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These new data show that the majority of patients who received Viread for up to 144 weeks experienced sustained suppression of HBV DNA levels in the blood to below 400copies/ml.
Additionally, cumulatively over 144 weeks, 8% of all patients in Study 103 (HBeAg-positive) experienced 's' antigen (HBsAg) loss, which can contribute to resolution of chronic hepatitis B infection. Notably, no mutations associated with resistance to Viread developed in any patients up to 144 weeks of treatment.
Studies 102 and 103 were multi-center, randomized, double-blind Phase III clinical trials comparing Viread to Hepsera among HBeAg-negative presumed pre-core mutant (n=375) and HBeAg-positive (n=266) chronic hepatitis B patients with compensated liver disease, respectively. The majority of patients were treatment-naive upon study initiation, although some patients were lamivudine-experienced.
Patients originally randomized to Hepsera in both studies rolled over to open-label Viread (n=196) at week 48, while patients originally randomized to Viread continued open-label Viread treatment (n=389). After 72 weeks, patients with confirmed viremia had the option of adding emtricitabine treatment by substituting Truvada for Viread. By 144 weeks, 87% of patients remained in Study 102 (n=328) and 80% of patients remained in study 103 (n=214).
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