title: Evaluation of four tenofovir-containing regimens as first-line treatments in Cameroon and Senegal: the ANRS 12115 DAYANA Trial.
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.
authors: Department of Infectious Diseases, Bichat Claude Bernard Hospital and Université Paris Diderot, Paris, France. landman.roland@gmail.com.
authors: Roland
authors: R
authors: Landman
authors: Sinata
authors: S
authors: Koulla-Shiro
authors: Papa Salif
authors: PS
authors: Sow
authors: Maguy
authors: M
authors: Ngolle
authors: Mahamadou-Baila
authors: MB
authors: Diallo
authors: Ndèye Fatou Ngom
authors: NF
authors: Guèye
authors: Vincent
authors: V
authors: Le Moing
authors: Sabrina
authors: S
authors: Eymard-Duvernay
authors: Aïda
authors: A
authors: Benalycherif
authors: Charlotte
authors: C
authors: Charpentier
authors: Gilles
authors: G
authors: Peytavin
authors: Eric
authors: E
authors: Delaporte
authors: Pierre-Marie
authors: PM
authors: Girard
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002163:Cameroon; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012675:Senegal; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine