Descovy (emtricitabine and tenofovir alafenamide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2016

Specific Treatments:

HIV-1 infection

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General Information

Descovy is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors.

Descovy is specifically indicated in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Descovy is supplied as tablets for oral administration. Prior to initiation of Descovy, patients should be tested for hepatitis B virus infection, and estimated creatinine clearance, urine glucose and urine protein should be obtained. The recommended dose is one tablet taken orally once daily with or without food in adults and pediatric patients 12 years of age and older with body weight at least 35 kg and creatinine clearance greater than or equal to 30 mL per minute. 

Clinical Results

FDA Approval

The FDA approval of Descovy was based on the following trials:

In trials of emtricitabine (FTC) + tenofovir alafenamide (TAF) with EVG+COBI in HIV-1 infected adults as initial therapy in those with no antiretroviral treatment history (N=866) and to replace a stable antiretroviral regimen in those who were virologically-suppressed for at least 6 months with no known resistance substitutions (N=799), 92% and 96% of patients in the two populations, respectively, had HIV-1 RNA less than 50 copies per mL at Week 48.

In a trial of FTC+TAF with EVG+COBI in 23 treatment-naïve HIV-1 infected pediatric patients aged 12 to less than 18 years old and weighing greater than 35 kg, the virologic response rate (i.e., HIV-1 RNA less than 50 copies per mL) was 91% at 24 weeks.

In a trial in 248 HIV-1 infected adult patients with estimated creatinine clearance greater than 30 mL per minute but less than 70 mL per minute, 95% (235/248) of the combined population of treatment-naïve subjects (N=6) began on FTC+TAF with EVG+COBI and those previously virologically-suppressed on other regimens (N=242) and switched to FTC+TAF with EVG+COBI had HIV-1 RNA less than 50 copies per mL at Week 24. 

Side Effects

The mot common adverse reaction associated with the use of Descovy is nausea.

Descovy comes with a black box warning lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs. Descovy is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Descovy.

Mechanism of Action

Descovy is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors.

Additional Information

For additional information regarding Descovy or HIV-1 infection, please visit https://www.descovy.com/