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Triumeq FDA Approval History

FDA Approved: Yes (First approved August 22, 2014)
Brand name: Triumeq
Generic name: abacavir, dolutegravir and lamivudine
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.

  • Triumeq works by interfering with the action of two enzymes (reverse transcriptase and integrase) to prevent the virus from replicating and further infecting cells.
  • Triumeq is administered once a day.
    • Triumeq tablets (abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg) are indicated for the treatment of HIV-1 infection in adults.
    • Triumeq PD tablets for oral suspension (abacavir 60 mg, dolutegravir 5 mg, and of lamivudine 30 mg) are indicated for the treatment of HIV-1 infection in pediatric patients weighing at least 10 kg.
  • The Triumeq product label carries a boxed warning for serious hypersensitivity reactions and exacerbations of hepatitis B virus (HBV). Triumeq is associated with the following warnings and precautions: hepatotoxicity; lactic acidosis and severe hepatomegaly with steatosis; embryo-fetal toxicity; and immune reconstitution syndrome.
  • Common adverse reactions include insomnia, headache, and fatigue.

Development timeline for Triumeq

Mar 30, 2022Approval ViiV Healthcare Announces US FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-Daily Treatment for Children Living with HIV
Aug 22, 2014Approval FDA Approves Triumeq for the Treatment of HIV-1 Infection

Further information

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