The Body Covers: The XIV International AIDS Conference
Dramatic Results for Patients With Both HIV and Hepatitis B Using Tenofovir
July 10, 2002
So, what happens if patients with both HIV and hepatitis B go on a regimen that contains tenofovir? This study sought to answer that question by looking at those patients who were in Gilead's study 907 of tenofovir who had chronic hepatitis B.
Recall that 907 was a large study in which patients on stable antiviral regimens with detectable viral load were randomized two to one to add tenofovir or placebo. This is one of the studies that led to the licensing of tenofovir.
Fourteen co-infected patients were identified in the trial. Twelve were on the tenofovir arm and two were on placebo. They were switched to open-label tenofovir after six months. Half of them had lamivudine (3TC) resistant hepatitis B virus at baseline.
The hepatitis B virus viral load dropped by more than four log (10,000 fold!) and was maintained for the 48 weeks of the study. In contrast, viral load rose slightly while on placebo. The benefit was equal in those with and without the 3TC-resistant virus, although the 3TC mutation (at the so-called YMDD motif) remained. Liver enzymes improved, and became normal in two patients. One patient seroconverted, that is, developed antibody to hepatitis B antigen. Seroconversion may signal the end of chronic hepatitis.
Although these data are based on small numbers, they provide some compelling evidence of the efficacy, and so far, the safety of tenofovir in hepatitis B co-infected HIV patients. If a tenofovir-containing regimen is appropriate for these patients, it probably should be used.
Tenofovir has no activity against hepatitis C -- a problem for an enormous number of people living with HIV. Adefovir is getting close to licensing as a treatment for hepatitis B (also from Gilead, the company that produces tenofovir), targeted initially at people without HIV. It has the advantage of being effective at a tiny dose (10 mg) and very large safety studies are being conducted. It will be interesting to learn whether it is better to add a tiny dose (hopefully at low cost) of adefovir as a single pill once daily, or to use tenofovir for HIV/HBV co-infected persons.
This represents exciting progress in hepatitis B. Hepatitis C drugs, however, that offer an alternative to peg-interferon are in active development but remain several years away.
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