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PROMISE: Triple antiretroviral regimens effectively prevent mother-to-child HIV transmission
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SEATTLE — Results from the PROMISE trial presented at CROI 2015 support the current WHO recommendations for prevention of mother-to-child transmission with the use of triple antiretroviral regimens during pregnancy.
The PROMISE trial — an ongoing, prospective, open-label randomized study at 15 sites in seven countries — consists of pregnant and postpartum women with HIV and high CD4 counts. The trial’s goal is to assess efficacy and safety of prevention of mother-to-child HIV transmission using ART during three periods: pregnancy through 14 days postpartum, breast-feeding and after risk for mother-to-child transmission has passed.
Study researcher Mary Glenn Fowler, MD, of the Johns Hopkins University School of Medicine, and colleagues presented data using a cohort of 3,529 pregnant women and 3,234 live births.
Mary Glenn Fowler
“We presented both the efficacy and safety findings in the pregnancy part of the study through 14 days after delivery. We compared the use of zidovudine [Retrovir, ViiV Healthcare] during pregnancy to triple regimens using either Combivir [lamivudine/zidovudine, ViiV Healthcare] or tenofovir FTC [emtricitabine] backbone [Truvada, Gilead Sciences] plus a PI lopinavir/ritonavir [Kaletra, AbbVie],” Fowler said during a press conference.
Fourteen days after delivery, HIV infection rates among infants was significantly lower among those whose mothers received lamivudine (3TC)/zidovudine plus lopinavir/ritonavir (0.5%) and tenofovir/emtricitabine plus lopinavir/ritonavir (0.6%) vs. those who received zidovudine plus a single dose of nevirapine at delivery plus tenofovir/emtricitabine (1.8%).
Triple antiretroviral regimens were associated with an overall increase in moderate maternal adverse events, including chemistry and hematology. Further, there was a significantly higher risk for moderate pregnancy outcomes, including low birth weight and preterm delivery.
There was a significantly reduced risk for early infant death among the lamivudine/zidovudine plus lopinavir/ritonavir arm compared with the tenofovir/emtricitabine plus lopinavir/ritonavir arm. However, there were no significant differences between the tenofovir triple arm and the zidovudine arm.
“These findings do support WHO recommendations in terms of use of triple antiretrovirals for the lowest risk of transmission. Further, we concluded that the preterm birth and birth weight seen in the triple arms require further follow up, particularly at 1 year after delivery,” Fowler said. “The unexplained safety differences in early infant death between the zidovudine and 3TC and the tenofovir 3TC triple arms are going to be further evaluated, but we do not have an explanation at this time for them.” – by Amanda Oldt
Reference:
Fowler MG, et al. Abstract 31LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 23-26, 2015; Seattle.
Disclosure: The researchers report no relevant financial disclosures.