Researchers Identify Better Hepatitis C Treatment for People with HIV
The preferred treatment for hepatitis C, peg-interferon and ribavirin,
is safe for people who are also infected with HIV, according to
a new study in the July 29 issue of The New England Journal of Medicine.
Moreover, this treatment proved superior for the treatment of hepatitis
C virus (HCV) in HIV-coinfected persons when compared with the previously
accepted treatment, standard interferon and ribavirin.
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
"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. Press releases, fact sheets and other NIAID-related
materials are available on the NIAID Web site at http://www.niaid.nih.gov.
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).