Tablets indicated for children as young as 4 weeks

WASHINGTON — The FDA approved dolutegravir (Tivicay, tablets; Tivicay PD, tablets for oral suspension) in combination with other antiretroviral treatments for pediatric patients with HIV-1 infection who are ages ≥4 weeks and who weigh ≥3 kg.

“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, MD, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research, in a statement. “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.”

The FDA noted that this drug application received Priority Review.

This approval was based on results from a clinical trial of 75 infants, children, and adolescents ages 4 weeks to <18 years with HIV-1 infection (average age: 27 months). This trial found that the safety and efficacy of dolutegravir in this patient population was “comparable to adults taking dolutegravir,” the FDA explained. “”At 24 weeks, 62% of pediatric patients taking [dolutegravir] had an undetectable viral load… 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 effects of dolutegravir are insomnia, fatigue, and headache, the FDA wrote. In addition, some patients reported hypersensitivity reactions — such as rash and organ dysfunction — while taking the drug; patients who experience these or other hypersensitivity reactions should immediately discontinue treatment with dolutegravir.

“Patients taking dolutegravir regimens have reported liver toxicity,” the agency warned. “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.”

Tivicay and Tivicay PD are manufactured by ViiV Healthcare.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 339

Topic ID: 338,339,339,730,190,27,138,192,725