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TENOFOVIR ALAFENAMIDE FUMARATE
TENOFOVIR ALAFENAMIDE FUMARATE is a Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drug. It is currently FDA-approved (first approved 2015).
At a glance
| Generic name | TENOFOVIR ALAFENAMIDE FUMARATE |
|---|---|
| Drug class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
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
- Vomiting
- Flatulence
- Dyspepsia
- Abdominal pain
- Rash
- Depression
Serious adverse events
- Suicidal ideation
- Suicide attempt
- Depression suicidal
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (PHASE2)
- Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (EARLY_PHASE1)
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (PHASE1)
- Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (PHASE2, PHASE3)
- Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TENOFOVIR ALAFENAMIDE FUMARATE CI brief — competitive landscape report
- TENOFOVIR ALAFENAMIDE FUMARATE updates RSS · CI watch RSS
Frequently asked questions about TENOFOVIR ALAFENAMIDE FUMARATE
What is TENOFOVIR ALAFENAMIDE FUMARATE?
TENOFOVIR ALAFENAMIDE FUMARATE is a Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drug.
What drug class is TENOFOVIR ALAFENAMIDE FUMARATE in?
TENOFOVIR ALAFENAMIDE FUMARATE belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] class. See all Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drugs at /class/human-immunodeficiency-virus-nucleoside-analog-reverse-transcriptase-inhibitor-epc.
When was TENOFOVIR ALAFENAMIDE FUMARATE approved?
TENOFOVIR ALAFENAMIDE FUMARATE was first approved on 2015.
What development phase is TENOFOVIR ALAFENAMIDE FUMARATE in?
TENOFOVIR ALAFENAMIDE FUMARATE is FDA-approved (marketed).
What are the side effects of TENOFOVIR ALAFENAMIDE FUMARATE?
Common side effects of TENOFOVIR ALAFENAMIDE FUMARATE include Diarrhea, Nausea, Headache, Vomiting, Flatulence, Dyspepsia. Serious adverse events: Suicidal ideation, Suicide attempt, Depression suicidal.