Last reviewed 2026-05-31 · How we verify

Truvada

Truvada is a Small molecule drug developed by Professor Francois Venter. It is currently FDA-approved. Also known as: TDF/FTC 300/200mg Oral Tablet, Pre-Exposure Prophylaxis (PrEP), Tenofovir/emtricitabine, Emtricitabine.

Truvada is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil, which work as a human immunodeficiency virus type 1 reverse transcriptase inhibitor.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is

Common side effects

• Hyperpigmentation
• Diarrhea
• Nausea
• Fatigue
• Headache
• Dizziness
• Depression
• Insomnia
• Abnormal dreams
• Rash
• Skin discoloration
• Anemia

Serious adverse events

• Proximal renal tubulopathy
• Hypophosphatemia
• Bone mineral density loss (lumbar spine >4%)

Key clinical trials

• 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)
• Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
• 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)
• A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (PHASE3)
• Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
• REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE: A Multi-Center, Single-Arm, Open-Label, Phase 4 Study Assessing the Safety and Efficacy of B/F/TAF in HIV-Positive Adults Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks (PHASE4)

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:

• Truvada CI brief — competitive landscape report
• Truvada updates RSS · CI watch RSS
• Professor Francois Venter portfolio CI

Frequently asked questions about Truvada

Related

• Manufacturer: Professor Francois Venter — full pipeline
• Therapeutic area: All drugs in Other
• Also known as: TDF/FTC 300/200mg Oral Tablet, Pre-Exposure Prophylaxis (PrEP), Tenofovir/emtricitabine, Emtricitabine, Tenofovir

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing