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Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts *
Author(s) -
De Lazzari E,
León A,
Arnaiz JA,
Martinez E,
Knobel H,
Negredo E,
Clotet B,
Montaner J,
Storfer S,
Asenjo MA,
Mallolas J,
Miró JM,
Gatell JM
Publication year - 2008
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2008.00552.x
Subject(s) - nevirapine , medicine , confidence interval , hazard ratio , odds ratio , antiretroviral therapy , rash , clinical endpoint , gastroenterology , randomized controlled trial , human immunodeficiency virus (hiv) , immunology , viral load
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) (400 cells/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.