Lallemant Marc auteur aut IRD Amzal B. auteur aut IRD Sripan P. auteur aut IRD Urien S. auteur aut IRD Cressey T. R. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Klinbuayaem V. auteur aut IRD Rawangban B. auteur aut IRD Sabsanong P. auteur aut IRD Siriwachirachai T. auteur aut IRD Jarupanich T. auteur aut IRD Kanjanavikai P. auteur aut IRD Wanasiri P. auteur aut IRD Koetsawang S. auteur aut IRD Jourdain Gonzague auteur aut IRD Le Coeur S. auteur aut IRD text journalArticle eng text/pdf born digital access Introduction: Infants born to women living with HIV initiating combination antiretroviral therapy (cART) late in pregnancy are at high risk of intrapartum infection. Mother/infant perinatal antiretroviral intensification may substantially reduce this risk. Methods: In this single-arm Bayesian trial, pregnant women with HIV receiving standard of care antiretroviral prophylaxis in Thailand (maternal antenatal lopinavir-based cART; nonbreastfed infants 4 weeks' postnatal zidovudine) were offered "antiretroviral intensification" (labor single-dose nevirapine plus infant zidovudine-lamivudine-nevirapine for 2 weeks followed by zidovudine-lamivudine for 2 weeks) if their antenatal cART was initiated <= 8 weeks before delivery. A negative birth HIV-DNA polymerase chain reaction (PCR) followed by a confirmed positive PCR defined intrapartum transmission. Before study initiation, we modeled intrapartum transmission probabilities using data from 3738 mother/infant pairs enrolled in our previous trials in Thailand using a logistic model, with perinatal maternal/infant antiretroviral regimen and predicted viral load at delivery as main covariates. Using the characteristics of the women enrolled who received intensification, prior intrapartum transmission probabilities (credibility intervals) with/without intensification were estimated. After including the transmission data observed in the current study, the corresponding Bayesian posterior transmission probability was derived. Results: No intrapartum transmission of HIV was observed among the 88 mother/infant pairs receiving intensification. The estimated intrapartum transmission probability was 2 center dot 2% (95% credibility interval 0 center dot 5-6 center dot 1) without intensification versus 0 center dot 3% (0 center dot 0-1 center dot 6) with intensification. The probability of superiority of intensification over standard of care was 94 center dot 4%. Antiretroviral intensification appeared safe. Conclusion: Mother/infant antiretroviral intensification was effective in preventing intrapartum transmission of HIV in pregnant women receiving <= 8 weeks antepartum cART. specialized HIV prevention of mother-to-child transmission Bayesian design antiretroviral therapy clinical trial historical control meta-analysis Thailand THAILANDE 050 052 84 3 313-322 2020 1525-4135 https://www.documentation.ird.fr/hor/fdi:010079321 10.1097/qai.0000000000002350 1525-4135 [F B010079321] https://www.documentation.ird.fr/hor/fdi:010079321 https://www.documentation.ird.fr/intranet/publi/2020/08/010079321.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2020-09-17 2025-02-24 fdi:010079321 fre