FDA approves dolutegravir to treat HIV-1 infection
The FDA today approved dolutegravir for the treatment of HIV-1 infection, according to a press release.
Dolutegravir (Tivicay, GlaxoSmithKline) is an integrase strand transfer inhibitor that interferes with the enzymes that allow HIV to multiply. The pill is taken once daily in combination with other antiretroviral drugs.
“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
Dolutegravir is approved for use both for treatment-naïve and experienced adult patients. The drug is also approved for patients aged 12 years and older weighing at least 40 kg who are treatment-naïve or experienced but have not taken other integrase strand transfer inhibitors.
The approval for adult patients was based on the results of four clinical trials that included 2,539 participants. Depending on the trial, patients received either dolutegravir or raltegravir (Isentress, Merck) in combination with other antiretroviral drugs, or a fixed dose of efavirenz, emtricitabine and tenofovir (Atripla, Gilead). Regiments that included dolutegravir were effective in reducing viral loads.
A fifth trial demonstrated the pharmacokinetics, safety and activity of dolutegravir in children aged 12 years and older.
Adverse events included insomnia, headache, hypersensitivity reactions and abnormal liver function in patients co-infected with hepatitis B and/or hepatitis C.