TY - JOUR
T1 - 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)
T2 - The kesho bora randomized controlled trial
AU - Dioulasso, Bobo
AU - Faso, Burkina
AU - Meda, Nicolas
AU - Fao, Paulin
AU - Ky-Zerbo, Odette
AU - Gouem, Clarisse
AU - Somda, Paulin
AU - Hien, Hervé
AU - Ouedraogo, Patrice Elysée
AU - Kania, Dramane
AU - Sanou, Armande
AU - Kossiwavi, Ida Ayassou
AU - Sanogo, Bintou
AU - Ouedraogo, Moussa
AU - Siribie, Issa
AU - Valéa, Diane
AU - Ouedraogo, Sayouba
AU - Somé, Roseline
AU - Rouet, François
AU - Rollins, Nigel
AU - McFetridge, Lynne
AU - Naidu, Kevi
AU - Luchters, Stanley
AU - Reyners, Marcel
AU - Irungu, Eunice
AU - Katingima, Christine
AU - Mwaura, Mary
AU - Ouattara, Gina
AU - Mandaliya, Kishor
AU - Wambua, Sammy
AU - Thiongo, Mary
AU - Nduati, Ruth
AU - Kose, Judith
AU - Njagi, Ephantus
AU - Mwaura, Peter
AU - Newell, Marie Louise
AU - Mepham, Stephen
AU - Viljoen, Johannes
AU - Bland, Ruth
AU - Mthethwa, Londiwe
N1 - Funding Information:
The Nairobi site was funded by the Centers for Disease Control and Prevention (CDC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through a cooperative agreement, The South-African sites were funded by the Department for International Development (DFID), EDCTP, UNICEF, and WHO/HRP. The Nutrition and laboratory coordination were funded by ANRS.
Funding Information:
Financial support. Financial support was provided by Agence Natio-nale de Recherche sur le Sida et les hépatites virales; Department for International Development; European and Developing Countries Clinical Trials Partnership; Thrasher Research Fund; Belgian Directorate General for International Cooperation; US Centers for Disease Control and Prevention; Eunice Kennedy Shriver National Institute of Child Health and Human Development; and UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction. Potential conflicts of interest All authors: No reported conflicts.
Funding Information:
The Bobo-Dioulasso site was funded by l’Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS) and UNDP/ UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (WHO/HRP), The Mombasa site was funded by ANRS, WHO/HRP, European and Developing Countries Clinical Trials Partnership (EDCTP), Thrasher Research Fund, and Belgian Directorate General for International Cooperation.
PY - 2012/8/1
Y1 - 2012/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84863927001&partnerID=8YFLogxK
U2 - 10.1093/cid/cis461
DO - 10.1093/cid/cis461
M3 - Article
C2 - 22573845
AN - SCOPUS:84863927001
SN - 1058-4838
VL - 55
SP - 449
EP - 460
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 3
ER -
