Last data update: May 13, 2024. (Total: 46773 publications since 2009)
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Query Trace: McFetridge L[original query] |
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Maternal HIV-1 disease progression 18-24 months postdelivery according to antiretroviral prophylaxis regimen (triple-antiretroviral prophylaxis during pregnancy and breastfeeding vs zidovudine/single-dose nevirapine prophylaxis): the Kesho Bora randomized controlled trial
Dioulasso B , Faso B , Meda N , Fao P , Ky-Zerbo O , Gouem C , Somda P , Hien H , Ouedraogo PE , Kania D , Sanou A , Kossiwavi IA , Sanogo B , Ouedraogo M , Siribie I , Valea D , Ouedraogo S , Some R , Rouet F , Rollins N , McFetridge L , Naidu K , Luchters S , Reyners M , Irungu E , Katingima C , Mwaura M , Ouattara G , Mandaliya K , Wambua S , Thiongo M , Nduati R , Kose J , Njagi E , Mwaura P , Newell ML , Mepham S , Viljoen J , Bland R , Mthethwa L . Clin Infect Dis 2012 55 (3) 449-460 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. (2012 The Author.) |
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