FDA expands chronic HBV treatment to patients as young as 6 years
Tenofovir alafenamide was approved in 2022 to treat pediatric patients aged 12 years and older.
FDA expands chronic HBV treatment to patients as young as 6 years | Image Credit: © Orawan- © Orawan - stock.adobe.com.
An expanded indication for tenofovir alafenamide (Vemlidy; Gilead Sciences) has been approved by the FDA to treat chronic hepatitis B virus (HBV) in pediatric patients aged 6 years and older who weigh at least 25 kg with compensated liver disease.
The once-daily 25 mg tablets are a targeted prodrug of tenofovir that was approved by the federal agency in 2016 as a once-daily treatment for adults with chronic HBV with chronic liver disease. Tenofovir alafenamide was approved in 2022 to treat pediatric patients aged 12 years and older.
The expanded indication approval of the supplemental New Drug Application was based on week 96 data from the phase 2 clinical "Trial 1092," which compared treatment with tenofovir alafenamide 25 mg to placebo in 18 treatment-naïve and treatment-experienced patients aged 6 to less than 12 years weighing at least 25 kg (Cohort 2, Group 1), according to Gilead Sciences.
Participants in the tenofovir alafenamide and placebo group who switched to open-label tenofovir alafenamide after week 24 "demonstrated progressive increases in the rates of virological suppression through week 96 overall and within both study cohorts (children and adolescents)," stated Gilead.
"Chronic hepatitis B can have a significant and lasting impact on the health of children. If left untreated, hepatitis B can lead to liver cirrhosis and liver cancer,” Chaun-Hao Lin, MD, associate professor, Clinical Pediatrics Krek School of Medicine of USC, said in a statement.
“As a clinician, I am well aware of the critical importance of promptly treating this disease to avoid possible complications and liver damage. The clinical trial demonstrated that tenofovir alafenamide may represent an effective treatment option for children as young as [6] years old affected by this chronic disease," Lin said.
In the week 96 pediatric population, the most common adverse events reported (≥5%) were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, abdominal pain upper.
Abdominal pain upper and metabolic nephropathy were the study drug-related adverse events, which occurred in "> 1 participant, reported in 2.3% (2/88 participants) each."
According to the press release, tenofovir alafenamide has a boxed warning regarding post-treatment severe acute exacerbation of hepatitis B.
Reference:
FDA expands indication for Gilead's Vemlidy (tenofovir alafenamide) to treat chronic HBV infection in pediatric patients as young as six. Gilead Sciences. Press release. March 28, 2024. Accessed March 28, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/3/fda-expands-indication-for-gileads-vemlidy-tenofovir-alafenamide-to-treat-chronic-hbv-infection-in-pediatric-patients-as-young-as-six
