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Dolutegravir approved in Canada—what you need to know

Tuesday, 19 November 2013 Written by // CATIE - HIV and Hep C Info Resource Categories // Health, Treatment, Living with HIV, CATIE - HIV and Hep C Info Resource

From CATIE, a report on the latest drug in the arsenal against HIV that may be able to help those with drug resistance issues

Dolutegravir approved in Canada—what you need to know

This article by Sean R. Hosein previously appeared on the CATIE website here.

Une version française est disponible ici.

On October 31, 2013, Health Canada licensed the sale and use of a new anti-HIV drug called dolutegravir. This drug will be sold under the brand name Tivicay and is made by the pharmaceutical company ViiV Healthcare. Dolutegravir is already licensed in the U.S. and approval is pending in the European Union and Australia.

Dolutegravir belongs to the class of drugs called integrase inhibitors and is meant to be used as part of combination therapy for the treatment of HIV; such therapy is commonly called ART or HAART.

For most patients, dolutegravir can be taken at a dose of 50 mg once daily. This drug does not have any food or water restrictions and it can be taken day or night. Dolutegravir was relatively well tolerated in clinical trials. When side effects occurred, they were generally mild. Further details on side effects appear later in this CATIE News bulletin.


In clinical trials where dolutegravir was used as part of initial therapy for HIV, dolutegravir-based combinations have been very effective in reducing the amount of HIV in the blood (viral load) and improving the health of the immune system by increasing the number of CD4+ T-cells.

In HIV-positive people who are treatment experienced but who were not previously exposed to integrase inhibitors, clinical trials have found that dolutegravir can be very effective and in some cases better than existing regimens.

In HIV-positive people who are treatment experienced and who have HIV that is somewhat resistant to integrase inhibitors, dolutegravir-based regimens have, in most cases, been able to greatly reduce the amount of HIV in the blood.

In a study called Viking, researchers enrolled 51 HIV-positive people who were highly treatment experienced and who were using, or who had previously used, the integrase inhibitor raltegravir (Isentress). All participants were either experiencing treatment failure with raltegravir-based regimens or had HIV that was resistant to raltegravir when they enrolled in the study. Furthermore, the majority of participants had HIV that was resistant to many other anti-HIV drugs. Researchers used resistance testing to find the best possible background therapy for participants and then added dolutegravir (50 mg once or twice daily) to their regimens. Overall results six months later showed that participants who took dolutegravir 50 mg twice daily had the best response, with 75% having a viral load of less than 50 copies/ml (compared to 41% taking dolutegravir once daily). In general, dolutegravir was well tolerated.

Looking more closely at the data, the virologic response was better in participants who had a greater number of active anti-HIV drugs in their regimen. In other words, participants who had HIV that was susceptible to more drugs did better than participants who had HIV that was susceptible to fewer drugs.

Common side effects

In clinical trials, dolutegravir, like all integrase inhibitors, was well tolerated, generally safe and effective. However, as with any treatment, there were side effects that users should be aware of. The most common side effects were as follows:

  • headache
    difficulty falling asleep

Bear in mind that, like all new drugs, as dolutegravir becomes more widely used in the community, there may be reports of other side effects.

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