Abstract
ABSTRACT: OBJECTIVE: To assess the 18-month field effectiveness on severe events of a pediatric package combining early HIV-diagnosis and targeted cotrimoxazole prophylaxis in HIV-infected children from age six-week before the antiretroviral era, in Abidjan, Cote d'Ivoire. METHODS: Data from two consecutive prevention of HIV mother-to-child transmission programs were compared: the ANRS 1201/1202 Ditrame-Plus cohort (2001-2005) and the pooled data of the ANRS 049a Ditrame randomized trial and its following open-labeled cohort (1995-2000), used as a reference group. HIV-infected pregnant women [greater than or equal to]32-36 weeks of gestation were offered a short-course peri-partum antiretroviral prophylaxis (ZDV in Ditrame, and ZDV+/-3TC+single-dose (sd) NVP in Ditrame-Plus). Neonatal prophylaxis was provided in Ditrame-Plus only: 7-day ZDV and sdNVP 48-72h after birth. A 6-week pediatric HIV-RNA diagnosis was provided online in the Ditrame-Plus while it was only oriented on clinical symptoms in Ditrame. Six-week HIV-infected children received a daily cotrimoxazole prophylaxis in Ditrame-Plus while no prophylaxis was provided in Ditrame. The determinants of severe events (death or hospitalization) were assessed in a Cox regression model. RESULTS: Between 1995 and 2003, 98 out of the 1121 live-births were diagnosed as HIV-infected in peri-partum: 45 from Ditrame-Plus and 53 from Ditrame. The 18-month Kaplan-Meier cumulative probability of presenting a severe event was 66% in Ditrame-Plus (95% confidence interval [95%CI]: 50%-81%) and 77% in Ditrame (95%CI: 65%-89%), Log Rank test: p=0.47. After adjustment on maternal WHO clinical stage, maternal death, 6-week pediatric viral load, birth-weight, and breastfeeding exposure, the 18-month risk of severe event tended to be lower in Ditrame-Plus than in Ditrame but this trend was not statistically significant (adjusted Hazard Ratio (aHR): 0.55, 95%CI: 0.3-1.1; p=0.07). Maternal death was the only variable determinant of the occurrence of severe events in children (aHR: 3.73; CI: 2.2-11.2; p=0.01). CONCLUSION: We probably lacked of statistical power to show a significant major effect of early cotrimoxazole in HIV-infected infants. However, these results argued that an early pediatric HIV-diagnosis could better target infant eligible for HIV-care and reduce the family burden of HIV-infection in the context of universal antiretroviral access.