Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts.
OBJECTIVE
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 >or=3 months. CD4 cell cell counts were classified as high (HCD4) (400 cells/microL for males and 250 cells/microL 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.
De Lazzari
E
E
Biostatistic Unit, Hospital Clinic, University of Barcelona, Spain.
León
A
A
Arnaiz
J A
JA
Martinez
E
E
Knobel
H
H
Negredo
E
E
Clotet
B
B
Montaner
J
J
Storfer
S
S
Asenjo
M A
MA
Mallolas
J
J
Miró
J M
JM
Gatell
J M
JM
D000328:Adult; D019380:Anti-HIV Agents / Q000633:toxicity*; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury; D004359:Drug Therapy, Combination; D005076:Exanthema / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology*; D015497:HIV-1; D006801:Humans; D008107:Liver Diseases / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000633:toxicity*; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D019562:Viral Load
D019380:Anti-HIV Agents; D019829:Nevirapine