peginterferon alfa andribavirin alone as the chance for a sustained response was too low to compensate for side effects such as nausea, insomnia, depression and diarrhoea.

Both Incivo and Victrelis work the same way by inhibiting the activity of the NS3/4A serine protease, an enzyme that is essential for viral replication.

NICE said that the serine protease may be partially responsible for the ability of the hepatitis C virus to evade clearance by the host immune system.

The guidance was welcomed by patient group, the Hepatitis C Trust. The organisation’s chief executive Charles Gore said: "People living with genotype-1 hepatitis C who have perhaps been delaying starting treatment, or who have lost hope after their previous treatment had failed them, can now be offered cost effective treatments that offer them a much better chance of clearing the virus than ever before.

“This is really great news and I look forward to direct acting anti-virals being made available to all patients on the NHS as soon as possible."

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Hepatitis B and C prevalence among the high risk groups of Pakistani population. A cross sectional study

Published on: 2012-04-26

Hepatitis B and C cause significant morbidity and mortality worldwide. Little is known about the existence of hepatitis B and C among high risk groups of thePakistani population.

The present study was conducted to determine the prevalence of Hepatitis B and C in high risk groups, their comparison and the possible mode of acquisition by obtaining the history of exposure to known risk factors.

Methods: This cross sectional study was carried out in Karachi, from January 2007 to June 2008.HBsAg and Anti HCV screening was carried out in blood samples collected from four vulnerable or at risk groups which included Iinjecting drug users (IDUs), prisoners, security personnel and health care workers (HCWs). Demographic informations was recorded and the possible mode of acquisition was assessed by detailed interview.

Logistic regression analysis was conducted using the STATA software.

Results: We screened 4202 subjects, of these, 681 individuals were reactive either with hepatitis B or C. One hundred and thirty three (3.17%) were hepatitis B reactive and 548 (13.0%) were diagnosed with hepatitis C.

After adjusting for age, security personnel, prisoners and IV drug users were 5, 3 and 6 times more likely to be hepatitis B reactive respectively as compared to the health care workers. IDUs were 46 times more likely to be hepatitis C positive compared withto health care workers.

Conclusion: The prevalence of hepatitis B and C was considerably higher in IDUs, prisoners and security personnel compared to HCWs group.

Hepatitis C is more prevalent than hepatitis B in all these risk groups. Prevalence of hepatitis C increased with the increase in age.

Uses of unsterilized syringes, used syringes, body piercing andillicit sexual relations were found to be important associated risk factors for higher prevalence of Hepatitis B and C in these groups.

Author: Abdul Rauf MemonKashif ShafiqueAshraf MemonAgha Umer DrazMohammad Uzair Abdul RaufSalahuddin Afsar

Credits/Source: Archives of Public Health 2012, 70:9

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FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

This update is in follow-up to the FDA Drug Safety Communication¹: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs on 2/4/2012.

Safety Announcement

[4-26-2012] The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).

Patients should not stop taking any of their hepatitis C or HIV medicines without talking to their healthcare professional. Patients should contact their healthcare professional with any questions or concerns.

Healthcare professionals who started patients infected with both chronic HCV and HIV on Victrelis while the patient was taking antiretroviral therapy containing one of these ritonavir-boosted protease inhibitors should closely monitor patients for treatment response (no HCV virus detected in the blood) and for potential HCV or HIV virologic rebound (HCV or HIV virus is detected in the blood again after becoming undetectable).

Ritonavir is an HIV protease inhibitor that is taken as a small dose along with other HIV protease inhibitors in order to increase their levels in the blood and make them more effective. This is known as ritonavir boosting.

In February 2012², FDA issued a Drug Safety Communication (DSC) regarding a drug-drug interaction study, which showed that taking Victrelis while taking any one of the three ritonavir-boosted HIV protease inhibitors could reduce the desired blood levels of both medicines. Because lower blood levels could lead to less effective treatment of HCV and HIV infections, FDA recommended that healthcare professionals closely monitor the treatment response of patients who might be taking these drug combinations.

There is limited information on the effectiveness of Victrelis and ritonavir-boosted HIV protease inhibitors when they are used together in patients co-infected with HIV and HCV. A small clinical trial measured treatment outcomes of HIV-HCV co-infected patients whose HCV infection was treated with either peginterferon/ribavirin or boceprivir plus peginterferon/ribavirin and whose HIV infection was treated with ritonavir-boosted atazanavir, ritonavir-boosted darunavir, lopinavir/ritonavir, or raltegravir (Isentress). Persons who received boceprevir plus peginterferon/ribavirin were more likely to have undetectable HCV viral loads 12 weeks after completing HCV treatment than individuals who received peginterferon/ribavirin alone. Overall, seven patients had HIV virologic rebound, 3/64 randomized to receive boceprevir with peginterferon/ribavirin and 4/34 randomized to peginterferon/ribavirin alone. Preliminary results of this clinical trial were presented at the 19th Conference on Retroviruses and Opportunistic Infections on March 6, 2012. The clinical trial abstract is available here³.

