1. Evaluation of four tenofovir-containing regimens as first-line treatments in Cameroon and Senegal: the ANRS 12115 DAYANA Trial.
- Author
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Landman R, Koulla-Shiro S, Sow PS, Ngolle M, Diallo MB, Guèye NF, Le Moing V, Eymard-Duvernay S, Benalycherif A, Charpentier C, Peytavin G, Delaporte E, and Girard PM
- Subjects
- Adenine administration & dosage, Adenine adverse effects, Adenine therapeutic use, Adult, Anti-HIV Agents administration & dosage, Anti-HIV Agents adverse effects, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Cameroon, Drug Therapy, Combination, Female, Follow-Up Studies, Genotype, HIV Infections immunology, HIV Infections virology, Humans, Male, Medication Adherence, Middle Aged, Organophosphonates administration & dosage, Organophosphonates adverse effects, Senegal, Tenofovir, Treatment Outcome, Viral Load, Young Adult, Adenine analogs & derivatives, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1 genetics, Organophosphonates therapeutic use
- Abstract
Background: The aim of the present study was to determine appropriate tenofovir-based regimens meriting evaluation in large-scale randomized trials among sub-Saharan African patients., Methods: This was a randomized open-label 96-week prospective pilot study evaluating four first-line regimens: tenofovir/emtricitabine/nevirapine (group 1), tenofovir/lopinavir/ritonavir (group 2), tenofovir/emtricitabine/zidovudine (group 3) and tenofovir/emtricitabine/efavirenz (group 4) in antiretroviral-naive, HIV-1-infected patients in Senegal and Cameroon. The primary end point was defined as an HIV-1 RNA viral load <50 copies/ml (study detection limit) at week 16 in ≥50% of patients using intention-to-treat analysis., Results: At baseline, 119 patients included were 34% male, had a median plasma viral load of 5.4 log10 copies/ml and median CD4(+) T-cell count of 200 cells/mm(3) (range 53-358). The primary end point was achieved for groups 1, 3 and 4 (58% [n=31], 62% [n=29] and 53% [n=30], respectively), but not for group 2 (38% [n=29]). At week 96, undetectable HIV-1 RNA had been achieved in 74% of patients in group 1, 38% in group 2, 72% in group 3 and 73% in group 4. Patients with detectable HIV-1 RNA at week 16 were more likely to have baseline HIV-1 RNA≥100,000 copies/ml (adjusted OR 5.56, 95% CI 1.72, 16.67). HIV mutations associated with protease inhibitor resistance emerged in three patients, all of whom were in group 2. Anaemia occurred in two group 3 patients and was the only serious treatment-related adverse event., Conclusions: Three efficient and safe tenofovir-based triple regimens were identified; the two-drug regimen (tenofovir/lopinavir/ritonavir) did not achieve the protocol-defined virological threshold of efficacy.
- Published
- 2014
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