Lopinavir/ritonavir combined with raltegravir demonstrated similar antiviral efficacy and safety as lopinavir/ritonavir combined with tenofovir disoproxil fumarate/emtricitabine in treatment-naïve HIV-1 infected subjects
Presented by Jacques Reynes (France).
J. Reynes1, A. Lawal2, F. Pulido3, R. Soto-Malave4, J. Gathe5, M. Tian2, L. Fredrick2, T. Correll2, T. Podsadecki2, A. Nilius2
1Hôpital Gui de Chauliac, Montpellier, France, 2Abbott, Abbott Park, United States, 3Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain, 4Innovative Care PSC, Bayamon, Puerto Rico, 5Therapeutic Concepts, Houston, United States
Background: A three drug combination including two nucleoside reverse transcriptase inhibitors (NRTIs) is currently recommended to treat antiretroviral (ARV) naïve patients. The current study directly compares an NRTI-sparing dual agent regimen of lopinavir/ritonavir (LPV/r) combined with raltegravir (RAL) to a regimen of LPV/r combined with tenofovir and emtricitabine (TDF/FTC) in ARV-naïve subjects.
Methods: Study M10-336 (PROGRESS) is an ongoing, randomized, open-label, 96-Week trial of LPV/r 400/100 mg BID combined with either RAL 400 mg (BID) (n=101) or with TDF/FTC 300/200 QD (n=105) in ARV-naïve subjects. The primary efficacy endpoint is the proportion of subjects with plasma HIV-1 RNA < 40 copies/mL at week 48, based on the FDA time to loss of virologic response (ITT-TLOVR) algorithm. Per protocol, the non-inferiority of the RAL regimen is demonstrated if the lower bound of the 95% confidence interval for the difference in response (RAL - TDF/FTC) is ≥ -20%.
Results: Demographics were similar across treatment groups. Mean baseline HIV-1 RNA was 4.25 log10 copies/ml, mean baseline CD4 count was 293.5 cells/mm3. A similar proportion of subjects in each arm discontinued the study prematurely (12% RAL, 11% TDF/FTC). The RAL regimen was non-inferior to the TDF/FTC regimen: 83% (RAL) and 85% (TDF/FTC) had HIV-1 RNA < 40 copies/mL at Week 48 (95% CI for the difference: -12%, 8%). The mean CD4+ T-cell increases through 48 weeks were similar (215 cells/mm3 RAL, 245 cells/mm3 TDF/FTC, P=0.237). Treatment-emergent moderate/severe study drug-related adverse events were similar between groups; the most common of these events were diarrhea (8% RAL, 13% TDF/FTC, P=0.261) and hypercholesterolaemia (8% RAL, 5% TDF/FTC; P=0.401).
Conclusions: The novel NRTI-sparing regimen of LPV/r+RAL resulted in non-inferior efficacy and similar tolerability as a traditional 3-drug antiviral regimen. These results demonstrate that a two drug NRTI-sparing regimen can provide an alternative approach to treatment of ARV-naïve patients..
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