Health Canada grants Gilead Sciences Canada Inc. a Notice of Compliance for Biktarvy (bictegravir), 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 and is indicated as a complete regimen for HIV-1 infection in adults. No dosage adjustment is required for patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
“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,” says 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.”
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 ethnicities.
The drug met its primary objective of non-inferiority at 48 weeks across all four studies. Through the 48 weeks, there were no participants in any of the four studies that failed Biktarvy with treatment-emergent virologic resistance; there were no patients that 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.
“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,” says 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.”
Additionally, Gilead has ongoing clinical trials of Biktarvy including a study in women, as well as a study in adolescents and children living with HIV.