1.2. Pediatrics
Safety and efficacy of DAAs for use in children younger than 18 years of age has been established with sofosbuvir (Sovaldi®), sofosbuvir/velpatasvir (Epclusa®), glecaprevir/pibrentasvir (Mavyret®), elbasvir/grazoprevir (Zepatier®), and ledipasvir/ sofosbuvir (Harvoni®)2-8, 10-11. Safety and effectiveness of sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) has not been established in pediatric patients less than 18 years of age9. Recommended DAA dosages in pediatric patients are summarized in Table 3.
Drug Name | Dosage Form/Strength | Treatment Indication | Duration and Coadministration | Maximum Recommended Dosage |
---|---|---|---|---|
elbasvir/grazoprevir (Zepatier®) | 50 mg/100 mg tablet |
Chronic HCV treatment in pediatric patients 12 years of age and older weighing at least 30kg with or without mild hepatic impairment (Child-Pugh A):
|
12 weeks | Patients 12-17 years of age: 50 mg elbasvir and 100 mg grazoprevir tablet once daily |
genotype 1a: treatment naïve or peginterferon and ribavirin experienced with baseline NS5A polymorphisms∆ | 16 weeks plus ribavirin* | |||
genotype 1b: treatment naïve or peginterferon and ribavirin experienced | 12 weeks | |||
genotypes 1a£ or 1b: Peginterferon, ribavirin, and NS3/4A protease inhibitor experienced | 12 weeks plus ribavirin* | |||
genotype 4: treatment naïve | 12 weeks | |||
genotype 4: treatment naïve or peginterferon and ribavirin experienced | 16 weeks plus ribavirin* | |||
glecaprevir/pibrentasvir (Mavyret®) |
100 mg/40 mg tablets 50 mg/20 mg oral pellet packets |
Chronic HCV treatment in pediatric patients 3 years of age and older:
|
8 weeks |
|
genotype 1 previously treated with an NS5A inhibitor (ledipasvir and sofosbuvir or daclatasvir with pegylated or nonpegylated interferon plus ribavirin) without prior NS3/4A treatment without cirrhosis or with compensated cirrhosis (Child-Pugh A) | 16 weeks | |||
genotype 1 liver or kidney transplant recipients previously treated with an NS5A inhibitor without prior NS3/4A treatment | 16 weeks | |||
genotype 1 previously treated with an NS3/4A protease inhibitor (containing simeprivir, and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated or nonpegylated interferon and ribavirin) without previous NS5A inhibitor treatment | 12 weeks | |||
genotypes 1, 2, 4, 5, or 6 previously treated with peginterferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor without cirrhosis | 8 weeks | |||
genotypes 1, 2, 4, 5, or 6 previously treated with peginterferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor with compensated cirrhosis (Child-Pugh A) | 12 weeks | |||
genotype 3 previously treated with peginterferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor | 16 weeks | |||
genotype 3 liver or kidney transplant recipients previously treated with peginterferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor | 16 weeks | |||
Liver or kidney transplant recipients | 12 weeks | |||
ledipasvir/sofosbuvir (Harvoni®, generics) |
33.75 mg/150 mg oral pellet packets 45 mg/200 mg oral pellet packets 45 mg/200 mg tablet 90 mg/400 mg tablet |
Chronic HCV treatment in pediatric patients 3 years of age and older:
|
8¥ or 12 weeks |
|
treatment experienced† without cirrhosis | 12 weeks | |||
treatment experienced† with compensated cirrhosis (Child-Pugh A) | 24 weeks** | |||
treatment naïve and treatment experienced† with decompensated cirrhosis (Child-Pugh B or C) | 12 weeks plus ribavirin | |||
genotype 1 or 4 treatment naïve and treatment experienced† liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A) | 12 weeks plus ribavirin | |||
genotype 4,5, or 6 treatment naïve or experienced† patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) | 12 weeks | |||
sofosbuvir/velpatasvir (Epclusa®, generics) |
150 mg/37.5 mg oral pellet packets 200 mg/50 mg oral pellet packets 200 mg/50 mg tablets 400 mg/100 mg tablets |
Chronic HCV treatment pediatric patients 3 years of age and older:
|
12 weeks |
Weight based dosing for patients 3-17 years of age:
|
genotype 1, 2, 3, 4, 5, or 6 that are treatment naïve or experienced†† with decompensated cirrhosis (Child-Pugh B and C) | 12 weeks plus ribavirin | |||
sofosbuvir (Sovaldi ®) |
150 mg oral pellet packet 200 mg oral pellet packet 200 mg tablet 400 mg tablet |
Chronic HCV genotype 2 or 3 treatment for pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis (Child-Pugh A)
|
12 weeks plus ribavirin* |
Weight based dosing for patients 3-17 years of age:
|
genotype 3 for treatment naïve or experienced# patients | 24 weeks plus ribavirin* |