Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 363, Issue 16, Pages 1499-1509Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa0906626
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Funding
- National Institute of Allergy and Infectious Diseases [U01AI068636, AI38838, SDMC AI68634]
- National Center for Research
- National Institutes of Health [K24 AI56933, 5401A1068636-04]
- Boehringer Ingelheim
- Medicines Development
- Pfizer
- Tibotec
- Virionyx
- Schering-Plough
- Merck
- Abbott Speakers Bureau
- Abbott Virology
- Gilead Sciences
- Idenix Pharmaceuticals
- Chimerix
- RFS Pharmaceuticals,
- Panacos Pharmaceuticals
- Abbott Laboratories
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BACKGROUND Peripartum administration of single-dose nevirapine reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) but selects for nevirapine-resistant virus. METHODS In seven African countries, women infected with HIV-1 whose CD4+ T-cell counts were below 200 per cubic millimeter and who either had or had not taken single-dose nevirapine at least 6 months before enrollment were randomly assigned to receive antiretroviral therapy with tenofovir-emtricitabine plus nevirapine or tenofovir-emtricitabine plus lopinavir boosted by a low dose of ritonavir. The primary end point was the time to confirmed virologic failure or death. RESULTS A total of 241 women who had been exposed to single-dose nevirapine began the study treatments (121 received nevirapine and 120 received ritonavir-boosted lopin-avir). Significantly more women in the nevirapine group reached the primary end point than in the ritonavir-boosted lopinavir group (26% vs. 8%) (adjusted P = 0.001). Virologic failure occurred in 37 (28 in the nevirapine group and 9 in the ritonavir-boosted lopinavir group), and 5 died without prior virologic failure (4 in the nevirapine group and 1 in the ritonavir-boosted lopinavir group). The group differences appeared to decrease as the interval between single-dose nevirapine exposure and the start of antiretroviral therapy increased. Retrospective bulk sequencing of baseline plasma samples showed nevirapine resistance in 33 of 239 women tested (14%). Among 500 women without prior exposure to single-dose nevirapine, 34 of 249 in the nevirapine group (14%) and 36 of 251 in the ritonavir-boosted lopinavir group (14%) had virologic failure or died. CONCLUSIONS In women with prior exposure to peripartum single-dose nevirapine (but not in those without prior exposure), ritonavir-boosted lopinavir plus tenofovir-emtricitabine was superior to nevirapine plus tenofovir-emtricitabine for initial antiretroviral therapy.
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