406. Lopinavir/ritonavir (LPV/r) Combined with Raltegravir (RAL) or Tenofovir/Emtricitabine (TDF/FTC) in Antiretroviral-na´ve Subjects: 96-Week Efficacy and Safety Results of the PROGRESS Study
Session: Poster Abstract Session: HIV - Antiretroviral Therapy
Friday, October 21, 2011
Room: Poster Hall B1
Background:  

The PROGRESS study compared the novel nucleoside/nucleotide reverse transcriptase inhibitor (NRTI)-sparing antiretroviral (ARV) regimen of a protease inhibitor (LPV/r) combined with an integrase inhibitor (RAL) to a regimen of LPV/r combined with two NRTIs (TDF/FTC) in ARV-naïve subjects. At the week 48 primary endpoint, 83.2% in the LPV/r + RAL regimen and 84.8% in the LPV/r + TDF/FTC regimen (P=0.850, difference -1.6%, 95% exact confidence interval [CI] -12.0%, 8.8%) were responders with plasma HIV-1 RNA <40 copies/mL by the FDA time to loss of virologic response (FDA-TLOVR) algorithm. LPV/r + RAL was noninferior to LPV/r + TDF/FTC as the lower limit of the 95% exact CI for the difference between regimens was ≥ the protocol-defined threshold of -12%. Safety and tolerability were similar between regimens. Results through week 96 are presented.

Methods:  

PROGRESS was a randomized, open-label, 96-week trial comparing LPV/r 400/100mg twice-daily (BID) combined with either RAL 400mg BID or with TDF/FTC 300/200mg once-daily (QD) in ARV-naïve subjects.

Results:  

206 subjects were randomized and treated (LPV/r + RAL, N=101; LPV/r + TDF/FTC, N=105). Baseline demographics/disease characteristics were similar between regimens; 17% of subjects had plasma HIV-1 RNA >100,000 copies/mL and 26% had CD4+ T-cell concentrations <200 cells/mm3. A similar proportion of subjects in each regimen discontinued the study prematurely (19% LPV/r + RAL, 14% LPV/r + TDF/FTC). At 96 weeks, 66% of subjects receiving LPV/r + RAL and 69% of subjects receiving LPV/r + TDF/FTC were responders by the FDA-TLOVR algorithm (P=0.767, 95% CI for the difference: -15.1%, 10.8%). The mean CD4+ T-cell increases through 96 weeks were similar (281 cells/mm3 LPV/r + RAL, 296 cells/mm3 LPV/r +TDF/FTC, P=0.598). The frequency of treatment-emergent moderate/severe study drug-related AEs was similar between regimens.

Conclusion: 

Through 96 weeks, the novel combination of LPV/r + RAL resulted in similar efficacy, safety, and tolerability as LPV/r + TDF/FTC. These results support further evaluation of the LPV/r + RAL regimen.


Subject Category: H. HIV/AIDS and other retroviruses

Joseph Gathe, MD1, Jacques Reynes, MD, PhD2, Federico Pulido, MD3,4, Ruth Soto-Malave, MD5,6, Min Tian7, Linda Fredrick, MS7, Thomas Podsadecki, MD7 and Angela Nilius, PhD7, (1)Therapeutic Concepts, Houston, TX, (2)Montpellier University Hospital , Montpellier, France, (3)Unidad VIH. Hospital Universitario 12 de Octubre, i+12, Madrid, Spain, (4)Universidad Complutense de Madrid, Madrid, Spain, (5)University of Puerto Rico, School of Medicine, San Juan, PR, (6)Innovative Care PSC, Bayamon, PR, (7)Abbott, Abbott Park, IL

Disclosures:

J. Gathe, Abbott, Tibotec, Merck, Boehringer-Ingelheim, and Schering-Plough: Scientific Advisor, Speaker honorarium

J. Reynes, Abbott, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer, Roche, Schering-Plough, Tibotec, ViiV Healthcare: Scientific Advisor, Research grant and Speaker honorarium

F. Pulido, Abbott, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme and Pfizer: Scientific Advisor, Consulting fee and Speaker honorarium

R. Soto-Malave, Abbott and Tibotec pharmaceuticals: Scientific Advisor, Consulting fee and Speaker honorarium

M. Tian, Abbott: Employee, Salary and Stock or options

L. Fredrick, Abbott: Employee, Salary and Stock or options

T. Podsadecki, Abbott: Employee, Salary and Stock or options

A. Nilius, Abbott: Employee, Salary and Stock or options

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.