The
KLEAN Study: Fosamprenavir + Ritonavir versus Lopinavir/Ritonavir Current
guidelines recommend lopinavir/ritonavir [Kaletra] (LPV/r) as a preferred PI for
antiretroviral (ART)-naïve patients. No study comparing fosamprenavir [Lexiva]/ritonavir
(FPV/r) to LPV/r in treatment-naive patients has been reported. This
was 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).
Joseph Eron of the University of North Carolina at Chapel Hill presented results
of the study at the Toronto AIDS meeting. 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 individuals.
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.
In
conclusion, the authors write, "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." University
of North Carolina at Chapel Hill, Chapel Hill, United States, Hopital Bichat,
Paris, France, Therapeutic Concepts, PA, Houston, United States, Hospital Clínico
San Carlos, Madrid, Spain, Orlando Immunology Center, Orlando, United States,
Hospital of the J.W. Goethe University, Frankfurt, Germany, ID Consultants, PA,
Charlotte, United States, GlaxoSmithKline, Research Triangle Park, USA. 08/18/06 Reference
J Eron, P Yeni, J Gathe Jr , V Estrada, and others. The KLEAN Study: Fosamprenavir
+ ritonavir (FPV/r) versus lopinavir/ritonavir (LPV/r) in antiretroviral-naïve
(ART-Naïve) HIV-1 infected adults over 48 weeks. 16th International AIDS
Conference. August 13-18, 2006. Toronto, Canada. Abstract THLB0205.
|
