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Session 105 Poster Session Pediatric HIV Infection: Disease Progression and Responses to Therapy Session Time: 4:30-6:30 pm Room 4E-F

809-W. Difficulties to Achieve Suppression of Viral Replication in Vertically HIV-1-Infected Infants Early Treated with d4T+ddI+NFV -- The PENTA 7 Study A. Compagnucci*1, Y. Saidi1, M. L. Chaix2, C. Rouzioux2, D. M. Gibb3, C. Giaquinto4, and A. Faye5 for the PENTA 7 Committees. 1INSERM SC10, Villejuif, France; 2Hosp. Necker, Paris, France; 3CTU MRC, London, UK; 4Univ. of Padova, Italy; and 5Hosp. R. Debré, Paris, France Background: Although U.S. guidelines recommend early antiretroviral therapy (ART) for all infants with HIV infection, there are few data on the success of this approach. Methods: Early treatment with d4T+ddI+NFV was administered to vertically HIV-1-infected infants <3 months of age without AIDS from European centres in order to evaluate toxicity, tolerability, and antiretroviral activity. Genotypic resistance test was performed at baseline in all children and on last sample available from children failing to therapy (> 400 copies/mL on 2 consecutive viral load measures after 12 weeks of therapy). Results: 20 infants were enrolled from 5 European countries. Mean age at baseline was 2.6 months (range 0.9-4.5). Median (IQR) viral load (VL) at baseline was 5.5 log10 copies/mL (range 5.4-6.2). Median (IQR) CD4% was 33 (24-46). Median follow-up was 63 weeks (range 24-72) with 16 children beyond week 48. Only 2 patients temporarily discontinued or switched therapy due to minor adverse events. Treatment was stopped in 1 child for non-response/poor adherence; 2 children switched therapy due to virological failure. 1 death in a premature infant (respiratory distress) was unrelated to HIV or ART. Median (IQR) VL reduction from baseline was -2.05 (-3.39 to -1.06) log10 copies/mL and -1.96 (-3.43 to -0.88) respectively at week 24 and week 48. The proportion of children < 400 copies/mL was 40 % and 37.5 % at week 24 and week 48 respectively. Median (IQR) change from baseline to week 24 in CD4 % was 5 (-6 to 18). None of the children except 2 had resistance mutations at baseline. 5 patients out of the 13 children who failed to ART acquired resistance mutations at a median of 32 weeks (range 12-72). Conclusions: Triple combination with d4T+ddI+NFV was well tolerated. VL suppression was difficult to obtain in very young infants leading to the development of drug-resistant mutations. The strategy to start early ART in asymptomatic infants infected with HIV requires further consideration in the light of these data. Pharmacological and adherence studies are underway in order to provide an information on virological failures.

©2002 9th Conference on Retroviruses and Opportunistic Infections