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

August 13, 2013

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. [...]

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 and

Follow Warren on Twitter: @WarrenAtTheBody.

Copyright © 2013 Remedy Health Media, LLC. All rights reserved.

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This article was provided by TheBodyPRO.

Reader Comments:

Comment by: DAVE S (MYRTLE POINT OR.) Sat., Aug. 31, 2013 at 12:42 am UTC
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Comment by: elena (petris,ca) Sat., Aug. 17, 2013 at 11:21 am UTC
I was exposed to hiv and got tested it came back negative but i have serious syptoms
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Replies to this comment:
Comment by: Tony D (Newark, NJ) Thu., Aug. 22, 2013 at 5:12 pm UTC
Elena, consider HTLV.

Comment by: Tony D (Newark, NJ) Thu., Aug. 15, 2013 at 4:43 pm UTC
What's next is that the BMS attachment inhibitor needs to complete clinical trials & approved - there's still an urgent need for new HIV drugs for people who are failing on the current drugs.
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