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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

808-W. Evaluation of Ritonavir (RTV) in Combination with Stavudine (d4T) and Lamivudine (3TC) in HIV-Infected Children in 4 Nigerian Centres E. Ekong*1, I. Grant-Isibor2, T. Igbu3, and A. Uwah3 1Nigerian Army Reference Hosp., Yaba; 2Lagos Univ. Teaching Hosp., Idi-Araba; and 3Central Med. Lab., Yaba, Lagos, Nigeria Background: Not much is reported about efficacy of antiretroviral (ARV) therapy in children in developing countries and resource limited settings where switch can be very expensive. Our objective here was to study the efficacy, tolerance, side effects and compliance of triple therapy of RTV, d4T, and 3TC on HIV-infected children in 4 clinical centres in Nigeria. Methods: This was an open-label, randomized, multi-centric, prospective study of 29 HIV-infected children from February 2000 to August 2001. Demographic, clinical, and ARV data were noted. Drug combination was RTV 350-400 mg/m2 BID, d4T 1 mg/kg q12h, and 3TC 4 mg/kg q12h, and the children evaluated 4-weekly for efficacy, side effects, tolerance, and adherence. AIDS-defining conditions (ADEs), weight, height, PCV, fetal Hb, G6PD levels, Hb genotype, wbc count especially lymphocytes, CD4 and CD8, and biochemistry were noted at baseline, weeks 4, 8, 12, 24, 32, 40, 48, and 52. Viral load estimate was only done twice. Data analysis was by EPI-info software. Results: Of 29 children, median age was 9.5 years (range 3-15), 65% were male, 88% had perinatally acquired HIV infection. 1 child was G6PD deficient, 2 were HbSS, and 1 HbSC genotype. Only 20% were ARV experienced, with zidovudine and nevirapine. Mean baseline CD4 was 423 ±112 cells/mm3. Viral load was estimated only after June 2000, and the mean was 4.8 ±1.2 log10 copies/mL. Only 4 children (age 11-15 ears) had ADEs at baseline. At week 8, the median increase in CD4 was 92 cells/mm3, and 20% for weight. The G6PD deficient child developed severe jaundice at week 11 and therapy was discontinued. By week 24, median CD4 increase was a further 98 cells/mm3, ADEs were minimal, and 2 other children had their doses modified due to GI intolerance with severe vomiting. Mean viral load drop was 1.6 log10 copies/mL four weeks after the first estimate. Vaso-occlusive crises in the HbSS children were reduced since commencement of ARVs. By week 40, median CD4 increase was 119 cells/mm3, and viral load dropped by further 1.8 log10 copies/mL, 1 child was lost to follow-up. 1 child died from deranged LFTs at week 46. Conclusion: RTV in combination with d4T and 3TC is very potent with minimal side effects in children. This is especially useful in the developing world setting with limited resources where switch is expensive, and targeted therapy is necessary. This combination seems to confer anti-sickling effects on HbSS and HbSC children.

©2002 9th Conference on Retroviruses and Opportunistic Infections