R. Shapiro, M. Hughes, A. Ogwu, D. Kitch, S. Lockman, C. Moffat, J. Makhema, S. Moyo, I. Thior, K. McIntosh, E. van Widenfelt, J. Leidner, K. Powis, A. Asmelash, E. Tumbare, S. Zwerski, U. Sharma, E. Handelsman, O. Jayeoba, E. Moko, S. Souda, E. Lubega, M. Akhtar, C. Wester, W. Snowden, M. Martinez-Tristani, L. Mazhani, M. Essex, The Mma Bana Study Team
5th IAS Conference on HIV Treatment, Pathogenesis and Prevention, Cape Town
Background: No randomized trial has previously compared highly active antiretroviral therapy (HAART) regimens in pregnancy or during breastfeeding.
Methods: HIV-infected pregnant women with CD4 ≥200 cells/mm3 randomized to co-formulated abacavir/zidovudine/lamivudine (Arm A) vs. lopinavir/ritonavir/combivir (Arm B) from 26-34 weeks gestation through planned weaning by 6 months postpartum. Women with CD4 < 200 cells/mm3 received nevirapine/combivir (observational group) from 18-34 weeks gestation. Primary outcomes were: 1) maternal HIV-1 RNA suppression < 400 copies/mL at delivery and throughout breastfeeding at 1, 3, 6 months (or weaning), and 2) MTCT rates by infant HIV DNA PCR at birth and 1, 3, 6 months.
Results: 730 women were enrolled: 560 randomized, 170 observational. Stillbirths occurred in 3% (Arm A), 2% (Arm B), and 7% (observational). Prematurity was more common in Arm B than Arm A (23% vs. 15%, p=0.04); low birth weight did not differ by HAART regimen. HIV-1 RNA suppression did not differ by randomization arm at birth (96% Arm A vs. 93% Arm B, p=0.18), or throughout breastfeeding (92% Arm A vs. 93% Arm B, p=0.98). HIV-1 RNA suppression in the observational group was also high (94% at birth, 95% throughout breastfeeding). MTCT rates were low: 2% Arm A (3 in utero and 2 breastfeeding transmissions) and < 1% Arm B (1 in utero transmission) (p=0.53). Inclusion of an unconfirmed Arm A in utero transmission (death following positive birth PCR) did not change results (p=0.42). One in utero transmission (< 1%) occurred in the observational group. Treatment-limiting maternal adverse events occurred in 2% (Arm A), 2% (Arm B), and 11% (observational). 71% breastfed for >5 months, < 1% beyond 6 months. Infant 6-month mortality was 2% (Arm A), 3% (Arm B), and 4% (observational). Conclusions: Maternal virologic suppression rates at delivery and during breastfeeding did not differ by HAART regimen. HAART from pregnancy through 6 months postpartum allowed for safe breastfeeding, with an overall MTCT rate only 1%.