At a glance
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Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating Tenofovir and Peginterferon-alfa 2a and tenofovir for Hepatitis B. Completed, enrolled 201 participants across 21 sites in 2 countries.
Detailed Summary
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).
Study Details
Timeline
Interventions
300 mg daily for 192 weeks (4 years)
A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).