Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B

The Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN Immune Active) study sought to compare the long-term efficacy of combination therapy with peginterferon plus tenofovir versus tenofovir monotherapy in the treatment of chronic hepatitis B. This randomized (1:1) parallel group trial compared (i) tenofovir disoproxil fumarate (TDF) 300 mg daily for 192 weeks (4 years) and (ii) peginterferon (PegIFN) alfa-2a 180 µg weekly for 24 weeks plus TDF 300 mg daily for 192 weeks (4 years). Enrolled participants were stratified by HBeAg status (positive/negative), genotype (A versus all others), and cirrhosis (present versus absent). After 192 weeks of treatment, participants meeting criteria for treatment discontinuation stopped treatment and were followed for 48 weeks (total duration of treatment and follow up was 240 weeks). Emtricitabine/tenofovir coformulated as Truvada, approved for treatment of HIV but not for treatment of hepatitis B virus (HBV) infection, was offered to patients with primary nonresponse, partial virological response, or confirmed virologic breakthrough.