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(CATIE) INFECTION FIGHTERS: Adefovir (GS 840) for hepatitis B
Sein Hosein
October 20, 1996
TreatmentUpdate 72, Vol. 8, No. 8; October 1996

Background Gilead Sciences which makes the anti-CMV drug cidofovir is also developing a treatment called adefovir (Bis-POM PMEA) for hepatitis B infection. Although most people quickly recover from HBV (hepatitis B virus) infection, a few develop continuous (chronic), low-level HBV infection in the liver. Over time HBV infects more liver cells and the damage slowly spreads through the entire organ. Eventually the liver damage is so severe that some people die and others get liver cancer. Doctors rely on interferon alpha to treat HBV infection but this drug is not always useful.

Study details Doctors enrolled 20 subjects with chronic HBV infection into this study. Sixty-five percent of them also had HIV infection. Doctors randomly selected 15 subjects and gave each, one tablet of adefovir (125 mg) daily and 5 other subjects fake adefovir, both for 1 month.

Results Levels of HBV fell by 97% compared to their pre-study level in subjects receiving adefovir. Subjects receiving fake adefovir had their level of HBV rise by 7% during the study. This difference in HBV levels between the two groups of subjects was statistically significant. This means that the changes in HBV levels were likely due to the use of adefovir and not a chance event.

Toxicity Two subjects using adefovir had nausea while three had higher than normal levels of liver enzymes in their blood ; which indicated mild liver damage. HBV infection can also cause increases in liver enzyme levels. In other studies, nearly 200 HBV-infected people have used adefovir 125 mg/day for up to 14 months "without any sign of toxicity." In the US, adefovir is also being tested with AZT and related drugs as well as protease inhibitors as a treatment for HIV infection.

REFERENCES: 1. Gilson RI, Chopra K, Murray-Lyon I, et al . Adefovir dipivoxil (Bis-POM PMEA) treatment for chronic hepatitis B infection; a placebo-controlled phase I/II study. Abstract LB01.

2. Anonymous. Gilead Sciences announces statistically significant antiviral activity against hepatitis B virus. Press release 16 September, 1996.