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5th International Workshop on HIV Drug Resistance & Treatment Strategies4-8 June 2001, Scottsdale, Arizona |
INTRODUCTION: Emtricitabine is a nucleoside analogue with potent activity against HIV and hepatitis B virus (HBV) and has been shown to be more potent than lamivudine both in vitro and in short-term HIV monotherapy trial. In a Phase III HIV trial, genotypic analysis of virological failure showed less M184V mutation for emtricitabine versus lamivudine (14 versus 56%).
METHODS: FTCB 102 is a double-blind, randomized comparison of emtricitabine as 25, 100 and 200 mg once daily. Patients were evaluated every 4 weeks, serum viraemia was assessed by HBV DNA Digene Hybrid Capture II; lower limit of detection (LOD) of 4700 copies/ml. Genotype of the polymerase (domains A–E) was performed by di-deoxy sequencing on week- 56 samples with measurable DNA and the matching baseline sample. All analyses are intention-to-treat (ITT), missing equal failure.
RESULTS: Ninety-eight patients were randomized, mean age 37 years; 70% male, 88% Asian. At 1 year, 37.5, 42 and 54.5% of the patients had undetectable viraemia in the 25, 100 and 200 mg groups, respectively. Overall, 45.5% of the patients lost e Ag in the first year. Twenty-one patients entered the study with e Ag negative infection (pre-core mutant). These patients had a better viral suppression than the e antigen positive patients (74% below LOD at 1 year). Genotypic analysis of six pairs of viral isolate from the 200 mg dose with detectable level at 1 year showed genetic change from baseline in the pol gene in only one (YMDD). The incidence of mutation at 1 year in the 200 mg dose group is 4% (95% CI: 0–10%). Emtricitabine was well tolerated at all doses. Three patients discontinued due to adverse reaction, one in each dose group.
CONCLUSION: Emtricitabine produced potent and durable viral suppression of HBV, a high rate of loss of e antigen with a low incidence of mutations at the high dose. These results are very encouraging in view of the 14–30% incidence of YMMD mutation observed with lamivudine at 1 year in HBV and close to 90% at 4 years in HIV-infected patients with dual infection. Emtricitabine has a significant potential for the treatment of patients with HIV–HBV co-infection.
PRESENTING AUTHOR: F Rousseau
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