Descovy (emtricitabine / tenofovir alafenamide)

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Descovy (emtricitabine / tenofovir alafenamide)

How to buy Descovy: You can order Descovy (emtricitabine / tenofovir alafenamide) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Gilead Sciences Pty Ltd
Disease HIV / AIDS
Indication HIV-1 infection
Mode of Action Antiviral
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 200 mg / 10 mg, 200 mg / 25 mg

Who is emtricitabine / tenofovir alafenamide for?

Descovy (emtricitabine / tenofovir alafenamide) is indicated for the treatment of individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged over 12 years and who weigh at least 35 kg [1].

Recommended dose

Complete information about Descovy (emtricitabine / tenofovir alafenamide) dosage and administration can be found here [2][3][4].

The FDA standard dosage is:

  • 1 tablet 200 mg / 25 mg daily

The EMA and TGA standard dosage is

  • 200 mg / 10 mg once daily if taken together with atazanavir with ritonavir or cobicistat, darunavir with ritonavir or cobicistat, or lopinavir with ritonavir
  • 200 mg / 25 mg once daily if taken with dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, or raltegravir [2][4]

Consult your treating doctor for personalised dosing.

What is emtricitabine / tenofovir alafenamide and how does it work?

Descovy (emtricitabine / tenofovir alafenamide) is an antiviral medicine used to treat adults and adolescents aged over 12 years and who weigh at least 35 kg infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS) [1].

Each tablet of Descovy (emtricitabine / tenofovir alafenamide) contains 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide. Inside the body tenofovir alafenamide is converted into the active substance tenofovir. Tenofovir and emtricitabine block the activity of the enzyme made by the virus to reproduce itself in the cells it has infected. It thus keeps the amount of HIV in the blood at a low level.

Descovy (emtricitabine / tenofovir alafenamide) does not cure HIV infection or AIDS, but it can prevent damages to the immune system and the development of infections and diseases associated with AIDS.

What is emtricitabine / tenofovir alafenamide's approval status?

Descovy (emtricitabine / tenofovir alafenamide) was approved among others by:

  • FDA on April 4, 2016 [5]
  • EMA (EU) on April 21, 2016 [1]
  • TGA (AUS) on November 22, 2016 [4]

For the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older in combination with other antiretroviral agents.  

The approvals were based on several studies that compared emtricitabine /tenofovir alafenamide (F/TAF)-based regimens (i.e. regimens including Descovy) with emtricitabine / tenofovir disoproxil (F/TDF)-based regimens (e.g. regimens including Viread), and demonstrated the ability of Descovy (F/TAF) to produce the same drug levels as F/TDF regimens at a dose of tenofovir of less than one tenth [5][2].

Clinical studies on treatment-naive patients (GS-US-292-0104 and GS-US-292-0111) have shown that F/TAF-based regimens produce similar results, in terms of viral load, to F/TDF-based regimens. The number of individuals with a viral load (HIV-1 RNA) of less than 50 copies per mL of plasma after 48 weeks was 92 % for those on F/TAF and 90 % for those on F/TDF, while being 84 % vs 80 % after 144 weeks [2].

In study GS-US-311-1089, the efficacy and safety of switching from F/TDF to Descovy (F/TAF) while maintaining the third antiretroviral agent were evaluated in patients with a stable low viral load for at least 6 months (HIV-1 RNA < 50 copies/mL). The percentage of individuals with a maintained low viral load was similar in the tested cohorts and in both around 90 % [2].

Moreover, F/TAF-based regimens were associated with smaller reductions in bones mineral density (BMD) and a lower impact on renal safety parameters as compared to F/FDF-based regimens [2].

The most common side effect is nausea (feeling sick). Other common side effects include diarrhoea and headache. [1].

References
[1] EMA. Human Medicines: Descovy (emtricitabine / tenofovir alafenamide), 01/06/2016, cited on 01/08/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004094/human_med_001978.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics [EMA]: Descovy (emtricitabine / tenofovir alafenamide), Gilead Sciences International Ltd., Apr. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004094/WC500207650.pdf
[3] Summary of Product Characteristics [FDA]: Descovy (emtricitabine / tenofovir alafenamide), Gilead Sciences Inc., Apr. 2017
https://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en
[4] Summary of Product Characteristics [TGA]: Descovy (emtricitabine / tenofovir alafenamide), Gilead Sciences Pty Ltd, May 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-02120-1&d=2017040616114622483
[5] Drugs.com. FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy. 04/04/2016
https://www.drugs.com/newdrugs/fda-approves-descovy-emtricitabine-tenofovir-alafenamide-gilead-s-third-taf-based-hiv-therapy-4362.html









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