Page 8 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 8
Genotype 3, Option 3 Genotype 4, IFN-free Option 1
• Patients infected with HCV genotype 3 without cirrhosis • Patients infected with HCV genotype 4 can be treated
can be treated with an IFN-free combination of daily with the IFN-free fixed-dose combination of sofosbuvir
sofosbuvir (400 mg) and daily daclatasvir (60 mg) for 12 (400 mg) and ledipasvir (90 mg) in a single tablet
weeks (A1) administered once daily (A1)
• Treatment-naïve and treatment-experienced patients • Patients without cirrhosis, including treatment-naïve
infected with HCV genotype 3 with cirrhosis should and treatment-experienced patients, should be treated
receive this combination with daily weight-based with this fixed-dose combination for 12 weeks without
ribavirin (1000 or 1200 mg in patients <75 kg or ≥75 ribavirin (A1)
kg, respectively) for 24 weeks, pending further data
comparing 12 weeks with ribavirin and 24 weeks with • Based on data in patients infected with HCV genotype
and without ribavirin in this population (B1) 1, patients with compensated cirrhosis, including
treatment-naïve and treatment-experienced patients,
Treatment of HCV genotype 4 infection should be treated with this fixed-dose combination for
12 weeks with daily weight-based ribavirin (1000 or
Six treatment options are available in 2015 for patients 1200 mg in patients <75 kg or ≥75 kg, respectively) (B1)
infected with HCV genotype 4, including 2 IFN-containing
regimens and 4 IFN-free regimens. In settings where none • Patients with compensated cirrhosis with contra-
of these options is available, the combination of PegIFN- indications to the use of ribavirin or with poor tolerance
αand ribavirin remains acceptable; see prior EASL Clinical to ribavirin on treatment should receive the fixed-dose
Practice Guidelines. combination of sofosbuvir and ledipasvir for 24 weeks
without ribavirin (B1)
Genotype 4, IFN-containing Option 1
• Based on data in patients infected with HCV genotype
1, treatment with the fixed-dose combination of
sofosbuvir and ledipasvir with ribavirin can be prolonged
to 24 weeks in treatment-experienced patients with
compensated cirrhosis and negative predictors of
response, such as a platelet count <75 x 103/μl (B1)
• Patients infected with HCV genotype 4 can be treated Genotype 4, IFN-free Option 2
with a combination of weekly PegIFN-α, daily weight-
based ribavirin (1000 or 1200 mg in patients <75 kg or • Patients infected with HCV genotype 4 without cirrhosis
≥75 kg, respectively), and daily sofosbuvir (400 mg) 12 can be treated with an IFN-free regimen comprising
weeks (B1) the fixed-dose combination of ombitasvir (75 mg),
paritaprevir (12.5 mg) and ritonavir (50 mg) in one
Genotype 4, IFN-containing Option 2 single tablet (two tablets once daily with food), for 12
weeks with daily weight-based ribavirin (1000 or 1200
• Patients infected with HCV genotype 4 can be treated mg in patients <75 kg or ≥75 kg, respectively), without
with a combination of weekly PegIFN-α, daily weight- dasabuvir (B1)
based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively), and daily simeprevir (150 mg) • Patients infected with HCV genotype 4 with cirrhosis
(B1) should be treated with the fixed-dose combination
of ombitasvir (75 mg), paritaprevir (12.5 mg) and
• Simeprevir should be administered 12 weeks in ritonavir (50 mg) in one single tablet (two tablets once
combination with PegIFN-α and ribavirin. PegIFN-α daily with food), for 24 weeks with daily weight-based
and ribavirin should then be administered alone for ribavirin (1000 or 1200 mg in patients <75 kg or ≥75 kg,
an additional 12 weeks (total treatment duration 24 respectively), without dasabuvir, pending further data
weeks) in treatment-naïve and prior relapser patients, (B1)
including cirrhotic patients, an additional 36 weeks (total
treatment duration 48 weeks) in prior partial and null
responders, including cirrhotic patients (B1)
• HCV RNA levels should be monitored on treatment.
