Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for Biktarvy™ (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
BIKTARVY combines the potency of a novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. BIKTARVY is Gilead’s third DESCOVY-based STR approved in Canada in the past three years.
BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY. No dosage adjustment is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
“To help support the long-term health of people living with HIV, it is ideal that treatment regimens deliver both durable viral suppression and a demonstrated tolerability profile,” said Dr. Jason Brunetta, Operations and Finance Director at Maple Leaf Research, a treating physician at Maple Leaf Medical Clinic, and a Principal Investigator on BIKTARVY clinical trials. “In clinical trials through 48 weeks, BIKTARVY has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, BIKTARVY will simplify treatment initiation, and follow-up, over time.”
The approval of BIKTARVY 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. These trials are comprised of a diverse population of 2,414 participants, including a wide range of adult age groups and races/ethnicities. BIKTARVY met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies failed BIKTARVY with treatment-emergent virologic resistance, no patients discontinued BIKTARVY 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 BIKTARVY were diarrhea, nausea and headache.
In Study 1489, a total of 629 treatment-naïve adults with HIV were randomized 1:1 to receive BIKTARVY or abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC) once daily. At Week 48, 92 per cent (n=290/314) of patients taking BIKTARVY and 93 per cent (n=293/315) of patients taking ABC/DTG/3TC achieved the primary endpoint of HIV-1 RNA <50 c/mL. In Study 1490, a total of 645 treatment-naïve adults with HIV were randomized 1:1 to receive BIKTARVY or DTG+FTC/TAF. At Week 48, 89 per cent (n=286/320) of patients taking BIKTARVY and 92 per cent (n=302/325) of patients taking DTG+FTC/TAF achieved the primary endpoint of HIV-1 RNA <50 c/mL.
In Study 1878, a total of 577 virologically suppressed (HIV-1 RNA <50 c/mL) adults with HIV taking regimens of a boosted protease inhibitor (bPI; atazanavir or darunavir) plus a dual-NRTI backbone (ABC/3TC or FTC/tenofovir disoproxil fumarate) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIKTARVY once daily. At the primary endpoint of Week 48, switching to BIKTARVY was non-inferior to continuing on a bPI regimen with 2 per cent of patients in each group having HIV-1 RNA ≥50 c/mL; the proportion of patients with HIV-1 RNA <50 c/mL was 92 per cent in the BIKTARVY arm and 89 per cent in the bPI arm, according to FDA snapshot algorithm.
In Study 1844, a total of 563 virologically suppressed adults with HIV taking a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) were randomized 1:1 in a blinded fashion to continue a once-daily fixed-dose combination of ABC/DTG/3TC or to switch to BIKTARVY, to evaluate the efficacy and safety of switching from a regimen to BIKTARVY. Through Week 48, BIKTARVY was found to be statistically non-inferior to ABC/DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance.
“Gilead Canada is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including the ultimate goal of therapies that could potentially cure HIV infection in patients,” said Kennet Brysting, General Manager, Gilead Canada. “We are pleased to offer BIKTARVY, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with guideline-recommended dual-NRTI backbone of DESCOVY in a once-daily single tablet regimen.”
Additional clinical trials of BIKTARVY are ongoing, including a dedicated study in women, as well as a study in adolescents and children living with HIV.
BIKTARVY does not cure HIV infection or AIDS.
