Medical Advocates for Social Justice
Conference Abstract
from the
2nd IAS Conference on HIV and Pathogenesis
Paris, France

July 14-17, 2003
 

 

A Randomized, Double-Blind, Multicenter Comparison of
Emtricitabine QD to Stavudine BID in Treatment-Naïve
HIV-Infected Patients

 F. Raffi1, M. Saag2, P. Cahn3, M. Wolff4, D. Pearce5, J. Molina6,
J. Hinkle7, A. Shaw7, E. Mondou7, J. Quinn7 and F. Rousseau7
1CHU de Nantes, Nantes, France; 2UAB, Birmingham, AL; 3Fundacion HUESPED,
Buenos Aires, Argentina; 4San-Borja Arriarian Hospital, Santiago, Chile; 5St. Luke
Medical Group, San Diego, CA; 6Saint-Louis Hospital, Paris, France; 7Gilead Sciences,
 Inc., Durham, NC, USA

 

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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 analog (NRTI) for the treatment of HIV infection.

Methods:
Antiretroviral naïve 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 openlabel 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. 
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A Randomized, Double-Blind, Multicenter Comparison of Emtricitabine QD to Stavudine BID
 in Treatment-Naïve HIV-Infected Patients
A Medical Advocates for Social Justice Update