Dolutegravir approved for use in Australia

HIV News LogoDolutegravir (Tivicay ®), a second generation integrase inhibitor, has been approved for use in Australia in February 2014.

Integrase inhibitors are a class of antiretroviral medication that prevent HIV from replicating by blocking integrase, an HIV enzyme.

Dolutegravir was first approved for use in the US by the FDA in August 2013, and in Europe in January 2014.

Dolutegravir is used to treat HIV-positive adults and patients 12 years and older weighing 40 kilos or more. It must be taken combination with other antiretroviral medications and according to your health care provider’s instructions. It can be taken with or without food.


Dolutegravir is available in 50mg tablet form. For people living with HIV starting antiretroviral therapy for the first time, or those who have been treated with other antiretrovirals in the past but have not used an integrase inhibitor, the correct dose is one 50mg tablet, once-a-day.

For treatment-experienced individuals who have HIV that is resistant to the first-generation integrase inhibitors Isentress (raltegravir) or elvitegravir, Dolutegravir needs to be taken twice-a -day.

Potential side effects

In clinical trials1-4, Dolutegravir had low rates of discontinuation due to adverse events (1-3%) in both treatment-naive and treatment-experienced patients.

The most common side effects seen in clinical studies were difficulty sleeping/insomnia and headaches. Other side effects and toxicity observed included: nausea, diarrhoea, dizziness, fatigue, weakness, and upset stomach or indigestion. Associated with a small increase in creatinine (sign of kidney toxicity) resulting from the anticipated inhibition of creatinine secretion without affecting actual glomerular filtration rate (kidney test).

Dolutegravir approved for use in Australia – Australian Federation of AIDS Organisations.


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