Profile of bictegravir/emtricitabine/tenofovir alafenamide fixed dose combination and its potential in the treatment of HIV-1 infection: evidence to date

References

• ZhangHCustodioJMWeiXClinical pharmacology of the HIV integrase strand transfer inhibitor bictegravirPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2017Seattle, WA Available from: http://www.croiconference.org/sessions/clinical-pharmacology-hiv-integrase-strand-transfer-inhibitor-bictegravirAccessed May 29, 2018
   Google Scholar
• LazerwithSECaiRChenXDiscovery of GS-9883, an HIV-1 integrase strand transfer inhibitor (INSTI) with improved pharmacokinetics and in vitro resistance profilePaper presented at: ASM Microbe2016Boston, MA Available from: http://www.natap.org/2016/HIV/062016_05.htmAccessed May 29, 2018
   Google Scholar
• TsiangMJonesGSGoldsmithJAntiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profileAntimicrob Agents Chemother201660127086709727645238
   PubMed Web of Science ®Google Scholar
• Biktarvy [package insert]Foster City, CAGilead Sciences Inc.2018
   Google Scholar
• US Department of Health and Human ServicesDepartment of Health and Human Services Adults and Adolescents Antiretroviral Guidelines Panel classifies a fixed-dose combination product of bictegravir/tenofovir alafenamide/emtricitabine as one of the recommended initial regimens for most people with HIVAIDSinfo2018 Available from: https://aidsinfo.nih.gov/news/2044/department-of-health-and-human-services-adults-and-adolescents-antiretroviral-guidelines-panel-classifies-a-fixed-dose-combination-product-of-bictegravir-tenofovir-alafen-amide-emtricitabine-as-one-of-the-recommended-initial-regimens-forAccessed May 29, 2018
   Google Scholar
• GallantJEThompsonMDejesusEAntiviral activity, safety, and pharmacokinetics of bictegravir as 10-Day monotherapy in HIV-1-infected adultsJ Acquir Immune Defic Syndr2017751616628196003
   PubMed Web of Science ®Google Scholar
• SaxPEDejesusECrofootGBictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trialLancet HIV201744e154e16028219610
   PubMed Web of Science ®Google Scholar
• GallantJLazzarinAMillsABictegravir, 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 trialLancet2017390101072063207228867497
   PubMed Web of Science ®Google Scholar
• SaxPEPozniakAMontesMLCoformulated 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 trialLancet2017390101072073208228867499
   PubMed Web of Science ®Google Scholar
• WhiteKKulkarniRWillkimMPooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patientsPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/pooled-week-48-efficacy-and-baseline-resistance-bftaf-treatment-naive-patientsAccessed May 29, 2018
   Google Scholar
• MolinaJMWardDBrarISwitch to bictegravir/F/TAF from DTG and ABC/3TCPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.natap.org/2018/CROI/croi_09.htmAccessed May 29, 2018
   Google Scholar
• DaarEDejesusERuanePPhase 3 randomized, controlled trial of switching to fixed-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from boosted protease inhibitor-regimes in virologically suppressed Adults: Week 48 resultsPaper presented at: ID Week2017San Diego, CA Available from: https://idsa.confex.com/idsa/2017/webprogram/Paper67504.htmlAccessed May 29, 2018
   Google Scholar
• AndreattaKWillkomMMartinRResistance analysis of bicte-gravir/emtricitabine/tenofovir alafenamide switch studiesPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/resistance-analyses-bictegraviremtricitabinetenofovir-alafenamide-switch-studiesAccessed May 29, 2018
   Google Scholar
• KityoCHaginsDKoenigESwitching to bictegravir/emtricitabine/tenofovir alafenamide in womenPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/switching-bictegraviremtracitabinetenofovir-alafenimide-bftaf-womenAccessed May 29, 2018
