Page 11 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 11
component of HCV clinical management (B2) 11. Retreatment of non-sustained
virological responders
• In persons who actively inject drugs, access to harm
reduction programs is mandatory (A1) • Patients who failed after PegIFN-α and ribavirin
combination treatment must be retreated like
• Peer-based support should be evaluated as a means to treatment-naïve patients, according to the above
improve HCV clinical management (B2) recommendations by HCV genotype (A1)
• Patients should be counselled to abstain from alcohol • Patients infected with HCV genotype 1 who failed after
during antiviral therapy. Patients with on-going alcohol a triple combination regimen of PegIFN-α, ribavirin and
consumption during treatment should receive additional either telaprevir or boceprevir should be retreated with
support during antiviral therapy (A1) the IFN-free combination of sofosbuvir and ledipasvir,
or sofosbuvir and daclatasvir, with ribavirin for 12 weeks
• HCV treatment can be considered also for patients (A1)
actively using drugs, provided they wish to receive
treatment and are able and willing to maintain regular • Recommendations for retreatment after failure of
appointments. Also, the potential for drug-drug second-wave DAA-based anti-HCV regimens are based
interactions involving prescribed and non-prescribed on indirect evidence and subject to change when more
drugs needs to be considered (A1) data become available (A1)
10. Post-treatment follow-up of patients who • Patients who failed on a second-wave DAA-containing
achieve an SVR regimen, with or without PegIFN-α, with or without
ribavirin, should be retreated with an IFN-free regimen
• Non-cirrhotic patients with SVR should be retested for for 12 weeks with weight-based ribavirin. Extending
ALT and HCV RNA at 48 weeks post-treatment, then therapy to 24 weeks with ribavirin may be considered,
discharged if ALT is normal and HCV RNA is negative especially in patients with advanced liver disease,
(B1) including extensive fibrosis (F3) and cirrhosis (F4) (B2)
• Cirrhotic patients, and probably also patients with • Patients who failed on sofosbuvir alone or sofosbuvir
advanced fibrosis (F3), with SVR should undergo plus ribavirin or sofosbuvir plus PegIFN-α and ribavirin
surveillance for HCC every 6 months by means of can be retreated with a combination of sofosbuvir plus
ultrasound (B1) simeprevir (genotype 1 or 4), sofosbuvir plus daclatasvir
(all genotypes) or sofosbuvir plus ledipasvir (genotypes
• Guidelines for management of portal hypertension and 1, 4, 5 or 6), or with ritonavir-boosted paritaprevir,
varices should be implemented, though index variceal ombitasvir and dasabuvir (genotype 1), or with ritonavir-
bleed is seldom seen in low-risk patients after the boosted paritaprevir and ombitasvir (genotype 4) (B2)
achievement of SVR (unless additional causes for on-
going liver damage are present and persist) (A2) • Patients infected with HCV genotype 1 or 4 who failed
on a regimen combining PegIFN-α, ribavirin and
• Patients with on-going drug use should not be excluded simeprevir should be retreated with a combination of
from HCV treatment on the basis of perceived risk of sofosbuvir with daclatasvir or ledipasvir (B2)
reinfection (B1)
• Patients who failed on a regimen combining PegIFN-α,
• The risk of reinfection should be explained to individuals ribavirin and daclatasvir should be retreated with
with on-going risk behaviour, to positively modify risk a combination of sofosbuvir and simeprevir (if they
behaviour (B1) are infected with genotype 1 or 4). Patients infected
with other genotypes should be retreated with the
• Following SVR, monitoring for HCV reinfection through combination of sofosbuvir and daclatasvir (genotypes
annual HCV RNA assessment should be undertaken in 2, 3, 5 and 6) or with the combination of sofosbuvir and
people who inject drugs or men who have sex with men ledipasvir (genotypes 5 and 6) (B2)
with on-going risk behaviour (B2)
• Patients infected with genotype 1 or 4 who failed on a
regimen containing sofosbuvir and simeprevir should
be retreated with a combination of sofosbuvir with
daclatasvir or ledipasvir (B2)
• Patients who failed on a regimen containing sofosbuvir
and daclatasvir or sofosbuvir and ledipasvir should
be retreated with a combination of sofosbuvir and
simeprevir (genotype 1 and 4). Patients infected
with other genotypes should be retreated with the
combination of sofosbuvir and daclatasvir (genotypes
2, 3, 5 and 6) or with the combination of sofosbuvir and
