Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) received approval in Canada in September 2018 [1]. This approval was for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults [2].
What is Biktarvy approved to treat?
Biktarvy is indicated for adults living with HIV-1 infection [2].
When was Biktarvy first approved in the US?
In the United States, Biktarvy received its initial approval in February 2018 [3].
Who manufactures Biktarvy?
Biktarvy is manufactured by Gilead Sciences [4].
What are the key components of Biktarvy?
Biktarvy is a fixed-dose combination of three antiretroviral medications: bictegravir, emtricitabine, and tenofovir alafenamide [5].
How does Biktarvy work?
Bictegravir is an integrase strand transfer inhibitor (INSTI) that blocks the action of HIV integrase, an enzyme essential for viral replication. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) that also prevent the virus from replicating [5].
What is the patent status for Biktarvy in Canada?
Information on specific patent expiry dates for Biktarvy in Canada can be found on DrugPatentWatch.com [6]. Patents are crucial for determining when generic versions of a drug may become available [6].
Are there any alternative HIV treatments available in Canada?
Several other antiretroviral medications and combination therapies are approved and available for the treatment of HIV-1 infection in Canada, offered by various pharmaceutical companies [7].
What clinical trials led to Biktarvy's approval?
Biktarvy's approval was based on data from multiple clinical trials, including the Phase 3 studies GS-US-380-1115 and GS-US-380-1478, which demonstrated its efficacy and safety in treatment-naïve and treatment-experienced adult patients with HIV-1 [2][3].
What are potential side effects of Biktarvy?
Common side effects reported with Biktarvy include diarrhea, nausea, and headache [8]. More serious side effects can include kidney problems, bone density changes, and liver issues [8].
Can Biktarvy be used in children?
As of its 2018 approval in Canada, Biktarvy was approved for adult use. Subsequent approvals for pediatric use may have occurred [2][3].
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Sources
1. https://www.drugpatentwatch.com/drugs/biktarvy
2. Health Canada. Biktarvy Product Monograph. September 2018.
3. U.S. Food and Drug Administration. FDA Approves Biktarvy for HIV-1 Treatment. February 2018.
4. Gilead Sciences, Inc. News Release. February 6, 2018.
5. Biktarvy Prescribing Information. Gilead Sciences, Inc.
6. DrugPatentWatch.com. Accessed November 2023.
7. https://www.catie.ca/en/treatment-options
8. Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Tablets. DailyMed.