Clinicians treating children with chronic hepatitis B now have a treatment option following the approval of tenofovir alafenamide by the US FDA.^1,2

Tenofovir alafenamide, a nucleoside analog reverse transcriptase inhibitor, is already approved for use in adults with chronic hepatitis B with compensated liver disease. With this new approval, it can now be administered to children ≥12 years with chronic hepatitis B infection with compensated liver disease and body weight a minimum of 35 kg.

Dose: 25 mg tablets once-daily

Side effects: Headache, upper respiratory infections, fever, cough, abdominal pain, backache, joint pains, fatigue, nausea, diarrhea, dyspepsia, pyrexia.

Contraindication: Patients with decompensated hepatic impairment, end stage renal disease

Warnings and precautions

• Avoid use of the drug alone for treatment of HIV-1 infection due to the risk of development of HIV-1 resistance in patients with HBV/HIV-1 coinfection. Test for HIV infection before starting treatment.
• Monitor renal function in all patients before and during therapy. Discontinue the drug if renal impairment or Fanconi syndrome develops. Stop treatment if lactic acidosis or hepatotoxicity develops.
• The drug label carries a boxed warning about the risk for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

References

1. FDA expands tenofovir alafenamide (Vemlidy) use to adolescents with chronic hbv - Medscape - Nov 04, 2022.

2.    https://www.gilead.com/news-and-press/press-room/press-releases/2022/11/us-food-and-drug-administration-approves-vemlidy-tenofovir-alafenamide-for-treatment-of-chronic-hepatitis-b-virus-infection-in-pediatric-patients