Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts

E. De Lazzari, A. León*, J. A. Arnaiz, E. Martinez, H. Knobel, E. Negredo, B. Clotet, J. Montaner, S. Storfer, M. A. Asenjo, J. Mallolas, J. M. Miró, J. M. Gatell

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

53 Citations (Scopus)


Objectives: A warning advising a higher risk of hepatotoxicity in antiretroviral-naive patients starting a nevirapine-containing combination antiretroviral therapy (NcART) has been issued by health authorities. It is unclear whether this higher risk also applies to stable virologically suppressed patients starting NcART. Methods: We performed a meta-analysis of published randomized studies including virologically suppressed patients who switched to NcART with a follow-up ≥3 months. CD4 cell cell counts were classified as high (HCD4) (400cells/μL for males and 250 cells/μL for females) or low (LCD4). The main endpoint was hepatotoxicity within the first 3 months. Results: Four studies with a pooled total of 410 patients were included. The risk of hepatotoxicity within the first 3 months was 2% and 4% in the LCD4 and HCD4 groups, respectively, with a combined odds ratio of 1.46 [95% confidence interval (CI) 0.43-4.98; P = 0.54]. The risk of hepatotoxicity at any point during the study was similar in both groups, with a combined hazard ratio of 0.8 (95% CI 0.3-2.5; P = 0.80). Conclusions: In our study, virologically suppressed patients switching to nevirapine did not have a significantly higher risk of hepatotoxicity or rash when stratified by gender and CD4 cell count, although small differences may have gone undetected because of the sample size limitation.

Original languageAmerican English
Pages (from-to)221-226
Number of pages6
JournalHIV Medicine
Issue number4
Publication statusPublished - Apr 2008


  • CD4 count
  • Gender
  • Hepatotoxicity
  • Meta-analysis
  • Nevirapine

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