Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257

Clinical Infectious Diseases

Volumn 60, Issue 12, 2015, Pages 1842-1851

  Ofotokun, Ighovwerha ^a   Na, Lumine H ^b   Landovitz, Raphael J ^c   Ribaudo, Heather J ^b   Mccomsey, Grace A ^d   Godfrey, Catherine ^e   Aweeka, Francesca ^f   Cohn, Susan E ^g   Sagar, Manish ^h   Kuritzkes, Daniel R ⁱ   Brown, Todd T ^j   Patterson, Kristine B ^k   Para, Michael F ^l   Leavitt, Randi Y ^m   Villasis Keever, Angelina ⁿ   Baugh, Bryan P ^o   Lennox, Jeffrey L ^a   Currier, Judith S ^c  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d CASE WESTERN RESERVE UNIVERSITY   (United States)

^e NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g NORTHWESTERN UNIVERSITY   (United States)

^h BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ BRIGHAM AND WOMEN S HOSPITAL   (United States)

^j JOHNS HOPKINS UNIVERSITY   (United States)

^k UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^l THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^m MERCK RESEARCH LABORATORIES   (United States)

ⁿ BRISTOL MYERS SQUIBB   (United States)

^o JANSSEN RESEARCH AND DEVELOPMENT   (United States)

more..

Author keywords

CART; HIV AIDS; Lipids; Metabolic syndrome

Indexed keywords

ATAZANAVIR; DARUNAVIR; EMTRICITABINE; GLUCOSE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; RALTEGRAVIR; RITONAVIR; TENOFOVIR DISOPROXIL; TRIACYLGLYCEROL; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; GLUCOSE BLOOD LEVEL; LIPID;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ANTIVIRAL THERAPY; ARTICLE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DIET RESTRICTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; METABOLIC SYNDROME X; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRIACYLGLYCEROL BLOOD LEVEL; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG EFFECTS; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; METABOLISM;

ADULT; ANTI-HIV AGENTS; ATAZANAVIR SULFATE; BLOOD GLUCOSE; DARUNAVIR; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LIPIDS; MALE; RALTEGRAVIR POTASSIUM; RITONAVIR;

EID: 84983246866     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ193     Document Type: Article

