Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: The ARTEN Trial

Antiviral Therapy

Volumn 16, Issue 3, 2011, Pages 339-348

  Soriano, Vicente ^a   Arastéh, Keikawus ^b   Migrone, Horacio ^c   Lutz, Thomas ^d   Opravil, Milos ^e   Andrade Villanueva, Jaime ^f   Antunes, Francisco ^g   Di Perri, Giovanni ^h   Podzamczer, Daniel ⁱ   Taylor, Steve ^j   Domingo, Pere ^k   Gellermann, Holger ^l   De Rossi, Lothar ^l  

^a HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^b Epimed GmbH   (Germany)

^c Fundación Infectologia de Atencion Ambulatoria   (Argentina)

^d Infektiologicum Frankfurt   (Germany)

^e UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^f HOSPITAL CIVIL DE GUADALAJARA FRAY ANTONIO ALCALDE   (Mexico)

^g HOSPITAL DE SANTA MARIA   (Portugal)

^h UNIVERSITY OF TURIN   (Italy)

ⁱ HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^j BIRMINGHAM HEARTLANDS HOSPITAL   (United Kingdom)

^k HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^l BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN A1; ATAZANAVIR PLUS RITONAVIR; CREATININE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; NEVIRAPINE; TRIACYLGLYCEROL; VIRUS RNA;

ADULT; ARTICLE; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERBILIRUBINEMIA; HYPERTRIGLYCERIDEMIA; JAUNDICE; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PATIENT COMPLIANCE; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN TOXICITY; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS; VIRUS MUTATION; VIRUS RESISTANCE;

ADENINE; ADULT; ANTI-HIV AGENTS; CARDIOVASCULAR DISEASES; DEOXYCYTIDINE; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; NEVIRAPINE; OLIGOPEPTIDES; PHOSPHONIC ACIDS; PYRIDINES; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; TREATMENT OUTCOME;

EID: 79959435688     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: 10.3851/IMP1745     Document Type: Article

References (44)

1. Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 2010; 304:321-333.
2. European AIDS Clinical Society. HIV guidelines (Updated November 2009. Accessed 1 December 2010.) Available from http://www. europeanaidsclinicalsociety.org/guidelines.asp
3. Gazzard BG, Anderson J, Babiker A. British HIV Association Guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med 2008; 9:563-608.
4. US Department of Health and Human Services. Panel on Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. (Updated 1 December 2009. Accessed 1 December 2010.) Available from http://www.aidsinfo.nih.gov/
5. Jiménez-Nácher I, Garcia B, Barreiro P, et al. Trends in the prescription of antiretroviral drugs and impact on plasma HIV-RNA measurements. J Antimicrob Chemother 2008; 62:816-822.
6. van Leth F, Phanuphak P, Ruxrungtham K, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363:1253-1263. (Pubitemid 38496486)
7. Martínez E, Arnaiz JA, Podzamczer D, et al. Three-year follow-up of protease inhibitor-based regimen simplification in HIV-infected patients. AIDS 2007; 21:367-369. (Pubitemid 46175050)
8. Podzamczer D, Ferrer E, Consiglio E, et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients (the Combine Study). Antivir Ther 2002; 7:81-90. (Pubitemid 36427149)
9. Martínez E, Arnaiz JA, Podzamczer D, et al. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with HIV infection. N Engl J Med 2003; 349:1036-1046. (Pubitemid 37087618)
10. Franssen R, Sankatsing R, Hassink E, et al. Nevirapine increases high-density lipoprotein cholesterol concentration by stimulation of apolipoprotein A-I production. Arterioscler Thromb Vasc Biol 2009; 29:1336-1341.
11. Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008; 372:646-655.
12. Fernández-Montero JV, Barreiro P, Soriano V. HIV protease inhibitors: recent clinical trials and recommendations on use. Expert Opin Pharmacother 2009; 10:1615-1629.
13. Soriano V, Garcia-Gasco P, Vispo E, et al. Efficacy and safety of replacing lopinavir with atazanavir in HIVinfected patients with undetectable plasma viraemia: final results of the SLOAT trial. J Antimicrob Chemother 2008; 61:200-205.
14. Gatell J, Salmon-Ceron D, Lazzarin A, et al. Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: the SWAN Study (AI424-097) 48-week results. Clin Infect Dis 2007; 44:1484-1492. (Pubitemid 46801594)
15. Rubio R, Serrano O, Carmena J, et al. Effect of simplification from protease inhibitors to boosted atazanavir-based regimens in real-life conditions. HIV Med 2010; 11:545-553.
16. Division of AIDS. Table for grading the severity of adult and pediatric adverse events. (Updated December 2009. Accessed 10 May 2010.) Available from www.niaid.nih.gov/research/resources/DAIDSClinRsrch/PDF/Safety/ DAIDSAEGradingTable.pdf
17. European AIDS Clinical Society. European guidelines for the clinical management and treatment of HIV infected adults. 2005. (Accessed 10 May 2010.) Available from www.europeanaidsclinicalsociety.org/guidelines.asp
18. Battegay M, Fluckiger U, Hirschel B, Furrer H. Late presentation of HIV-infected individuals. Antivir Ther 2007; 12:841-851. (Pubitemid 47492554)
19. Battegay M, Fehr J, Fluckiger U, Elzi L. Antiretroviral therapy of late presenters with advanced HIV disease. J Antimicrob Chemother 2008; 62:41-44. (Pubitemid 351865872)
20. US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for industry. Antiretroviral drugs using plasma HIV RNA measurements - clinical considerations for accelerated and traditional approval. (Updated October 2002. Accessed 10 December 2009.) Available from http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf
21. Ortiz R, de Jesus E, Khanlou H, 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.
22. Rey D, Hoen B, Chavanet P, et al. High rate of early virological failure with the once-daily tenofovir/lamivudine/nevirapine combination in naive HIV-1-infected patients. J Antimicrob Chemother 2009; 63:380-388.
23. Lapadula G, Costarelli S, Quiros-Roldan E, et al. Risk of early virological failure of once-daily tenofovir-emtricitabine plus twice-daily nevirapine in antiretroviral therapy-naive HIV-infected patients. Clin Infect Dis 2008; 46:1127-1129. (Pubitemid 351589888)
24. Labarga P, Medrano J, Seclen E, et al. Safety and efficacy of tenofovir/emtricitabine plus nevirapine in HIV-infected patients. AIDS 2010; 24:777-779.
25. McIntyre J, Hughes M, Mellors J. Efficacy of ART with NVP+TDF/FTC vs LPV/r+TDF/FTC among antiretroviralnaive women in Africa: OCTANE Trial 2/ACTG A5208. 17th Conference on Retroviruses and Opportunistic Infections. 16-19 February 2010, San Francisco, CA, USA. Abstract 153LB.
26. Deeks SG, Phillips AN. HIV infection, antiretroviral treatment, ageing, and non-AIDS related morbidity. BMJ 2009; 338:a3172.
27. Martínez E, Larrousse M, Gatell JM. Cardiovascular disease and HIV infection: host, virus, or drugs? Curr Opin Infect Dis 2009; 22:28-34.
28. Worm SW, Sabin C, Weber R, et al. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study. J Infect Dis 2010; 201:318-330.
29. The DAD Study Group. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med 2007; 356:1723-1735.
30. Lang S, Mary-Krause M, Cotte L, et al. Increased risk of myocardial infarction in HIV-infected patients in France, relative to the general population. AIDS 2010; 24:1228-1230.
31. Dubé MP, Stein JH, Aberg JA, et al. Guidelines for the evaluation and management of dyslipidemia in HIV-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the IDSA and the ACTG. Clin Infect Dis 2003; 37:613-627. (Pubitemid 37100800)
32. Moyle GJ. Lipid abnormalities during ART: it's the drug, not the class. AIDS Read 2004; 14:15-16.
33. Martínez E, Gatell JM. Considerations on the effectiveness of nevirapine in protease inhibitor-based regimen simplification. AIDS 2007; 21:1829-1830. (Pubitemid 47237577)
34. Cooney MT, Dudina A, De Bacquer D, et al. HDL cholesterol protects against cardiovascular disease in both genders, at all ages and at all levels of risk. Atherosclerosis 2009; 206:611-616.
35. Walldius G, Jungner I. Rationale for using apolipoprotein B and apolipoprotein A-I as indicators of cardiac risk and as targets for lipid-lowering therapy. Eur Heart J 2005; 26:210-212. (Pubitemid 40222357)
36. Smith KY, Weinberg WG, De Jesus E, et al. Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT. AIDS Res Ther 2008; 5:5-16.
37. van den Berg-Wolf M, Hullsiek K, Peng G, et al. Virologic, immunologic, clinical, safety, and resistance outcomes form a long-term comparison of efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected patients. HIV Clin Trials 2008; 9:324-336.
38. Letendre SL, Ellis RJ, Everall I, Ances B, Bharti A, McCutchan JA. Neurologic complications of HIV disease and their treatment. Top HIV Med 2009; 17:46-56.
39. Best BM, Letendre SL, Brigid E, et al. Low atazanavir concentrations in cerebrospinal fluid. AIDS 2009; 23:83-87.
40. Vernazza P, Daneel S, Schiffer V, et al. The role of compartment penetration in PI-monotherapy: the Atazanavir-Ritonavir Monomaintenance (ATARITMO) trial. AIDS 2007; 21:1309-1315. (Pubitemid 46883485)
41. Taylor S, van Heeswijk R, Hoetelmans R, et al. Concentrations of nevirapine, lamivudine and stavudine in semen of HIV-1-infected men. AIDS 2000; 14:1979-1984.
42. Basu RP, Grimes RM, Helmy AF. Cost to achieve an undetectable viral load using recommended antiretroviral regimens. HIV Clin Trials 2006; 7:309-318. (Pubitemid 46164965)
43. WHO. Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents. (Updated 30 November 2009. Accessed 10 May 2010.) Available from http://www.who.int/hiv/pub/arv/advice/en/index.html
44. Calmy A, Vallier N, Nguyen A, et al. Safety and efficacy of once-daily nevirapine dosing: a multicohort study. Antivir Ther 2009; 14:931-938.