Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results
| Autor: | Joseph Gathe, Adebayo Lawal, Ruth Soto-Malave, Angela Nilius, Min Tian, Federico Pulido, Jacques Reynes, Thomas Podsadecki, Linda M Fredrick |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Anti-HIV Agents Organophosphonates Integrase inhibitor Lopinavir/ritonavir HIV Infections Pharmacology Emtricitabine Deoxycytidine Drug Administration Schedule Lopinavir Raltegravir Potassium immune system diseases Antiretroviral Therapy Highly Active Medicine Humans Pharmacology (medical) HIV Integrase Inhibitors Tenofovir Ritonavir business.industry United States Food and Drug Administration Adenine virus diseases HIV Protease Inhibitors Middle Aged Viral Load Raltegravir Pyrrolidinones United States Regimen Infectious Diseases Treatment Outcome HIV-1 RNA Viral Reverse Transcriptase Inhibitors Drug Therapy Combination Female business Algorithms medicine.drug |
| Zdroj: | HIV clinical trials. 12(5) |
| ISSN: | 1528-4336 |
| Popis: | Current antiretroviral regimens recommended for treatment-naïve patients include 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). The purpose of this study is to evaluate whether a new NRTI-sparing regimen may provide an alternative for persons for whom traditional regimens may not be the best option.PROGRESS is a 96-week, randomized, open-label, multicenter trial comparing the efficacy and safety of a boosted protease inhibitor (PI) and an integrase inhibitor (lopi-navir/ritonavir [LPV/r] + raltegravir [RAL]) to a boosted PI and 2 NRTIs (LPV/r + tenofovir/ emtricitabine [TDF/FTC]) in antiretroviral (ARV)-naïve HIV-1-infected adults.A total of 206 subjects were randomized to receive LPV/r + RAL (n=101) or LPV/r + TDF/FTC (n=105) and analyzed for ARV efficacy using the US Food and Drug Administration time to loss of virologic response (FDA-TLOVR) algorithm. The percentage of subjects with plasma HIV-1 RNA40 copies/mL at week 48 was 83.2% in the LPV/r + RAL group and 84.8% in the LPV/r + TDF/FTC group (P = .850; difference -1.6%; exact 95% CI, -12.0% to 8.8%). As the lower limit of the exact 95% CI for the difference between regimens was at or above the protocol-defined threshold of -20% (as well as the more stringent threshold of -12%), LPV/r + RAL was noninferior to LPV/r + TDF/FTC. The occurrence of treatment-related, moderate/severe adverse events was similar between treatment groups through 48 weeks of treatment.The HIV treatment regimen of LPV/r + RAL resulted in noninferior efficacy and comparable safety and tolerability compared with a traditional NRTI-containing regimen through 48 weeks of treatment. These results support further evaluation of the LPV/r + RAL regimen. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|