FDA Approves Vemlidy for Children with Hepatitis B

The FDA has expanded the indication of Vemlidy (tenofovir alafenamide) for patients with chronic hepatitis B virus (HBV) infection. It now approved to treat pediatric patients 6 years of age and older and weighing at least 25 kg. Vemlidy is already available to treat adults and adolescents 12 years and older.

Hepatitis B (HBV) is a serious disease that attacks the liver and can cause chronic infection, cirrhosis of the liver, liver cancer, and death in up to a third of patients. Hepatitis B is spread through infected blood or body fluids, sexual contact, injection drug use, or perinatally from mother to child.

Chaun-Hao Lin, M.D.

“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, M.D., Associate Professor of Clinical Pediatrics Krek School of Medicine of USC, said in a news release.

Developed by Gilead Sciences, Vemlidy is a targeted prodrug of tenofovir that was first approved by the FDA in 2016. In 2023, Vemlidy generated total worldwide sales of $862 million compared with 842 million in 2022.

Vemlidy 25 mg has a price of $1,528 for 30 tablets, according to Drugs.com. Patients with commercial insurance may be eligible for a $0 copay with an annual limit of $6,000 a year. Gilead notes in its terms and conditions that it may reduce or discontinue the copay assistance if a patient’s plan has a copay accumulator or maximizer program.

With accumulator programs, the money from copay cards does not count toward patients’ annual deductible or out-of-pocket limit. With maximizer programs, the copay assistance is evenly spread over the year but still doesn't count toward the deductible or out-of-pocket limit.

Vemlidy’s approval in the patient population is supported by week 96 data from a phase 2 clinical trial comparing treatment with Vemlidy 25 mg with placebo among 18 treatment-naïve and treatment-experienced patients aged 6 to less than 12 years. In the trial, 47 patients received Vemlidy and 23 received placebo. Patients in the Vemlidy group and in the placebo group who switched to open-label Vemlidy after week 24 demonstrated progressive increases in the rates of virological suppression through week 96 overall.

Most common adverse events in the children were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, and abdominal pain.

Vemlidy has a boxed warning in its product label about the risk of new or worsening renal impairment, the risk of HIV-1 resistance, and the risk of lactic acidosis.