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Hepatitis B Treatment Update
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11th Annual Retrovirus Conference
Feb 8-11, 2004, San Francisco
Nancy Shulman, MD
Stanford University
Tenofovir has good anti-HIV activity and this activity was described in a cohort study called the TECOVIR study from France. 119 HIV/HBV+ patients were started on tenofovir at 300mg as a part of HAART. Most (95%) were on lamivudine prior to initiation of tenofovir. Overall 32% became HBV DNA undetectable, 16 of 17 who were undetectable at baseline remained undetectable. Median reduction of viral load was -3.8 logs. 5 patients became HBV e Ag negative and 3 became e antibody positive. The average followup was 8 months (range: 1-24 months).
Athough adefovir was axed as an HIV drug because of kidney toxicity seen at the doses used to treat HIV, it is approved for HBV treatment at much lower doses, 10mg/day and has good efficacy. Another French study evaluated adefovir 10mg added to 3TC in 35 HIV+ patients who had detectable 3TC resistant HBV and who were on HAART. According to the presenters, the DNA levels were almost back to the pre 3TC baseline levels in most of the patients. 28 patients reached 144 weeks of treatment (3 years). 48% had undetectable HBV at 144 weeks and 2/3 normalized their ALT. The median HBV DNA was -5.45 logs from baseline at week 144. 3 patients became e antigen negative and 2 became e antibody positive. Most importantly, no kidney toxicity was seen defined as an increase in Creatinine of 0.5 mg/dl from baseline or a phosphorus level <0.5 mg/dl, and no adefovir resistant HIV or HBV emerged during the course of the study.
Gilead presented HBV activity of FTC (emtricitabine) in patients with HIV and HBV enrolled in their registration trials. 39 antiretroviral naïve patients were HBV DNA. At 48 weeks, only 17 had samples for HBV DNA, of which DNA decreased by -2.72 logs and 59% had HBV DNA <4,700 copies (the limit of detection for the assay used). The drug looks comparable in HIV+ and HIV- patients with HBV. 12% developed a YMDD mutation that confers HBV resistance to FTC and 3TC. This is similar to what is seen with 3TC.
References:
1. Piketty, et al. Abstract 834, 11th CROI.
2. Benhamou, et al. Abstract 835, 11th CROI.
3. Snow, et al. Abstract 836, 11th CROI.
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