{"id":1093,"date":"2018-04-02T08:00:43","date_gmt":"2018-04-02T13:00:43","guid":{"rendered":"https:\/\/blog.unmc.edu\/infectious-disease\/?p=1093"},"modified":"2018-03-27T11:44:21","modified_gmt":"2018-03-27T16:44:21","slug":"pharm-to-exam-table-meet-biktarvy-the-newest-of-the-antiretroviral-family","status":"publish","type":"post","link":"https:\/\/blog.unmc.edu\/infectious-disease\/2018\/04\/02\/pharm-to-exam-table-meet-biktarvy-the-newest-of-the-antiretroviral-family\/","title":{"rendered":"Pharm to Exam Table: Meet Biktarvy, the Newest of the Antiretroviral Family!"},"content":{"rendered":"

Pharm to Exam Table: Clinical Pharmacology\/Antimicrobial Updates –\u00a0Biktarvy, a new co-formulated integrase inhibitor-based treatment approved for HIV<\/strong><\/p>\n

On February 7th 2018, the Food and Drug Administration approved a new combination antiretroviral drug called Biktarvy\u00ae(1). Biktarvy\u00ae (B\/F\/TAF) is a single-tablet, once daily regimen containing the novel integrase strand transfer inhibitor bictegravir coformulated with emtricitabine and tenofovir alafenamide (1). Current HIV guidelines recommend integrase strand transfer inhibitor (INSTI)-based regimens as initial therapy for HIV patients due to their high potency and a favorable side effect profile. Consequently, the introduction of a new integrase inhibitor underscores the importance of integrase strand transfer inhibitors in treating HIV infections.<\/p>\n

B\/F\/TAF is a small, once-daily, single tablet regimen that offers several advantages over existing antiretroviral regimens. No HLA-B*5701 testing (abacavir hypersensitivity) is required prior to initiation, no food intake requirements, and it has a lower potential for drug-drug interactions with its lack of a pharmacokinetic booster within the formulation1. A number of randomized controlled phase III trials were instrumental in assessing the efficacy and safety of B\/F\/TAF. Study 1489 was a randomized, non-inferiority, trial comparing B\/F\/TAF to dolutegravir, abacavir, and lamivudine (3). 92\u00b74% of treatment naive subjects in the B\/F\/TAF arm achieved viral suppression at 48 weeks compared to 93% in the dolutegravir, abacavir, and lamivudine arm (3).<\/p>\n

Study 1490 was a randomized, non-inferiority, phase III trial comparing B\/F\/TAF to dolutegravir, emtricitabine and tenofovir alafenamide. 89.4% of treatment naive subjects in the B\/F\/TAF arm achieved viral suppression at 48 weeks compared to 92.9% in the dolutegravir, emtricitabine and tenofovir alafenamide arm (4). Study 1878 was an open label, randomized study comparing subjects who were virologically suppressed on a boosted protease inhibitor plus a dual nucleoside inhibitor containing regimen and then switched to B\/F\/TAF2. 92.1% of subjects who switched to B\/F\/TAF were virologically suppressed after 48 weeks compared to 88.9 % in the boosted protease inhibitor arm (2).<\/p>\n

Notably, no treatment-emergent resistance to bictegravir was identified in any of the aforementioned studies. B\/F\/TAF was well tolerated with nausea, vomiting and diarrhea as the most common side effects reported. Given its unique properties, potency, and tolerable safety profile, B\/F\/TAF provides offers another viable option as initial therapy or as an alternative antiretroviral therapy for the treatment of HIV infection.<\/p>\n

References<\/strong>
\n1 Biktarvy\u00ae [package insert].Foster City, Gilead Sciences Pharmaceuticals Incorporated; 2018 <\/em>
\n2 Gilead. Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine\/Tenofovir or Abacavir\/Lamivudine to Bictegravir\/Emtricitabine\/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02603107<\/em>
\n3 Gallant J et al.\u00a0 (2017). 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. 390(10107); 2063-2072<\/em>
\n4 Sax PE 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(10107):2073-2082.<\/em><\/p>\n

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Content provided courtesy Allan O. Osiemo, UNMC Pharm.D. Candidate 2018<\/em><\/p><\/div>\n