Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial

HIV Medicine

Volumn 14, Issue 1, 2013, Pages 49-59

  Orkin, C ^a   Dejesus, E ^b   Khanlou, H ^c   Stoehr, A ^d   Supparatpinyo, K ^e   Lathouwers, E ^f   Lefebvre, E ^g   Opsomer, M ^f   Van de Casteele, T ^f   Tomaka, F ^h  

^a BARTS HEALTH NHS TRUST   (United Kingdom)

^b ORLANDO IMMUNOLOGY CENTER   (United States)

^c AIDS HEALTHCARE FOUNDATION   (United States)

^d Institute for Interdisciplinary Medicine   (Germany)

^e CHIANG MAI UNIVERSITY   (Thailand)

^f TIBOTEC BVBA   (Belgium)

^g Janssen   (Netherlands)

^h Tibotec Inc   (United States)

Author keywords

Darunavir; Efficacy; Lopinavir; Safety; Treatment na ve

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; DARUNAVIR PLUS RITONAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOPINAVIR PLUS RITONAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; RNA DIRECTED DNA POLYMERASE INHIBITOR; TRIACYLGLYCEROL; VIRUS RNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4 LYMPHOCYTE COUNT; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; CREATININE CLEARANCE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INTENTION TO TREAT ANALYSIS; KIDNEY FAILURE; LONG TERM CARE; MAJOR CLINICAL STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; TREATMENT DURATION; TREATMENT FAILURE; TRIACYLGLYCEROL BLOOD LEVEL;

ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, MULTIPLE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LOPINAVIR; MALE; PROTEASE INHIBITORS; RITONAVIR; RNA, VIRAL; SULFONAMIDES; VIRAL LOAD;

EID: 84870533547     PISSN: 14642662     EISSN: 14681293     Source Type: Journal    
DOI: 10.1111/j.1468-1293.2012.01060.x     Document Type: Article

References (18)

1. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. October 14, 2011. Available at www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (accessed 15 October 2012).
2. European AIDS Clinical Society. Clinical management and treatment of HIV-infected adults in Europe. Version 6.0 - October 2011. Available at www.europeanaidsclinicalsociety.org/ (accessed 15 October 2012).
3. Clotet B, Bellos N, Molina J-M etal. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet 2007; 369: 1169-1178.
4. Madruga JV, Berger D, McMurchie M etal. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet 2007; 370: 49-58.
5. Cahn P, Fourie J, Grinsztejn B etal. Week 48 analysis of once-daily vs twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS 2011; 25: 929-939.
6. Ortiz R, Dejesus E, Khanlou H etal. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1-infected patients at week 48. AIDS 2008; 22: 1389-1397.
7. Mills A, Nelson M, Jayaweera D etal. Once-daily darunavir/ritonavir vs lopinavir/ritonavir in treatment-naïve, HIV-1-infected patients: 96-week analysis. AIDS 2009; 23: 1679-1688.
8. Lathouwers E, DeMeyer S, Dierynck I etal. Virological characterization of patients failing darunavir/ritonavir or lopinavir/ritonavir treatment in the ARTEMIS study: 96-week analysis. Antivir Ther 2011; 16: 99-108.
9. Johnson VA, Brun-Vézinet F, Clotet B etal. Update of the drug resistance mutations in HIV-1: December 2010. Top HIV Med 2010; 18: 156-163.
10. Hughes RA, Sterne JA, Walsh J etal. Long-term trends in CD4 cell counts and impact of viral failure in individuals starting antiretroviral therapy: UK Collaborative HIV Cohort (CHIC) study. HIV Med 2011; 12: 583-593.
11. Uy J, Yang R, Thiry A etal. Efficacy and safety by baseline HIV-RNA and CD4 count in treatment-naive patients treated with atazanavir/r and lopinavir/r in the CASTLE study. J Int AIDS Soc 2008; 11 (Suppl. 1): P8.
12. Pulido F, Estrada V, Baril JG etal. Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks. HIV Clin Trials 2009; 10: 76-87.
13. Molina JM, Andrade-Villanueva J, Echevarria J etal. Once daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naïve HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008; 372: 646-655.
14. Zhu T, Chiu Y, Doan T etal. New tablet formulation of lopinavir/ritonavir is bioequivalent to the capsule at a dose of 800/200mg. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, USA, December 2005 [Poster H-1894].
15. Tomaka F, Lefebvre E, Sekar V etal. Effects of ritonavir-boosted darunavir versus ritonavir-boosted atazanavir on lipid and glucose parameters in HIV-negative, healthy volunteers. HIV Med 2009; 10: 318-327.
16. Overton T, Aberg JA, Gupta S etal. METABOLIK: Week 48 comparison of metabolic parameters and biomarkers in subjects receiving darunavir/ritonavir or atazanavir/ritonavir. 10th International Congress on Drug Therapy in HIV Infection. Glasgow, UK, November 2010 [Abstract P74].
17. Moal G, Beraud G, Prazuck T, Hocqueloux L, Dupuis A, Venisse N. Lopinavir to atazanavir or darunavir switch in HIV-1 infected patients with dyslipidemia: an observational study. J Int AIDS Soc 2010; 13 (Suppl. 4): P46.
18. + persons on fully suppressive LPV/r or FPV/r with high serum triglycerides. 18th Conference on Retroviruses and Opportunistic Infections. Boston, USA, February-March 2011 [Abstract 817].