In light of both the findings of the drug-drug interaction study and the clinical trial, FDA has revised the Victrelis drug label to state that co-administration of Victrelis with ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), or Kaletra (lopinavir/ritonavir) to patients infected with both chronic HCV and HIV is not recommended at this time.

FDA is aware that a larger clinical trial⁴ is planned that will evaluate HCV treatment with boceprevir and peginterferon/ribavirin in patients infected with both HCV and HIV who are also receiving HIV antiretroviral therapy containing ritonavir-boosted HIV protease inhibitors. FDA will communicate any important new information about co-administration of these drugs in co-infected patients when it becomes available.

-

Related Information

• FDA Drug Safety Communication: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs⁵

Victrelis (boceprevir) Information⁶

 

Contact FDA

1-800-332-1088

1-800-FDA-0178 Fax

Report a Serious Problem

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Regular Mail: Use postage-paid FDA Form 3500⁸

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Southern Research Signs Agreement with Apath, LLC to Conduct Preclinical Studies with Virus-Based HCV Screenings

PRESS RELEASE

April 25, 2012, 1:15 p.m. EDT

BIRMINGHAM, Ala., April 25, 2012 /PRNewswire via COMTEX/ -- Southern Research today announced that it has signed an agreement with Apath, LLC which will allow Southern Research to conduct laboratory testing, research, and/or screening of potential therapeutic agents for hepatitis C (HCV) on an exclusive, fee-for-service basis using Apath's HCV virus-based technology.

Apath--a privately held technology company focusing on HCV and other human viral pathogens--was founded by Charles M. Rice, Ph.D., Professor at The Rockefeller University and formerly of the Washington University School of Medicine.

"Preclinical screening using a virus-based system will advance potential treatments for the disease because new therapies for HCV will be screened against the actual virus rather than a subset of the replication machinery," said Andrew D. Penman, Ph.D. vice president of Drug Development at Southern Research. "We are very pleased to work with Dr. Rice, a world renowned HCV expert and offer this new service to our clients."

Most preclinical drug screening for new HCV therapies use cell lines that harbor replicons--intracellular sub-genomic, self-replicating RNA molecules that contain the nucleotide sequences required for RNA replication, transcription, and translation, but are not themselves infectious.

Using a virus-based system, researchers can now develop antiviral treatments targeting viral entry into the cell, all of the replication machinery of the replicon, as well as downstream events such as viral assembly and release from the cell. As such, the entire viral life cycle is available for drug discovery and development.

"Successful treatment for chronic hepatitis C, given HCV diversity and the spectrum of disease, is likely to require combination therapy and new drugs well beyond those already approved," said Dr. Rice.

"As part of our commitment to remaining the global leader in the sublicensing of HCV-related technologies, I am particularly pleased with the expansion of our contract services agreement with Southern Research Institute, and I am extremely encouraged by the potential of this business venture assisting our clients in the fight against hepatitis C," said Robert M. Roth, Apath vice president, Strategic Operations.

Southern Research conducts both contract research and basic research for clients, providing preclinical drug discovery, development, and clinical trial support services in cancer, infectious diseases, and CNS/neurological disease to pharmaceutical and biotechnology companies. Scientists conduct translational science to invent small molecules and advance them from the design stage to the clinic. Services available include medicinal chemistry, molecular biology, biochemistry, high-throughput screening and a full set of in-house GLP development services including toxicology, ADME/PK, animal models, formulations, and bioanalytical services.

ABOUT SOUTHERN RESEARCHSouthern Research Institute is a not-for-profit 501(c)(3) scientific research organization founded in 1941 that conducts preclinical drug discovery and development, advanced engineering research in materials, systems development, and environment and energy research. More than 550 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy industries. Southern Research is headquartered in Birmingham, Ala., with facilities in Wilsonville, Ala., Frederick, Md., and Durham, NC and offices in Huntsville, Ala., New Orleans, La., and Washington, DC.

CONTACT: Rhonda Jung 205-337-9634 Jung@SouthernResearch.org

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Microbiologist Irving Millman, 88, helped develop hepatitis B vaccine

Courtesy of Fox Chase Cancer Center - Irving Millman helped develop the hepatitis B vaccine, an innovation recognized as one of the most important medical advances of the latter 20th century and one that continues to save thousands of lives every year.

