Gilead Sciences Korea announced on the 24th that its hepatitis B treatment Vemlidy (tenofovir alafenamide, TAF) has been approved by the Ministry of Food and Drug Safety for the treatment of chronic hepatitis B in children aged 6 years and older.

Vemlidy offers improved renal and bone safety compared to existing chronic hepatitis B treatments. The long-term efficacy and safety profile for hepatitis B, which requires prolonged treatment like chronic diseases, has been demonstrated through various clinical studies, including 8-year clinical data.

With this extended indication, Vemlidy has become the only treatment option available in Korea for patients as young as 6 years of age, the lowest age among tenofovir formulations currently available in the country.

Previously, treatment options for chronic hepatitis B were limited to ▲entecavir formulations (for patients aged 2 years and older) ▲TDF drugs such as Viread (for patients aged 12 years and older) ▲TAF drugs such as Vemlidy (for adults).

However, with the approval, pediatric patients aged 6 years and older weighing at least 25 kg may now access a treatment that has high viral suppression rates confirmed by long-term data and improved outcomes in terms of kidney function and bone density.

This indication expansion applies only to Vemlidy and will not apply to its generic version for 4 years from the date of approval. The dosage is the same as for adults: one tablet once daily, regardless of food intake.

This indication expansion approval was based on the results of a global clinical trial in pediatric and adolescent patients with chronic hepatitis B (CHB).

The study was a randomized, double-blind, placebo-controlled clinical trial involving 88 patients aged 6 to 18 years with chronic hepatitis B. The trial was converted to an open-label design after 24 weeks and continued for 96 weeks.

Results showed that the viral suppression rate (HBV DNA <20 IU/mL) at Week 96 was 61% in the Vemlidy continuous treatment group and 48% in the placebo group that switched to Vemlidy.

In a two-year follow-up, no drug resistance to TAF was observed, and similar safety and viral suppression efficacy were confirmed in pediatric patients as in adults.

In terms of safety, no serious adverse events related to TAF were reported, and changes in renal function and bone density at Week 96 were similar to those in the Vemlidy and placebo groups.

Sunhee Kwon, Senior Director of Gilead Sciences Korea’s Virology Business Unit, said, “Vemlidy’s indication expansion to pediatric patients holds significance as it can provide improved safety and convenience compared to existing treatment options for pediatric patients with chronic hepatitis B, for whom early treatment intervention is important.”

Kwon added, “Gilead has been setting new standards in hepatitis treatment in Korea over 30 years of expertise and innovation in the field of antiviral therapies. With the indication expansion, we will continue to strive to create an environment where all hepatitis B patients, regardless of age, can receive the best possible treatment.”