FDA approves first hepatitis C treatment for HIV patients
March 01 2005 1:00 AM ET
The Food and Drug Administration on Friday approved the use of Roche's Pegasys (peginterferon alfa-2a) and Copegus (ribavirin USP) for the treatment of chronic hepatitis C in patients coinfected with HIV. Pegasys combination therapy is the first and only regimen FDA-approved for hepatitis C treatment in patients with HIV. Pegasys, the most prescribed hepatitis C medication in the United States, was approved in 2002 by the FDA for use alone and in combination with Copegus for the treatment of HIV-negative adults with chronic hepatitis C.
"For the first time, the 300,000 Americans who are coinfected with hepatitis C and HIV have an FDA-approved hepatitis C treatment option. This is a very important advance for the HIV community," said Jeffery Smith, director of clinical research for the American Foundation for AIDS Research in a Roche press release. "Hepatitis C has become one of the leading killers of people with HIV because advances in HIV treatment are helping patients live longer and because hepatitis C progresses much more quickly to liver failure in people with HIV."
Hepatitis C and HIV are the two most prevalent blood-borne infections in the United States. It is estimated that approximately 30% of Americans with HIV are also coinfected with the hepatitis C virus. Research also has shown that hepatitis C is more resistant to treatment in people with HIV. Recent guidelines by the National Institutes of Health and Centers for Disease Control and Prevention recommend that people with HIV be screened for hepatitis C and that all patients with chronic hepatitis C, including those with HIV, be considered for treatment.
"Studies have shown that hepatitis C-and-HIV coinfected patients treated with Pegasys combination therapy had response rates that were three times higher than those treated with conventional interferon combination therapy," said Douglas Dieterich, a professor of medicine at the Mount Sinai School of Medicine in New York City. The results of the largest-ever study evaluating chronic hepatitis C treatment in patients coinfected with HIV showed that 40% of patients treated with Pegasys and Copegus achieved a sustained virological response. Sustained virological response refers to a patient's continued undetectable hepatitis C levels in the blood 24 weeks after finishing a course of treatment.