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Abstract
The KLEAN Study: Fosamprenavir + ritonavir (FPV/r) versus lopinavir/ritonavir (LPV/r) in antiretroviral-naïve (ART-Naïve) HIV-1 infected adults over 48 weeks
J. Eron1, P. Yeni2, J. Gathe, Jr.3, V. Estrada4, E. DeJesus5, S. Staszewski6, P. Lackey7, L. Yau8, D. Sutherland-Phillips8, P. Wannamaker8, M. Shaefer8
1University of North Carolina at Chapel Hill, Chapel Hill, United States, 2Hopital Bichat, Paris, France, 3Therapeutic Concepts, PA, Houston, United States, 4Hospital Clínico San Carlos, Madrid, Spain, 5Orlando Immunology Center, Orlando, United States, 6Hospital of the J.W. Goethe University, Frankfurt, Germany, 7ID Consultants, PA, Charlotte, United States, 8GlaxoSmithKline, Research Triangle Park, United States
Background: Current guidelines recommend LPV/r as a preferred PI for ART-naïve patients. No study comparing FPV/r to LPV/r in treatment-naive patients has been reported.
Methods: A large, randomized (1:1), open-label, multicenter, international study to assess non-inferiority (12% margin) of FPV/r twice daily (BID) versus LPV/r BID, each administered with the abacavir (ABC)/lamivudine (3TC) tablet once daily (QD). Eligible subjects had HIV-1 RNA (vRNA) 1,000 copies/mL (c/mL) (stratified < or 100,000) and any CD4+ cell count at screening. NRTI switches for suspected ABC HSR were permitted. Protocol-defined virologic failure (VF) was failure to achieve vRNA <400 c/mL by Week (Wk) 24 or confirmed rebound 400 c/mL. Primary endpoints were proportion of subjects with vRNA <400 c/mL at Wk 48 [time to loss of virologic response (TLOVR)] and treatment discontinuations due to adverse events (AEs).
Results: ITT(E) population included 878. Baseline demographics (median age 37 years; 78% male; 58% white/Caucasian; 11% CDC Class C; vRNA 5.07 log10 c/mL; CD4+ cell count 192 cells/mm3) were similar between arms. Seventy-seven percent (679/878) completed the study. Incidence of ABC HSR was 6%. Similar increases in fasting lipid values were observed for both regimens.
*(95% CI -3.26, 5.47)
Conclusions: FPV/r + ABC/3TC is non-inferior to LPV/r + ABC/3TC with similar virologic response at 48 weeks using TLOVR <400 and <50 cut-offs. 95% CI around the treatment difference suggests highly overlapping responses. Immunologic and tolerability outcomes were also comparable.
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