Triumeq TGA approved

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19 Jan 2015

A new single tablet regimen (STR), Triumeq, has been approved by the Therapeutic Goods Administration for the treatment of HIV in adults and adolescents from 12 years of age.

The drug, developed by ViiV Healthcare, was listed as ‘active’ on the TGA website on 14 January. Hailed as an important step forward in treating HIV, Triumeq has been found to be highly effective, well-tolerated and easy to take.

A once daily dose, Triumeq contains three medications: 600mg abacavir, 300mg lamivudine and 50mg of dolutegravir. It is intended for people who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents.

Triumeq, which is already approved overseas by both the US Food and Drug Administration and the European Union, becomes the fourth STR available to people living with HIV in Australia. An important point of difference with Triumeq is that all the other STRs — Atripla, Eviplera and Stribild — contain tenofovir, which can be associated with an increase risk of side effects of the kidneys and a decrease in bone mineral density (BDM).   

Triumeq does not contain tenofovir, making it an attractive option for patients with, or who may develop such conditions. Also, Triumeq has no food restrictions (so can be taken with or without with food) and people can take Triumeq regardless of their viral load or CD4 count (other drugs have constraints). Importantly, Triumeq does not cause drowsiness so can be taken at any time of the day.

The primary drug component in Triumeq is dolutegravir — a second-generation integrase inhibitor that has performed well in clinical trials. For people who have resistance to raltegravir or elvitegravir, dolutegravir offers further treatment options within the integrase inhibitor class of treatment.

Triumeq contains abacavir and it is estimated that up to 5% of people living with HIV have a genetic hypersensitivity to abacavir which can result in a serious allergic reaction. A blood test can determine if someone has a genetic hypersensitivity and Australian treatment guidelines recommend all people living with HIV have this blood test at the time of diagnosis.  

People living with HIV can ask their treating doctor if they have had this blood test and what the results were so they can be informed as to whether or not they are able to take abacavir and the co-formulations that contain abacavir such as Kivexa, Trizivir & Triumeq.

A decision by the Pharmaceutical Benefits Advisory Committee to list Triumeq on the PBS is expected within the second quarter of the year.