This article is more than 5 years old. Information may no longer be current.

Entecavir/tenofovir may benefit chronic HBV patients with higher DNA levels

Therapy with entecavir and tenofovir was similarly as effective as entecavir alone in patients with chronic HBV, but improved response among hepatitis B e antigen-positive patients with higher baseline HBV DNA levels in a recent study.

In an open-label, multicenter superiority study, researchers randomly assigned 379 nucleos(t)ide-naive patients with chronic HBV either 0.5 mg entecavir (ETV) (n=182) or 0.5 mg ETV with 300 mg tenofovir disoproxil fumarate (TDF) (n=197) for 100 weeks. The cohort included 264 hepatitis B e antigen-positive (HBeAg-positive) and 115 HBeAg-negative patients. Primary endpoint was an HBV DNA level less than 50 IU/mL.

The proportion of patients reaching the primary endpoint was similar between groups after 96 weeks (83.2% receiving combination therapy vs. 76.4% receiving ETV alone; P=.088). Rate of response was similar among HBeAg-negative patients in the two groups (89.8% for HBeAg-negative patients receiving combination therapy, 91.1% for those receiving ETV alone; P=.82). ALT level normalization occurred more frequently in the monotherapy group at 96 weeks (81.9% of patients vs. 69.0%; P=.004).

A significantly larger number of HBeAg-positive patients receiving combination therapy (80.4%) achieved the endpoint than HBeAg-positive patients receiving ETV alone (69.8%) (P=.046 for difference), but the difference only occurred among patients with baseline DNA levels of 10⁸ IU/mL or greater: In this subgroup, more patients receiving combination therapy achieved the endpoint (78.8% vs. 62.0%; P=.018), but rates were similar among patients with levels less than 10⁸ IU/mL (83.0% for both treatment methods). The proportion of HBeAg-positive patients achieving seroconversion (P=.08) and loss (P=.16) were similar between groups.

The mean change to HBV DNA levels from baseline was similar at 96 weeks between groups (–5.96 log10 IU/mL for combination therapy vs. –5.7 log10 IU/mL for ETV monotherapy; P=.25), but HBeAg-positive patients in the combination therapy group experienced a larger change (–6.62 log10 IU/mL for combination vs. –6.30 log10 IU/mL for monotherapy; P=.04).

“Over 96 weeks of treatment, the antiviral efficacy of ETV monotherapy is similar to that of ETV plus TDF combination therapy in a mixed population of NA-naive patients with [chronic HBV],” the researchers concluded. “Evaluation of the combination of ETV plus TDF beyond 96 weeks is necessary to confirm its safety and efficacy during long-term use.”

Disclosure: See the study for a full list of relevant disclosures.