Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials

摘要: BACKGROUND The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone 334) in treatment-experienced HIV-1-infected patients. METHODS primary objective at week 48 was to investigate durability efficacy, as measured by the percentage patients maintaining their 24 response or improving. Efficacy analyses used intent-to-treat population. RESULTS A total 73.7% randomized group remained on treatment through versus 21.3% originally control group. At 48, a higher proportion responders maintained were new than each responder category: HIV-1 RNA level > =1.0 log(10) change from baseline, <400 copies/mL <50 (37.4%, 30.4%, 18.3% vs. 17.1%, 12.0%, 7.8% group, respectively; P < 0.0001 for all comparisons). CD4 cell count increases baseline twice great CONCLUSION These data demonstrate durable efficacy over weeks.