Gilead Sciences Canada announced that effective July 31, the Ontario Drug Benefit Program will provide eligible patients with access to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) tablets, a once-daily single tablet and complete regimen for the treatment of HIV-1 infection in adults. Health Canada granted a Notice of Compliance for BIKTARVY in July 2018.
“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, Director at Maple Leaf Research, a treating physician at Maple Leaf Medical Clinic (Toronto), and a Principal Investigator on BIKTARVY clinical trials.
“In clinical trials through 96 weeks, BIKTARVY has shown high efficacy and zero resistance. With convenient once-a-day dosing of a small single tablet and few pre-screening or ongoing monitoring requirements, BIKTARVY has simplified treatment initiation, and follow-up, over time.”
Treatment for people living with HIV is evolving, with an increasing focus on dealing with longer-term age-related health matters, including non-HIV comorbidities (such as cardiac, renal, liver or bone disease), and drug-related issues that develop at younger ages and more often among people living with HIV than among those without HIV infection.2
Canada Strives to Achieve 90-90-903
UNAIDS has set a goal of 90-90-90 by 2020 meaning: 90 per cent of all people living with HIV will know their HIV status; 90 per cent of all people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 90 per cent of all people receiving antiretroviral therapy will have viral suppression.4 According to the most recent data from the Public Health Agency of Canada (2016), 63,110 people were living with HIV in Canada. In 2016, it was estimated that 86 per cent of Canadians living with HIV are diagnosed, 81 per cent of patients diagnosed are on treatment, and 91 per cent of positive Canadians on treatment have achieved viral suppression.5
“Gilead Canada is pleased that Ontario will provide access to new treatment options that help address the evolving needs of a range of people living with HIV,” said Kennet Brysting, Vice President and General Manager, Gilead Canada. “Gilead is committed to improving care and simplifying therapy for people living with HIV, providing new treatments to support Canada to achieve its 90-90-90 goals, and continuing to invest in research in next-generation treatments, including the ultimate goal of therapies that could potentially cure HIV infection in patients.”
BIKTARVY AND TAF
BIKTARVY is Gilead Canada’s fourth tenofovir alafenamide (TAF)-based therapy. The TAF-based therapies include: Genvoya (elvitegravir 150 mg/cobicistat 150 mg/ emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and 25 mg) tablets and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) tablets.
Process and analytical development of bictegravir, one of the components of BIKTARVY, took place in Canada, where Gilead Alberta ULC (Gilead Alberta) supports the development of new innovative therapies with its process development and manufacturing facilities. The facility produces active pharmaceutical ingredients (APIs) for the company’s investigational compounds as well as for some commercial products including those APIs used in BIKTARVY for HIV.
The approval of BIKTARVY was supported by data from four 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 were 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.
BIKTARVY does not cure HIV infection or AIDS.
Source: Company Press Release