Session: Poster Session: Antiretroviral Therapy: Clinical Trials
Sunday, October 26, 2008: 12:00 AM
Room: Hall C
Background: Lopinavir/ritonavir (LPV/r) single-agent therapy can achieve and sustain virologic suppression in a variety of treatment strategies. Long-term data of the durability of LPV/r as (SAT) in naïve subjects remain limited. Methods: : IMANI-2 is a prospective, phase II, single-arm, open-label, 96-week pilot trial of LPV/r single-agent therapy in 39 ARV naïve subjects. Any VL and CD4 count without baseline resistance to LPV/r were eligible. Study endpoints at 48 weeks (VL <75 in 79% ITT M=F) have been reported previously. Final 96 week data on virologic and immunologic response are presented. Results: At week 96, 29/39 (74.3% ITT M=F) and 29/33 (87.8% AT ) subjects had VL <75 copies/ml. 4 were viremic (101, 217, 794, 24,778 copies). 6 D/C prior to 96 weeks, 1 due to protocol violation, and 5 LTFU. 5 intensified before 48 weeks. 4/5 <75 copies/ml by week 48, but were among the LTFU before week 96. 12 experienced transient viremia (7 multiple, 5 singular) after achieving VL<75 copies/ml felt to be due to non-adherence. No primary PI mutations were observed. Mean CD4 change from BL to 96 weeks was +310 CD4+ cells/mm3, range 72→572. Conclusions: LPV/r SAT in ARV naïve subjects demonstrated durable virologic control through 96 weeks in 74% of subjects (ITT M=F). Transient viremia or virologic failure was associated with non-adherence or concurrent illness. These data speak to the efficacy, safety and durability of virologic control for LPV/r SAT in naïve patients and should encourage ongoing clinical study of this strategy.