Headline: In 2022, Tenofovir Alafenamide was approved to treat paediatric patients aged 12 years and older by FDA.
Tenofovir alafenamide, is approved and expanded to treat patients aged 6 years older as of now. An expanded indication for Tenofovir Alafenamide known as Vemlidy has been approved by the FDA to treat chronic hepatitis B virus in paediatric patients aged 6 years and older who weigh at least 25 kg with compensated liver disease. This anti-viral medication needs to be taken 25 mg tablets; the once-daily is 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.
However, the Tenofovir alafenamide was approved in 2022 after an array of successful trial period to treat paediatric patients aged 12 years and older. As per Gilead Sciences, the expanded indication approval of the supplemental new drug application was based on week 96 data from the phase 2 clinical trial No:1092.
In the trial period, participants are in the tenofovir alafenamide and placebo group who switched open-label tenofovir alafenamide after week 24 demonstrated progressive increases the rates of virological suppression through week 96 within both study cohorts’ children and adolescents. As per, Dr. Chaun-Hao Lin, MD, Associate Professor, Clinical Paediatrics, Keck School of Medicine of USC, he said, chronic hepatitis B can have a significant and lasting impact on health of children. If left untreated, it can lead to liver cirrhosis and cancer.
However, Dr. Lin also said, 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. In the week 96 paediatric population, the most common adverse events reported ?5% were nasopharyngitis, headache, COVID-19, pyrexia, diarrhoea, upper respiratory tract infection, cough, respiratory tract infection viral, abdominal pain upper symptoms are seen.
He also said, abdominal pain upper and metabolic nephropathy were the study drug-related adverse events, which occurred in > 1 participant, reported in 2.3% means 2/88 participants each.
To know more in the details about this information. Please watch this video till end.
