R. Landman*1, R. Schiemann1, S. Thiam2, E. Delaporte3, S. Mboup2, M. Vray4, S. Badiane2, P. Coulaud1, G. Peytavin1, P. M. Girard5, and I. Ndoye2for the ANRS 12-04 Study Group.
1IMEA, Hop. Bichat Claude Bernard; Paris, France;2IHS, Dakar, Senegal;3IRD, Montpellier;4INSERM, Paris; and5Rothschild Hosp., Paris, France.
Background:Our goal was to assess the feasibility, efficacy and safety of a once-a-day HAART regimen combining Didanosine (ddI), Lamivudine (3TC) and Efavirenz (EFV) in antiretroviral-naive patients with advanced immune deficiency in Senegal.
Methods:24-week open study in 40 HIV-1-infected patients. Eligible criteria: CD4 <350/mm3and plasma HIV- 1 RNA >30 000 c/ml. All three drugs were taken at bedtime: 3TC (300 mg), ddI (400 mg if = 60 kg, 200 mg if = 60 kg) and EFV (600 mg). Patients were seen at weeks 2and 4 and every 4 weeks thereafter.
Results:50% of the patients were women. Mean age was 37 ± 8 years. 15%, 40%, 45% were CDC stage A, B , and C, respectively. Mean CD4 count was 164 ± 75 cells/mm3and mean plasma HIV RNA was 366 ± 254 103 c/ ml (Roche Amplicor) at baseline. Among the 23 patients having reached W24 in September 2000, 22 had a viral load <500 c/ml, including 18 with <50 c/ml. Mean decrease in plasma HIV RNA was 3.5 ± 0.7 log3c/ml. Mean increase in CD4 count was 153 ± 87 cells/mm3. The treatment was well tolerated. 10 adverse events grade 3 or 4 occurred and were unrelated to treatment except three (rash; elevation of transaminases and elevation of amylase). All plasma drug trough levels at W4 were in the therapeutic range (available in 30/40 patients).
Conclusions:Simple once-a-day HAART regimen may help increase compliance of patients in developed and developing countries. Our first results confirm the good compliance to this efficient and easy to take regimen even in patients with advanced immune deficiency and high viral load. Further evaluation of long-term efficacy is ongoing.© 8th Conference on Retroviruses and Opportunistic Infections