A One-Year Trial of Lamivudine for Chronic Hepatitis B

TLDR

Lamivudine, an oral nucleoside analogue, has shown promise in preliminary trials for treating chronic hepatitis B. A one‑year, double‑blind, randomized trial of lamivudine in 358 Chinese chronic hepatitis B patients compared 25 mg, 100 mg, and placebo, with liver biopsies before and after treatment and a primary endpoint of a ≥2‑point reduction in Knodell necroinflammatory score.

Abstract

In preliminary trials, lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year, double-blind trial of lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of lamivudine (142 patients), 100 mg of lamivudine (143), or placebo (73) orally once daily. The patients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score.