Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients

AIDS

Volumn 25, Issue 7, 2011, Pages 929-939

  Cahn, Pedro ^a   Fourie, Jan ^b   Grinsztejn, Beatriz ^c   Hodder, Sally ^d   Molina, Jean Michel ^e   Ruxrungtham, Kiat ^f   Workman, Cassy ^g   Van De Casteele, Tom ^h   De Doncker, Piet ^h   Lathouwers, Erkki ^h   Tomaka, Frank ⁱ  

^a FUNDACIÓN HUÉSPED   (Argentina)

^b Dr Jan Fourie Medical Practice ^*  (South Africa)

^c Funda??o Oswaldo Cruz   (Brazil)

^d UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^e SAINT LOUIS HOSPITAL   (France)

^f CHULALONGKORN UNIVERSITY   (Thailand)

^g AIDS Research Initiative   (Australia)

^h TIBOTEC BVBA   (Belgium)

ⁱ Tibotec Inc   (United States)

Author keywords

Darunavir; efficacy; HIV; once daily; safety; treatment experienced; twice daily

Indexed keywords

ABACAVIR; DARUNAVIR PLUS RITONAVIR; DIDANOSINE; EFAVIRENZ; INDINAVIR; LAMIVUDINE; LOPINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; STAVUDINE; TENOFOVIR; VIRUS RNA; ZIDOVUDINE;

ABNORMAL LABORATORY RESULT; ADULT; ARTICLE; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; FEMALE; HEADACHE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; TREATMENT DURATION; TREATMENT FAILURE; TRIACYLGLYCEROL BLOOD LEVEL; VIRUS MUTATION; VOMITING;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; RITONAVIR; RNA, VIRAL; SULFONAMIDES; TREATMENT OUTCOME;

EID: 79954967838     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e328345ee95     Document Type: Article

