Last reviewed 2026-05-14 · How we verify

Vemlidy (TENOFOVIR ALAFENAMIDE)

Vemlidy works by inhibiting the HIV reverse transcriptase enzyme, preventing viral replication.

Vemlidy (Tenofovir alafenamide) is a small molecule antiviral medication developed by Gilead Sciences Inc. It is used to treat human immunodeficiency virus (HIV) infection. Vemlidy works by inhibiting viral replication, specifically targeting the HIV reverse transcriptase enzyme. It is a patented medication, but generic versions are available from two manufacturers. Key safety considerations include renal impairment and bone mineral density changes.

At a glance

Mechanism of action

Tenofovir alafenamide is an antiviral drug against the hepatitis virus [see Microbiology (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

• Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed (PHASE3)
• Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) (PHASE2)
• Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen (PHASE3)
• Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen (PHASE3)
• Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PHASE3)
• Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers (PHASE2)
• A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2,PHASE3)
• Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Vemlidy CI brief — competitive landscape report
• Vemlidy updates RSS · CI watch RSS
• Gilead Sciences portfolio CI