Raffi F, Saag M, Cahn P, Wolff M, Pearce D, Molina JM, Hinkle J, Shaw A, Mondou E, Quinn JB, Rousseau F; The FTC1 Study Team; IAS Conference on HIV Pathogenesis and Treatment (2nd : 2003 : Paris, France).
Antivir Ther. 2003; 8 (Suppl.1): abstract no. 38.
CHU de Nantes, Nantes, France
BACKGROUND: Emtricitabine (FTC) is a new once daily (QD) NRTI in development with potent activity against HBV and HIV. Stavudine (d4T) is a frequently used nucleoside analogue (NRTI) for the treatment of HIV infection. METHODS: Antiretroviral naive patients with screening plasma HIV-1 RNA (VL) >5000 c/ml were randomized in a 1:1 ratio to 200 mg FTC QD or d4T BID at standard doses. All patients also received open-label didanosine (ddI) QD and efavirenz (EFV) QD and were evaluated at Baseline (BL), every 4 weeks to W48 and then every 12 weeks. Virologic failure (VF) was defined as never achieving VL <400 c/ml, or two consecutive visits >400 c/ml after achieving <400 c/ml. Efficacy failure (EF) was defined as VF, new CDC class C progression event, or loss to follow-up. Tolerability failure (TF) was defined as permanent discontinuation of blinded study medication due to AE. The Kaplan-Meier (KM) probability of failure was compared between treatment arms using a log-rank test. Absolute CD4+ and CD4% change from BL were compared between treatment arms at W60. RESULTS: A total of 571 (285 d4T, 286 FTC) patients were enrolled. The median BL VL was 4.9 log10 and the median BL CD4+ was 288 cells/mm3. The majority of patients were male (85%) and Caucasian (52%). The median duration of follow-up was 60 weeks. BL characteristics were comparable between the two arms. The KM probabilities at W60 were: VF, 15.3% for d4T and 7.4% for FTC (P=0.001); EF, 22.0% for d4T and 12.5% for FTC (P=0.002); and TF, 16.6% for d4T and 7.4% for FTC (P=0.003). Mean increase from BL at W60 in absolute CD4+ was 163 cells/mm3 (FTC) and 137 cells/mm3 (d4T); mean increase from BL in CD4% was 8.6% (FTC) and 5.1% (d4T). The majority of adverse events in both treatment arms were mild or moderate in severity. CONCLUSION: Once-daily FTC demonstrated durable and superior virologic efficacy and tolerability through 60 weeks of follow-up compared to twice-daily d4T when used with once-daily ddI and EFV.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiretroviral Therapy, Highly Active
- Deoxycytidine
- Didanosine
- Drug Therapy, Combination
- HIV
- HIV Infections
- HIV Seropositivity
- Humans
- Male
- Oxazines
- Stavudine
- drug therapy
- efavirenz
- emtricitabine
- therapy
Other ID:
UI: 102262369
From Meeting Abstracts