FDA Expands Tenofovir Alafenamide (Vemlidy ) Use to Adolescents With Chronic HBV
The US Food and Drug Administration (FDA) has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, Gilead Sciences has announced.
The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naïve and treatment-experienced patients aged 12 to < 18 years weighing at least 35 kg.
@priya The study met its primary endpoint of percentage of patients with HBV DNA levels < 20 IU/mL at 24 weeks of therapy, Gilead said in a press release.
Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA < 20 IU/mL at 24 weeks compared with none of 23 (0%) treated with placebo.
The rates of serum alanine aminotransferase normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).
The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide- and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).