European Commission has granted Marketing Authorization for Biktarvy ( Bictegravir 50mg / Emtricitabine 200 mg / Tenofovir alafenamide 25 mg; BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) for the treatment of HIV-1 infection.
BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor ( INSTI ) Bictegravir, with the demonstrated safety and efficacy profile of Descovy ( Emtricitabine 200 mg / Tenofovir alafenamide 25 mg; FTC/TAF ), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor ( NRTI ) backbone.
In European Union, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, Emtricitabine or Tenofovir.
No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance ( CrCL ) greater than or equal to 30 mL per minute.
BIC/FTC/TAF has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.
The decision is supported by data from four ongoing phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults.
The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.
Through 48 weeks, no participants in any of the four studies failed BIC/FTC/TAF with treatment-emergent virologic resistance, no participants discontinued BIC/FTC/TAF due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhea, nausea and headache. ( Xagena )
Source: Gilead, 2018