WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.
“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, M.D., director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen. Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
According to the U.S. Centers for Disease Control and Prevention, at the end of 2016, there were 2,238 children younger than 13 years old living with HIV in the U.S. and dependent areas, with 99 new HIV-1 infections diagnosed in this age group in 2017. Effective treatment is important in reducing the amount of virus in the blood.
Tivicay and Tivicay PD are intended to treat pediatric patients at least 4 weeks old and 3 kg who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor (INSTI) class drug.
The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents 4 weeks to less than 18 years old. The average age was 27 months old. This trial, where both the researchers and subjects knew which treatment was being administered, along with another trial, showed that the safety, effectiveness and pharmacokinetics of Tivicay and Tivicay PD in pediatric patients was comparable to adults taking dolutegravir. At 24 weeks, 62% of pediatric patients taking Tivicay or Tivicay PD had an undetectable viral load (the presence of virus in the blood) and at 48 weeks, 69% had an undetectable viral load. Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.
The most common adverse reactions observed in adult patients treated with Tivicay are insomnia, fatigue and headache. Patients with a hypersensitivity to dolutegravir should not take Tivicay or Tivicay PD. Tivicay and Tivicay PD should not be administered with dofetilide. Some patients reported hypersensitivity reactions such as rash and organ dysfunction. Patients should discontinue Tivicay or Tivicay PD if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Patients taking dolutegravir regimens have reported liver toxicity. Patients with underlying hepatitis B or C may be at increased risk for worsening or elevated liver enzyme levels and should be monitored. Patients in the first trimester of pregnancy should consider an alternative treatment to dolutegravir due to the risk of neural tube defects and should be counseled about using effective contraception. Immune reconstitution inflammatory syndrome (IRIS), where the immune system begins to recover but then responds to a previously acquired infection with an inflammatory response that unexpectedly makes symptoms of the infection worse, has been reported in patients treated with combination antiretroviral therapy, including Tivicay and Tivicay PD. Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable for one another on a milligram per milligram basis.
This application received Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.
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