References (29)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelinesfortheuseofantiretroviral agentsin HIV-1-infected adults and adolescents. Department of Health and Human Services. 1 December 2009. pp. 1-161. http://www.aidsinfo. nih.gov/ContentFiles/AdultandAdolescentGLpdf.
2. Molina JM. Efficacy and safety of once-daily regimens in the treatment of HIV infection. Drugs 2008; 68:567-578.
3. Parienti JJ, Bangsberg DR, Verdon R, Gardner EM. Better adherence with once-daily antiretroviral regimens: a meta-analysis. Clin Infect Dis 2009; 48:484-488.
4. Zajdenverg R, Podsadecki TJ, Badal-Faesen S, Andrade-Villanueva J, Gathe J, Mingrone H, et al. Similar safety and efficacy of once-and twice-daily lopinavir/ritonavir tablets in treatment-experienced HIV-1-infected subjects at 48 weeks. J Acquir Immune Defic Syndr 2010; 54:143-151.
5. European AIDS Clinical Society (EACS). Guidelines: clinical management of treatment of HIV infected adults in Europe. Version 5. November 2009. http://www.europeanaidsclinical-society.org/guidelinespdf/1-Treatment-of-HIV- Infected-Adults. pdf.
6. Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, et al. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS 2009; 23:1679-1688.
7. Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, et al. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a ran-domised controlled phase III trial. Lancet 2007; 370:49-58. (Pubitemid 47023100)
8. Haubrich R, Berger D, Chiliade P, Colson A, Conant M, Gallant J, et al. Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS 2007; 21:F11-F18. (Pubitemid 46568621)
9. Katlama C, Esposito R, Gatell JM, Goffard JC, Grinsztejn B, Pozniak A, et al. Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1. AIDS 2007; 21:395-402.
10. De Meyer S, Spinosa-Guzman S, Vangeneugden T, de Bethune MP, Miralles D. Efficacy of once-daily darunavir/ritonavir 800/100mg in HIV-infected, treatment-experienced patients with no baseline resistance-associated mutations to darunavir. J Acquir Immune Defic Syndr 2008; 49:179-182.
11. De Meyer S, Dierynck I, Lathouwers E, Van Baelen B, Vangen-eugden T, Spinosa-Guzman S, et al. Phenotypic and genotypic determinants of resistance to darunavir: analysis of data from treatment-experienced patients in POWER 1, 2, 3 and DUET-1 and 2 [abstract 31]. 16th International HIV Drug Resistance Workshop; 10-14June 2008; Sitges, Spain.
12. Johnson VA, Brun-Vezinet F, Clotet B, Gunthard HF, Kuritzkes DR, Pillay D, et al. Update of the drug resistance mutations in HIV-1: December 2009. Top HIV Med 2009; 17:138-145.
13. AIDS Clinical Trials Group. Division ofAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; December 2004. http://www.aactg.org/node/88.
14. Johnson V, Brun-Vézinet F, Clotet B, Gunthard HF, Kuritzkes DR, Pillay D, et al. Update of the drug resistance mutations in HIV-1. Top HIV Med 2008; 16:138-145.
15. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972; 18:499-502.
16. Rinehart AR, de Béthune MP, Picchio G, Bacheler LT, Pattery T, Wasikowski B, et al. Prevalence of darunavir resistance-associated mutations in samples received for routine clinical resistance testing [abstract 44]. 5th European HIV Drug Resis-tance Workshop; 28-30 March; Cascais, Portugal; 2007.
17. Lathouwers E, De Meyer S, Dierynck I, Van der Borght K, Bacheler L, Pattery T, et al. Update on the prevalence of the 2007 darunavir resistance-associated mutations in samples received for routine clinical resistance testing [abstract 68]. 6th European HIV Drug Resistance Workshop; 26-28 March; Budapest, Hungary; 2008.
18. De Meyer S, Lathouwers E, Dierynck I, De Paepe E, van Baelen B, Vangeneugden T, et al. Characterization of virologic failure patients on darunavir/ritonavir in treatment-experienced patients. AIDS 2009; 23:1829-1840.
19. Cahn P, HodderS, Mootsikapun P, Suleiman J, Van de Casteele T, de Doncker P, et al. Subgroup analysis and predictors of virological response in treatment-experienced, HIV-1-infected patients in theODIN trial [abstract LBPE15]. XVIIIInternational AIDS Conference; 18-23 July 2010; Vienna, Austria.
20. Spinosa-Guzman S, Vangeneugden T, Sekar V, De Meyer S. A randomized, controlled, open-label trial to compare the effi-cacy, safety and tolerability of TMC114/RTV versus LPV/RTV in treatment-experienced HIV-1 infected subjects. Week-48 primary efficacy analysis.Tibotec Pharmaceuticals Ltd, Clinical Research Report TMC114-C214; 2008.
21. Arastéh K, Yeni P, Pozniak A, Grinsztejn B, Jayaweera D, Roberts A, et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther 2009; 14:859-864.
22. Tomaka F, Lefebvre E, Sekar V, Van Baelen B, Vangeneugden T, Vandevoorde A, et al. Effects of ritonavir-boosted darunavir vs. ritonavir-boosted atazanavir on lipid and glucose parameters in HIV-negative, healthy volunteers. HIV Med 2009; 10:318 327.
23. Fontas E, van Leth F, Sabin CA, Friis-Møller N, Rickenbach M, d'Arminio Monforte A, et al. Lipid profiles in HIV-infected patients receiving combination antiretroviral therapy: are different antiretroviral drugs associated with different lipid profiles? J Infect Dis 2004; 189:1056-1074. (Pubitemid 38373099)
24. Ortiz R, Dejesus E, Khanlou H, Voronin E, van Lunzen J, Andrade-Villanueva J, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS 2008; 22:1389-1397.
25. Hill A, Sawyer W, Gazzard B. Effects of first-line use of nucleoside analogues, efavirenz, and ritonavir-boosted protease inhibitors on lipid levels. HIV Clin Trials 2009; 10:1-12.
26. Moore DAJ, Goodall RL, Ives NJ, Hooker M, Gazzard BG, Easterbrook PJ. How generalizable are the results of large randomized controlled trials of antiretroviral therapy? HIV Med 2000; 1:149-154.
27. Sekar V, Vanden Abeele C, Van Baelen B, Vis P, Lavreys L, De Pauw M, et al. Pharmacokinetic-pharmacodynamic analyses of once-daily darunavir in the ARTEMIS study [abstract L-103]. 15th Conference on Retroviruses and Opportunistic Infections; 3-6 February; 2008; Boston, Massachusetts, USA.
28. Sekar V, De Paepe E, Van Baelen B, Vis P, Tomaka F, De Pauw M, et al. Pharmacokinetic/pharmacodynamic (PK/PD) ana-lyses of darunavir in the TITAN study [abstract P4.1/10]. 11th European AIDS Conference; 24-27 October 2007; Madrid, Spain.
29. Boffito M, Moyle G, Hill A, Sekar V, Lefebvre E, De Pauw M, et al. The pharmacokinetic (PK) profile of darunavir with low-dose ritonavir (DRV/r) in various multiple-dose regimens over 120h [abstract P31]. 9th International Workshop on Clinical Pharmacology of HIV Therapy; 7-9 April 2008; New Orleans, USA.