Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial

Dorothy Sebikari, MBChB, MPH; Mona Farhad, MS; Terry Fenton, EdD; Maxensia Owor, MBChB; Jeffrey S. A. Stringer, MD; Min Qin, PhD; Nahida Chakhtoura, MD; Benjamin H. Chi, MD, MSc; Friday Saidi, MBBS; Neetal Nevrekar, MD; Avy Violari, MD; Tsungai Chipato, MBChB, MCE; James A. McIntyre, MBChB, FRCOG; Dhayendre Moodley, PhD; Taha E. Taha, MBBS, MCM, MPH, PhD; Gerhard Theron, MD; Mary Glenn Fowler, MD, MPH


J Acquir Immune Defic Syndr. 2019;81(5):521-532. 

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In conclusion, these analyses demonstrate that, even after adjustment for a number of well-established clinical, demographic, and obstetrical risk factors, maternal PI-based ART regimens given for PMTCT among HIV-infected pregnant women remained an important risk factor for PTD/VPTD and LBW/VLBW outcomes, compared with antenatal ZDV alone. Moreover, TDF-based ART was significantly associated with greater numbers of severe adverse pregnancy outcomes than was ZDV-based ART. With the current rollout of lifetime ART according to "test and treat" recommendations by WHO and being implemented by the Ministries of Health, these results, which corroborate potential negative effects of maternal ART on pregnancy outcomes, need to be considered in the management of HIV-positive pregnant women so as to reduce the risk of LBW and PTD outcomes, as well as composite adverse pregnancy outcomes, that are associated with high rates of infant morbidity and mortality, particularly in resource limited settings. Further research is needed to elucidate the biologic mechanisms underlying these adverse pregnancy outcomes, to optimize maternal treatment/PMTCT regimens. In addition, more studies are required to investigate whether this effect occurs with other PI's or more recent ARV's such as some integrase inhibitors.