ledipasvir (genotypes 5 and 6) for 24 weeks (B2)
10
virological responders
• In persons who actively inject drugs, access to harm
reduction programs is mandatory (A1) • Patients who failed after PegIFN-α and ribavirin
combination treatment must be retreated like
• Peer-based support should be evaluated as a means to treatment-naïve patients, according to the above
improve HCV clinical management (B2) recommendations by HCV genotype (A1)
• Patients should be counselled to abstain from alcohol • Patients infected with HCV genotype 1 who failed after
during antiviral therapy. Patients with on-going alcohol a triple combination regimen of PegIFN-α, ribavirin and
consumption during treatment should receive additional either telaprevir or boceprevir should be retreated with
support during antiviral therapy (A1) the IFN-free combination of sofosbuvir and ledipasvir,
or sofosbuvir and daclatasvir, with ribavirin for 12 weeks
• HCV treatment can be considered also for patients (A1)
actively using drugs, provided they wish to receive
treatment and are able and willing to maintain regular • Recommendations for retreatment after failure of
appointments. Also, the potential for drug-drug second-wave DAA-based anti-HCV regimens are based
interactions involving prescribed and non-prescribed on indirect evidence and subject to change when more
drugs needs to be considered (A1) data become available (A1)
10. Post-treatment follow-up of patients who • Patients who failed on a second-wave DAA-containing
achieve an SVR regimen, with or without PegIFN-α, with or without
ribavirin, should be retreated with an IFN-free regimen
• Non-cirrhotic patients with SVR should be retested for for 12 weeks with weight-based ribavirin. Extending
ALT and HCV RNA at 48 weeks post-treatment, then therapy to 24 weeks with ribavirin may be considered,
discharged if ALT is normal and HCV RNA is negative especially in patients with advanced liver disease,
(B1) including extensive fibrosis (F3) and cirrhosis (F4) (B2)
• Cirrhotic patients, and probably also patients with • Patients who failed on sofosbuvir alone or sofosbuvir
advanced fibrosis (F3), with SVR should undergo plus ribavirin or sofosbuvir plus PegIFN-α and ribavirin
surveillance for HCC every 6 months by means of can be retreated with a combination of sofosbuvir plus
ultrasound (B1) simeprevir (genotype 1 or 4), sofosbuvir plus daclatasvir
(all genotypes) or sofosbuvir plus ledipasvir (genotypes
• Guidelines for management of portal hypertension and 1, 4, 5 or 6), or with ritonavir-boosted paritaprevir,
varices should be implemented, though index variceal ombitasvir and dasabuvir (genotype 1), or with ritonavir-
bleed is seldom seen in low-risk patients after the boosted paritaprevir and ombitasvir (genotype 4) (B2)
achievement of SVR (unless additional causes for on-
going liver damage are present and persist) (A2) • Patients infected with HCV genotype 1 or 4 who failed
on a regimen combining PegIFN-α, ribavirin and
• Patients with on-going drug use should not be excluded simeprevir should be retreated with a combination of
from HCV treatment on the basis of perceived risk of sofosbuvir with daclatasvir or ledipasvir (B2)
reinfection (B1)
• Patients who failed on a regimen combining PegIFN-α,
• The risk of reinfection should be explained to individuals ribavirin and daclatasvir should be retreated with
with on-going risk behaviour, to positively modify risk a combination of sofosbuvir and simeprevir (if they
behaviour (B1) are infected with genotype 1 or 4). Patients infected
with other genotypes should be retreated with the
• Following SVR, monitoring for HCV reinfection through combination of sofosbuvir and daclatasvir (genotypes
annual HCV RNA assessment should be undertaken in 2, 3, 5 and 6) or with the combination of sofosbuvir and
people who inject drugs or men who have sex with men ledipasvir (genotypes 5 and 6) (B2)
with on-going risk behaviour (B2)
• Patients infected with genotype 1 or 4 who failed on a
regimen containing sofosbuvir and simeprevir should
be retreated with a combination of sofosbuvir with
daclatasvir or ledipasvir (B2)
• Patients who failed on a regimen containing sofosbuvir
and daclatasvir or sofosbuvir and ledipasvir should
be retreated with a combination of sofosbuvir and
simeprevir (genotype 1 and 4). Patients infected
with other genotypes should be retreated with the
combination of sofosbuvir and daclatasvir (genotypes
2, 3, 5 and 6) or with the combination of sofosbuvir and
ledipasvir (genotypes 5 and 6) for 24 weeks (B2)
10
