Page 6 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 6
Genotype 1, IFN-containing Option 1 should be treated with this fixed-dose combination for
12 weeks with daily weight-based ribavirin (1000 or
• Patients infected with HCV genotype 1 can be treated 1200 mg in patients <75 kg or ≥75 kg, respectively) (A1)
with a combination of weekly PegIFN-α, daily weight-
based ribavirin (1000 or 1200 mg in patients <75 kg or • Patients with compensated cirrhosis with contra-
≥75 kg, respectively), and daily sofosbuvir (400 mg) 12 indications to the use of ribavirin or with poor tolerance
weeks (A1) to ribavirin on treatment should receive the fixed-dose
combination of sofosbuvir and ledipasvir for 24 weeks
Genotype 1, IFN-containing Option 2 without ribavirin (B1)
• 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 (B2)
• Patients infected with HCV genotype 1 can be treated Genotype 1, 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 1 can be treated
≥75 kg, respectively), and daily simeprevir (150 mg) with an IFN-free regimen comprising the fixed-dose
(A1) combination of ombitasvir (75 mg), paritaprevir (12.5
mg) and ritonavir (50 mg) in one single tablet (two
• This combination is not recommended in patients tablets once daily with food), and dasabuvir (250 mg)
infected with subtype 1a who have a detectable Q80K (one tablet twice daily) (A1)
substitution in the NS3 protease sequence at baseline,
as assessed by population sequencing (direct sequence • Patients infected with subtype 1b without cirrhosis
analysis) (A1) should receive this combination for 12 weeks without
ribavirin (A1)
• Simeprevir should be administered for 12 weeks in
combination with PegIFN-α and ribavirin. PegIFN-α • Patients infected with subtype 1b with cirrhosis should
and ribavirin should then be administered alone for an receive this combination for 12 weeks with daily weight-
additional 12 weeks (total treatment duration 24 weeks) based ribavirin (1000 or 1200 mg in patients <75 kg or
in treatment-naïve and prior relapser patients, including ≥75 kg, respectively) (A1)
cirrhotic patients, and for an additional 36 weeks (total
treatment duration 48 weeks) in prior partial and null • Patients infected with subtype 1a without cirrhosis
responders, including cirrhotic patients (B1) should receive this combination for 12 weeks with daily
weight-based ribavirin (1000 or 1200 mg in patients <75
• HCV RNA levels should be monitored on treatment. kg or ≥75 kg, respectively) (A1)
Treatment should be stopped if HCV RNA level is ≥25
IU/ml at treatment week 4, week 12 or week 24 (A2) • Patients infected with subtype 1a with cirrhosis should
receive this combination for 24 weeks with daily weight-
Genotype 1, IFN-free Option 1 based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively) (A1)
• Patients infected with HCV genotype 1 can be treated
with the IFN-free fixed-dose combination of sofosbuvir Genotype 1, IFN-free Option 3
(400 mg) and ledipasvir (90 mg) in a single tablet
administered once daily (A1) • Patients infected with HCV genotype 1 can be treated
with an IFN-free combination of daily sofosbuvir (400
• Patients without cirrhosis, including treatment-naïve mg) and daily simeprevir (150 mg) for 12 weeks (A1)
and treatment-experienced patients, should be treated
with this fixed-dose combination for 12 weeks without • Based on data with other IFN-free combinations,
ribavirin (A1) adding daily weight-based ribavirin (1000 or 1200
mg in patients <75 kg or ≥75 kg, respectively) is
• Treatment may be shortened to 8 weeks in treatment- recommended in patients with cirrhosis (B1)
naïve patients without cirrhosis if their baseline HCV
RNA level is below 6 million (6.8 Log) IU/ml. This should • In patients with cirrhosis with contra-indications to the
be done with caution, especially in patients with F3 use of ribavirin, extending duration of treatment to 24
fibrosis, pending demonstration of the accuracy of HCV weeks must be considered (B1)
RNA level determination within this range of values
and real-life confirmation that 8 weeks of treatment are
sufficient to achieve high SVR rates (B1)
• Patients with compensated cirrhosis, including
treatment-naïve and treatment-experienced patients,
should be treated with this fixed-dose combination for
12 weeks with daily weight-based ribavirin (1000 or
1200 mg in patients <75 kg or ≥75 kg, respectively) (A1)
5 • Patients with compensated cirrhosis with contra-
