Background:  Our objectives were to study the effectiveness and tolerance of a new, simple once-daily HAART regimen in HIV-1⁺ adults in Senegal.

Methods:  In a prospective, open-label single-arm study, 40 treatment-naive HIV-1-infected patients took the following regimen at bedtime with a light meal:  tenofovir (TDF) 245 mg, emtricitabine (FTC) 300 mg, and efavirenz (EFV) 600 mg. The analysis was done on an intent-to-treat basis. Those lost to follow-up, dead, or missing data were treated as failures.

Results:  Respectively, 7.5%, 70%, and 22.5% of patients were CDC stage A, B, or C. Median (range) plasma HIV RNA level was 5.3 (2.6 to 6.6) log ₁₀ copies/mL, CD4 cell count was 122 (3 to 310)/mm³ at baseline. The proportions of patients with plasma HIV-1 RNA below 400 copies/mL at months 1, 3, 6, 9, were 55%, 85%, 87.5%, 87.5%, and <50 copies/mL were 22.5%, 50% , 80% ,77.5%, respectively. Median (range) CD4 cell count at months 3, 6, and 9 were 248 (10 to 482)/mm³, 232 (67 to 494)/mm³ and 242 (65 to 599)/mm³, respectively. During follow-up, 3 patients developed pulmonary tuberculosis and 1 pregnancy was reported; 2 patients were lost to follow-up; and 3 patients, who had CD4 <5 cells/mm³ at baseline, died before week 12. During the first 2 weeks 50% of patients experienced EFV-related dizziness, but only 1 patient switched treatment for grade 3 dizziness; 16% experienced mild nausea, and 12% diarrhea, grade 1 or 2. No treatment discontinuation was reported due to biological adverse events of grade 3 or 4.

Conclusions:  In this first evaluation in a developing country, this easy-to-take once-daily regimen of TDF, FTC, and EFV was well accepted and tolerated and exhibited potent antiretroviral and immunological effect in patients with advanced HIV infection. A fixed dose of this combination is expected and could be a major advance.