Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery. (1st July 2020)

• Record Type: Journal Article
• Authors: Lallemant, Marc; Amzal, Billy; Sripan, Patumrat; Urien, Saïk; Cressey, Tim R.; Ngo-Giang-Huong, Nicole; Klinbuayaem, Virat; Rawangban, Boonsong; Sabsanong, Prapan; Siriwachirachai, Thitiporn; Jarupanich, Tapnarong; Kanjanavikai, Prateep; Wanasiri, Phaiboon; Koetsawang, Suporn; Jourdain, Gonzague; Le Coeur, Sophie
• Is Part Of: Journal of acquired immune deficiency syndromes. Volume 84:Number 3(2020)
• Publication Date: 2020-07-01
• Subjects: HIV -- prevention of mother-to-child transmission -- Bayesian design -- antiretroviral therapy -- clinical trial -- historical control -- meta-analysis -- Thailand; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome -- Periodicals; AIDS (Disease); Periodicals; 616.9792005
• DOI: 10.1097/QAI.0000000000002350
• Languages: English
• ISSNs: 1525-4135

Abstract

Abstract : 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 2·2% (95% credibility interval 0·5–6·1) without intensification versus 0·3% (0·0–1·6) with intensification. The probability of superiority of intensification over standard of care was 94·4%. 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. Abstract : Supplemental Digital Content is Available in the Text.