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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

(2012) CLINICAL INFECTIOUS DISEASES. 55(3). p.449-460
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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.
Keywords
TRANSMISSION, INFECTED ADULTS, INTERRUPTION, THERAPY, WOMEN

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Please use this url to cite or link to this publication:

Chicago
Meda, Nicolas, Paulin Fao, Odette Ky-Zerbo, Clarisse Gouem, Paulin Somda, Hervé Hien, Patrice Elysée Ouedraogo, et al. 2012. “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.” Clinical Infectious Diseases 55 (3): 449–460.
APA
Meda, N., Fao, P., Ky-Zerbo, O., Gouem, C., Somda, P., Hien, H., Ouedraogo, P. E., et al. (2012). 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. CLINICAL INFECTIOUS DISEASES, 55(3), 449–460.
Vancouver
1.
Meda N, Fao P, Ky-Zerbo O, Gouem C, Somda P, Hien H, et al. 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. CLINICAL INFECTIOUS DISEASES. 2012;55(3):449–60.
MLA
Meda, Nicolas, Paulin Fao, Odette Ky-Zerbo, et al. “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.” CLINICAL INFECTIOUS DISEASES 55.3 (2012): 449–460. Print.
@article{2979795,
  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 {\textlangle}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 ({\textlangle}5\%) with initial CD4(+) counts of {\textrangle}= 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 {\textlangle}350/mm(3), ARVs should not be discontinued in this group.},
  author       = {Meda, Nicolas and Fao, Paulin and Ky-Zerbo, Odette and Gouem, Clarisse and Somda, Paulin and Hien, Herv{\'e} and Ouedraogo, Patrice Elys{\'e}e and Kania, Dramane and Sanou, Armande and Kossiwavi, Ida Ayassou and Sanogo, Bintou and Ouedraogo, Moussa and Siribie, Issa and Val{\'e}a, Diane and Ouedraogo, Sayouba and Som{\'e}, Roseline and Rouet, Fran\c{c}ois and Rollins, Nigel and McFetridge, Lynne and Naidu, Kevi and L{\"u}chters, Stanley and Reyners, Marcel and Irungu, Eunice and Katingima, Christine and Mwaura, Mary and Ouattara, Gina and Mandaliya, Kishor and Wambua, Sammy and Thiongo, Mary and Nduati, Ruth and Kose, Judith and Njagi, Ephantus and Mwaura, Peter and Newell, Marie-Louise and Mepham, Stephen and Viljoen, Johannes and Bland, Ruth and Mthethwa, Londiwe and Bazin, Brigitte and Rekacewicz, Claire and Taylor, Allan and Flowers, Nicole and Thigpen, Michael and Fowler, Mary Glenn and Jamieson, Denise and Mofenson, Lynne M and Read, Jennifer S and Bork, Kirsten and Cames, C{\'e}cile and Cournil, Amandine and Claeys, Patricia and Temmerman, Marleen and Van de Perre, Philippe and Becquart, Pierre and Foulongne, Vincent and Segondy, Michel and de Vincenzi, Isabelle and Gaillard, Philippe and Farley, Tim and Habib, Ndema and Landoulsi, Sihem},
  issn         = {1058-4838},
  journal      = {CLINICAL INFECTIOUS DISEASES},
  language     = {eng},
  number       = {3},
  pages        = {449--460},
  title        = {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},
  url          = {http://dx.doi.org/10.1093/cid/cis461},
  volume       = {55},
  year         = {2012},
}

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