1.2. Pediatrics

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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.

Table 3: Maximum recommended DAA dosages in pediatric chronic HCV infections^2-12
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): genotypes 1a: treatment naïve or peginterferon alfa and ribavirin experienced without baseline NS5A polymorphisms	12 weeks	Patients 12-17 years of age: 50 mg elbasvir and 100 mg grazoprevir tablet once daily
		genotype 1a: treatment naïve or peginterferon alfa and ribavirin experienced with baseline NS5A polymorphisms∆	16 weeks plus ribavirin*
		genotype 1b: treatment naïve or peginterferon alfa and ribavirin experienced	12 weeks
		genotypes 1a£ or 1b: Peginterferon alfa, ribavirin, and NS3/4A protease inhibitor experienced	12 weeks plus ribavirin*
		genotype 4: treatment naïve	12 weeks
		genotype 4: treatment naïve or peginterferon alfa 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: treatment naïve patients with any genotype without cirrhosis or with compensated cirrhosis (Child-Pugh A)	8 weeks	Patients 3-11 years of age: Less than 20 kg: three 50 mg/ 20 mg packets of oral pellets once daily 20 kg to less than 30 kg: four 50 mg/ 20 mg packets of oral pellets once daily 30 kg to less than 45 kg: five 50 mg/ 20 mg packets of oral pellets once daily 45 kg and greater OR 12 years of age and older: 300 mg/120 mg (three 100 mg/ 40 mg tablets once daily)
		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: genotype 1 treatment naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)	8¥ or 12 weeks	Patients 3-17 years of age: Less than 17 kg: 33.75 mg/150 mg (one 33.75 mg/150 mg oral pellet packet) once daily 17 kg to less than 35 kg: 45 mg/200 mg (one 45 mg/200 mg tablet OR one 45 mg/200 mg oral pellet packet) once daily 35 kg or more: 90 mg/400 mg (one 90 mg/400 mg tablet OR two 45 mg/200 mg tablets OR two 45 mg/200 mg oral pellet packets) once daily
		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: genotype 1, 2, 3, 4, 5, or 6 that are treatment naïve or experienced†† without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks	Weight based dosing for patients 3-17 years of age: Less than 17 kg: one 150 mg/37.5 mg oral pellet packet once daily 17 kg to less than 30 kg: one 200 mg/50 mg oral pellet packet OR one tablet once daily 30 kg or greater: two 200 mg/50 mg oral pellet packets, two 200 mg/50 mg tablets, OR one 400 mg/100 mg tablet once daily
		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) genotype 2 for treatment naïve or experienced# patients	12 weeks plus ribavirin*	Weight based dosing for patients 3-17 years of age: Less than 17 kg: one 150 mg oral pellet packet daily 17 kg to less than 35 kg: one 200 mg tablet or one 200 mg oral pellet packet once daily 35 kg or greater: 400 mg tablet, two 200 mg tablets, or two 200 mg oral pellet packets once daily
		genotype 3 for treatment naïve or experienced# patients	24 weeks plus ribavirin*

Legend:

HCV = hepatitis C virus
NS5A inhibitors = Nonstructural protein 5A (NS5A) inhibitors
NS3/4A protease inhibitors = Nonstructural protein 3/4A protease inhibitors
∆ NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93. Testing prior to the initiation of therapy, subsection NS5A resistance testing in HCV genotype 1a-infected patients
* Weight based dosing of ribavirin
£ The optimal ZEPATIER-based treatment regimen and duration of therapy for PegIFN/RBV/PI-experienced genotype 1a-infected patients with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, and 93 has not been established
¥ 8 weeks of treatment can be considered in treatment naïve patients who have pretreatment HCV RNA less than 6 million IU/mL
† Treatment-experienced pediatric subjects have failed a peginterferon alfa +/- ribavirin based regimen with or without an HCV protease inhibitor
** HARVONI + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin
†† In clinical trials in adults, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)
# Treatment-experienced patients have failed an interferon-based regimen with or without ribavirin