Treatment should be stopped if HCV RNA level is ≥25
IU/ml at treatment week 4, week 12 or week 24 (A2)
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• Patients infected with HCV genotype 3 without cirrhosis • Patients infected with HCV genotype 4 can be treated
can be treated with an IFN-free combination of daily with the IFN-free fixed-dose combination of sofosbuvir
sofosbuvir (400 mg) and daily daclatasvir (60 mg) for 12 (400 mg) and ledipasvir (90 mg) in a single tablet
weeks (A1) administered once daily (A1)
• Treatment-naïve and treatment-experienced patients • Patients without cirrhosis, including treatment-naïve
infected with HCV genotype 3 with cirrhosis should and treatment-experienced patients, should be treated
receive this combination with daily weight-based with this fixed-dose combination for 12 weeks without
ribavirin (1000 or 1200 mg in patients <75 kg or ≥75 ribavirin (A1)
kg, respectively) for 24 weeks, pending further data
comparing 12 weeks with ribavirin and 24 weeks with • Based on data in patients infected with HCV genotype
and without ribavirin in this population (B1) 1, patients with compensated cirrhosis, including
treatment-naïve and treatment-experienced patients,
Treatment of HCV genotype 4 infection should be treated with this fixed-dose combination for
12 weeks with daily weight-based ribavirin (1000 or
Six treatment options are available in 2015 for patients 1200 mg in patients <75 kg or ≥75 kg, respectively) (B1)
infected with HCV genotype 4, including 2 IFN-containing
regimens and 4 IFN-free regimens. In settings where none • Patients with compensated cirrhosis with contra-
of these options is available, the combination of PegIFN- indications to the use of ribavirin or with poor tolerance
αand ribavirin remains acceptable; see prior EASL Clinical to ribavirin on treatment should receive the fixed-dose
Practice Guidelines. combination of sofosbuvir and ledipasvir for 24 weeks
without ribavirin (B1)
Genotype 4, IFN-containing Option 1
• Based on data in patients infected with HCV genotype
1, treatment with the fixed-dose combination of
sofosbuvir and ledipasvir with ribavirin can be prolonged
to 24 weeks in treatment-experienced patients with
compensated cirrhosis and negative predictors of
response, such as a platelet count <75 x 103/μl (B1)
• Patients infected with HCV genotype 4 can be treated Genotype 4, IFN-free Option 2
with a combination of weekly PegIFN-α, daily weight-
based ribavirin (1000 or 1200 mg in patients <75 kg or • Patients infected with HCV genotype 4 without cirrhosis
≥75 kg, respectively), and daily sofosbuvir (400 mg) 12 can be treated with an IFN-free regimen comprising
weeks (B1) the fixed-dose combination of ombitasvir (75 mg),
paritaprevir (12.5 mg) and ritonavir (50 mg) in one
Genotype 4, IFN-containing Option 2 single tablet (two tablets once daily with food), for 12
weeks with daily weight-based ribavirin (1000 or 1200
• Patients infected with HCV genotype 4 can be treated mg in patients <75 kg or ≥75 kg, respectively), without
with a combination of weekly PegIFN-α, daily weight- dasabuvir (B1)
based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively), and daily simeprevir (150 mg) • Patients infected with HCV genotype 4 with cirrhosis
(B1) should be treated with the fixed-dose combination
of ombitasvir (75 mg), paritaprevir (12.5 mg) and
• Simeprevir should be administered 12 weeks in ritonavir (50 mg) in one single tablet (two tablets once
combination with PegIFN-α and ribavirin. PegIFN-α daily with food), for 24 weeks with daily weight-based
and ribavirin should then be administered alone for ribavirin (1000 or 1200 mg in patients <75 kg or ≥75 kg,
an additional 12 weeks (total treatment duration 24 respectively), without dasabuvir, pending further data
weeks) in treatment-naïve and prior relapser patients, (B1)
including cirrhotic patients, an additional 36 weeks (total
treatment duration 48 weeks) in prior partial and null
responders, including cirrhotic patients (B1)
• HCV RNA levels should be monitored on treatment.
Treatment should be stopped if HCV RNA level is ≥25
IU/ml at treatment week 4, week 12 or week 24 (A2)
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