Newly Approved HIV Medications

Ian Villaluz, PharmD Candidate 2021; Glenn R. Grantner, PharmD, BCPS

Disclosures

US Pharmacist. 2020;45(10):17-25. 

In This Article

Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a fixed-dose, once-daily combination tablet containing a novel integrase inhibitor and two nucleoside/nucleotide reverse transcriptase inhibitors. The individual components in Biktarvy are bictegravir 50 mg (an integrase strand transfer inhibitor [INSTI]), emtricitabine 200 mg (an NRTI) and tenofovir alafenamide 25 mg (an NRTI). BIC/FTC/TAF is indicated as a complete regimen in HIV-1–infected adults with no history of ART or to replace the current ART regimen of patients who are virologically suppressed (viral load ≤50 copies per mL) on a stable ARV regimen for at least 3 months and no history of treatment failure or resistance to its individual components. Most significantly, it is a one-pill, complete regimen requiring no other ARVs.[20]

BIC/FTC/TAF was approved in 2018 after four clinical trials. Two of the clinical trials tested the efficacy and safety of BIC/FTC/TAF in patients with no history of ART: Trial 1489 (randomized, BIC/FTC/TAF vs. abacavir/dolutegravir/lamivudine, [ABC/DTG/3TC] and Trial 1490 (randomized, BIC/FTC/TAF vs. dolutegravir + emtricitabine/tenofovir alafenamide [DTG + FTC/TAF]).[21,22] In Trial 1489, the primary endpoint of viral load <50 copies/mL was achieved in 92% of the BIC/FTC/TAF group and 93% of the ABC/DTG/3TC group (treatment difference of -0.6%; 95% confidence interval [CI], -4.8% to 3.6%). In Trial 1490, the primary endpoint of viral load <50 copies/mL was achieved in 89% of the BIC/FTC/TAF group and 93% of the DTG + FTC/TAF group (treatment difference of -3.5%; 95% CI, -7.9% to 1.0%).[21,22]

The other two trials tested efficacy and safety of BIC/FTC/TAF in virologically suppressed patients who would be switched from their current ART regimens to BIC/FTC/TAF: Trial 1844 (randomized, switching from dolutegravir plus abacavir/lamivudine [DTG + ABC/3TC] or ABC/DTG/3TC to BIC/FTC/TAF) and Trial 1878 (open-label, switching from atazanavir [ATV] or boosted darunavir plus abacavir/emtricitabine [DRV + ABC/3TC] or emtricitabine/tenofovir disoproxil fumarate [FTC/TDF] to BIC/FTC/TAF).[23,24] In Trial 1844, the primary endpoint of patients who lost their virologic suppression status (viral load ≥50 copies per mL) was seen in 1% of the BIC/FTC/TAF group and <1% of the original regimen group (treatment difference of 0.7%, 95% CI, -1.0% to 2.8%). In Trial 1878, the primary endpoint of patients who lost their virologic suppression status was seen in 2% of the BIC/FTC/TAF group and 2% of the original regimen group (treatment difference of 0.0%; 95% CI, -2.5% to 2.5%).[23,24]

BIC/FTC/TAF is dosed once daily by mouth with or without food. The most commonly reported adverse reactions seen in patients were diarrhea, nausea, and headache.[20–24]

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