Viral suppression is comparable with 0.5 mg and 1.0 mg daily doses of entecavir in treatment-naive HBV decompensated cirrhosis
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PMID: 33404519 DOI: 10.3851/IMP3375
Abstract
Background: For patients with hepatitis B virus (HBV) infection who have decompensated cirrhosis (DC), a higher dose (1.0 mg/day) of entecavir is recommended than that used for those with compensated disease (0.5 mg/day), though with very little supporting data. We therefore compared the viral suppression achieved with 0.5 mg/day and 1.0 mg/day of entecavir in patients with HBV-related DC (NCT03345498).
Methods: Treatment-naïve patients with HBV-related DC and serum HBV DNA titer exceeding 100,000 IU/mL received either dose of entecavir for 24 weeks. HBV DNA concentration was measured in blood specimens collected at baseline, and after 2, 4, 8, 12 and 24 weeks of entecavir treatment.
Results: Participants in the 0.5 mg/day (n=13) and 1.0 mg/day (n=16) groups had similar baseline HBeAg positivity rates (12/13 and 12/16; p=0.34) and median (range) log10 serum HBV DNA levels (6.81 [5.01-8.12] and 7.45 [5.24-8.65]; p=0.17). The two doses led to similar reductions in serum HBV DNA levels after 2, 4, 8, 12 and 24 weeks of entecavir administration. At 24 weeks, 3 of the 13 patients receiving 0.5 mg/day and one of the 16 patients receiving 1.0 mg/day of entecavir had undetectable serum HBV DNA. Serum albumin level showed significant and similar improvement at the end of 24 weeks in the two groups.
Conclusions: Treatment-naïve patients with HBV-related DC can be treated with entecavir in a 0.5 mg/day dose instead of the higher 1.0 mg/day dose, without compromising the degree of virological suppression.
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