Effect of baseline characteristics on the efficacy and safety of once-daily darunavir/ ritonavir in HIV-1-infected, treatment-naïve ARTEMIS patients at week 96.

Abstract:

OBJECTIVES:ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naïve, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r patients. METHODS:Patients received once-daily DRV/r plus fixed-dose tenofovir/emtricitabine. Week 96 efficacy and safety data were analyzed by gender (males, n=239; females, n=104), age (≤30, n=115; 31-45, n=175; >45, n=53), race (Asian, n=44; Black, n=80; Caucasian/White, n=137; Hispanic, n=77), and hepatitis B and/or C virus coinfection (n=43). RESULTS:Week 96 virologic response rates (HIV-1 RNA<50 copies/mL) were as follows: gender: 79% for both males and females; age: 72% (≤30), 81% (31-45), and 89% (>45); race: 96% (Asian), 71% (Black), 77% (Caucasian/White), and 79% (Hispanic); coinfection status: 72% (coinfected) and 80% (non-coinfected). The incidence of treatment-related adverse drug reactions (ADRs) and laboratory abnormalities were comparable across gender, age, and race subgroups. Coinfected patients had a higher incidence of liver-related ADRs than non-coinfected patients. CONCLUSIONS:DRV/r 800/100 mg qd is an effective, well-tolerated treatment option for treatment-naïve patients of different gender, age, race, or coinfection status.

journal_name

HIV Clin Trials

journal_title

HIV clinical trials

authors

Fourie J,Flamm J,Rodriguez-French A,Kilby D,Domingo P,Lazzarin A,Ballesteros J,Sosa N,Van De Casteele T,DeMasi R,Spinosa-Guzman S,Lavreys L

doi

10.1310/hct1206-313

subject

Has Abstract

pub_date

2011-11-01 00:00:00

pages

313-22

issue

6

eissn

1528-4336

issn

1945-5771

pii

E5PQ72L570574615

journal_volume

12

pub_type

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    pub_type: 杂志文章

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    pub_type: 临床试验,杂志文章

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