Landman R., Koulla-Shiro S., Sow P. S., Ngolle M., Diallo M. B., Gueye N. F. N., Le Moing V., Eymard-Duvernay Sabrina, Benalycherif A., Charpentier C., Peytavin G., Delaporte Eric, Girard P. M. (2014). Evaluation of four Tenofovir-containing regimens as first-line treatments in Cameroon and Senegal : the ANRS 12115 DAYANA Trial. Antiviral Therapy, 19 (1), p. 51-59. ISSN 1359-6535.
Titre du document
Evaluation of four Tenofovir-containing regimens as first-line treatments in Cameroon and Senegal : the ANRS 12115 DAYANA Trial
Année de publication
2014
Auteurs
Landman R., Koulla-Shiro S., Sow P. S., Ngolle M., Diallo M. B., Gueye N. F. N., Le Moing V., Eymard-Duvernay Sabrina, Benalycherif A., Charpentier C., Peytavin G., Delaporte Eric, Girard P. M.
Source
Antiviral Therapy, 2014,
19 (1), p. 51-59 ISSN 1359-6535
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 log 10 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.
Plan de classement
Sciences fondamentales / Techniques d'analyse et de recherche [020]
;
Santé : généralités [050]
;
Entomologie médicale / Parasitologie / Virologie [052]
Description Géographique
CAMEROUN ; SENEGAL
Localisation
Fonds IRD [F B010062019]
Identifiant IRD
fdi:010062019
