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New Hepatitis B Drug Better Than Others
Feb. 26, 2003 -- A new drug appears to be giving patients with chronic hepatitis B something they have not had before -- effective suppression of their virus without the acquired resistance and hard-to-live-with side effects that have plagued current treatments.
An international team of researchers is reporting that Hepsera, approved by the FDA last September, is as effective as the two standard therapies now used to treat chronic hepatitis B virus infections. But unlike the oldest hepatitis B drug interferon alfa, patients in the study groups experienced few treatment-related side effects. Even more surprising is that none of the patients developed resistance to the treatment during the 48-week study period. Patients on lamivudine -- the most widely used hepatitis B drug -- develop resistance at a rate of about 15% a year. Resistance has been reported in up to 65% of patients.
The studies are published in the Feb. 27 issue of TheNew England Journal of Medicine. In an accompanying editorial viral hepatitis experts Mark E. Mailliard, MD, and John Gollan, MD, PhD, wrote the new drug is ushering in a new era in the treatment of hepatitis B.
"[Hepsera] is the first of a large group of [drugs] that [is] coming out for the treatment of hepatitis B," Mailliard tells WebMD. "As more drugs become available we are likely to see a combination approach to therapy similar to AIDS and hepatitis C treatment. By combining drugs you make it more difficult for nature to find ways to develop resistance."
Worldwide, more than 350 million people, including 1.25 million Americans, are chronically infected with hepatitis B. The virus is transmitted through body fluids and is 100 times more contagious than HIV. It can lead to cirrhosis, liver cancer, and liver failure in about 40% of people with chronic infection but symptoms typically do not occur until decades after infection.
Hepsera was originally developed as an HIV drug, but was rejected because high doses of caused kidney damage. In the new studies, researchers concluded that a relatively low dose (10 mg per day) was as effective as higher doses, and no kidney problems were reported.
The drug elicited good responses among patients who were positive for hepatitis B e antigen (HBeAg), a marker of infectiousness, and also harder-to-treat patients who were HBeAg-negative. HBeAg-negative hepatitis B infection is common in southern Europe and Asia, but a continued suppression of the virus with treatment is rare in this group.
In the two studies, 53% of the patients with HBeAg-positive virus and 64% with HBeAg-negative virus showed improvement in liver function after 48 weeks of 10 mg of Hepsera per day. The patients tolerated the drug well and no drug resistance was seen.
Most of the patients in the study are still taking the drug, and Patrick Marcellin, MD, tells WebMD that they continue to show very little resistance two years into treatment.
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