On Friday, the U.S. Food and Drug Administration (FDA) announced the approval of dolutegravir (Tivicay) tablets and Tivicay PD tablets for the treatment of HIV-1 infection in infants and children in combination with other antiretroviral drugs.
Director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research Dr. Debra Birnkrant said, “For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults.”
“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,” she added.
“Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen,” Dr. Birnkrant continued. “Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
In the United States, there were 2,238 children, where were under the age of 13, living with HIV at the end of 2016, according to the U.S. Centers for Disease Control and Prevention (CDC). In 2017, the CDC reported 99 new HIV-1 infections in this age group.
Tivicay and Tivicay PD are advised for the treatment of HIV-1 in pediatric patients who are at least 4 weeks old and 6.6 lbs and who have never been treated for HIV. The drug is also for those who have been treated but not with an integrase strand transferase inhibitor (INSTI) drug.
The FDA approved Tivicay and Tivicay PD based on their safety and efficacy in a trial that involved 75 pediatric patients with HIV-1 infection.
At 24 weeks, more than 60 percent of pediatric patients who received Tivicay or Tivicay PD had an undetectable viral load, and at 48 weeks, nearly 70 percent had an undetectable viral load.
In addition, the participants were found to have higher levels of CD4 cells that help the body to fight off infections.
The FDA said some of the most common side effects of Tivicay observed in adult patients are headaches, fatigue, and insomnia.
Tivicay or Tivicay PD is not advised to patients who are allergic to dolutegravir. Some patients reported allergic reactions such as rash and organ dysfunction.
Some patients who received the drug have reported liver toxicity. Patients with a history of hepatitis B or C are at increased risk of elevated liver enzyme levels; they should be carefully monitored during the treatment. ViiV Healthcare, a North Carolina-based pharmaceutical company specializing in the development of therapies for HIV infection, received the approval of Tivicay and Tivicay PD from the FDA.