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Emtriva (EMTRICITABINE)
Emtriva works by blocking the reverse transcriptase enzyme, which is necessary for HIV to replicate.
Emtriva (Emtricitabine) is a small molecule nucleoside analog reverse transcriptase inhibitor developed by Gilead, targeting the treatment of human immunodeficiency virus (HIV) infection. It was FDA-approved in 2003 and remains under the ownership of Gilead. Emtriva is now off-patent, with multiple generic manufacturers available. As a nucleoside analog, Emtriva works by inhibiting the reverse transcriptase enzyme, which is essential for viral replication. It has a half-life of 10 hours and is used in combination with other antiretroviral medications to treat HIV infection.
At a glance
| Generic name | EMTRICITABINE |
|---|---|
| Sponsor | Gilead Sciences |
| Drug class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2003 |
| Annual revenue | 2400 |
Mechanism of action
Emtricitabine is an antiviral drug. [See Clinical Pharmacology (12.4)].
Approved indications
- Human immunodeficiency virus infection
Boxed warnings
- WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B 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 BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. 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 BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )
Common side effects
- diarrhea
- nausea
- headache
- fatigue
- abnormal dreams
- dizziness
- insomnia
- abdominal distention
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2,PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2,PHASE3)
- Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2,PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Emtriva CI brief — competitive landscape report
- Emtriva updates RSS · CI watch RSS
- Gilead Sciences portfolio CI