Health Canada has approved Gilead Sciences’ new integrase-inhibitor-based single-tablet antiretroviral regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for the treatment of HIV among those who lack viral mutations associated with resistance to any of the three medications included in the tablet.
The bictegravir component of the tablet is an integrase inhibitor while the components of Descovy (emtricitabine/tenofovir alafenamide) serve as a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone in Biktarvy.
Biktarvy is the smallest integrase-inhibitor-based single-tablet regimen on the market.
The approval, which was preceded by a nod from the Food and Drug Administration in the United States, is based on four ongoing Phase III studies that included a cumulative 2,414 participants. The study population included a diverse range of adult age groups and ethnicities.
Studies 1489 and 1490 were conducted among those who were new to HIV treatment and who were randomized to receive Biktarvy or Triumeq (dolutegravir/abacavir/lamivudine) plus Descovy. Studies 1844 and 1878 included those taking fully suppressive antiretroviral regimens who were randomized to stay on their initial regimen or switch to Biktarvy. In Study 1844, this meant they started the trial taking Triumeq. In Study 1878, this meant taking a boosted protease inhibitor, Reyataz (atazanavir) or Prezista (darunavir), plus a dual-NRTI backbone of Epzicom (abacavir/lamivudine) or Truvada (tenofovir disoproxil fumarate/emtricitabine).
In all four studies, the researchers concluded that Biktarvy was noninferior to, or as effective at treating HIV as, the opposing HIV regimens. Through the initial 48 weeks of each trial, none of those who took Biktarvy developed drug resistance related to the tablet. Additionally, by that point, none of the study members stopped taking Biktarvy because of kidney-related adverse health events, nor were there any cases of the kidney diseases tubulopathy or Fanconi syndrome.
To read a press release about the approval, click here.