Chronic Hepatitis B Treatment "Vemlidy" Approved for Expanded Pediatric Indication in Patients Aged Six and Older

Proven Safety and Efficacy for Children Aged 6 Years and Over 25kg
61% Viral Suppression Rate in Global Clinical Trial for Ages 6 to 18

Gilead Sciences Korea announced on June 24 that its hepatitis B treatment "Vemlidy" (active ingredient: tenofovir alafenamide, TAF) has received additional approval from the Ministry of Food and Drug Safety for the treatment of chronic hepatitis B in pediatric patients aged six years and older.

Vemlidy is a treatment that improves the renal and bone safety profile compared to existing chronic hepatitis B therapies. Through various clinical studies, including eight years of clinical data, Vemlidy has demonstrated long-term efficacy and safety for hepatitis B, which requires prolonged treatment similar to other chronic diseases. Previously, chronic hepatitis B treatments were limited to entecavir formulations (for patients aged two years and older), TDF formulation Viread (for patients aged twelve years and older), and TAF formulation Vemlidy (previously for adults only). However, with this expanded indication, Vemlidy has become the only treatment option among tenofovir formulations available in Korea that can be used in patients as young as six years old.

The expanded indication applies only to Vemlidy and will not be extended to generic products for four years from the date of approval. The dosage is the same as for adults: one tablet once daily, regardless of meals.

This approval is based on the results of a global clinical trial in pediatric and adolescent chronic hepatitis B (CHB) patients. The study was a randomized, double-blind, placebo-controlled clinical trial involving 88 patients aged six to under eighteen years with chronic hepatitis B. After 24 weeks, the study switched to an open-label format and continued for a total of 96 weeks.

At week 96, the rate of viral suppression (HBV DNA <20 IU/mL) in the group that continuously received Vemlidy was 61%. In the group that switched from placebo to Vemlidy, the suppression rate was 48%. Additionally, no drug resistance to TAF was observed during the two-year follow-up. Pediatric patients demonstrated safety and viral suppression effects similar to those seen in adults. No serious adverse events related to TAF were reported, and changes in renal function or bone mineral density at week 96 were comparable to those in the placebo group.

Kwon Sunhee, Vice President of Gilead Korea’s Viral Diseases Division, stated, "The expanded pediatric indication for Vemlidy is significant in that it provides improved safety and convenience compared to existing treatment options for pediatric chronic hepatitis B patients, for whom early therapeutic intervention is crucial. We will continue our efforts to ensure that all hepatitis B patients have access to the best possible treatment environment."