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Stribild (the Quad) Approved in Canada

November 28, 2012

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Women

In clinical trials with Stribild, about 10% of participants were women. This is less than ideal. Gilead Sciences is committed to conducting further research with Stribild and HIV-positive women. Also, the safety of Stribild in pregnant women is not known.


The Long and Winding Road

Once Health Canada approves a drug, physicians can prescribe it but patients must pay for it unless their private insurance plan provides coverage. HIV/AIDS is a catastrophic disease that can affect people's ability to work and requires expensive care. 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.

After federal approval, each HIV medicine must undergo another review process called Common Drug Review (CDR). As part of this review, recommendations are made as to whether the drug in question should be:

  • listed on formularies
  • listed on formularies with conditions, which means its use is restricted
  • not listed at all

The CDR may also result in no decision being made as additional information is gathered. With the exception of Quebec, all provinces and territories, the Departments of National Defense and Veterans Affairs, and the Non-Insured Health Benefits plan participate in the CDR.

Stribild will undergo the CDR process in 2013 with the results available later that year.


In Quebec

Gilead Sciences plans to submit a dossier on Stribild to L'Institut national d'excellence en santé et en services sociaux (INESSS) shortly. Stribild will hopefully be listed on the Quebec formulary -- Liste des médicaments assurés du Québec -- in 2013.


Cost

The wholesale price of Stribild in Canada is approximately $16,600 per person per year; this is considerably less than the wholesale price in the U.S., which is about $28,500 per person per year.


Availability

Pharmacies will be able to place orders for Stribild from December 31, 2012, and the company will ship them the drug shortly thereafter.


Resources

Quad (Stribild) -- safety and effectiveness issues in depth -- TreatmentUpdate 191

The Quad (Stribild) and changes to assessments of kidney health -- TreatmentUpdate 192

Cobicistat and elvitegravir –- safe with methadone or buprenorphine and naloxone -- TreatmentUpdate 194

A CATIE Fact Sheet on Stribild is under development.


References

  1. Rockstroh J, DeJesus E, Henry K, et al. Elvitegravir/cobicistat/emtricitabine/tenofovir DF (Quad) has durable efficacy and differentiated safety compared to atazanavir boosted by ritonavir plus emtricitabine/tenofovir DF at week 96 in treatment-naive HIV-1-infected patients. In: Program and abstracts of the 11th International Congress on Drug Therapy in HIV Infection, 11–15 November 2012, Glasgow, UK. Abstract 424b.
  2. Zolopa A, Gallant J, Cohen C, et al. Elvitegravir/cobicistat/emtricitabine/tenofovir DF (Quad) has durable efficacy and differentiated safety compared to efavirenz/emtricitabine/tenofovir DF at week 96 in treatment-naive HIV-1-infected patients. In: Program and abstracts of the 11th International Congress on Drug Therapy in HIV Infection, 11–15 November 2012, Glasgow, UK. Abstract 424a.
  3. DeJesus E, Felix J, Vanderwalle B, et al. Indirect treatment comparison of efficacy, safety and resistance of EVG/COBI/FTC/TDF (Quad) vs. RAL + FTC/TDF in treatment-naive HIV patients. In: Program and abstracts of the 11th International Congress on Drug Therapy in HIV Infection, 11–15 November 2012, Glasgow, UK. Poster 265.
  4. Lee FJ, Carr A. Tolerability of HIV integrase inhibitors. Current Opinion in HIV/AIDS. 2012 Sep;7(5):422-8.
  5. Lepist EI, Phan TK, Roy A, et al. Cobicistat boosts the intestinal absorption of transport substrates, including HIV protease inhibitors and GS-7340, in vitro. Antimicrobial Agents and Chemotherapy. 2012 Oct;56(10):5409-13.
  6. German P, Liu HC, Szwarcberg J, et al. Effect of cobicistat on glomerular filtration rate in subjects with normal and impaired renal function. Journal of Acquired Immune Deficiency Syndromes. 2012 Sep 1;61(1):32-40.
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This article was provided by Canadian AIDS Treatment Information Exchange. Visit CATIE's Web site to find out more about their activities, publications and services.
 
See Also
More News on Stribild (Elvitegravir/Cobicistat/FTC/Tenofovir)

 

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