Entecavir at Five Years Shows Long-Term Maintenance of High Genetic Barrier to Hepatitis B Virus Resistance

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Abstract
Aims: Entecavir (ETV) provides both potent viral suppression and a high genetic barrier to resistance, requiring ≥3 resistance substitutions. As a result, in nucleoside-naïve patients, ETV resistance (ETVr) was rare through 4 years. The genetic barrier in lamivudine(LVD)-refractory patients was reduced. Methods: All patients receiving continuous therapy in phase II/III trials were monitored for resistance through year 5. Detectable patient HBV DNA (≥300 copies/mL) was sequenced in each year. Cumulative probabilities of resistance were determined through year 5. Results: In years 1 through 5, respectively, 663, 278, 149, 120 and 108 nucleoside-naïve patients were treated and monitored, with 93% in year 5 having HBV DNA Conclusions: ETVr remains rare (1.2%) in nucleoside-naive patients through 5 years. LVDr patients have a reduced barrier to ETV resistance and may benefit from combination therapy.

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