459-W. First Evaluation of d4T, ddI, and Efavirenz in Antiretroviral-Naïve Patients in Senegal: ANRS 12-06 / IMEA 012 Study

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

459-W.

First Evaluation of d4T, ddI, and Efavirenz in Antiretroviral-Naïve Patients in Senegal: ANRS 12-06 / IMEA 012 Study
R. Landman*¹, A. Canestri¹, S. Thiam², 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 the antiretroviral regimen combining stavudine (d4T) , didanosine EC (ddI) and efavirenz (EFV ) in patients with advanced immune deficiency in Senegal.
Methods: Multicenter, 18-month pilot trial in 40 HIV-1-infected patients. Biological, virological, and immunological parameters were evaluated every 3 months. Intent to treat analysis. Inclusion criteria: CD4< 350 cells/mm³, plasma HIV1-RNA >30,000 copies/mL. d4T (30/40 mg BID), EFV and ddI were taken at bedtime (ddI 250/400 mg and EFV 600 mg qd).
Results: Inclusion characteristics: 23 women, 17 men; mean age (±SD) was 36±7 years; 47.5%, 52.5% were CDC stage B and C, respectively. Mean CD4 cell count was 133±92 cells/mm³ and mean plasma HIV1-RNA was 5.5±0.4 log₁₀ copies/mL (Roche, Amplicor) at baseline. Mean increase in CD4 cell count was 110±121 cells /mm³ (n= 38 patients) and 105±120 cells /mm³ (n=35 patients) at M3 and M6 respectively. Mean decrease in plasma HIV1-RNA was 3.4±0.7 log and 3.2±1.1 log (n=35 patients) at M3 and M6, respectively. Plasma HIV1-RNA < 500 copies/ml: 91% and 77% of patients at M3 and M6 compare to baseline respectively. Plasma HIV1-RNA < 50 copies/mL: 40% and 51% of patients at M3 and M6 compare to baseline respectively. Adverse events: peripheral neuropathy grade 1-2 (n=4), grade 3 (n=2) with interruption of d4T and ddI, dizziness (n=11) occurring during the first month of treatment and leading to transitory discontinuation in only 1 case. Kaposi’s sarcoma worsened in one patient at M3. 4 deaths related to reactivation of atypical mycobacteria disease at M2 (n=1), diarrhoea with septicemia at M4 and M6 (n=2), encephalopathy with fever in an alcoholic non-compliant patient.
Conclusions: These results indicate: peripheral neuropathy may be a treatment limitation for d4T and ddI combination in this population and despite HAART regimen, 10% case-fatality rate was observed mainly in patients with low CD4 cells at baseline (3 patients/4 < 50/ mm³); these interim results show a similar rate of undetectable viral load as compared to other HAART regimen even in symptomatic patients with low CD4 cells (30% of patients <50/mm³) and high viral load at baseline.