Lipid levels and changes in body fat distribution in treatment-naive, HIV-1-infected adults treated with rilpivirine or efavirenz for 96 weeks in the ECHO and THRIVE trials

Clinical Infectious Diseases

Volumn 59, Issue 3, 2014, Pages 425-434

  Tebas, Pablo ^a   Sension, Michael ^b   Arribas, José ^d   Duiculescu, Dan ^e   Florence, Eric ^f   Hung, Chien Ching ^h   Wilkin, Timothy ^c   Vanveggel, Simon ^g   Stevens, Marita ^g   Deckx, Henri ^g  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b Comprehensive Care Center ^*  (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d HOSPITAL UNIVERSITARIO LA PAZ IDIPAZ   (Spain)

^e CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^f INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^g JANSSEN RESEARCH FOUNDATION   (Belgium)

^h NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

Author keywords

Dual energy x ray absorptiometry; Efavirenz; Lipids; Lipodystrophy; Rilpivirine

Indexed keywords

2',3' DIDEOXYNUCLEOSIDE DERIVATIVE; ABACAVIR; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; BENZOXAZINE DERIVATIVE; DRUG COMBINATION; EFAVIRENZ; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; RILPIVIRINE; RNA DIRECTED DNA POLYMERASE; RNA DIRECTED DNA POLYMERASE INHIBITOR; TENOFOVIR; ZIDOVUDINE;

ADOLESCENT; ADULT; AGED; ANTAGONISTS AND INHIBITORS; BODY FAT DISTRIBUTION; CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; DRUG EFFECTS; FEMALE; HIV INFECTIONS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; MALE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PHOTON ABSORPTIOMETRY; RANDOMIZED CONTROLLED TRIAL; VERY ELDERLY; YOUNG ADULT;

ABSORPTIOMETRY, PHOTON; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-HIV AGENTS; BENZOXAZINES; BODY FAT DISTRIBUTION; DIDEOXYNUCLEOSIDES; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HIV REVERSE TRANSCRIPTASE; HIV-1; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; REVERSE TRANSCRIPTASE INHIBITORS; RILPIVIRINE; TENOFOVIR; YOUNG ADULT; ZIDOVUDINE;

EID: 84904610350     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu234     Document Type: Article

References (40)

