TRIUMEQ

What it is

TRIUMEQ is a film-coated tablet containing 50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir (as abacavir sulfate) and 300 mg of lamivudine. The tablets are purple, oval and biconvex, debossed with '572 Trı' on one side.

Approved indications

— Treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in TRIUMEQ.

Dosing overview

The recommended dose of TRIUMEQ in adults and adolescents weighing at least 40 kg is one tablet once daily, taken with or without food. Because TRIUMEQ is a fixed dose tablet, it should not be prescribed for patients requiring dose adjustment, including adults or adolescents weighing less than 40 kg, children less than 12 years of age, patients with creatinine clearance less than 30 mL/min, patients with mild hepatic impairment, or patients resistant to integrase inhibitors.

Key safety warnings

Abacavir, a component of TRIUMEQ tablets, is associated with hypersensitivity reactions, which can be life-threatening and in rare cases fatal. TRIUMEQ tablets, or any other medicinal product containing abacavir, must never be restarted following a hypersensitivity reaction. Hypersensitivity to abacavir is a multi-organ clinical syndrome which can occur at any time during treatment, but most often occurs within the first 6 weeks of therapy. The risk is significantly increased for patients who test positive for the HLA-B*5701 allele. Testing for HLA-B*5701 status is recommended before initiating abacavir treatment and also before re-starting abacavir treatment in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Hypersensitivity reactions have been reported with integrase inhibitors, including dolutegravir, and were characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. TRIUMEQ should be discontinued and other suspect agents should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues either alone or in combination, including abacavir and lamivudine. Caution should be exercised when administering TRIUMEQ particularly to those with known risk factors for liver disease. Treatment with TRIUMEQ should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis with or without hepatitis.

Contraindications

TRIUMEQ is contraindicated in patients with known hypersensitivity to dolutegravir, abacavir or lamivudine, or to any of the excipients. TRIUMEQ must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to dofetilide, pilsicainide or fampridine. TRIUMEQ is not recommended for use in patients with the HLA-B*5701 allele or in patients who have had a suspected abacavir hypersensitivity reaction while taking any medicinal product containing abacavir.

PBS listing

PBS listing information is not provided in the source documents.

Regulatory history

TRIUMEQ received approval on 2015-01-08 for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-naive or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in TRIUMEQ. ARTG registration 218644 was first listed on 2015-01-14. In November 2017, the PBAC recommended an amendment to the current PBS listing to expand the eligibility criteria for abacavir + dolutegravir + lamivudine to include patients with HIV-1 infection who are initiating antiretroviral therapy.