Entecavir is a novel and selective nucleoside analogue with potent activity against hepatitis B virus (HBV).
In this study, published in the December issue of Gastroenterology, the safety and efficacy of entecavir (0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally) were compared with lamivudine (100 mg/day orally).
The research team performed a 24-week, double-blind, randomized, multicenter, phase II clinical trial.
The team assessed 169 patients, chronically infected with HBV (hepatitis B e antigen [HBeAg]-positive and -negative).
When compared with lamivudine, the team found that entecavir reduced HBV DNA by an additional 0.97 log10 at the 0.1-mg/day dose and an additional 1.28 log10 at the 0.5-mg/day dose.
|Overall, entecavir was found to be well tolerated.|
They observed a clear dose-response relationship for entecavir, with the higher doses showing significantly greater viral suppression.
Furthermore, in patients treated with entecavir 0.5 mg/day, 84% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay. This figure was 58% in patients treated with 100 mg/day lamivudine.
However, by week 22 few patients achieved HBeAg loss and/or seroconversion, in either treatment arm.
The team found that more patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase levels at week 22.
Overall the researchers found entecavir to be well tolerated. Most adverse events were mild to moderate, transient, and comparable in all study arms.
Dr Ching-Lung Lai's team concluded, "This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients".
In a related editorial in the same publication, Dr Tim Shaw and colleagues also discuss chemotherapy for hepatitis B.
They conclude by questioning whether, "Future research will eventually produce solutions to the problem of eradication of intrahepatic HBV DNA…[and whether this would] lead to…improved quality of life and extended life expectancy".
"Could the achievement of this goal be regarded as a real "cure"?"