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

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.


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.


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.


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


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.