NVP should be started in the first week of life in infants with TB/HIV co-infections. NVP is safe and effective even among infants with NVP levels below the ideal therapeutic PK target.
NVP Vs. INH
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Study Design
RT-naïve HIV-infected children aged 3–35 months with and without TB were treated with NVP 200 mg/m2 twice daily plus two NRTIs. The new WHO recommended higher dosages of rifampin and isoniazid were used. After 4 weeks of ART, PK samples were collected at 0, 2, 6, and 12 hours post- dose to measure NVP plasma concentrations, using a validated LC/MS/MS assay. In the co-infected patients, sampling was repeated after 4 weeks off TB therapy. PK parameters were calculated using noncompartmental analysis and were compared between groups using Wilcoxon Rank-sum test and within group using Signed-rank test
Study Results
Of the 53 patients, 23 (43%) had TB coinfection, of whom 15 completed PK sampling on (PK1) and off (PK2) anti-TB therapy. Baseline characteristics were similar in the two groups except co-infected children had lower median height-for-age-Z-score. Median NVP concentrations were lowest in the children with TB/HIV coinfection on TB therapy, followed by HIV infection only and highest in the co-infected off TB therapy. Median NVP Cmax, Cmin and AUC0-12h were not significantly different between children with HIV and those with TB/HIV on or off anti-TB therapy. In multivariate analysis, TBtransition to LPV/r-based ART, thought to be adherence-related. Median NVP trough concentration at 1 and 2 wks was 3.01 mcg/mL (at median 15 hrs); 48% of concentrations were below the therapeutic target of 3.0 mcg/mL (including 10% BQL, indicating non-adherence); concentrations did not correlate with the magnitude of decline in HIV RNA log copies/mL at either 2 or 4 wks.
Study Conclusions
The authors concluded that NVP, ZDV, 3TC started in the first week of life was safe and effective, even among infants with NVP levels below the ideal therapeutic PK target. Although poor tolerability often led to transient viral rebound following transition to LPV/r-based ART, almost all children were able to achieve HIV RNA declines to < 400 copies/mL by 12 weeks of life.
References
Enimil, A, Yang, H, Gillani, F, Alghamdi, W, Ortsin, A, Dompreh, A, etc.. Effect of antituberculosis therapy on nevirapine pharmacokinetics in young children. Conference On Retroviruses And Opportunistic Infections. 2019; : .
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