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Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial
- Source :
- Antiviral Therapy. 19:51-59
- Publication Year :
- 2014
- Publisher :
- SAGE Publications, 2014.
-
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 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Genotype
Tenofovir
Anti-HIV Agents
First line
Organophosphonates
MEDLINE
HIV Infections
Medication Adherence
law.invention
Young Adult
Pharmacotherapy
Randomized controlled trial
immune system diseases
law
Antiretroviral Therapy, Highly Active
Internal medicine
medicine
Humans
Pharmacology (medical)
Cameroon
Young adult
Pharmacology
business.industry
Adenine
virus diseases
Middle Aged
Viral Load
Senegal
CD4 Lymphocyte Count
Clinical trial
Treatment Outcome
Infectious Diseases
HIV-1
Drug Therapy, Combination
Female
business
Viral load
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 20402058 and 13596535
- Volume :
- 19
- Database :
- OpenAIRE
- Journal :
- Antiviral Therapy
- Accession number :
- edsair.doi.dedup.....cb8e73d4a2b1952b328055a54d90f215