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

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...

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Published in:	Clinical infectious diseases Vol. 55; no. 3; pp. 449 - 460
Main Authors:	Dioulasso, B., Faso, B., Meda, N., Fao, P., Ky-Zerbo, O., Gouem, C., Somda, P., Hien, H., Ouedraogo, P. E., Kania, D., Sanou, A., Kossiwavi, I. A., 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, M.-L., Mepham, S., Viljoen, J., Bland, R., Mthethwa, L.
Format:	Journal Article
Language:	English
Published:	Oxford Oxford University Press 01-08-2012
Subjects:	Adult AIDS Anti-Retroviral Agents - administration & dosage Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral drugs Antiretroviral Therapy, Highly Active - methods Antiretrovirals Antiviral agents Biological and medical sciences Breast Feeding Breastfeeding Breastfeeding & lactation CD4 Lymphocyte Count Cell Cycle Proteins Chemoprevention - methods Disease Progression Disease transmission Drug therapy Female HIV HIV 1 HIV Infections - drug therapy HIV Infections - epidemiology HIV/AIDS Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infant Infant, Newborn Infectious Disease Transmission, Vertical - prevention & control Infectious diseases Medical sciences Pharmacology. Drug treatments Pregnancy Pregnancy Complications, Infectious - drug therapy Pregnancy Complications, Infectious - epidemiology Preventive medicine Statistical median Survival Analysis Time Factors Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Womens health Antiretroviral agent RNA-directed DNA polymerase Prognosis Nevirapine HIV-1 virus Non nucleoside compound Maternal diseases Prevention Reverse transcriptase inhibitor Nucleoside analog Antiviral Evolution Pyrimidine nucleoside Immunopathology Enzyme Transferases Single dose Enzyme inhibitor Retroviridae AIDS Breast feeding Immune deficiency Lentivirus Infection Virus Pregnancy Nucleotidyltransferases Dideoxynucleoside Viral disease Human immunodeficiency virus Zidovudine Comparative study
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Summary:	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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 ObjectType-Feature-1 Presented in part: XVIII International AIDS Conference, Vienna, Austria, July 2010. Abstract ThLBB105. Members of the Kesho Bora Study Group are listed in the Appendix.
ISSN:	1058-4838 1537-6591
DOI:	10.1093/cid/cis461