National Institute of Allergy and Infectious Diseases - Wednesday, July 28, 2004
Linda Joy (301) 402-1663, ljoy@niaid.nih.gov

The study compared the effectiveness of two forms of interferon: a once-weekly dose of peg-interferon and standard interferon taken three times weekly. Peg-interferon with ribavirin is currently the approved treatment for hepatitis C in persons without HIV. Prior to this study, limited data were available on the benefit and safety of peg-interferon and ribavirin in HIV-infected people.

The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Center for Research Resources (NCRR), both parts of the National Institutes of Health (NIH). NIAID's Adult AIDS Clinical Trials Group conducted the study at 21 research centers in the United States.

"We are pleased to see such a clear and definitive result from this study," says NIAID Director Anthony S. Fauci, M.D. "Just a decade ago treatment of HCV in persons infected with HIV was not a priority because they died from AIDS before developing serious complications of hepatitis C infection. As new anti-HIV drug treatments extend the lives of HIV-positive individuals, studies like this one provide essential guidance on treating other serious health problems affecting people living with HIV."

HCV is primarily spread through infected blood. Most people with the virus have no signs of illness, but in some the infection progresses to chronic liver disease, liver failure or liver cancer. The disease progresses more rapidly in people who have HIV.

The Centers for Disease Control and Prevention (CDC) estimate that HCV infects about 25,000 Americans annually and is responsible for about 8,000 to 10,000 deaths per year. About 3.9 million Americans have been infected with HCV, 2.7 million of whom are chronically infected, according to the CDC. It is also estimated that of the 1 million HIV-infected Americans, about 300,000 are also infected with HCV.

"We carefully monitored the study volunteers for side effects. Most tolerated the treatments well, and relatively few discontinued therapy prematurely. We were also encouraged that HIV infection remained under control during the study," says Raymond T. Chung, M.D., lead investigator and director of the Center for Liver Disorders in the Gastrointestinal Unit at Massachusetts General Hospital.

The 133 HIV-positive study volunteers were randomly assigned to take peg-interferon or interferon for 48 weeks. All study volunteers also took ribavirin, an antiviral drug that is also part of standard therapy for hepatitis C. Study volunteers who completed the treatments--16 withdrew early for various reasons--were followed for 24 more weeks to evaluate long term treatment success.

In the group that took peg-interferon, 27 percent of patients had no detectable HCV in their blood 24 weeks after completing treatment (sustained response). In contrast, of those who took interferon, only 12 percent had a sustained response. Importantly, more than one third of those volunteers who failed to clear HCV appeared to experience improvement in their liver biopsies, suggesting the treatment was beneficial in this group as well. Researchers also found that the volunteers whose HCV levels failed to fall substantially within the first 12 weeks never experienced a sustained response.

Roche Laboratories provided study medications and participated in the protocol team.

NCRR supported this research through its General Clinical Research Center Program with grants to University of Rochester, NY; University of North Carolina, Chapel Hill; and New York University. NCRR provides NIH-supported investigators with access to specialized basic and clinical research facilities, technologies, instrumentation, biomaterials, animal models, genetic stocks and more.

NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.

Reference: R.T. Chung et al. A randomized controlled trial of PEG-interferon alfa-2a plus ribavirin vs. interferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-co-infected persons: the U.S. AIDS Clinical Trials Group A5071 study team. The New England Journal of Medicine 351(5):451-459 (2004).
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