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Session 65 Poster Session Antiretroviral Chemotherapy in Resource Limited Settings Session Time: 4:30-6:30 pm Room 4E-F

458-W. Long-Term Evaluation (15 Months) of ddI, 3TC and Efavirenz Once-Daily Regimen in Naïve Patients in Senegal: ANRS 12-04/IMEA 011 Study R. Landman*1, S. Thiam2, A. Canestri1, E. Delaporte3, S. Mboup2, M. Vray4, C. Dalban4, S. Badiane2, P. Sow2, A. F. Niang2 , P. M. Gueye2, I. Lanièce2, J. P. Coulaud1 , P. M. Girard1, and I. Ndoye2 1IMEA, Paris, France; 2PNLS, Dakar, Senegal; 3IRD, Montpellier, France; and 4INSERM SC4, France Background: To assess the feasibility, efficacy and tolerance of once-a-day regimen combining didanosine (ddI), lamivudine (3TC) and efavirenz (EFV) in adults infected with HIV1 in Senegal. Methods:This was a multicenter, 18-month-pilot trial in 40 HIV-1-infected patients. Inclusion criteria were: CD4 cells count between 50 and 350 cells/mm3; and plasma HIV1-RNA > 30 000 copies/mL. All 3 drugs were taken at bedtime, which included 3TC (300 mg); ddI (400/200 mg) and EFV (600 mg). Clinical parameters, dispensary drug, and compliance were assessed monthly. Biological, virological, and immunological were evaluated every 3 months. Results: Inclusion characteristics: sex ratio was 1; mean age (±sd) was 37±8 years, 15%, 40%, 45% were CDC stage A, B, C respectively. Mean CD4 cell count was 164±75 cells/mm3 and mean plasma HIV-1-RNA was 5.4±0.4 log10 copies/mL (Roche, Amplicor) at baseline. Mean increase in CD4 cell count was 142±88 cells/mm3 (n= 39 patients) and 199±101 cells /mm3 (n=38 patients) at M6 and M15 respectively. Mean decrease in plasma HIV1-RNA was 3.5±0.6 log (n=40 patients) and 3.4±0.7 log (n=36 patients) at M6 and M15 respectively. Plasma HIV1-RNA < 500 copies/mL: 95% and 92% of patients at M6 and M15 compare to baseline respectively. Plasma HIV1-RNA < 50 copies/mL: 78% and 69% of pts at M6 and M15 compare to baseline respectively. All plasma drug trough levels at M1 were in the therapeutic range (data available in 30/40 patients). The treatment was well tolerated, (36/38) patients were judged compliant by patient questionary. 12 adverse events grade 3 or 4 occurred and were unrelated to treatment except two (rash, transaminases raise). 2 pregnancies occurred during the study with 1 abortion and 1 switch of efavirenz for nevirapine. Conclusions: These results indicate virological and immunological long-term efficacy of a simple once-daily HAART regimen in patients with advanced immune deficiency and high viral load in Senegal. This simple regimen may increase compliance of patients in Africa.

©2002 9th Conference on Retroviruses and Opportunistic Infections