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Peginterferon and Ribavirin Combination Appears Promising for Those with HIV and HCV

Since the introduction of highly active combination drug therapy for HIV, liver failure attributable to infection with the hepatitis C virus (HCV) has become a leading cause of death among those infected with the virus that causes AIDS. Now a multi-center study has found that the newest treatment for patients infected with HCV alone also helps those infected with both pathogens by significantly improving the clearance of HCV from the bloodstream. The report appears in the July 29 New England Journal of Medicine.

"Hepatitis C has become the new opportunistic infection among HIV-infected patients," says Raymond Chung, MD, director of the Center for Liver Disorders in the Gastrointestinal Unit at Massachusetts General Hospital (MGH), who led the study. "About 25 percent of those with HIV are coinfected with HCV, largely because these viruses share modes of transmission. The problem is immense and growing. (Note: Dr. Raymond Chung was the recipient of HFI’s Career Development Research Award in 2000) 

Chung notes that what had been the standard treatment for those infected with HCV only – interferon and ribavirin – was not effective for patients also infected with HIV. In those with both viruses, control of HCV levels in the blood was diminished and side effects were more pronounced, leading many patients to stop therapy. Recently, the FDA has approved a treatment for HCV-only infection using a chemically modified form of interferon, which keeps the drug active in the body for a longer period of time. The current study was designed to investigate whether this new approach could safely improve treatment success in those infected with both viruses. 

Researchers at 21 centers around the U.S. enrolled patients infected with both HCV and HIV who had not previously received interferon treatment. The 133 enrolled patients were randomized to receive either the newer drug peginterferon and ribavirin or the previous standard treatment of interferon and ribavirin. Halfway through the 48-week study period, blood tests were taken to see whether HCV blood levels had dropped in response to therapy. Participants who did not show a viral response had liver biopsies to determine whether the treatment had reduced liver damage. Those who exhibited either viral clearance or improved liver biopsy findings continued with the experimental treatment, while those with no response discontinued therapy. 

At the end of the study period, about 40 percent of those receiving peginterferon had cleared HCV from their bloodstream, compared with only 12 percent of the interferon group. Follow-up blood tests were taken 24 weeks after the study period, and again those in the peginterferon group fared significantly better, with 27 percent showing sustained clearance of HCV compared to 12 percent in the interferon group. The number of participants who discontinued treatment because of side effects was low, at a level similar to that seen in patients with HCV only, and no participants showed progression of HIV symptoms or adverse drug interactions with their anti-HIV drugs. 

"This is really a foot in the door, a promise that we will be able to help many of these patients without adversely affecting control of their HIV disease," says Chung, an assistant professor of Medicine at Harvard Medical School. "Even among those who failed to clear HCV from their blood, over one third of those receiving treatment were found to have improved liver biopsies, which suggests that maintenance therapy with peginterferon at doses that do not clear virus could still help prevent the progression of liver disease." 

The study, supported by grants from the National Institute of Allergy and Infectious Diseases, was conducted through the AIDS Clinical Trial Group. Chung's co-authors are Gregory Robbins, MD, and Atul Bhan, MD, of the MGH; Janet Andersen, ScD, and Tun Liu, Harvard School of Public Health; Paul Volberding, MD, and Marion Peters, MD, University of California at San Francisco; Kenneth Sherman, MD, PhD, University of Cincinnati; Margaret Koziel, Beth Israel Deaconess Medical Center; Beverly Alston, MD, National Institute of Allergy and Infectious Diseases; Dodi Colquhoun, Frontier Science Technology and Research Foundation; Tom Nevin, Social and Scientific Systems; George Harb, MD, Roche Laboratories; and Charles van der Horst, MD, University of North Carolina at Chapel Hill.

Two Young Scientists Receive HFIs Research Awards — 
Focus on Hepatitis B and C

The Board of Directors approved research applications from two young research scientists to expand the understanding of the epidemiology of hepatitis B and  C. Scott Fung, MD, FRCP, who is a Research Fellow in Internal Medicine at the University of Michigan Medical Center, will be conducting his research under the supervision of Dr. Anna Lok, world renowned hepatologist.

The focus of Dr. Fung’s research is to differentiate patients with E-chronic hepatitis B from inactive HBsAg carriers. This study will help identify active carriers of hepatitis B previously misclassified as inactive carriers who may benefit from antiviral therapy reducing the risk of cirrhosis and end-stage liver disease.

