학술논문
Short communication: comparable safety and efficacy with once-daily versus twice-daily dosing of lopinavir/ritonavir tablets with emtricitabine + tenofovir DF in antiretroviral-naive, HIV type 1-infected subjects: 96 week final results of the randomized trial M05-730
Document Type
Report
Author
Source
AIDS Research and Human Retroviruses. August 1, 2010, Vol. 26 Issue 8, p841, 5 p.
Subject
Language
English
ISSN
0889-2229
Abstract
LOPINAVIR IS A PEPTIDOMIMETIC HIV-1 PROTEASE inhibitor coformulated with low-dose ritonavir, which acts as a pharmacokinetic enhancer by blocking CYP3A4-mediated lopinavir metabolism. In numerous clinical trials, lopinavir/ ritonavir (LPV/r)-based therapy [...]
Sustained viral suppression with antiretroviral therapy improves clinical outcomes for HIV-infected individuals. Study M05-730 evaluated the long-term antiviral activity, safety, tolerability, emergence of resistance, and compliance with once-daily (QD) versus twice-daily (BID) lopinavir/ritonavir (LPV/r) combination therapy in treatment-naive, HIV-1-infected subjects through 96 weeks. Antiretroviral-naive subjects with HIV-1 RNA levels >1000 copies/ml were randomized to LPV/r QD (N = 333) or BID (N = 331) with tenofovir DF and emtricitabine. Through 96 weeks, 77 subjects from each group discontinued prematurely; adverse or HIV-related events contributed to discontinuation of 36 subjects overall, with no significant differences between treatment groups. At 96 weeks, 216 QD subjects (64.9%) and 229 BID subjects (69.2%) had HIV-1 RNA
Sustained viral suppression with antiretroviral therapy improves clinical outcomes for HIV-infected individuals. Study M05-730 evaluated the long-term antiviral activity, safety, tolerability, emergence of resistance, and compliance with once-daily (QD) versus twice-daily (BID) lopinavir/ritonavir (LPV/r) combination therapy in treatment-naive, HIV-1-infected subjects through 96 weeks. Antiretroviral-naive subjects with HIV-1 RNA levels >1000 copies/ml were randomized to LPV/r QD (N = 333) or BID (N = 331) with tenofovir DF and emtricitabine. Through 96 weeks, 77 subjects from each group discontinued prematurely; adverse or HIV-related events contributed to discontinuation of 36 subjects overall, with no significant differences between treatment groups. At 96 weeks, 216 QD subjects (64.9%) and 229 BID subjects (69.2%) had HIV-1 RNA