Once-a-day highly active antiretroviral therapy in treatment-naive HIV-1-infected adults in Senegal

Objectives: To study the effectiveness, adherence and tolerance of a once-a-day highly active antiretroviral therapy regimen in adults in Senegal. Design and methods: In a prospective, open-label one-arm study, 40 treatment-naive HIV-1-infected patients took the following three drugs once a day at bedtime: didanosine, lamivudine and efavirenz. The primary endpoint was the percentage of patients with plasma HIV-1 RNA below 500 copies/ml at 6 months. The analysis was done on an intent-to treat basis. Results: Eighty-five per cent of patients were at Centers for Disease Control and Prevention stage B or C and the plasma HIV RNA level was 5.4+/-0.4 log(10) copies/ml at baseline. The percentage of patients with plasma HIV-1 RNA below 500 copies/ml at 6 months was 95% [95% confidence interval (CI), 83-99]. The proportions of patients with plasma HIV-1 RNA below 50 copies/ml at months 3, 6, 9, 12 and 15 were 26% (n=39; 95% CI, 12-39), 78% (n=40; 95% CI, 65-90), 70% (n=40; 95% CI, 56-84), 77% (n=39; 95% CI, 64-90) and 69% (n=39; 95% CI, 55-84), respectively. The CD4 cell count was 164+/-75x10(6)/l at baseline and increased by a mean of 199+/-101x10(6)/l at month 15. Permanent treatment discontinuation was never necessary for serious adverse effects. Adherence was excellent, as shown by plasma drug concentrations and according to the results of the questionnaire. Conclusions: The once-daily regimen of didanosine, lamivudine and efavirenz was safe, easy-to-take and demonstrated strong antiretroviral and immunologic effects in African patients with advanced HIV infection. (C) 2003 Lippincott Williams Wilkins.