|Manufacturer||Gilead Sciences Pty Ltd|
|Disease||HIV / AIDS|
|Mode of Action||Antiviral|
|Approval Status||EMA approved (EU); FDA approved (USA); TGA approved (AUS)|
|Strength||200 mg / 10 mg, 200 mg / 25 mg|
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 .
The FDA standard dosage is:
The EMA and TGA standard dosage is
Consult your treating doctor for personalised dosing.
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) .
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.
Descovy (emtricitabine / tenofovir alafenamide) was approved among others by:
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 .
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 .
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 % .
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 .