Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK study

AIDS Research and Human Retroviruses

Volumn 29, Issue 6, 2013, Pages 859-870

  Squires, Kathleen E ^a   Bekker, Linda Gail ^b   Eron, Joseph J ^c   Cheng, Benjamin ^d   Rockstroh, Juergen K ^e   Marquez, Farid ^f   Kumar, Princy ^g   Thompson, Melanie ^h   Campo, Rafael E ⁱ   Mounzer, Karam ^j   Strohmaier, Kim M ^k   Lu, Chengxing ^k   Rodgers, Anthony ^k   Jackson, Beth E ^k   Wenning, Larissa A ^k   Robertson, Michael ^k   Nguyen, Bach Yen T ^k   Sklar, Peter ^k  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d International HIV Partners   (United States)

^e UNIVERSITY OF BONN   (Germany)

^f Palm Springs Research Institute   (United States)

^g GEORGETOWN UNIVERSITY   (United States)

^h AIDS Research Consortium   (United States)

ⁱ UNIVERSITY OF MIAMI   (United States)

^j Philadelphia Fight   (United States)

^k MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DARUNAVIR; EMTRICITABINE; LOPINAVIR PLUS RITONAVIR; RALTEGRAVIR; RITONAVIR; TENOFOVIR;

ADULT; AGED; ARTICLE; BRAZIL; CHOLESTEROL BLOOD LEVEL; CLINICAL EVALUATION; CONTROLLED STUDY; DIARRHEA; DOMINICAN REPUBLIC; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; JAMAICA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OBSERVATIONAL STUDY; OPEN STUDY; PAIN; PRIORITY JOURNAL; RHABDOMYOLYSIS; SIDE EFFECT; SOUTH AFRICA; TREATMENT DURATION; UNITED STATES; VOMITING;

ADULT; AGED; ANTI-HIV AGENTS; CONTINENTAL POPULATION GROUPS; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HUMANS; MALE; MIDDLE AGED; PYRROLIDINONES; SEX FACTORS; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84877862377     PISSN: 08892229     EISSN: 19318405     Source Type: Journal    
DOI: 10.1089/aid.2012.0292     Document Type: Article

References (39)

