Entecavir Is Superior to Epivir-HBV

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Entecavir Is Superior to Epivir-HBV in Reducing HBV DNA Levels Among Patients with Chronic Hepatitis B

By Ronald Baker, PhD

There are currently 3 FDA-approved agents for the treatment of chronic hepatitis B: Epivir-HBV (GlaxoSmithKline), Intron A (Schering-Plough) and Hepsera (Gilead Sciences). A number of new agents are in development for the treatment of hepatitis B. Entecavir is a promising new experimental nucleoside analog drug from Bristol-Myers Squibb that has entered Phase III clinical trials for efficacy, the final stage of testing prior to FDA evaluation for approval as a prescription drug.

Entecavir shows superior effectiveness compared to Epivir-HBV (lamivudine; 3TC) in reducing HBV DNA levels in patients with chronic HBV, according to results of a Phase II study published in the December issue of Gastroenterology. The 24-week randomized, double blind study was conducted in 169 patients with chronic hepatitis B. The multicenter study took place at sites in China, Malaysia, The Philippines, Belgium, Canada and the US.

The safety and efficacy of entecavir at various doses (0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally) were compared with Epivir-HBV (100 mg/day orally). Patients with chronic HBV (hepatitis B "e" antigen [HBeAg]-positive and -negative) were evaluated for efficacy using the two treatments.

Compared with Epivir-HBV, entecavir reduced HBV DNA by an additional 0.97 log (10) at the 0.1-mg/day dose and an additional 1.28 log (10) at the 0.5-mg/day dose (P < 0.0001). A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater HBV suppression.

In patients treated with entecavir 0.5 mg/day, 83.7% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics), compared with 57.5% treated with 100 mg/day lamivudine (P = 0.008).

In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine (P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms.

The authors conclude, "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."

1/03/03

Reference
CL Lai and others. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 2002 Dec; 123(6): 1831-1838.


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