Doctoral student at Harvard School of Public Health, Robert Suruki, also the recipient of HFIs Career Development Research Award will examine the correlation between baseline levels of markers for immunity and the progression of hepatitis C to more severe disease. The potential benefit for early identification of subjects that may have an increased chance for more severe disease has great public health importance.

The purpose of HFI’s Career Development Awards is to provide funds to support research projects in hepatitis epidemiology, health promotion and outcomes research and to encourage young investigators to continue research in the field of viral hepatitis.

HCV Killer Cells Linked to Genes
In a study to be published in Science online Aug. 6, researchers at Johns Hopkins have found that genes involved in suppressing the body's defensive "killer" immune cells are a potential key factor in spontaneous recovery from hepatitis C.

News and Medical Updates on Hepatitis from the AASLD 2003 Meetings.  Visit HCV Advocate now!

January 8, 2004, Nutley, N.J. --  Roche announces the FDA approval of the availability of Pegasys in a pre-filled syringe.

November 26, 2003 -- The results of a study on the environmental stability of hcv infected blood outside the body begin to shed light on a very important questions asked by patients and providers.

November 14, 2003, Pasadena, CA -- An abstract was presented by Myron Tong, M.D., et al on the results of a Continuous Pump Infusion of Consensus Interferon in Non-responders to HCV Therapy.

November 2, 2003, Germany -- A new and promising drug called BILN 2061 that targets an enzyme to block the replication of the hepatitis C virus is under close study.

October 24, 2003, San Francisco, CA --  University of California San Francisco announces approval of an NIH sponsored to examine the effects of alcohol on the progression of chronic hepatitis C infection.  Dr. Norah Terrault, MD and Marion Peters, MD are the Investigators on this project.  For more information, call 1-888-286-1821.

September 23, 2003, Kenilworth, N.J. - Schering Plough to initiate first head-to-head study study with Peg-Intron and Pegasys.

August 20, 2003, San Francisco, CA -- The Hepatitis C Support Project announces the launch of their redesigned web site at www.hcvadvocate.org.  The web site features information on hepatitis C, including a monthly newsletter and its recent publication on depression and the hcv patient.

June 2, 2003, Santa Barbara, CA - The Santa Barbara Task Force on Hepatitis C announced the completion of the Strategic Plan. The process, led by Back to Life Santa Barbara is available to download. Santa Barbara is the second county in California (following Orange County) to set to task and develop such a document.

May 21, 2003 Digestive Disease Week, Orlando, Florida - Harvard Researchers are Building New Livers in Lab...

May 19, 2003 Digestive Disease Week, Orlando, Florida - Hepatitis C Recurrence
After Liver Transplant Generally Mild, New Study Finds...

April 7, 2003, New York - A certain type of cancer may be linked to 
hepatitis C...

April 3, 2003, Tarrytown, NY - Bayer Group announces approval for 
Versant HCV RNA, a test that measures the hepatitis C virus...

March 31, 2003, San Diego, CA - Intermune presents a review of the 
antiviral activity of both Interferon-gamma 1b and Infergen...

March 18, 2003 - Announcing a new online course on Hepatitis C designed for
addiction counselors and outreach professionals, sponsored by CEATTC...

January 23, 2003 - Intermune, Inc, Brisbane, CA announces Phase 1 clinical trials with PEG-Alfacon, a pegylated version of Infergen...

January 23, 2003 - Nabi Biopharmaceuticals announces FDA acceptance for priority review of a Hepatitis B Inmmune Globulin for the prevention of hepatitis B virus infection of transplanted livers in HbsAg-positive liver transplant patients...

January 16, 2003 - Public Health Advocacy Day in California is drawing near.  You can participate.  For more information, visit the new web site...

January 13, 2003 - Roche dramatically reduces the cost of combination therapy for millions of Americans Chronically Infected with Hepatitis C...

January 2, 2003, Vertex announces it will take the lead on development and commercialization of an oral protease inhibitor called VX-950 for hepatitis C...

December 31, 2002, Washington (AP) - The American Red Cross received reports that 134 people, including one who died, got hepatitis B after blood transfusions, but the organization did not investigate them...

December 20, 2002, New York - - A panel of experts has approved new
rules aimed at improving safety for living donors of partial livers for
transplantation performed in New York state

December 9, 2002, Nutley, N.J. - Roche launches new web site at www.pegasys.com for product information for both patients and medical providers.  Find complete Product Information on Pegasys and Copegus.

