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 and pre-exposure prophylaxis

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General Information

Descovy is a two-drug combination of (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/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. The FDA approved a pre-exposure prophylaxis (PrEP) indication for Descovy in October of 2019. Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.

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. 

The FDA approval of Descovy for pre-exposure prophylaxis was based on the phase 3 DISCOVER trial, a multi-year trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection. Enrollment included 5,387 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men. The primary efficacy endpoint of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. Among the 2,694 subjects (4,370 person-years (PY)) who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV-1 infections (HIV-1 incidence 0.16/100 PY) were reported. Among the 2,693 subjects (4,386 PY) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported. These results thus demonstrated that Descovy achieved non-inferiority to Truvada. Efficacy was strongly correlated to adherence to daily dosing. Statistically significant advantages were observed with respect to all six pre-specified secondary endpoints for both renal and bone laboratory parameters in patients receiving Descovy compared to Truvada.

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/