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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

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Journal of the International AIDS Society200811 (Suppl 1) :P272

  • Published:


  • Ritonavir
  • Darunavir
  • Etravirine
  • Enfuvirtide
  • Median Treatment Duration

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

At baseline, HBV and/or HCV status was known for 1,129 HIV-1-infected patients. Of these, 139 patients (12.3%) were co-infected with HBV and/or HCV; the sample size was too small to compare HBV and HCV groups separately. Median treatment duration for this analysis was 52.3 vs. 51.0 weeks in the ETR + BR and placebo + BR groups, respectively. In co-infected patients, grade 3 or 4 AEs, serious AEs and deaths were less frequent with ETR than with placebo. Grade 3 or 4 AST/ALT elevations were more frequent in co-infected patients receiving ETR, however, the differences between the ETR and placebo groups was small. The incidence of grade 3 or 4 hepatic AEs was similar in both treatment groups. See table in Figure 1.

Figure 1


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.

Authors’ Affiliations

Hospital Universitari Germans Trias i Pujol and IrsiCaixa Foundation, Barcelona, Spain
Département des Maladies Infectieuses et Tropicales, Hôpital Pitié-Salpêtrière, Paris, France
San Raffaele University, Milan, Italy
Tibotec BVBA, Mechelen, Belgium
Tibotec Inc., Pennsylvania, USA


© Clotet et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.