Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: Pooled 96 week results from the phase III DUET trials

Objectives: Human immunodeficiency virus (HIV)-infected patients are frequently co-infected with hepatitis B and/or C virus (HBV/HCV). The safety of etravirine was investigated over 96 weeks in patients co-infected with HIV type-1 (HIV-1) and HBV and/or HCV in the Phase III DUET trials. DUET-1 and DUET-2 are registered with clinicaltrials.gov (NCT00254046 and NCT00255099, respectively). Methods: Treatment-experienced, HIV-1-infected patients with documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance were randomized to receive either etravirine 200 mg or placebo, both twice daily plus a background regimen of darunavir/ritonavir, investigator-selected nucleoside reverse transcriptase inhibitors and optional enfuvirtide. Hepatitis co-infection status was confirmed by hepatitis B surface antigen or HCV antibody and qualitative HCV RNA. Co-infected patients were eligible if they did not require anti-hepatitis treatment and were clinically stable, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations