Last reviewed 2026-04-20 · How we verify

Truvada

Truvada, marketed by Professor Francois Venter, is a well-established drug in the pharmaceutical market. The key composition patent for Truvada is set to expire in 2028, providing a significant period of market exclusivity. The primary risk is the potential increase in competition following the patent expiry.

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

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