FRIDAY, June 12, 2020 (HealthDay News) -- Approval has been granted to Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for treatment of HIV-1 in pediatric patients, the U.S. Food and Drug Administration announced today.
The tablets, taken once daily, are indicated for children age 4 weeks and older and weighing at least 3 kg (6.61 lb) and are approved in combination with other antiretroviral treatments. The approval applies to patients who have never been treated for HIV or who received treatment other than an integrase strand transferase inhibitor class drug.
Approval was based on a trial of 75 HIV-1-infected children ages 4 weeks to 18 years, with an average age of 27 months. Researchers found that the safety, effectiveness, and pharmacokinetics of Tivicay and Tivicay PD in this patient population were comparable to that seen in adults taking dolutegravir. Sixty-two and 69 percent of patients receiving Tivicay or Tivicay PD had an undetectable viral load at 24 and 48 weeks, respectively. Researchers also found that, on average, these patients had higher levels of CD4 cells.
The most common adverse reactions reported in adults treated with Tivicay include insomnia, fatigue, and headache. The FDA notes that Tivicay and Tivicay PD should not be administered with dofetilide, and hypersensitivity reactions, including rash and organ dysfunction, have been reported. There have been reports of liver toxicity in patients taking dolutegravir, and physicians should monitor patients with hepatitis B or C as they may have an increased risk for worsening or elevated liver enzyme levels when taking Tivicay. Patients taking combination antiretroviral therapy, including Tivicay and Tivicay PD, have also reported immune reconstitution inflammatory syndrome.
Approval was granted to ViiV Healthcare.