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发表于 2003-9-4 07:54
Coviracil (FTC, emtricitabine) is an L nucleoside with potent selective activity against both HBV and HIV. In some studies, it appeared to have greater potency in vitro than Epivir-HBV.
Study 101 was a dose ranging study of hepatitis B infected individuals who received Coviracil at a dose of 25mg, 50mg, 100mg, 200mg or 300mg once daily for eight weeks. The antiviral activity was greater in all other arms compared with the 25mg arm.
A second study, 102, examined individuals, 88% of whom were Asian, who were randomized to receive Coviracil at a dose of 25mg, 100mg or 200mg for 48 weeks. Mean viral load at baseline ranged between 7.42 and 7.68 log10 copies/mL. Individuals could be HBeAg positive or negative with active viral replication. Individuals were stratified in this study by viral load and previous exposure to Coviracil in study 101. The results of this study are summarized below. (Fig 4.)
Only 3 patients discontinued the study due to adverse events, one of whom developed Hoenoch-Schonlein purpura. Grade 3 and 4 toxicity was low, being 9% in the 25mg arm, 3% in the 100mg arm and 6% in the 200mg arm.
Figure 4: FTC Study 102
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