H-1241. Single Agent Therapy with Lopinavir/Ritonavir Durably Suppresses Viral Replication in ARV Naïve Patients: IMANI II - 96 Week Final Results
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.
Bernie Miguel, MD1, Bryan Lipman, BBA2, Carl Mayberry, PA1, John Nemecek, MD1, Joseph Gathe, MD3, Michael Norton, PA-C2, Michael Fath, PhD4, Rosa Yeh, PharmD5 and  J. Gathe,
Abbott Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Speaker's Bureau, Received: Research Support, Speaker Honorarium, Consulting Fee.
Tibotec Role(s): Speaker's Bureau, Received: Speaker Honorarium.
BI Role(s): Investigator, Received: Research Grant.
BMS Role(s): Investigator, Received: Research Grant.
GSK Role(s): Investigator, Received: Research Grant.
Gilead Role(s): Investigator, Received: Research Grant., (1)Therapeutic Concepts, PA, (2)Abbott, (3)Plaza Medical Center, Houston, TX, (4)Abbott Laboratories, Abbott Park, IL, (5)The Universtiy of Houston