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Besifovir noninferior to entecavir for chronic HBV in phase 2b trial

Patients with chronic hepatitis B treated with besifovir experienced similar outcomes to entecavir recipients, but often required carnitine supplementation, in a recent study.

In a multicenter, phase 2b trial in Asia, researchers randomized 114 adult patients with chronic hepatitis B to receive either 0.5 mg entecavir (n=39) or 90 mg (n=36) or 150 mg (n=39) besifovir daily for 48 weeks. All participants had compensated liver disease and had been HBsAg-positive for more than 6 months prior to screening. Patients were evaluated biweekly for 4 weeks, then every 4 weeks until 24 weeks of treatment, then every 8 weeks until completion.

At all evaluated time points, HBV DNA reduction occurred at similar rates across the three groups. Incidence of undetectable HBV DNA did not differ significantly between groups, occurring in 63.6% of the 90 mg group, 62.9% of the 150 mg group and 58.3% of the entecavir group. ALT normalization also occurred at similar rates (91.7%, 76.9% and 89.7%, respectively), as did HBeAg seroconversion (11.11%, 15% and 9.52% of patients in each group). No participants experienced an HBV DNA reduction of fewer than 2 log₁₀ copies/mL after 24 weeks (primary treatment failure).

Nearly all besifovir recipients (94.1% across both groups), experienced a reduction in serum levels of L-carnitine, which resolved after supplementation. Significantly more patients in the 150 group experienced this reduction than in the 90 mg group (P=.002).

No participants developed resistant mutations or experienced serum creatinine increases of more than 0.5 mg/dL. One patient in the 90 mg group experienced virologic breakthrough. Three participants in the 150 mg group and two in the entecavir group experienced hepatic flares, but these were not considered related to treatment.

“With its high potency (comparable with entecavir), its effectiveness in lamivudine-resistant patients and its absence of renal toxicity up to 48 weeks of treatment, besifovir (taken together with carnitine supplement) is a potential alternative agent for the treatment of CHB,” the researchers concluded. “It is also an effective agent for patients with lamivudine or telbivudine resistance. … Further studies are required to determine which of these doses is the optimal dose.”

Disclosure: Researchers Ching-Lung Lai, MD, and Man-Fung Yueng, MD, PhD, reported serving as consultants for LG Life Sciences, Ltd. Jin-Woo Lee, MD, PhD, and Jeong-Ae Kim, PhD, are employees of LG Life Sciences.