AASLD: Emtricitabine Achieves Sustained Response in Patients with Chronic Hepa

liver411

AASLD: Emtricitabine Achieves Sustained Response in Patients with Chronic Hepatitis B

By Charles Bankhead
Special to DG News

BOSTON, MA -- November 5, 2002 -- The nucleoside analog emtricitabine demonstrated potent and sustained antiviral activity in patients with chronic hepatitis B infection during two years of treatment.

A sustained antiviral response to the lower limit of detection occurred in 42 percent of patients enrolled in the trial, Dr. Robert Gish reported here November 3 at the American Association for the Study of Liver Disease (AASLD).

Almost half the patients had loss of hepatitis B envelope antigen, and almost a third experienced seroconversion to HBeAb.

"Emtricitabine was both effective and well tolerated during two years of therapy," said Dr. Gish, a hepatologist at California Pacific Medical Center in San Francisco, California, United States. "The results are encouraging, given the characteristics of the study population, which have been typically associated with low response rates to other nucleosides."

The study involved 98 HBV-infected patients, including 77 who were HBeAb+ and 64 who were nucleoside naive. The median baseline HBV DNA level for the population was 7.58 log10 c/mL. During the first 48 weeks, patients received blinded therapy of 25 mg, 100 mg, or 200 mg of emtricitabine, then were switched to open-label emtricitabine 200 mg/day for an additional 48 weeks of treatment.

After 96 weeks of treatment, 42 percent of patients had undetectable viremia levels, 48 percent had loss of HBeAg, and 29 percent had seroconverted to HBeAb. Among patients who had undetectable viremia at least once during the two years of treatment, 68 percent had loss of HBeAg and 43 percent experienced seroconversion. Overall, 74 percent of patients had normal ALT levels after 96 weeks.

No treatment-related serious adverse events occurred during the trial, and only one serious adverse event altogether: a case of endometriosis. Four patients discontinued therapy because of adverse events that included Schonlein Henoch purpura, dizziness, asthenia, and a symptom constellation that included headache, infection, and nausea.