Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection

AIDS

Volumn 25, Issue 6, 2011, Pages

  Cohen, Calvin ^a   Elion, Richard ^a   Ruane, Peter ^a   Shamblaw, David ^a   Dejesus, Edwin ^a   Rashbaum, Bruce ^a   Chuck, Steven L ^a   Yale, Kitty ^a   Liu, Hui C ^a   Warren, David R ^a   Ramanathan, Srinivasan ^a   Kearney, Brian P ^a  

^a GILEAD SCIENCES   (United States)

Author keywords

booster; GS 9137; GS 9350; integrase inhibitor; JTK 303; quad; treatment naive

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; COBICISTAT; COBICISTAT PLUS ELVITEGRAVIR PLUS TENOFOVIR DISOPROXIL FUMARATE; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL; UNCLASSIFIED DRUG; VIRUS RNA;

ABNORMAL DREAMING; ANXIETY; ANXIETY DISORDER; ARTICLE; ATTENTION DISTURBANCE; B CELL LYMPHOMA; CD4+ T LYMPHOCYTE; CONTROLLED STUDY; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EUPHORIA; HALLUCINATION; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INJECTION SITE REACTION; INSOMNIA; LETHARGY; LEUKOPENIA; LYMPHADENOPATHY; MAJOR DEPRESSION; MALE GENITAL ORGAN CELLULITIS; MALE GENITAL SYSTEM DISEASE; MENTAL DISEASE; MOOD CHANGE; MULTICENTER STUDY; NEUROTOXICITY; NIGHTMARE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; SUICIDAL IDEATION; THROMBOCYTOPENIA; VIRUS LOAD;

ADENINE; ADULT; ANTI-HIV AGENTS; BENZOXAZINES; CARBAMATES; CD4 LYMPHOCYTE COUNT; DEOXYCYTIDINE; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; PATIENT COMPLIANCE; PATIENT SELECTION; PHOSPHONIC ACIDS; QUINOLONES; THIAZOLES; TREATMENT OUTCOME;

EID: 79953735724     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e328345766f     Document Type: Article

References (30)

1. Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents; 1 December 2009.
2. Thompson MA, Aberg JA, Cahn P, Montaner JS, Rizzardini G, Telenti A, et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 2010; 304:321-333.
3. Gazzard BG, Anderson J, Babiker A, Boffito M, Brook G, Brough G, et al. British HIV Association Guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med 2008; 9:563-608.
4. Stone VE, Jordan J, Tolson J, Pilon T. Potential impact of once daily regimens on adherence to HAART [abstract]. 40th Annual Meeting of the Infectious Disease Society of America. Chicago, Illinois, USA; 24-27 October 2002.
5. Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis 2000; 30:S171-S176. (Pubitemid 32268984)
6. Maggiolo F, Migliorino M, Maserati R, Rizzi L, Pan A, Rizzi A, et al. Once-a-day treatment for HIV infection: final 48-week results. 8th Conference on Retroviruses and Opportunistic Infections. Chicago, Illinois, USA; 4-8 February 2001.
7. Felizarta F, Becker S, Bellos N, Jayaweera D, Sands M, Slater L, et al. Adherence and efficacy with a once-daily efavirenz-based regimen: 48-week results from the Daily Antiretroviral Therapy II (DART II) Study [poster 5842]. XV International AIDS Conference. Bangkok, Thailand; 11-16 July 2004.
8. Arribas JR, Iribarren JA, Knobel H, Ribera E, Rubio R, Viciana P, et al. Adherence, treatment satisfaction and effectiveness of once-daily (QD) vs twice-daily (BID) antiretroviral therapy (AT), in a large prospective observational cohort (CUVA Study) [poster WePeB5780]. XV International AIDS Conference. Bangkok, Thailand; 11-16 July 2004.
9. Willig JH, Abroms S, Westfall AO, Routman J, Adusumilli S, Varshney M, et al. Increased regimen durability in the era of once-daily fixed-dose combination antiretroviral therapy. AIDS 2008; 22:1951-1960.
10. Matsuzaki Y, Watanabe W, Yamataka K, Sato M, Enya S, Kano M, et al. JTK-303/GS-9137, a novel small molecule inhibitor of HIV-1 integrase: Anti-HIV activity profile and pharmacokinetics in animals [poster number 508]. 13th Conference on Retroviruses and Opportunistic Infections. Denver, Colorado, USA; 5-9 February 2006.
11. DeJesus E, Berger D, Markowitz M, Cohen C, Hawkins T, Ruane P, et al. Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatment-experienced patients. J Acquir Immune Defic Syndr 2006; 43:1-5. (Pubitemid 44306480)
12. Gallant JE. Protease-inhibitor boosting in the treatment-experienced patient. AIDS Rev 2004; 6:226-233. (Pubitemid 40227884)
13. Mathias A, West S, Hui J, Kearney B. Dose-response of ritonavir on hepatic CYP3A activity and elvitegravir oral exposure. Clin Pharmacol Ther 2009; 85:64-70.
14. Mathias AA, German P, Murray BP, Wei L, Jain A, West S, et al. Pharmacokinetics and pharmacodynamics of GS-9350: a novel pharmacokinetic enhancer without anti-HIV activity. Clin Pharmacol Ther 2010; 87:322-329.
15. Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, et al. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis 2010; 201:814-822.
16. Shafran SD, Mashinter LD, Roberts SE. The effect of low-dose ritonavir monotherapy on fasting serum lipid concentrations. HIV Med 2005; 6:421-425. (Pubitemid 41723310)
17. Mathias AA, German P, Lee M, Callebaut C, Xu L, Tsai L, et al. GS-9350: a pharmacoenhancer without anti-HIV activity [oral presentation]. 16th Conference on Retroviruses and Opportunistic Infections. Montreal, Canada; 8-11 February 2009.
18. German P, Warren D, West S, Hui J, Kearney BP. Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dose combination regimen for the treatment of HIV. J Acquir Immune Defic Syndr 2010; 55:323-329.
19. Cohen C, Shamblaw D, Ruane P, Elion R, DeJesus E, Liu HC, et al. The single-tablet, fixed-dose regimen of elvitegravir/GS-9350/emtricitabine/ tenofovir DF (Quad) achieves a high rate of virologic suppression and GS-9350 is an effective booster [Oral Presentation]. 17th Conference on Retroviruses and Opportunistic Infections (CROI). San Francisco, California, USA; 16-19 February 2010.
20. Elion R, Gathe J, Rashbaum B, Shalit P, Hawkins T, Liu HC, et al. The single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; 'QUAD') maintains a high rate of virologic suppression, and cobicistat (COBI) is an effective pharmacoenhancer through 48 weeks [Poster H-938B]. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICACC). Boston, Massachusetts, USA; 12-15 September 2010.
21. Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, et al. Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr 2007; 46:125-133. (Pubitemid 47482607)
22. Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet 2009; 374:796-806.
23. Rihs TA, Begley K, Smith DE, Sarangapany J, Callaghan A, Kelly M, et al. Efavirenz and chronic neuropsychiatric symptoms: a cross-sectional case control study. HIV Med 2006; 7:544-548. (Pubitemid 44742355)
24. Cespedes MS, Aberg JA. Neuropsychiatric complications of antiretroviral therapy. Drug Saf 2006; 29:865-874. (Pubitemid 44511587)
25. Clifford DB, Evans S, Yang Y, Acosta EP, Goodkin K, Tashima K, et al. Impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals. Ann Intern Med 2005; 143:714-721.
26. Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, et al. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS 2010; 24:55-65.
27. Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, et al. Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection. J Acquir Immune Defic Syndr 2009; 52:350-356.
28. Fumaz CR, Munoz-Moreno JA, Molto J, Negredo E, Ferrer MJ, Sirera G, et al. Long-term neuropsychiatric disorders on efavirenz-based approaches: quality of life, psychologic issues, and adherence. J Acquir Immune Defic Syndr 2005; 38:560-565. (Pubitemid 40524478)
29. Maggiolo F. Efavirenz: a decade of clinical experience in the treatment of HIV. J Antimicrob Chemother 2009; 64:910-928.
30. Sierra-Madero J, Di Perri G, Wood R, Saag M, Frank I, Craig C, et al. Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study. HIV Clin Trials 2010; 11:125-132.