Collaborators
- Kesho Bora Study Group:
Bobo Dioulasso, Burkina Faso, Nicolas Meda, Paulin Fao, Odette Ky-Zerbo, Clarisse Gouem, Paulin Somda, Hervé Hien, Patrice Elysée Ouedraogo, Dramane Kania, Armande Sanou, Ida Ayassou Kossiwavi, Bintou Sanogo, Moussa Ouedraogo, Issa Siribie, Diane Valéa, Sayouba Ouedraogo, Roseline Somé, François Rouet, Nigel Rollins, Lynne McFetridge, Kevi Naidu, Stanley Luchters, Marcel Reyners, Eunice Irungu, Christine Katingima, Mary Mwaura, Gina Ouattara, Kishor Mandaliya, Sammy Wambua, Mary Thiongo, Ruth Nduati, Judith Kose, Ephantus Njagi, Peter Mwaura, Marie-Louise Newell, Stephen Mepham, Johannes Viljoen, Ruth Bland, Londiwe Mthethwa
PMID: 22573845 PMCID: PMC3393708
DOI: 10.1093/cid/cis461
Abstract
Background: Antiretroviral (ARV) prophylaxis effectively reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV). However, it is unclear whether stopping ARVs after breastfeeding cessation affects maternal HIV disease progression. We assessed 18-24-month postpartum disease progression risk among women in a randomized trial assessing efficacy and safety of prophylactic maternal ARVs.
Methods: From 2005 to 2008, HIV-infected pregnant women with CD4(+) counts of 200-500/mm(3) were randomized to receive either triple ARV (zidovudine, lamivudine, and lopinavir/ritonavir during pregnancy and breastfeeding) or AZT/sdNVP (zidovudine until delivery with single-dose nevirapine without postpartum prophylaxis). Maternal disease progression was defined as the combined endpoint of death, World Health Organization clinical stage 4 disease, or CD4(+) counts of <200/mm(3).
Results: Among 824 randomized women, 789 had at least 1 study visit after cessation of ARV prophylaxis. Following delivery, progression risk up to 24 months postpartum in the triple ARV arm was significantly lower than in the AZT/sdNVP arm (15.7% vs 28.3%; P = .001), but the risks of progression after cessation of ARV prophylaxis (rather than after delivery) were not different (15.0% vs 13.8% 18 months after ARV cessation). Among women with CD4(+) counts of 200-349/mm(3) at enrollment, 24.0% (95% confidence interval [CI], 15.7-35.5) progressed with triple ARV, and 23.0% (95% CI, 17.8-29.5) progressed with AZT/sdNVP, whereas few women in either arm (<5%) with initial CD4(+) counts of ≥350/mm(3) progressed.
Conclusions: Interrupting prolonged triple ARV prophylaxis had no effect on HIV progression following cessation (compared with AZT/sdNVP). However, women on triple ARV prophylaxis had lower progression risk during the time on triple ARV. Given the high rate of progression among women with CD4(+) cells of <350/mm(3), ARVs should not be discontinued in this group.
Clinical trials registration: ISRCTN71468410.
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