Descovy (emtricitabine and tenofovir alafenamide) is a two-drug, fixed-dose combination of 200 mg emtricitabine and 25 mg tenofovir alafenamide, originally approved by the U.S. Food and Drug Administration (FDA) in April 2016. Descovy was indicated, alongside other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients 12 and older who weigh at least 35kg and have a creatinine clearance greater ≥30 mL per minute.
Today’s monograph provides a detailed overview of Descovy, including its indications, warnings and precautions, appearances in clinical guidelines, and more.
Medication Overview:
- Brand Name: Descovy
- Generic Name: emtricitabine and tenofovir alafenamide
- Treatment for: HIV-1
- Manufacturer(s): Gilead
- Initial FDA Approval: April 2016
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| HIV-1 | In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. | Adult and Adolescent Patients | April 2016 |
| HIV-1 | For the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor. | Pediatric Patients | April 2016 |
| HIV-1 Pre-Exposure Prophylaxis (PrEP) | To reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP. | Adults and Adolescents | October 2019 |
Warnings and Precautions:
Comprehensive management to reduce the risk of sexually transmitted infections (STIs), including HIV-1, when Descovy is used for HIV-1 PrEP: Counsel on adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of STIs.
Management to reduce the risk of acquiring HIV-1 drug resistance when Descovy is used for HIV-1 PrEP: refer to full prescribing information for additional detail.
Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment.
New onset or worsening renal impairment: Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein when initiating Descovy and during use on a clinically appropriate schedule in all individuals. Also assess serum phosphorus in individuals with chronic kidney disease.
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue Descovy in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Dosage and Administration:
- Testing: Prior to or when initiating Descovy, test for hepatitis B virus infection. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus.
- HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating Descovy for HIV-1 PrEP and at least once every 3 months while taking Descovy, and upon diagnosis of any other sexually transmitted infections (STIs).
Recommended Dosage:
Treatment of HIV-1 infection:
- Adult and pediatric patients weighing at least 35 kg:
- One 200 mg/25 mg tablet once daily with or without food.
- Pediatric patients receiving Descovy with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors administered with either ritonavir or cobicistat, and weighing:
- At least 25 to less than 35 kg: One 200 mg/25 mg tablet once daily with or without food.
- At least 14 to less than 25 kg: One 120 mg/15 mg tablet once daily with or without food.
HIV-1 PrEP: One 200 mg/25 mg tablet once daily with or without food in individuals with body weight at least 35 kg.
Renal impairment: Descovy is not recommended in individuals with estimated creatinine clearance of 15 to below 30 mL per minute, or below 15 mL per minute who are not receiving chronic hemodialysis.
Contraindications:
Descovy for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
Drug Interactions:
Consult the Full Prescribing Information prior to and during use for potential drug interactions.
Adverse Reactions:
- In participants with HIV-1, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea.
- In adults without HIV-1 in a PrEP trial, the most common adverse reaction (incidence greater than or equal to 5%, all grades) was diarrhea.
Examples of Emtricitabine and Tenofovir Alafenamide in Guidelines
Antiretroviral Treatment for Adults Living with HIV-1
- British HIV Association, November 2025
- “Tenofovir AF/emtricitabine/bictegravir has been compared with abacavir/lamivudine/dolutegravir and with tenofovir AF/emtricitabine with dolutegravir. No significant differences for any critical outcome were demonstrated in either of these comparisons.”
Use of Antiretroviral Agents in Adults and Adolescents Living with HIV
- United States Department of Health and Human Services, September 2025
- “Because the second-generation INSTIs BIC and DTG have high barriers to resistance, BIC/tenofovir alafenamide (TAF)/emtricitabine (FTC) and DTG plus TAF/FTC or tenofovir disoproxil fumarate (TDF)/FTC are recommended for most people with HIV.”
- United States Department of Health and Human Services, June 2025
- “Bictegravir (BIC) plus tenofovir alafenamide (TAF) plus emtricitabine (FTC) (available as the fixed-dose combination [FDC] BIC/TAF/FTC) is now recommended as a Preferred antiretroviral therapy (ART) regimen for HIV during pregnancy.”
Please note: This article is current as of December 2, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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