Treatment of chronic hepatitis B infection in infants and young children: A systematic review

Table 1 Antiviral drugs approved by European Medicine Agency and Food and Drug Administration for adults, adolescents and children with chronic hepatitis B virus infection

	EMA age of approval	EMA recommended dose	FDA age of approval	FDA recommended dose	Formulations
IFNα-2b	Authorisation withdrawn	-	1 year	6 million IU/m2 3 times a week	Subcutaneous injection
pegIFNα-2a	3 years	180 μg/1.73 m2 once a week	3 years	180 μg/1.73 m2 once a week	Subcutaneous injection
pegIFNα-2b	Authorisation withdrawn	-	Not approved	-	-
Lamivudine	18 years	100 mg/daily	2 years	3 mg/kg daily	Oral solution (5 mg/mL) or tablets (100 mg)
Adefovir	Authorisation withdrawn	-	12 years	10 mg daily	Tablets (10 mg)
Telbivudine	Authorisation withdrawn	-	16 years	600 mg daily	Oral solution (100 mg/5 mL) or tablets (600 mg)
Entecavir	2 years	10-32.6 kg: 0.015 mg/kg daily (maximum 0.5 mg); 32.6 kg: 0.5 mg/daily	2 years	10-30 kg: 0.015 mg/kg daily (maximum 0.5 mg); > 30 kg: 0.5 mg daily	Oral solution (0.05 mg/mL) or tablets (0.5 mg and 1 mg)
Tenofovir disoproxil fumarate	2 years	10-35 kg: 6.5 mg/kg/daily1; 35 kg ( 12 years): 245 mg/daily1	2 years	10-35 kg: 8 mg/kg/daily2; 35 kg: 300 mg daily2	Oral powder (40 mg per 1 g) or tablets (150 mg, 200 mg, 250 mg, and 300 mg)
Tenofovir alafenamide	6 years	25 mg daily	6 years	25 mg daily	Tablets (25 mg)

¹Ddose expressed as tenofovir disoproxil.

²Dose expressed as tenofovir disoproxil fumarate.

EMA: European Medicine Agency; FDA: Food and Drug Administration; IFN: Interferon; pegIFN: Pegylated interferon.