indications to the use of ribavirin or with poor tolerance
12 weeks with daily weight-based ribavirin (1000 or
• Patients infected with HCV genotype 1 can be treated 1200 mg in patients <75 kg or ≥75 kg, respectively) (A1)
with a combination of weekly PegIFN-α, daily weight-
based ribavirin (1000 or 1200 mg in patients <75 kg or • Patients with compensated cirrhosis with contra-
≥75 kg, respectively), and daily sofosbuvir (400 mg) 12 indications to the use of ribavirin or with poor tolerance
weeks (A1) to ribavirin on treatment should receive the fixed-dose
combination of sofosbuvir and ledipasvir for 24 weeks
Genotype 1, IFN-containing Option 2 without ribavirin (B1)
• 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 (B2)
• Patients infected with HCV genotype 1 can be treated Genotype 1, 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 1 can be treated
≥75 kg, respectively), and daily simeprevir (150 mg) with an IFN-free regimen comprising the fixed-dose
(A1) combination of ombitasvir (75 mg), paritaprevir (12.5
mg) and ritonavir (50 mg) in one single tablet (two
• This combination is not recommended in patients tablets once daily with food), and dasabuvir (250 mg)
infected with subtype 1a who have a detectable Q80K (one tablet twice daily) (A1)
substitution in the NS3 protease sequence at baseline,
as assessed by population sequencing (direct sequence • Patients infected with subtype 1b without cirrhosis
analysis) (A1) should receive this combination for 12 weeks without
ribavirin (A1)
• Simeprevir should be administered for 12 weeks in
combination with PegIFN-α and ribavirin. PegIFN-α • Patients infected with subtype 1b with cirrhosis should
and ribavirin should then be administered alone for an receive this combination for 12 weeks with daily weight-
additional 12 weeks (total treatment duration 24 weeks) based ribavirin (1000 or 1200 mg in patients <75 kg or
in treatment-naïve and prior relapser patients, including ≥75 kg, respectively) (A1)
cirrhotic patients, and for an additional 36 weeks (total
treatment duration 48 weeks) in prior partial and null • Patients infected with subtype 1a without cirrhosis
responders, including cirrhotic patients (B1) should receive this combination for 12 weeks with daily
weight-based ribavirin (1000 or 1200 mg in patients <75
• HCV RNA levels should be monitored on treatment. kg or ≥75 kg, respectively) (A1)
Treatment should be stopped if HCV RNA level is ≥25
IU/ml at treatment week 4, week 12 or week 24 (A2) • Patients infected with subtype 1a with cirrhosis should
receive this combination for 24 weeks with daily weight-
Genotype 1, IFN-free Option 1 based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively) (A1)
• Patients infected with HCV genotype 1 can be treated
with the IFN-free fixed-dose combination of sofosbuvir Genotype 1, IFN-free Option 3
(400 mg) and ledipasvir (90 mg) in a single tablet
administered once daily (A1) • Patients infected with HCV genotype 1 can be treated
with an IFN-free combination of daily sofosbuvir (400
• Patients without cirrhosis, including treatment-naïve mg) and daily simeprevir (150 mg) for 12 weeks (A1)
and treatment-experienced patients, should be treated
with this fixed-dose combination for 12 weeks without • Based on data with other IFN-free combinations,
ribavirin (A1) adding daily weight-based ribavirin (1000 or 1200
mg in patients <75 kg or ≥75 kg, respectively) is
• Treatment may be shortened to 8 weeks in treatment- recommended in patients with cirrhosis (B1)
naïve patients without cirrhosis if their baseline HCV
RNA level is below 6 million (6.8 Log) IU/ml. This should • In patients with cirrhosis with contra-indications to the
be done with caution, especially in patients with F3 use of ribavirin, extending duration of treatment to 24
fibrosis, pending demonstration of the accuracy of HCV weeks must be considered (B1)
RNA level determination within this range of values
and real-life confirmation that 8 weeks of treatment are
sufficient to achieve high SVR rates (B1)
• Patients with compensated cirrhosis, including
treatment-naïve and treatment-experienced patients,
should be treated with this fixed-dose combination for
12 weeks with daily weight-based ribavirin (1000 or
1200 mg in patients <75 kg or ≥75 kg, respectively) (A1)
5 • Patients with compensated cirrhosis with contra-
indications to the use of ribavirin or with poor tolerance
