Fosamprenavir/RTV 1400/100 Once Daily vs Reyataz/RTV Once Daily
Reported by Jules Levin
ICAAC
San Francisco, Sept 24-26, 2006
THE ALERT Study
A Planned Week 24 Interim Analysis of Once Daily Boosted Fosamprenavir or Atazanavir with Tenofovir/FTC
Kimberly Smith reported these study results at the oral HIV session this afternoon.
IAS Guidelines recently added boosted FPV and ATV + 2 nucs as recommended initial therapy. FPV/r dose in US product label is 1400mg FPV + 200mg RTV once daily for naive patients. This study used a reduced FPV/r dose of 1400 FPV + 100mg RTV once daily that has not been previously studied. The study objective is to compare the efficacy, safety, and tolerability of RTV-boosted FPV versus RTV-boosted ATV (300/100), both in combination with TDF/FTC.
106 ART-naive subjects were randomized 1:1, open-label in a 48 week pilot study. Patients had HIV RNA >1000 with no CD4 restrictions. Patients were stratified by HIV RNA entry <100,000> c/ml. Baseline resistance testing was not done prior to entry because at the time the study started it was not being performed on naives.
The primary study endpoint was: proportion of patients with HIV RNA <50 copies/ml at 48 weeks.
The secondary endpoints are:
-- proportion of patients with HIV RNA <50 c/ml at 24 weeks;
-- proportion of patients with HIV RNA <400 c/ml at 24 & 48 weeks;
-- change from baseline in CD4 cell counts at 24 & 48 weeks;
-- HIV treatment-emergent resistance patterns;
-- difference between treatment arms in incidence, type and severity of adverse events.
Author Conclusions:
Both arms provided similar rates of virologic suppression & immunologic improvement at week 24
--lipid changes were similar
--overall, fewer severe adverse effects occurred in FPV/r than with ATV/r: difference were due to bilirubin associated AEs.
