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

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.