   Google Scholar
• GaurARodriguezCMcgrathEBictegravir/FTC/TAF single-tablet regimen in adolescents: Week-24 resultsPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/bictegravirftctaf-single-tablet-regimen-adolescents-week-24-resultsAccessed May 29, 2018
   Google Scholar
• ZhangHShaoYGarnerWThe effect of hepatic or renal impairment on bictegravir pharmacokineticsPaper presented at: The 18th International Workshop on Clinical Pharmacology of Antiviral Therapy2017Chicago, IL Available from: http://www.natap.org/2017/Pharm/Pharm_31.htmAccessed May 29, 2018
   Google Scholar
• CustodioJWestSVuAPharmacokinetics of bictegravir administered twice daily with rifampinPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/pharmacokinetics-bictegravir-administered-twice-daily-combination-rifampinAccessed May 29, 2018
   Google Scholar
• CerroneMAlfarisiONearyMRifampin effect on tenofovir alafenamide (TAF) plasma/intracellular pharmacokineticsPaper presented at: The Conference on Retroviruses and Opportunistic Infections (CROI)2018Boston, MA Available from: http://www.croiconference.org/sessions/rifampin-effect-tenofovir-alafenamide-taf-plasmaintracellular-pharmacokineticsAccessed May 29, 2018
   Google Scholar
• ZongJBorlandJJervaFWynneBChoukourMSongIThe effect of dolutegravir on the pharmacokinetics of metformin in healthy subjectsJ Int AIDS Soc2014174 Suppl 31958425394090
   PubMed Web of Science ®Google Scholar
• CustodioJWestSVuALack of clinically relevant effect of bictegravir on metformin pharmacokinetics and pharmacodynamicsPaper presented at: 18th International Workshop on Clinical Pharmacology of Antiviral Therapy2017Chicago, IL Available from: http://www.natap.org/2017/Pharm/Pharm_32.htmAccessed May 29, 2018
   Google Scholar
• EronJJCooperDASteigbigelRTEfficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trialsLancet Infect Dis201313758759623664333
   PubMed Web of Science ®Google Scholar
• RockstrohJKDejesusELennoxJLDurable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRKJ Acquir Immune Defic Syndr2013631778523412015
   PubMed Web of Science ®Google Scholar
• LennoxJLLandovitzRJRibaudoHJEfficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trialAnn Intern Med2014161746147125285539
   PubMed Web of Science ®Google Scholar
• SaxPEDejesusEMillsACo-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeksLancet201237998352439244822748591
   PubMed Web of Science ®Google Scholar
• DejesusERockstrohJKHenryKCo-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trialLancet201237998352429243822748590
   PubMed Web of Science ®Google Scholar
• WalmsleySLAntelaAClumeckNDolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infectionN Engl J Med2013369191807181824195548
   PubMed Web of Science ®Google Scholar
• MolinaJ-MClotetBvan LunzenJOnce-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b studyLancet HIV201524e127e13626424673
   PubMed Web of Science ®Google Scholar
• QuashiePKMesplèdeTWainbergMAEvolution of HIV integrase resistance mutationsCurr Opin Infect Dis2013261434923242340
   PubMed Web of Science ®Google Scholar
• CastagnaAMaggioloFPencoGDolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 studyJ Infect Dis2014210335436224446523
   PubMed Web of Science ®Google Scholar
• JonesGGoldsmithJMulatoABictegravir (GS-9883), a novel HIV-1 integrase strand transfer inhibitor (INSTI) with optimized in vitro resistance profilePaper presented at: ASM Microbe2016Boston, MA Available from: http://www.natap.org/2016/HIV/062016_03.htmAccessed May 29, 2018
   Google Scholar
• Dolutegravir [package insert]Research Triangle Park NCGlaxoS-mithKline2013
   Google Scholar
• FDAFDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)92018 Available from: https://www.fda.gov/Drugs/DrugSafety/ucm608112.htmAccessed May 29, 2018
   Google Scholar