- Winter 2004 -

New Treatments for Chronic Hepatitis C in African Americans

New data on response to treatment in African Americans with chronic hepatitis C using the combination of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) were reported recently at the American Association for the Study of Liver Diseases (AASLD) 54th annual meeting in Boston. This is the largest prospective study reporting the efficacy, safety and tolerability of pegylated interferon and ribavirin combination therapy in non-Hispanic African Americans compared to Caucasians, all of whom had genotype 1 hepatitis C—the most difficult to treat.

In this study, the combination therapy of Pegasys and Copegus yielded a 26% sustained virological response (SVR) in African-American patients. The sustained virological response rate for Caucasian patients in the study was 39%. Sustained virological response refers to a patient’s continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.

“These data are especially important because African Americans have historically been underrepresented in clinical trials for hepatitis C,” states Juan Carlos Lopez-Talavera, MD, PhD, medical director at Roche Laboratories, Inc. “With these data, we can better understand how best to manage this large and difficult to treat patient population.”

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral, were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.

The study was conducted at eleven sites in the United States and included 78 African-American patients and 28 Caucasian patients. All patients were interferon-naïve with chronic hepatitis C genotype 1 and elevated ALT levels. Patients received 180 mcg subcutaneously of Pegasys, once weekly, along with either 1000 or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24 weeks of treatment-free follow-up. Early virological response (EVR) was assessed at 12 weeks of therapy and SVR at week 72.

African Americans have the highest prevalence rates for hepatitis C among all racial and ethnic groups in the United States, but have historically been underrepresented in clinical trials examining the treatment of the disease. Almost all African Americans with hepatitis C are infected with genotype 1 (91% compared to 67% of Caucasians with hepatitis C). Hepatitis C is a blood-borne virus that chronically infects an estimated 2.7 million Americans. It can cause progressive liver injury and lead to fibrosis and eventually cirrhosis.