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Drug Evaluation

Efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1

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Pages 929-934 | Received 20 Feb 2018, Accepted 01 May 2018, Published online: 16 May 2018

References

  • Murray C, Ortblad K, Guinovart C, et al. Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384:1005–1070.
  • GBD 2015 HIV Collaborators. Estimates of global, regional, and national incidence, prevalence, and mortality of HIV, 1980–2015: the Global Burden of Disease Study 2015. Lancet HIV. 2016;3:e361–87.
  • Llibre JM, Clotet B. Once-daily single-tablet regimens: a long and winding road to excellence in antiretroviral treatment. AIDS Rev. 2012;14:168–178.
  • Soriano V, Fernandez-Montero JV, Benitez-Gutierrez L, et al. Dual antiretroviral therapy for HIV infection. Expert Opin Drug Saf. 2017;16:923–932.
  • McCoy C, Badowski M, Sherman E, et al. Society of infectious diseases pharmacists. Pharmacotherapy. 2018;38:86–107.
  • DHHS. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. [cited 2018 Mar]. Available from: (https://aidsinfo.nih.gov)
  • European AIDS Clinical Society. EACS guidelines v9. 0, [cited 2017 Oct]. Available from: http://www.eacsociety.org
  • Capetti A, Cossu M, Rizzardini G. Darunavir/cobicistat for the treatment of HIV-1: a new era for compact drugs with high genetic barrier to resistance. Expert Opin Pharmacother. 2015;16:2689–2702.
  • Mallolas J. Darunavir stands up as preferred HIV protease inhibitor. AIDS Rev. 2017;19:105–112.
  • Curran A, Pérez-Valero I, Rezolsta® MJ. (Darunavir/cobicistat): first boosted protease inhibitor co-formulated with cobicistat. AIDS Rev. 2015;17:114–120.
  • Clutter D, Jordan M, Bertagnolio S, et al. HIV-1 drug resistance and resistance testing. Infect Genet Evol. 2016;46:292–307.
  • Renjifo B, van Wyk J, Salem A, et al. Pharmacokinetic enhancement in HIV antiretroviral therapy: a comparison of ritonavir and cobicistat. AIDS Rev. 2015;17:37–46.
  • Echeverría P, Bonjoch A, Puig J, et al. Significant improvement in triglyceride levels after switching from ritonavir to cobicistat in suppressed HIV-1-infected subjects with dyslipidaemia. HIV Med. 2017;18:782–786.
  • Tseng A, Hughes C, Wu J, et al. Cobicistat versus ritonavir: similar pharmacokinetic enhancers but some important differences. Ann Pharmacother. 2017;51:1008–1022.
  • Corado K, Daar E. Emtricitabine + tenofovir alafenamide for the treatment of HIV. Expert Opin Pharmacother. 2017;18:427–432.
  • Tashima K, Crofoot G, Tomaka F, et al. Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a phase IIIb, open label single arm trial. AIDS Res Ther. 2014;11:39.
  • Orkin C, De Jesus E, Khanlou H, et al. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naive patients in the ARTEMIS trial. HIV Med. 2013;14:49–59.
  • Cahn P, Fourie J, Grinsztejn B, et al. Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. Aids. 2011;25:929–939.
  • Marzolini C, Gibbons S, Khoo S, et al. J Antimicrob Chemother. 2016;71:1755–1758.
  • Moltó J, Curran A, Miranda C, et al. Pharmacokinetics of darunavir/cobicistat and etravirine alone and co-administered in HIV-infected patients. J Antimicrob Chemother. 2017 Dec 11. doi: 10.1093/jac/dkx459. [Epub ahead of print].
  • Kumar P, Gordon L, Brooks K, et al. Differential influence of the antiretroviral pharmacokinetic enhancers ritonavir and cobicistat on intestinal P-glycoprotein transport and the pharmacokinetic/pharmacodynamic disposition of dabigatran. Antimicrob Agents Chemother. 2017;61:e01201–17.
  • Gervasoni C, Riva A, Cozzi V, et al. Effects of ritonavir and cobicistat on dolutegravir exposure: when the booster can make the difference. J Antimicrob Chemother. 2017;72:1842–1844.
  • Bartels H, Decosterd L, Battegay M, et al. Darunavir concentrations in CSF of HIV-infected individuals when boosted with cobicistat versus ritonavir. J Antimicrob Chemother. 2017;72:2574–2577.
  • Sax P, Wohl D, Yin M, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385:2606–2615.
  • Mills A, Arribas J, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Inf Dis. 2016;16:43–52.
  • Gallant J, Daar E, Raffi F, et al. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016;3:e158–65.
  • WHO. Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. World Health Organization; Geneva, [cited 2017 July]. Available from: http://www.who.int/guidelines
  • Daar E. Novel approaches to HIV therapy. F1000 Res. 2017;6:759.
  • De Clercq E. Role of tenofovir alafenamide (TAF) in the treatment and prophylaxis of HIV and HBV infections. Biochem Pharmacol. 2017;17:30709–30718.
  • Cattaneo D, Minisci D, Baldelli S, et al. Effect of cobicistat on tenofovir disoproxil fumarate (TDF): what is true for TAF may also be true for TDF. J Acquir Immune Defic Syndr. 2018;77:86–92.
  • Gallant J, Orkin C, Molina JM, et al. Week 48 results of AMBER: a phase 3, randomised, double-blind trial in antiretroviral treatment (ART)-naive HIV-1-infected adults to evaluate the efficacy and safety of the once-daily, single-tablet regimen (STR) of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) versus darunavir/cobicistat (DRV/c) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). 17th EACS; 2017 October 13–15; Milano, Italy [abstract PS8/2].
  • Orkin C, Molina JM, Negredo E, et al. EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5:e23–e34.
  • Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390:2063–2072.
  • Sax P, Pozniak A, Montes M, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390:2073–2082.
  • Walmsley S, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369:1807–1818.
  • Llibre JM, Hung C, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018;391:839–849.
  • Trottier B, Lake J, Logue K, et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, phase IIIb study. Antivir Ther. 2017;22:295–305.
  • Lathouwers E, Wong E, Luo D, et al. HIV-1 resistance rarely observed in patients using darunavir once-daily regimens across clinical studies. HIV Clin Trials. 2017;18:196–204.
  • Moltó J, Valle M, Ferrer E, et al. Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: a randomized clinical trial. J Antimicrob Chemother. 2015;70:1139–1145.
  • Molina J-M, El Abassi E, Gallien S, et al. Efficacy and safety of darunavir dose reduction from 800 to 400 mg daily with ritonavir and TDF/FTC or ABC/3TC in virologically suppressed HIV-1-infected adults: an open-label study (ANRS-165 DARULIGHT substudy). 9th IAS Conference; 2017 July 23–26; Paris, France [abstract MOPEB0313].
  • Boyd M, Cooper D, Gilks C. Towards a universal second-line fixed-dose combination ART. Lancet HIV. 2018;5:e3–e5.
  • Gueler A, Moser A, Calmy A, et al.; Swiss HIV Cohort Study. Life expectancy in HIV-positive persons in Switzerland: matched comparison with general population. Aids. 2017;31:427–436.
  • Clay P, Nag S, Graham C, et al. Meta-analysis of studies comparing single and multi-tablet fixed dose combination HIV treatment regimens. Medicine (Baltimore). 2015;94:e1677.

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