CATIE News

27 July 2017 

Generic tenofovir + FTC coming to Canada

There is a pill called Truvada that contains the two following medicines:

  • tenofovir DF (disoproxil fumarate)
  • FTC (emtricitabine)

For many years Truvada has been an important part of many combinations used in the treatment of HIV infection. However, that changed several years ago when clinical trials found that Truvada has an additional benefit. The use of daily oral Truvada significantly reduces the risk of HIV transmission for HIV-negative people when it is provided along with a comprehensive prevention package that includes regular testing and treatment of sexually transmitted infections, and ongoing adherence and risk-reduction counselling. This is called pre-exposure prophylaxis (PrEP).

Health Canada based its approval of Truvada to prevent HIV infection on data from clinical trials in men who have sex with men as well as in heterosexual couples where one partner was HIV positive. In these studies, Truvada was taken once daily every day and was highly effective in reducing the risk of HIV infection.

A drawback for many people who wish to use Truvada as part of lowering their risk for HIV infection is the price. This medicine costs about $CAN 1,000 monthly per person.

Enter the generics

Earlier this year, Health Canada approved the use and sale of generic fixed-dose formulations of tenofovir DF + FTC. This approval was based on data provided by generic companies showing two important things:

  • that their versions of the drugs were absorbed as well as the branded version   
  • that levels of the generic drugs in the blood were within the range that is seen with the branded version

Showing that generic drugs have both similar absorption and blood concentrations to brand name drugs is called bio-equivalence. This is often the standard procedure for licensure of generic drugs in many therapeutic areas in Canada and other high-income countries.

In a study of 293 people in London, England, who purchased a generic combination of tenofovir DF + FTC, researchers found that most had levels of the drugs in their blood that were “similar to or slightly higher than” levels that were seen in a study of Truvada. No serious side effects occurred and no one developed HIV or hepatitis B virus infection.

Cost and access issues

In general, generic medicines are cheaper than the same medicines produced by brand name companies. In the case of the generic pill containing tenofovir DF + FTC, the wholesale price is expected to be around $400 monthly per patient (pharmacies will charge somewhat more). Although at least two generic companies will be offering a pill containing tenofovir DF + FTC, only such pills made by the generic company Teva are approved for use as HIV prevention and treatment.

This expected price will still be high for many people in need of PrEP. Ideally, Canada’s provinces and territories can begin the process of securing the generic formulation of tenofovir DF + FTC at greatly reduced prices and adding it to the list of subsidized medicines that they offer for both HIV treatment and prevention.

As more companies enter the market and sell generic tenofovir DF + FTC, the price is expected to fall further.

The generic pill containing tenofovir DF + FTC will be available for pharmacies to order from wholesalers as of July 26. 

Quebec already subsidizes Truvada for prevention and treatment. A major financial reason for subsidizing a pill containing generic tenofovir DF + FTC for prevention is that at least two studies in Canada have shown that the cost of preventing HIV is far cheaper than treating it.

As for the formal listing of a pill containing generic tenofovir + FTC for the prevention of HIV infection on provincial formularies, this is something that will take time and for which local advocacy is needed.

CATIE resources

CATIE statement on the use of oral pre-exposure prophylaxis (PrEP) as a highly effective strategy to prevent the sexual transmission of HIV

Pre-exposure prophylaxis (PrEP) resources

Oral pre-exposure prophylaxis (PrEP) – fact sheet

Toronto-led team explores different PrEP deployment scenariosCATIE News

—Sean R. Hosein

REFERENCES:

  1. Wang X, Nwokolo N, Korologou-Linden R, et al. InterPrEP: internet-based pre-exposure prophylaxis with generic tenofovir disoproxil fumarate/emtrictabine in London—analysis of pharmacokinetics, safety and outcomes. HIV Medicine. 2017; in press.
  2. MacFadden DR, Tan DH, Mishra S, et al. Optimizing HIV pre-exposure prophylaxis implementation among men who have sex with men in a large urban centre: a dynamic modelling study. Journal of the International AIDS Society. 2016 Sep 23;19(1):20791.
  3. Ouellet E, Durand M, Guertin JR, et al. Cost effectiveness of ‘on demand’ HIV pre-exposure prophylaxis for non-injection drug-using men who have sex with men in Canada. Canadian Journal of Infectious Diseases and Medical Microbiology. 2015 Jan-Feb;26(1):23-9.
  4. Kesler MA, Kaul R, Myers T, et al. Perceived HIV risk, actual sexual HIV risk and willingness to take pre-exposure prophylaxis among men who have sex with men in Toronto, Canada. AIDS Care. 2016 Nov;28(11):1378-85.
  5. Juusola JL, Brandeau ML, Owens DK, et al. The cost-effectiveness of pre-exposure prophylaxis for HIV prevention in the United States in men who have sex with men. Annals of Internal Medicine. 2012 Apr 17;156(8):541-50.
  6. Schneider K, Gray RT, Wilson DP. A cost-effectiveness analysis of HIV pre-exposure prophylaxis for men who have sex with men in Australia. Clinical Infectious Diseases. 2014 Apr;58(7):1027-34.
  7. Bayoumi AM, Barnett PG, Joyce VR, et al. Cost-effectiveness of newer antiretroviral drugs in treatment-experienced patients with multidrug-resistant HIV disease. Journal of Acquired Immune Deficiency Syndromes. 2013 Dec 1;64(4):382-91.
  8. Krentz HB, Gill MJ. Cost of medical care for HIV-infected patients within a regional population from 1997 to 2006. HIV Medicine. 2008 Oct;9(9):721-30.
  9. Farnham PG, Gopalappa C, Sansom SL, et al. Updates of lifetime costs of care and quality-of-life estimates for HIV-infected persons in the United States: late versus early diagnosis and entry into care. Journal of Acquired Immune Deficiency Syndromes. 2013 Oct 1;64(2):183-9.
  10. Nakagawa F, Miners A, Smith CJ, et al. Projected lifetime healthcare costs associated with HIV infection. PLoS One. 2015 Apr 22;10(4):e0125018.