321   Once-Daily Combination Therapy with Emtricitabine, Didanosine and Efavirenz in Treatment-Naive HIV-Infected Adults: 64-Week Follow-Up of the ANRS 091 Trial.

J. M. Molina*, S. Perusat, F. Ferchal, C. Rancinan, F. Raffi, W. Rozenbaum, D. Sereni, P. Morlat, G. Chene, and the Montana Study Group.
Hosp. of Paris, Nantes, and Bordeaux and ANRS, France.

Background:In an effort to optimize treatment compliance and patients' quality of life, the availability of a simple once-a-day HAART regimen is awaited.

Methods:We conducted a pilot study to assess the safety, antiviral and immunologic effects of emtricitabine (FTC), didanosine (ddI) and efavirenz (EFV) administered in combination as a once-daily regimen among 40 antiretroviral-naïve HIV-infected patients. Eligible patients had to have a CD4 cell count>100/mm³and a plasma HIV RNA>5000 copies/ml at baseline. All three drugs were taken once a day at bedtime: FTC (200 mg), ddI (400 mg if>60 kg; 250 mg if <60 kg) and EFZ (600 mg). We present here the results of the 64-week follow-up of this study.

Results:88% of patients were male with a mean age of 33 years; 92% were CDC stage A. Median plasma HIV RNA was 4.77 log₁₀copies/mL at baseline, decreasing by a median of 3.4 log₁₀copies/mL at 24 weeks, with 98% of patients achieving a plasma HIV RNA below 400 copies/mL. At week 64, 90% of patients (36/40, 95% CI: 76—97) maintained a plasma HIV RNA below 400 copies/mL (noncompleter = failure analysis). One patient was lost to follow-up, two patients were off therapy, and one patient experienced a virological failure. Median baseline CD4 count was 373 cells/mL, increasing by a median of 159 and 219 cells/mL at weeks 24 and 64, respectively. The most common treatment-related adverse events occurred during the first 24 weeks of the study and were mild to moderate central nervous system symptoms (in 73% of patients), diarrhea (in 37% of patients), rashes (in 10% of patients), and biochemical abnormalities. Only two patients experienced severe hypertriglyceridemias that were possibly treatment-related. Only two patients stopped trial treatment because of adverse events.

Conclusions:The once-daily combination therapy of emtricitabine, didanosine and efavirenz was safe and well- tolerated and demonstrated strong antiviral and immunologic effects lasting for the 64-week period of the study.