References (31)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, 2014:521-7. Available at: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 2 May 2014.
2. World Health Organization. WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Geneva, Switzerland: WHO, 2013:1-272. Available at: http://www.who.int/hiv/pub/guidelines/arv2013/en/. Accessed 2 May 2014.
3. Periard D, Telenti A, Sudre P, et al. Atherogenic dyslipidemia in HIVinfected individuals treated with protease inhibitors. The Swiss HIV Cohort Study. Circulation 1999; 100:700-5.
4. Lennox JL, Dejesus E, Berger DS, et al. Raltegravir versus efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr 2010; 55:39-48.
5. Eron JJ, Young B, Cooper DA, et al. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet 2010; 375:396-407.
6. Martinez E, Larrousse M, Llibre JM, et al. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS 2010; 24:1697-707.
7. Boffito M. Differences between PI effects on plasma RTV levels: Analysis of cross-over pK trials and clinical trials. In: 8th International Workshop on Clinical Pharmacology of HIV Therapy, Budapest, Hungary, 16-18 April 2007.
8. Kumar GN, Rodrigues AD, Buko AM, Denissen JF. Cytochrome P450- mediated metabolism of the HIV-1 protease inhibitor ritonavir (ABT- 538) in human liver microsomes. J Pharmacol Exp Ther 1996; 277:423-31.
9. Lillibridge JH, Liang BH, Kerr BM, et al. Characterization of the selectivity and mechanism of human cytochrome P450 inhibition by the human immunodeficiency virus-protease inhibitor nelfinavir mesylate. Drug Metab Dispos 1998; 26:609-16.
10. de Gonzalez RD, Blanco F, Garcia-Benayas T, Jimenez-Nacher I, Gonzalez- Lahoz J, Soriano V. Correlation between lopinavir plasma levels and lipid abnormalities in patients taking lopinavir/ritonavir. AIDS Patient Care STDS 2003; 17:443-5.
11. Gatti G, Di Biagio A, Casazza R, et al. The relationship between ritonavir plasma levels and side-effects: implications for therapeutic drug monitoring. AIDS 1999; 13:2083-9.
12. Lennox JL, Landovitz RJ, Ribaudo HJ, et al. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: A randomized, controlled equivalence trial. Ann Intern Med 2014; 161:461-71.
13. Chi J, Jayewardene AL, Stone JA, Motoya T, Aweeka FT. Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir and amprenavir in human plasma by LC/MS/MS. J Pharm Biomed Anal 2002; 30:675-84.
14. Executive summary of the 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). JAMA 2001; 285:2486-97.
15. Alberti KG, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: A joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 2009; 120:1640-5.
16. Aberg JA, Tebas P, Overton ET, et al. Metabolic effects of darunavir/ritonavir versus atazanavir/ritonavir in treatment-naive, HIV type 1-infected subjects over 48 weeks. AIDS Res Hum Retroviruses 2012; 28:1184-95.
17. Riddler SA, Smit E, Cole SR, et al. Impact of HIV infection and HAART on serum lipids in men. JAMA 2003; 289:2978-82.
18. Kassi E, Pervanidou P, Kaltsas G, Chrousos G. Metabolic syndrome: definitions and controversies. BMC Med 2011; 9:48.
19. Volberding PA, Deeks SG. Antiretroviral therapy and management of HIV infection. Lancet 2010; 376:49-62.
20. Grunfeld C, Pang M, Doerrler W, Shigenaga JK, Jensen P, Feingold KR. Lipids, lipoproteins, triglyceride clearance, and cytokines in human immunodeficiency virus infection and the acquired immunodeficiency syndrome. J Clin Endocrinol Metab 1992; 74:1045-52.
21. Wohl DA, Brown TT. Management of morphologic changes associated with antiretroviral use in HIV-infected patients. J Acquir Immune Defic Syndr 2008; 49(suppl 2):S93-S100.
22. Krishnan S, Schouten JT, Atkinson B, et al. Metabolic syndrome before and after initiation of antiretroviral therapy in treatment-naive HIV- 1infected individuals. J Acquir Immune Defic Syndr 2012; 61:381-9.
23. Worm SW, Lundgren JD. The metabolic syndrome in HIV. Best Pract Res Clin Endocrinol Metab 2011; 25:479-86.
24. Worm SW, Friis-Moller N, Bruyand M, et al. High prevalence of the metabolic syndrome in HIV-infected patients: impact of different definitions of the metabolic syndrome. AIDS 2010; 24:427-35.
25. Ervin RB. Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003-2006. Natl Health Stat Report 2009:1-7.
26. Westley RL, May FE. A twenty-first century cancer epidemic caused by obesity: the involvement of insulin, diabetes, and insulin-like growth factors. Int J Endocrinol 2013; doi:10.1155/2013/632461.
27. Teede H, Deeks A, Moran L. Polycystic ovary syndrome: A complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med 2010; 8:41.
28. Brumpton BM, Camargo CA Jr, Romundstad PR, Langhammer A, Chen Y, Mai XM. Metabolic syndrome and incidence of asthma in adults: the HUNT study. Eur Respir J 2013; 42:1495-502.
29. Tomaka F, Lefebvre E, Sekar V. Similar changes in metabolic parameters of darunavir (TMC114) and atazanavir, each coadministered with lowdose ritonavir in healthy volunteers (TMC114-C159). In: American Conference for the Treatment of HIV (ACTHIV), Dallas, TX, 31 May-3 June 2007.
30. Heat-stable Norvir tablet provides similar drug levels to capsule. AIDS Patient Care STDS. 2008; 22:761-2.
31. Autar RS, Boyd MA, Wit FW, et al. Relationships between drug exposure, changes in metabolic parameters and body fat in HIV-infected patients switched to a nucleoside sparing regimen. Antivir Ther 2007; 12:1265-71.