By Emily Langer, Published: April 25The Washington Post

Irving Millman, a microbiologist who played an instrumental role in developing the hepatitis B vaccine, an innovation recognized as one of the most important medical advances of the latter 20th century and one that has saved millions of lives, died April 17 at Sibley Memorial Hospital in the District. He was 88.

The cause was complications from internal bleeding, said his daughter Diane Millman. He had lived in Washington for the past decade.

Hepatitis B is an infectious virus that can lead to chronic liver disease, cirrhosis and a deadly form of cancer. More than 1 billion people worldwide have received the vaccine since it became commercially available in 1982. Because of the protection it provides against liver cancer, it has been called the first “cancer vaccine.”

In the late 1960s and early ’70s, Dr. Millman was the only trained immunologist on an eclectic team of hepatitis researchers at the Fox Chase Cancer Center in Philadelphia. Leading the team was scientist Baruch S. Blumberg, a future Nobel laureate.

Part biochemist and part anthropologist, Blumberg had spent the previous decade collecting blood samples from populations around the world for the study of infectious disease. Using the serum from an Australian aborigine, he had identified the hepatitis B virus. He received the 1976 Nobel Prize in Medicine for that work, and died last year at 85.

Once Blumberg had isolated the virus, the challenge was to halt its transmission from one person to another. Dr. Millman’s arrival at the Fox Chase laboratory in 1967, Blumberg wrote in an essay, was “perhaps the most important factor” in making the breakthrough discovery.

Without Dr. Millman, Blumberg told the Jewish Exponent in 1993, “we couldn’t have made that vaccine, no question about it.”

Dr. Millman launched his career at Northwestern University in Evanston, Ill., where he did research on a tuberculosis vaccine in the 1950s. Later, he joined the Merck pharmaceutical company and worked on vaccines for whooping cough and rubella.

At Fox Chase, Dr. Millman’s experience in immunology and virology was pivotal, said W. Thomas London, an internist and endocrinologist who also worked on the hepatitis B research.

Vaccines work by introducing into the body a weakened or inactive form of a particular disease. Those microbes — not powerful enough to sicken a person — stimulate a response from the immune system to ward off the disease.

In the case of hepatitis B, London said, Dr. Millman devised a way to separate the hepatitis B virus from a human blood sample, purify and then kill the virus through heat or a chemical treatment. This procedure became the process by which the vaccine was created.

It was dangerous work, London noted. By handling the blood samples, Dr. Millman and other researchers were constantly exposed to the hepatitis B virus. (Today, the vaccine is created through genetic recombination, a process that rejiggers a portion of the virus’s DNA and does not put researchers at risk of contracting the disease.)

Initially, pharmaceutical manufacturers showed little interest in the work by the researchers at Fox Chase.

“Vaccines are not an attractive product,” Blumberg wrote in an autobiographical sketch for the Nobel committee. “They are often used once or only a few times and they ordinarily do not generate as much income as a medication for a chronic disease that must be used for many years.”

After several years, Fox Chase signed a contract with Merck. The vaccine was approved by the Food and Drug Administration in 1981 and soon became widely used in the United States and around the world.

While at Fox Chase in the 1960s, Dr. Millman also helped create a screening test used to detect hepatitis B in blood samples. After blood banks began widely using the test in 1971, the transmission rate of hepatitis B through transfusions decreased by 25 percent, according to the National Inventors Hall of Fame in Akron, Ohio, which inducted Blumberg and Dr. Millman in 1993.

Irving Millman was born May 12, 1923, in New York City. His father, a Jewish immigrant from Russia, worked in the Garment District; his mother was a homemaker.

Dr. Millman served in the Army in Europe during World War II and received a Bronze Star Medal for capturing a German soldier, his daughter said.

He received a bachelor’s degree from City College of New York in 1948, a master’s degree in bacteriology from the University of Kentucky in 1951 and a doctorate, also in bacteriology, from Northwestern University in 1954.

While studying at the University of Kentucky, he married Edith Greifinger, a Polish Jew who escaped from the Warsaw ghetto and immigrated to the United States after World War II.

His wife died in 2009. Survivors include two children, Diane Millman of Washington and Steven Millman of Boston, and five grandchildren.

During his career with Fox Chase, Dr. Millman also conducted research on the bacterium linked to acne and taught microbiology at Hahnemann University in Philadelphia. He retired in 1989.

It has been said that the hepatitis B vaccine improved global health conditions so dramatically that the average human life span may have increased by several months since the vaccine was introduced.

“Not many people can say they have had an impact like that,” Fox Chase scientific director Jonathan Chernoff wrote in an e-mail.

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