Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial
2013; SAGE Publishing; Volume: 19; Issue: 1 Linguagem: Inglês
10.3851/imp2675
ISSN2040-2058
AutoresRoland Landman, Sinata Koulla‐Shiro, Papa Salif Sow, Maguy Ngolle, Mahamadou-Baila Diallo, Ndèye Fatou Ngom Gueye, Vincent Le Moing, Sabrina Eymard‐Duvernay, Aı̈da Benalychérif, Charlotte Charpentier, Gilles Peytavin, Éric Delaporte, Pierre‐Marie Girard,
Tópico(s)HIV/AIDS Research and Interventions
ResumoThe aim of the present study was to determine appropriate tenofovir-based regimens meriting evaluation in large-scale randomized trials among sub-Saharan African patients.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.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.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.
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