1. UNAIDS Report on the Global AIDS Epidemic 2010. Accessed on March 1, 2012 at www.unaids.org/globalreport/ Global-report.htm
2. Centers for Disease Control and Prevention: HIV Surveillance Report, 2010, vol. 22. www.cdc.gov/hiv/topics/ surveillance/resources/reports/. Published March 2012
3. Centers for Disease Control and Prevention: Fact sheet: HIV among African Americans, November 2011
4. Anastos K, Gange SJ, Lau B, et al.: Association of race and gender with HIV-1 RNA levels and immunologic progression. J Acquir Immune Defic Syndr 2000;24:218-226
5. 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, October 14, 2011; 1-167. Accessed on March 1, 2012 at www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf
6. Zorrilla CD and Tamayo Agrait VM: Why do we need the GRACE (Gender, Race & Clinical Experience) study? Future HIV Ther 2007;1:357-363
7. Sullivan PS, McNaghten AD, Begley E, Hutchinson A, and Cargill VA: Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. J Natl Med Assoc 2007;99:242-250
8. Gifford AL, Cunningham WE, Heslin KC, et al.: Participation in research and access to experimental treatments by HIVinfected patients. N Engl J Med 2002;346:1373-1382
9. Vidaver RM, Lafleur B, Tong C, et al.: Women subjects in HNIH-funded clinical research literature: Lack of progress in both representation and analysis by sex. J Womens Health Gend Based Med 2000;9:495-504
10. Grinsztejn B, Nguyen B-Y, Katlama C, et al.: Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: A Phase II randomized controlled trial. Lancet 2007;369:1261-1269
11. Gatell JM, Katlama C, Grinsztejn B, et al.: Long-Term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a Phase II study. J Acquir Immune Defic Syndr 2010;53:456-463
12. Steigbigel RT, Cooper, DA, Kumar PN, et al.: Raltegravir with optimized background therapy for resistant HIV-1 infection. N Eng J Med 2008;359:339-354
13. Cooper D, Steigbigel RT, Gatell JM, et al.: Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Eng J Med 2008;359:355-365
14. Steigbigel RT, Cooper DA, Teppler H, et al.: Long-Term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced patients with resistant HIV infection: Week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis 2010;50:605-612
15. Markowitz M, Morales-Ramirez JO, Nguyen BY, et al.: Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr 2006;43:509-515
16. Markowitz M, Nguyen B-Y, Gotuzzo E, et al.: Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-nai?ve patients with HIV-1 infection: Results of a 48-week controlled study. J Acquir Immune Defic Syndr 2007;46:125-133
17. Markowitz M, Nguyen BY, Gotuzzo E, et al.: Sustained antiretroviral efficacy of raltegravir as part of combination antiretroviral therapy in treatment-naive HIV-1 infected patients: 96-week data. J Acquir Immune Defic Syndr 2009; 52:350-356
18. Lennox JL, DeJesus E, Lazzarin A, et al.: Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-nai?ve patients with HIV-1 infection: A multicentre, double-blind randomised controlled trial. Lancet 2009;374:796-806
19. Lennox JL, DeJesus E, Berger DS, et al.: Raltegravir-based compared to efavirenz-based regimens in treatmentnaive HIV-1 infected patients: Efficacy, durability, subgroup, safety, and metabolic analyses through 96 weeks of follow-up. J Acquir Immune Defic Syndr 2010;55: 39-48
20. Rockstroh JK, Lennox JL, DeJesus E, et al.: Long-Term treatment with raltegravir or efavirenz combined with tenofovir/ emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis 2011;53(8):807-816
21. Eron JJ, Cooper DA, Steigbigel RT, Clotet B, Wan H, Zhao J, et al.: Exploratory analysis in the BENCHMRK studies at week 192: Late outcomes based on early virologic response. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention [Abstract MOPE225], Rome, Italy, July 2011
22. DeJesus E, Rockstroh J, Lennox J, Saag M, Lazzarin A, Wan H, et al.: Raltegravir (RAL)-based therapy demonstrates superior virologic suppression and immunologic response compared with efavirenz (EFV)-based therapy, with a favorable metabolic profile through 4 years in treatment-nai?ve patients: 192 week (Wk) results from STARTMRK. Presented at the 49th Annual Meeting of the Infectious Disease Society of American [Abstract 30623], Boston, MA, October 2011
23. Currier J, Bridge DA, Hagins D, et al.: Sex-based outcomes of darunavir-ritonavir therapy: A single-group trial. Ann Intern Med 2010;153:349-357
24. Squires KE, Johnson M, Yang R, et al.: Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother 2011;66:363-370
25. Merschman SA, Vallano PT, Wenning LA, Matuszewski BK, and Woolf EJ: Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci 2007;857:15-24
26. Geretti AM, Fearnhill E, Ceccherini-Silberstein F, et al.: Prevalence and patterns of raltegravir resistance in treated patients in Europe [abstract]. Antivir Ther 2010;15(Suppl 2):A62
27. Eron JJ, Young B, Cooper DA, et al.: Switch to a raltegravirbased regimen versus continuation of a lopinavir-ritonavirbased 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
28. Walmsley SL, Squires K, Weiss L, et al.: Multidrug-experienced HIV-1 infected women demonstrated similar virological and immunological responses to tipranavir/ritonavir compared with men. AIDS 2009;23:429-431
29. Jensen-Fangel S, Pedersen L, Pedersen C, et al.: The effect of race/ethnicity on the outcome of highly-Active antiretroviral therapy for human immunodeficiency virus type 1-infected patients. Clin Infect Dis 2002;35:1541-1548
30. Giordano TP, Wright JA, Hasan MQ, et al.: Do sex and race/ ethnicity influence CD4 cell response in patients who achieve virologic suppression during antiretroviral therapy? Clin Infect Dis 2003;37:433-437
31. Anastos K, Schneider MF, Gange SJ, et al.: The association of race, sociodemographic, and behavioral characteristics with response to highly active antiretroviral therapy in women. J Acquir Immune Defic Syndr 2005;39:537-544
32. Gulick RM, Ribaudo HJ, Shikuma CM, et al.: Three-vs fourdrug antiretroviral regimens for the initial treatment of HIV-1 infection: A randomized controlled trial. JAMA 2006; 296:769-781
33. Riddler SA, Haubrick R, DiRienzo G, et al.: Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008;358:2095-2106
34. Hartzell JD, Spooner K, Howard R, et al.: Race and mental health diagnosis are risk factors for highly active antiretroviral therapy failure in a military cohort despite equal access to care. J Acquir Immune Defic Syndr 2007;44:411-416
35. Weintrob AC, Grandits GA, Agan BK, et al.: Virologic response differences between African Americans and European Americans initiating highly active antiretroviral therapy with equal access to care. J Acquir Immune Defic Syndr 2009;52:574-580
36. Pence BW, Ostermann J, Kumar V, et al.: The influence of psychosocial characteristics and race/ethnicity on the use, duration, and success of antiretroviral therapy. J Acquir Immune Defic Syndr 2008;47:194-201
37. Brainard DM, Wenning LA, Stone JA, Wagner JA, and Iwamoto M: Clinical pharmacology profile of raltegravir, an HIV-1 integrase strand transfer inhibitor. J Clin Pharmacol 2011;51:1376-1402
38. Nicastri E, Leone S, Angeletti C, et al.: Sex issues in HIV-1 infected persons during highly active antiretroviral therapy: A systematic review. J Antimicrob Chemother 2007;60: 724-732
39. Kempf MC, Pisu M, Dumcheva A, Westfall AO, Kilby JM, and Saag MS: Gender differences in discontinuation of antiretroviral treatment regimens. J Acquir Immune Defic Syndr 2009;52:336-341