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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Evaluation of four tenofovir-containing regimens as first-line treatments in Cameroon and Senegal: The ANRS 12115 DAYANA trial
Antiviral Therapy, Volume 19, No. 1, Year 2014
Notification
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Description
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/mm3 (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. ©2014 International Medical Press.
Authors & Co-Authors
Landman, Roland
France, Paris
Hôpital Bichat-claude-bernard Ap-hp
France, Paris
Institut de Médecine et D'epidémiologie Appliquée
France, Paris
Infection, Anti-microbien, Modélisation, Évolution
Koulla-Shiro, Sinata
Cameroon, Yaounde
Université de Yaoundé I
Sow, Papa Salif
Senegal, Dakar
Fann Hospital
Ngolle, Maguy
Cameroon, Yaounde
Université de Yaoundé I
Diallo, Mamadou Baila
Senegal, Dakar
Fann Hospital
Guèye, Ndèye Fatou Ngom
Senegal, Dakar
Fann Hospital
Le-Moing, Vincent
France, Montpellier
Centre Hospitalier Universitaire de Montpellier
Eymard-Duvernay, Sabrina
France, Montpellier
Ird Centre de Montpellier
Benalycherif, Aïda
France, Paris
Institut de Médecine et D'epidémiologie Appliquée
Charpentier, Charlotte
France, Paris
Infection, Anti-microbien, Modélisation, Évolution
France, Paris
Hôpital Bichat-claude-bernard Ap-hp
Peytavin, Gilles
France, Paris
Infection, Anti-microbien, Modélisation, Évolution
France, Paris
Hôpital Bichat-claude-bernard Ap-hp
Delaporte, Éric
France, Montpellier
Centre Hospitalier Universitaire de Montpellier
France, Montpellier
Ird Centre de Montpellier
Girard, Pierre Marie
France, Paris
Institut de Médecine et D'epidémiologie Appliquée
France, Paris
Hôpital Saint-antoine
France, Paris
Institut Pierre Louis D'epidémiologie et de Santé Publique
France, Paris
Sorbonne Université
Statistics
Citations: 15
Authors: 13
Affiliations: 10
Identifiers
Doi:
10.3851/IMP2675
ISSN:
13596535
e-ISSN:
20402058
Research Areas
Infectious Diseases
Study Design
Cohort Study
Study Locations
Cameroon
Senegal
Participants Gender
Male