Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): A randomised, placebo controlled, phase 2 trial
The Lancet Infectious Diseases Mar 05, 2019
Wedemeyer H, et al. - Researchers performed two parallel, investigator-initiated, multicentre, double-blind randomized, controlled trials at 14 study sites in Germany, Greece, Romania, and Turkey to investigate the impact of prolonged treatment of hepatitis D virus (HDV) with 96 weeks of peginterferon on HDV RNA response rates and post-treatment relapses. By blinded stratified block randomization, they assigned patients with chronic HDV infection and compensated liver disease who were aged 18 years or older (1:1) to receive 180 μg of peginterferon alfa-2a weekly plus either tenofovir disoproxil fumarate (TDF) (300 mg once daily) or placebo for 96 weeks. Outcomes suggest no significant improvement in HDV RNA response rates at the end of treatment with the addition of TDF. These findings highlight the necessity for alternative treatment options for hepatitis D.
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