Journal Article

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

Wambua, S., Kose, J., McFetridge, L., Rollins, N., Irungu, E., Mwaura, M., Kania, D., Valea, D., Gouem, C., Rouet, F., Katingima, C., Meda, N., Njagi, E., Bland, R., Kossiwavi, I. A., Hien, H., Mwaura, P., Some, R., Mandaliya, K., Newell, M.-L., Ouedraogo, P. E., Dioulasso, B., Viljoen, J., Thiongo, M., Ouedraogo, M., Siribie, I., Reyners, M., Somda, P., Luchters, S., Mthethwa, L., Faso, B., Fao, P., Ky-Zerbo, O., Ouedraogo, S., Sanogo, B., Ouattara, G., Mepham, S., Nduati, R., Sanou, A., Naidu, K.

2012

Overview

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.

• Publisher: Oxford University Press,Oxford University Press (OUP)
• Subject: Adult / AIDS / Anti-Retroviral Agents - administration & dosage / Antibiotics. Antiinfectious agents. Antiparasitic agents / Antiretroviral 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 / Life Sciences / Medical sciences / Pharmacology. Drug treatments / Pregnancy / Pregnancy Complications, Infectious - drug therapy / Pregnancy Complications, Infectious - epidemiology / Preventive medicine / Prophylaxis / Ritonavir / Statistical median / Survival Analysis / Time Factors / Viral diseases / Viral diseases of the lymphoid tissue and the blood. Aids / Womens health