Determinants of virological outcome and adverse events in African children treated with paediatric nevirapine fixed-dose-combination tablets.

ABSTRACT: BACKGROUND:Nevirapine is the only nonnucleoside reverse transcriptase inhibitor currently available as a paediatric fixed-dose-combination tablet and is widely used in African children. Nonetheless, the number of investigations into pharmacokinetic determinants of virological suppression in African children is limited, and the predictive power of the current therapeutic range was never evaluated in this population, thereby limiting treatment optimization. METHODS:We analysed data from 322 African children (aged 0.3-13 years) treated with nevirapine, lamivudine, and either abacavir, stavudine, or zidovudine, and followed up to 144 weeks. Nevirapine trough concentration (Cmin) and other factors were tested for associations with viral load more than 100 copies/ml and transaminase increases more than grade 1 using proportional hazard and logistic models in 219 initially antiretroviral treatment (ART)-naive children. RESULTS:Pre-ART viral load, adherence, and nevirapine Cmin were associated with viral load nonsuppression [hazard ratio?=?2.08 (95% confidence interval (CI): 1.50-2.90, P?12.4?mg/l), hazard ratio?=?5.18 (95% CI 1.95-13.80, P?

SUBMITTER: Bienczak A 

PROVIDER: S-EPMC5572624 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature