Safety and tolerability of etravirine (ETR; TMC125) in hepatitis B and/or C co-infected patients in DUET-1 and DUET-2: pooled 48-week results
© Clotet et al; licensee BioMed Central Ltd. 2008
Published: 10 November 2008
Purpose of the study
The 48-week efficacy and safety analysis of the next-generation NNRTI etravirine (ETR) in the DUET studies has recently been completed. We report safety results from a planned pooled analysis, according to baseline hepatitis co-infection status.
HIV-1-infected patients on stable but virologically failing therapy were randomised to receive either ETR 200 mg twice daily or placebo, both in combination with a background regimen (BR) consisting of darunavir with low-dose ritonavir (DRV/r), investigator-selected NRTIs and optional enfuvirtide (ENF). Hepatitis B and/or C virus (HBV and/or HCV) co-infection status was confirmed by hepatitis B surface antigen or HCV antibody and qualitative HCV ribonucleic acid (RNA). Co-infected patients were eligible if they were clinically stable, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <5 × the upper limit of normal and did not require anti-hepatitis treatment. Adverse events (AEs) and laboratory parameters were analysed.
Summary of results
In general, the incidence and severity of AEs with ETR was similar to placebo, irrespective of co-infection status. The incidence of hepatic AEs and grade 3 or 4 AST/ALT elevations was higher in co-infected patients than in non-co-infected patients in both treatment groups, consistent with the underlying chronic hepatitis condition. ETR did not increase hepatic toxicity in patients with hepatitis co-infection and was generally well tolerated in all patients.
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