Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; emtricitabine/tenofovir alafenamide: 200 mg/25 mg) |
| Drug Class | HIV nucleoside analog reverse transcriptase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.
- Indicated in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg.
- Indicated in at-risk adults and adolescents weighing at least 35 kg for 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.
Summary
- Emtricitabine and tenofovir alafenamide (Descovy) is a combination antiretroviral drug used for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg, as well as those weighing between 14 kg to less than 35 kg when combined with other antiretroviral agents excluding protease inhibitors that require a CYP3A inhibitor. It's also indicated for pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing at least 35 kg to reduce the risk of sexually acquired HIV-1 infection.
- The two randomized controlled trials reviewed showed that Descovy demonstrated non-inferior efficacy compared to emtricitabine and tenofovir disoproxil fumarate for preventing HIV infections while showing improved bone mineral density and renal safety biomarkers after both short-term (48 weeks) and long-term use (96 weeks).
- These studies were conducted among adult cisgender men, transgender women who have sex with men, all identified as high-risk groups based on self-reported sexual behavior or recent history of sexually transmitted infections.
- In terms of safety profile, Descovy was found superior over emtricitabine/tenofovir disoproxil fumarate regarding six prespecified bone mineral density markers along with renal biomarkers indicating better kidney health outcomes associated with its usage.
- However, one notable side effect observed was weight gain among participants using Descovy; median weight gain reported being higher compared to those taking emtricitabine/tenofovir disoproxil fumarate during the study period.
- Overall these findings are derived from two Randomized Controlled Trials which provide robust evidence supporting the use of Descovy not only due its effectiveness but also because it offers an improved safety profile particularly concerning bone health & kidney function making it a viable option for long-term use in HIV prevention.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Randomized Controlled Trials
Sex Distribution:
F:1%
M:99%
5387Subjects
Year:
2021
Source:The Lancet HIV
Sex Distribution:
F:1%
M:99%
5387Subjects
Year:
2020
Source:The Lancet