21 March 2017
Odefsey approved for HIV in Canada—key information
In February 2017, Health Canada approved the use and sale of a fixed-dose combination of three anti-HIV medicines sold under the brand name Odefsey. Manufactured by Gilead Sciences, Odefsey should be ready for ordering by wholesalers and pharmacies in the last week of March.
Each pill of Odefsey contains the following medications:
- rilpivirine (Edurant) – 25 mg
- TAF (tenofovir alafenamide; the new formulation of tenofovir) – 25 mg
- FTC (emtricitabine, Emtriva) – 200 mg
Odefsey is available as film-coated grey capsule-shaped tablets and is a complete treatment in one pill. Odefsey is taken once daily with a meal. In clinical trials Odefsey was generally well tolerated and side effects were usually temporary and of mild to moderate intensity.
Odefsey is similar to an older complete treatment in one pill called Complera. The main difference is that Odefsey contains the newer formulation of tenofovir called TAF, while Complera has the older formulation called tenofovir DF. You can read more about TAF in TreatmentUpdate and in a CATIE News story about the drug Descovy.
Gilead Sciences notes that Odefsey is meant to be prescribed to adults with the following profile:
- those who have HIV that is not resistant to rilpivirine, nevirapine, efavirenz (Sustiva and in Atripla) and related drugs commonly called non-nukes (NNRTIs); and
- those who have a viral load of 100,000 copies/mL or lower
Furthermore, Gilead Sciences states that the safety and effectiveness of Odefsey have not been assessed in people whose previous HIV treatments have failed.
General side effects
In clinical trials, Odefsey was generally well tolerated. General side effects included the following:
These were usually graded by researchers as mild to moderate in intensity and occurred in less than 8% of participants.
Uncommon side effects
Examples of uncommon side effects associated with Odefsey included the following:
- depression – 5%
- sleep problems – 4%
- rash – 3%
- fatigue – 2%
- nausea – 2%
- vomiting – 1%
- dizziness – 1%
A CATIE fact sheet about Odefsey is under development and will have additional information, including warnings and drug interactions.
Odefsey has not formally been tested in the following populations:
- people co-infected with hepatitis B virus – Gilead Sciences states that “the safety and effectiveness of Odefsey have not been established in patients co-infected with HIV and HBV”
- people aged 65 years or older – Gilead says that Odefsey should be used “with caution in this population”
- pregnant women – Gilead advises that “Odefsey should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus”
After Health Canada licenses a drug, physicians can prescribe it but initially patients must pay for it themselves unless they have a private insurance plan that covers it. It may take weeks or months for such coverage to take effect after licensure.
If left untreated, HIV infection leads to catastrophic disease that can affect one’s ability to work. HIV treatment is also expensive. Therefore, in Canada, provincial and territorial ministries of health heavily subsidize the cost of anti-HIV medications. Each ministry has a listing of drugs for which it is prepared to pay. These listings are called formularies.
In the months ahead, Gilead Sciences and provincial and territorial formularies will be negotiating the price of Odefsey. Your pharmacist or doctor can tell you when Odefsey is listed on your region’s formulary.
Descovy approved in Canada—key information – CATIE News
Complera – CATIE fact sheet
—Sean R. Hosein
- Gilead Sciences. Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) tablets. Product Monograph. 9 February 2017.
- Orkin C, DeJesus E, Ramgopal M, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017; in press.
- DeJesus E, Ramgopal M, Crofoot G, et al. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017; in press.
- Häggblom A, Lindbäck S, Gisslén M, et al. HIV drug therapy duration; a Swedish real world nationwide cohort study on InfCareHIV 2009-2014. PLoS One. 2017 Feb 16;12(2):e0171227.
- Lewis JM, Smith C, Torkington A, et al. Real-world persistence with antiretroviral therapy for HIV in the United Kingdom: A multicentre retrospective cohort study. Journal of Infection. 2017 Apr;74(4):401-407.
- Armenia D, Di Carlo D, Calcagno A, et al. Pre-existent NRTI and NNRTI resistance impacts on maintenance of virological suppression in HIV-1-infected patients who switch to a tenofovir/emtricitabine/rilpivirine single-tablet regimen. Journal of Antimicrobial Chemotherapy. 2017; 72 (3): 855-865.
- Hohmann N, Reinhard R, Schnaidt S, et al. Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans. Journal of Antimicrobial Chemotherapy. 2016 Aug;71(8):2241-7.