1. Molina JM, Cahn P, Grinsztejn B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet 2011; 378: 238-46.
2. Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet 2011; 378: 229-37.
3. Cohen C, Molina JM, Cahn P, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naïve, HIV-1-infected patients: pooled results from the phase 3 double-blind, randomized ECHO and THRIVE trials. J Acquir Immune Defic Syndr 2012; 60: 33-42.
4. Cohen C, Molina JM, Cassetti I, et al. Week 96 efficacy and safety of rilpivirine in treatment-naïve, HIV-1 patients in two phase III randomized trials. AIDS 2013; 27: 939-50.
5. Edurant® (rilpivirine) [tablets]. Full prescribing information. Janssen-Cilag, 2014. Available at: http://www.edurant.com/sites/default/files/ EDURANT-PI.pdf. Accessed 15 May 2014.
6. Edurant® (rilpivirine) tablets, EU summary of product characteristics. Janssen-Cilag, February 2013. Available at: http://www.medicines.org.uk/EMC/medicine/25490/SPC/Edurant+25+mg+tablets/ #DOCREVISION. Accessed 15 May 2014.
7. COMPLERA™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets. Full prescribing information. Gilead Sciences, January 2013. Available at: http://www.gilead.com/~/media/Files/pdfs/medicines/hiv/complera/complera- pi.PDF. Accessed 15 May 2014.
8. EVIPLERA 200 mg/25 mg/245 mg film-coated tablets. Summary of Product Characteristics. Gilead Sciences, February 2013. Available at: http://www.medicines.org.uk/emc/medicine/25518/SPC/. Accessed 15 May 2014.
9. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Department of Health and Human Services. 1-239 (updated February 2013). Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/ adultandadolescentgl.pdf. Accessed 15 May 2014.
10. EACS guidelines: EACS European Guidelines for treatment of HIV infected adults in Europe. Version 6.1 (Updated November 2012). Available at: http://www.eacsociety.org/Portals/0/Guidelines-Online-131014.pdf. Accessed 15 May 2014.
11. Lichtenstein KA, Ward DJ, Moorman AC, et al. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS 2001; 15: 1389-98.
12. Estrada V, Portilla J. Dyslipidemia related to antiretroviral therapy. AIDS Rev 2011; 13: 49-56.
13. Domingo P, López-Aldeguer J, Villaroya F, et al. Fat redistribution syndromes associated with HIV-1 infection and combination antiretroviral therapy. AIDS Rev 2012; 14: 112-23.
14. Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med 2005; 352: 48-62.
15. Anuurad E, Semrad A, Berglund L. Human immunodeficiency virus and highly active antiretroviral therapy-associated metabolic disorders and risk factors for cardiovascular disease. Metab Syndr Relat Disord 2009; 7: 401-10.
16. Friis-Møller N, Weber R, Reiss R, et al. Cardiovascular disease risk factors in HIV patients - association with antiretroviral therapy: results from the DAD study. AIDS 2003; 17: 1179-93.
17. Worm SW, Kamara DA, Reiss P, et al. Elevated triglycerides and risk of myocardial infarction in HIV-positive persons. AIDS 2011; 25: 1497-504.
18. Flint OP, Noor MA, Hruz PW, et al. The role of protease inhibitors in the pathogenesis of HIV-associated lipodystrophy: cellular mechanisms and clinical implications. Toxicol Pathol 2009; 37: 65-77.
19. Crane HM, Grunefeld C, Willig JH, et al. Impact of NRTIs on lipid levels among a large HIV-infected cohort initiating antiretroviral therapy in clinical care. AIDS 2011; 24: 185-95.
20. 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: 318-30.
21. Maggi P, Bellacosa C, Carito V, et al. Cardiovascular risk factors in patients on long-term treatment with nevirapine-or efavirenz-based regimens. J Antimicrob Chemother 2011; 66: 896-900.
22. DAD Study Group Friis-Møller N, Reiss P, et al. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med 2007; 356: 1723-35.
23. Monforte AD, Reiss P, Ryom L, et al. Atazanavir is not associated with an increased risk of cardio or cerebrovascular disease events. AIDS 2013; 27: 407-15.
24. Mallal SA, John M, Moore CB, et al. Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection. AIDS 2000; 14: 1309-16.
25. Tsiodras S, Mantzoros C, Hammer S, et al. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med 2000; 160: 2050-6.
26. Pérez-Molina JA, Domingo P, Martínez E, et al. The role of efavirenz compared with protease inhibitors in the body fat changes associated with highly active antiretroviral therapy. J Antimicrob Chemother 2008; 62: 234-45.
27. Haubrich RH, DiRienzo AG, Komarow L, et al. Metabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatment. AIDS 2009; 23: 1109-18.
28. 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.
29. Division of AIDS table for grading the severity of adult and pediatric adverse events. Version 1.0. December 2004 (clarification August 2009). Available at: http://rsc.tech-res.com/Document/safetyandpharmacovigilance/Table- for-Grading-Severity-of-Adult-Pediatric-Adverse-Events.pdf. Accessed 22 August 2013.
30. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002; 106: 3143-421.
31. D'Agostino RB Sr, Vasan RS, Pencina MJ, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation 2008; 117: 743-53.
32. Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med 2006; 354: 251-60.
33. Lennox JL, DeJesus E, Lazzarin A, et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatmentnaïve patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet 2009; 374: 796-806.
34. Sax PE, Tierney C, Collier AC, et al. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med 2009; 361: 2230-40.
35. van Leth F, Phanuphak P, Stroes E, et al. Nevirapine and efavirenz elicit different changes in lipid profiles in antiretroviral-therapy-naïve patients infected with HIV-1. PLoS Med 2004; 1:e19.
36. Young J, Weber R, Rickenbach M, et al. Lipid profiles for antiretroviralnaïve patients starting PI- and NNRTI-based therapy in the Swiss HIV cohort study. Antivir Ther 2005; 10: 585-91.
37. Fätkenheuer G, Duvivier C, Rieger A, et al. Lipid profiles for etravirine versus efavirenz in treatment-naïve patients in the randomized, double-blind SENSE trial. J Antimicrob Chemother 2012; 67: 685-90.
38. Feeney ER, Mallon PW. HIV and HAART-associated dyslipidemia. Open Cardiovasc Med J 2011; 5: 49-63.
39. Cameron DW, da Silva BA, Arribas JR, et al. A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis 2008; 198: 234-40.
40. Dubé MP, Komarow L, Mulligan K, et al. Long-term body fat outcomes in antiretroviral-naive participants randomized to nelfinavir or efavirenz or both plus dual nucleosides. dual x-ray absorptiometry results from A5005s, a substudy of Adult Clinical Trials Group 384. J Acquir Immune Defic Syndr 2007; 45: 508-14.