Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48
AIDS, Volume 22, No. 12, Year 2008
Notification
URL copied to clipboard!
Description
Background: The present primary analysis of AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects (ARTEMIS) compares the efficacy and safety of once-daily darunavir/ritonavir (DRV/r) with that of lopinavir/ritonavir (LPV/r) in treatment-naive patients. Methods: Patients with HIV-1 RNA at least 5000 copies/ml were stratified by HIV-1 RNA and CD4 cell count in a phase III, open-label trial, and randomized to receive DRV/r 800/100 mg qd or LPV/r 800/200 mg total daily dose (bid or qd) plus fixed-dose tenofovir and emtricitabine for 192 weeks. The primary objective was to demonstrate non-inferiority of DRV/r as compared with LPV/r in HIV-1 RNA less than 50 copies/ml per-protocol time-to-loss of virologic response at 48 weeks. Results: Six hundred and eighty-nine patients were randomized and treated; mean baseline HIV-1 RNA: 4.85 log10 copies/ml and median CD4 count: 225 cells/μl. At 48 weeks, 84% of DRV/r and 78% of LPV/r patients achieved HIV-1 RNA less than 50 copies/ml (estimated difference = 5.6 [95% confidence interval -0.1-11]%), demonstrating non-inferiority of DRV/r as compared with LPV/r (P < 0.001; per-protocol time-to-loss of virologic response). Patients with HIV-1 RNA at least 100 000 copies/ml had a significantly higher response rate with DRV/r (79%) versus LPV/r (67%; P < 0.05). Median CD4 cell count increases (non-completer = failure; cells/μl) were 137 for DRV/r and 141 for LPV/r. DRV/r had a lower incidence of possibly treatment-related grade 2-4 gastrointestinal-related adverse events (7 versus 14%) and treatment-related moderate-to-severe diarrhea (4 versus 10%) than LPV/r. Adverse events leading to discontinuation were DRV/r: 3% and LPV/r: 7%. Conclusion: DRV/r 800/100 mg qd was non-inferior to LPV/r 800/200 mg at 48 weeks, with a more favorable safety profile. Significantly higher response rates were observed with DRV/r in patients with HIV-1 RNA at least 100 000 copies/ml. DRV/r 800/100 mg offers a new effective and well tolerated once-daily, first-line treatment option for treatment-naive patients. © 2008 Wolters Kluwer Health / Lippincott Williams & Wilkins.
Authors & Co-Authors
Ortiz, Roberto
United States, Orlando
Orlando Immunology Center
DeJesus, Edwin
United States, Orlando
Orlando Immunology Center
Khanlou, Homayoon
United States, Los Angeles
Aids Healthcare Foundation
Voronin, Evgeny E.
Russian Federation, Saint Petersburg (ex Leningrad)
Republican Hospital of Infectious Diseases
van Lunzen, Jan
Germany, Hamburg
Universitätsklinikum Hamburg-eppendorf
Andrade-Villanueva, Jaime
Mexico, Guadalajara
Hospital Civil de Guadalajara
Fourie, Jan
South Africa, Tygerberg
Chronic Diseases of Lifestyle Unit
de Meyer, Sandra M.J.
Belgium, Machelen
Tibotec Bvba
de Pauw, Martine
Belgium, Machelen
Tibotec Bvba
Lefebvre, Eric
Netherlands, Tilburg
Janssen-cilag B.v., Netherlands
Vangeneugden, Tony J.
Belgium, Machelen
Tibotec Bvba
Spinosa Guzmán, Sabrina M.
Belgium, Machelen
Tibotec Bvba
Statistics
Citations: 403
Authors: 12
Affiliations: 8
Identifiers
Doi:
10.1097/QAD.0b013e32830285fb
e-ISSN:
14735571
Research Areas
Infectious Diseases
Study Design
Cohort Study