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Biktarvy becomes a treatment option in Canada

In July 2018 Health Canada licensed the sale and use of Biktarvy for the treatment of HIV infection. Biktarvy, manufactured by Gilead Sciences, is supplied as tablets and contains the following drugs:

  • bictegravir – 50 mg
  • TAF (tenofovir alafenamide) – 25 mg
  • FTC (emtricitabine) – 200 mg

Of these three drugs, bictegravir is new. It belongs to a class of anti-HIV drugs called integrase inhibitors. Leading treatment guidelines in high-income countries recommend initiating combination treatment with an integrase inhibitor, as these drugs are generally well tolerated and highly effective. Integrase inhibitor combinations are also recommended for second-line use.

Each tablet of Biktarvy is a complete treatment and is taken once daily. Biktarvy can be taken with or without food, day or night.

Biktarvy has been tested as part of the initial treatment of HIV infection in clinical trials where it showed about the same level of general safety and effectiveness as the competing integrase inhibitor, dolutegravir (Tivicay and in Triumeq).

In this issue of TreatmentUpdate, we review recent clinical trials of Biktarvy in treatment-experienced people.

Bear in mind that bictegravir (the integrase inhibitor in Biktarvy) is new and has been tested in several thousand people in clinical trials. Many of these people were relatively young and healthy and side effects were generally mild. Once Biktarvy becomes subsidized by private and public drug plans, it will become more widely used in people who do not generally enter clinical trials. Such people may be older and/or have other conditions (co-morbidities) and in some cases may be ill. Their experience of side effects may be different than reported in pivotal clinical trials of Biktarvy. Also, as with any newly licensed medicine, the full range of side effects associated with Biktarvy, particularly rare ones, may not be known for at least another five years. However, the data collected so far suggests that Biktarvy is generally safe.

Access

It will likely be weeks or months before Biktarvy appears on the lists of medicines covered by private insurance formularies. Gilead Sciences will shortly begin the process of negotiating the price of Biktarvy with provincial and territorial formularies. As this is a long process, Biktarvy is not likely to be subsidized by formularies until the Spring of 2019.

—Sean R. Hosein

REFERENCE:

Gilead Sciences Canada. Biktarvy. Product Monograph. 10 July, 2018.