New Integrase Inhibitor Tivicay (Dolutegravir) Approved for Treatment of HIV by FDA

On Aug. 12, Tivicay (dolutegravir) was approved as a first-line and second-line HIV treatment option, according to a news release by the U.S. Food and Drug Administration (FDA). Tivicay is an integrase inhibitor taken as a once-daily pill.

According to the FDA release:

Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naive) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naive or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. [...]

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Tivicay's safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or raltegravir (Isentress), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads. [...]

Common side effects observed during clinical studies include difficulty sleeping (insomnia) and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The Tivicay label gives advice on how to monitor patients for the serious side effects.

Paul Sax, M.D., also wrote about Tivicay's approval, highlighting some of the strong results from clinical trials, including its non-inferiority to raltegravir (Isentress) and superior results over efavirenz/tenofovir/emtricitabine (Atripla).

However, he noted that this might be "the end of a remarkable stretch of HIV drug development, one that started in 2006 with darunavir, then marched through with maraviroc, raltegravir, etravirine, rilpivirine, and elvitegravir. The availability of these drugs, now with dolutegravir, means that pretty much anyone who takes their medications will achieve virologic suppression. Because after the tweak of tenofovir -- TAF -- what's next?"

Warren Tong is the research editor for TheBody.com and TheBodyPRO.com.

Follow Warren on Twitter: @WarrenAtTheBody.