December 3, 2002, Nutley, N.J. - FDA approves Pegasys and Copegus for the treatment of hepatitis C.

November 20, 2002, HealthScoutNews - Injection drug users who consistently use bleach may reduce transmission of the hepatitis C virus.

November 20, 2002, HealthScout News - Can ticks spread the hepatitis C virus to humans?

November 20, 2002, HealthScoutNews - Injection drug users who consistently use bleach may reduce transmission of the hepatitis C virus.

November 20, 2002, HealthScout News - Can ticks spread the hepatitis C virus to humans?

November 19, 2002, Associated Press, Nebraska - At least 81 people treated at a Nebraska clinic have tested positive for hepatitis C in an outbreak that may have been caused by a contaminated vial of medicine.

November 14, 2002, Bethesda, MD - FDA Advisory Committee met in a public hearing in and voted 11-0 to recommend to the FDA approval for the combination therapy of Pegasys plus Copegus (the Roche brand of ribavirin) for treating chronic hepatitis C for previously untreated patients.

November 13, 2002, Washington, D.C. Approximately 1/5th of all liver transplant recipients under the new policies have hepatocellular carcinoma.

November 13, 2002 - USA - ATTENTION PROVIDERS: CME On-Line provided by Medscape - Pegylated Interferons and Advances in Therapy for Chronic Hepatitis C.

November 13, 2002, Washington, D.C. Approximately 1/5th of all liver transplant recipients under the new policies have hepatocellular carcinoma.

November 13, 2002, Atlanta, Georgia - Centers for Disease Control and Prevention (CDC) reports reflect a decrease in the numbers of new hepatitis A, hepatitis B, and hepatitis C infections in 2001.

November 8, 2002, Tarrytown, NY - Bayer Announces FDA Approval for VERSANT(R) HCV RNA Qualitative Assay.

November 5, 2002, Brisbane, CA - InterMune announces Phase IV clinical trial data on Infergen in combination and its effectiveness compared to Rebetron at the meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston today.

November 4, 2002, San Mateo, CA - Results of a study presented at the American Association for the Study of Liver Diseases (AASLD) meeting suggest that Zadaxin in combination with pegylated alpha interferon may have a benefit for hepatitis C nonresponders.

November 4, 2002, Boston - Achillion Pharmaceuticals presents positive clinical and pharmaceutical data on a potential treatment for hepatitis B at the American Association for the Study of Liver Diseases (AASLD) meeting.

November 1, 2002, AIDS, (November 2002) - Trends in Hepatitis C and HIV Infection Among Inmates Entering Prisons in California, 1994 versus 1999.

October 31, 2002, San Diego, CA - Prometheus Laboratories, Inc. announces that it is introducing a non-invasive approach to help detect liver fibrosis in patients with chronic hepatitis C.

October 31, 2002, Costa Mesa, CA - Ribapharm, Inc. announces submittal of an application to the FDA to initiate Phase I clinical study for Hepavir B in patients with chronic hepatitis B.

October 21, 2002, Bethesda, MD - The National Center for Complementary and Alternative Medicine (NCCAM) and 16 Federal co-sponsors announce the launch of an Institute of Medicine (IOM) study of the scientific and policy implications of the use of complementary and alternative medicine (CAM) by the American public.

October 16, 2002, Nutley, NJ - The Food and Drug Administration has approved a new pegylated interferon called Pegasys for the treatment of hepatitis C.  More about the program>

October 8, 2002, Brisbane and San Carlos, Calif. - Intermune and Inhale Therapeutic Systems, Inc. announce an agreement for use of Inhale's technology to develop a PEGylated version of Infergen for the treatment of chronic hepatitis C infections.  More about this treatment>

October 7, 2002, San Francisco - Organizations establish a scholars program to provide scholarships to Hispanic and African-American students who have hepatitis C or who are dependents of a person with the disease.  Read NIH Announces Institute of Medicine Study of Complementary and Alternative Medicine

SEPTEMBER 28, 2002, ORANGE COUNTY – Back to Life, A Tides Center Project and the Advisory Council announce the publication of a Hepatitis C Strategic Plan for Orange County.

SEPTEMBER 20, 2002 WASHINGTON (AP) - FDA OKs Chronic Hepatitis B Drug.  Patients suffering from the liver-destroying hepatitis B virus will be able to use a new drug therapy.