Association of Maternal Viral Load and CD4 Count With Perinatal HIV-1 Transmission Risk During Breastfeeding in the PROMISE Postpartum Component
Year: 2021
Type: article
Abstract: BACKGROUND: Breastfeeding mothers with HIV infection not qualifying for antiretroviral therapy (ART) based on country-specific guidelines at the time of the Promoting Maternal-Infant Survival Everywhere trial and their uninfected neonates were randomized to maternal ART (mART) or infant nevirapine prophylaxis (iNVP) postpartum. HIV transmission proportions were similar (<1%) in the 2 arms. We assessed whether maternal viral load (MVL) and CD4 cell counts were associated with breastfeeding HIV transmission. METHODS: MVL was collected at entry (7-14 days postpartum) and at weeks 6, 14, 26, and 50 postpartum. CD4 cell counts were collected at entry and weeks 14, 26, 38, and 50 postpartum. Infant HIV-1 nucleic acid test was performed at weeks 1 and 6, every 4 weeks until week 26, and then every 12 weeks. The associations of baseline and time-varying MVL and CD4 cell counts with transmission risk were assessed using time-to-event analyses by randomized treatment arm. RESULTS: Two thousand four hundred thirty-one mother-infant pairs were enrolled in the study. Baseline MVL (P = 0.11) and CD4 cell counts (P = 0.51) were not significantly associated with infant HIV-1 infection. Time-varying MVL was significantly associated with infant HIV-1 infection {hazard ratio [95% confidence interval (CI)]: 13.96 (3.12 to 62.45)} in the mART arm but not in the iNVP arm [hazard ratio (95% CI): 1.04 (0.20 to 5.39)]. Time-varying CD4 cell counts were also significantly associated with infant HIV-1 infection [hazard ratio (95% CI): 0.18 (0.03 to 0.93)] in the mART arm but not in the iNVP arm [hazard ratio (95% CI): 0.38 (0.08 to 1.77)]. CONCLUSIONS: In women receiving mART, increased MVL and decreased CD4 cell counts during breastfeeding were associated with increased risk of infant HIV-1 infection.
Authors: Patricia M. Flynn, Taha E. Taha, Mae Cababasay, Kevin Butler, Mary G. Fowler, Lynne M. Mofenson, Maxensia Owor, Susan Fiscus, Lynda Stranix-Chibanda, Anna Coutsoudis, Devasena Gnanashanmugam, Nahida Chakhtoura, Katie McCarthy, Lisa Frenkel, Ingrid Beck, Cornelius Mukuzunga, Bonus Makanani, Dhayendre Moodley, Teacler Nematadzira, Bangani Kusakara, Sandesh Patil, Tichaona Vhembo, Raziya Bobat, Blandina T. Mmbaga, Maysseb Masenya, Mandisa Nyati, Gerhard Theron, Helen Mulenga, David E. Shapiro, the PROMISE Study Team
Institutions: St. Jude Children's Research Hospital, Johns Hopkins University, Harvard University, Johns Hopkins Medicine, Elizabeth Glaser Pediatric AIDS Foundation, MUJHU Research Collaboration, University of North Carolina at Chapel Hill, University of Zimbabwe, University of KwaZulu-Natal, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Family Health International 360, University of Washington, Seattle Children's Research Institute, Kamuzu Central Hospital, University of Malawi, Centre for the AIDS Programme of Research in South Africa, Kilimanjaro Christian Medical Centre, University of the Witwatersrand, Chris Hani Baragwanath Hospital, Stellenbosch University, Centre for Infectious Disease Research in Zambia
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1220961632, G32641939, International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group, UZ-UCSF Clinical Trials Unit, SDMC - IMPAACT Leadership Group, UZ-UCSF CTU, International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network, University of Washington/Fred Hutch Center for AIDS Research, The Johns Hopkins University-Blantyre Clinical Trials Unit, CURE CTU, Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication, KwaZulu-Natal Clinical Trials Unit, IMPAACT Leadership Group
OpenAlex ID: W3167543573