FDA expands Vemlidy approval for chronic HBV in children aged older than 12 years
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The FDA has updated the label indication for 25 mg tenofovir alafenamide for the treatment of chronic hepatitis B virus with compensated liver disease, expanding the patient population to include children aged 12 years older.
Vemlidy (tenofovir alafenamide, Gilead Sciences) — a nucleoside analog reverse transcriptase inhibitor — was previously approved for the adult population in 2016, when it eclipsed the higher-dose Viread (tenofovir disoproxil fumarate, Gilead Sciences) as an effective treatment.
“Chronic hepatitis B can have a significant long-term health impact on children, including the development of liver cancer later in life if the disease is left untreated,” Kathleen Schwarz, MD, a pediatric gastroenterologist at Rady Children’s Hospital-San Diego, said in a Gilead press release.
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“Chronic hepatitis B can have a significant long-term health impact on children, including the development of liver cancer later in life if the disease is left untreated, which is compounded by treatment challenges in this population,” Kathleen Schwarz, MD, a pediatric gastroenterologist at Rady Children’s Hospital-San Diego, said in a Gilead press release. “As a clinician, I recognize the critical importance of treating this disease as quickly as possible to help avoid complications and potential damage to the liver. In the clinical trial, we saw that tenofovir alafenamide may represent an effective treatment option for people as young as 12 years of age living with this chronic disease.”
The FDA based its approval on 24-week data from a phase 2 clinical trial that examined the efficacy and safety of Vemlidy 25 mg vs. placebo among 70 treatment-naïve and treatment-experienced patients aged 12 to 18 years, who weighed at least 35 kg. According to study results, 21% of patients who received Vemlidy 25 mg achieved HBV DNA levels less than 20 IU/mL at 24 weeks vs. 0% of patients who received placebo.
“While pediatric hepatitis B prevalence has dropped significantly in the U.S., children who develop chronic hepatitis B following an acute infection can experience lifelong health impact,” Merdad Parsey, MD, PhD, chief medical officer for Gilead Sciences, said in the release. “Gilead is focused on meeting the biggest challenges in liver disease and impacting the course of disease. With an established safety profile and once-daily dosing, Vemlidy provides physicians a new option to address the treatment needs of pediatric patients living with hepatitis B.”
Vemlidy includes a boxed warning in its product label regarding the risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV, according to Gilead. The drug is not recommended for the treatment of HIV-1 infection since safety and efficacy has not been established in patients with HBV/HIV-1 coinfection.
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