Page 12 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 12
• Patients infected with genotype 1 who failed on the Patients with an indication for liver
triple combination of ritonavir-boosted paritaprevir, transplantation
ombitasvir and dasabuvir should be retreated with
a sofosbuvir-based regimen, e.g. sofosbuvir and • In patients awaiting liver transplantation, antiviral
simeprevir, sofosbuvir and daclatasvir or sofosbuvir and therapy is indicated, because it prevents graft infection
ledipasvir (B2) (A1)
• Patients infected with genotype 4 who failed on the • Treatment should be initiated as soon as possible
double combination of ritonavir-boosted paritaprevir and in order to complete a full treatment course before
ombitasvir should be retreated with a sofosbuvir-based transplantation and assess the effect of viral clearance
regimen, e.g. sofosbuvir and simeprevir, sofosbuvir and on liver function, because significant improvement in
daclatasvir or sofosbuvir and ledipasvir (B2) liver function may lead to delisting selected cases (B1)
• Alternatively, patients without an urgent need for • Patients awaiting liver transplantation should be treated
treatment can wait until more data and/or alternative with an IFN-free regimen, in principle for 12 or 24
therapeutic options become available (A1) weeks, practically up to transplantation, with ribavirin
(A1)
• The efficacy and safety of a triple combination regimen
including sofosbuvir, an NS3 protease inhibitor and • Patients with conserved liver function (Child-Pugh
an NS5A protease inhibitor in patients who failed on a A) in whom the indication for transplantation is HCC
DAA-containing regimen is unknown (B2) can be treated with the combination of sofosbuvir
and ribavirin for 16-20 weeks (genotype 2), with the
• The utility of HCV resistance testing (i.e. the fixed-dose combination of sofosbuvir and ledipasvir
determination of the sequence of the DAA target region) with ribavirin for 12 weeks (genotypes 1, 4, 5 or 6),
prior to retreatment in patients who failed on any of the with the combination of ritonavir-boosted paritaprevir,
DAA-containing treatment regimens is unknown (B2) ombitasvir and dasabuvir with ribavirin for 12 weeks
(genotype 1b) or 24 weeks (genotype 1a), with the
12. Treatment of patients with severe liver combination of ritonavir-boosted paritaprevir and
disease ombitasvir with ribavirin for 12 weeks (genotype 4),
with the combination of sofosbuvir and simeprevir with
Patients with decompensated cirrhosis without ribavirin for 12 weeks (genotypes 1 and 4), or with the
an indication for liver transplantation combination of sofosbuvir and daclatasvir with ribavirin
for 12 weeks (all genotypes) (B1)
• Patients with decompensated cirrhosis (Child-Pugh B
and Child-Pugh C, up to 12 points) not on the waiting • Treatment with PegIFN-α, ribavirin and sofosbuvir for
list for liver transplantation and without concomitant 12 weeks is acceptable in patients with compensated
comorbidities that could impact their survival can (Child-Pugh A) cirrhosis awaiting liver transplantation if
be treated with the combination of sofosbuvir and IFN-free combinations are not available (B2)
ribavirin for 16-20 weeks (genotype 2), the fixed-dose
combination of sofosbuvir and ledipasvir (genotypes • Patients with decompensated cirrhosis (Child-Pugh
1, 4, 5 and 6), or the combination of sofosbuvir and B or C) awaiting liver transplantation can be treated
daclatasvir (all genotypes), with weight-based ribavirin, with the combination of sofosbuvir and ribavirin for 12
for 12 weeks (B1) weeks (genotype 2), with the fixed-dose combination
of sofosbuvir and ledipasvir with ribavirin for 12 weeks
• Patients with decompensated cirrhosis with contra- (genotypes 1, 4, 5 or 6), or with the combination of
indications to the use of ribavirin or with poor tolerance sofosbuvir and daclatasvir with ribavirin for 12 weeks
to ribavirin on treatment should receive the fixed-dose (all genotypes); however, data are limited in patients
combination of sofosbuvir and ledipasvir (genotypes with Child-Pugh C cirrhosis >12 points or with a MELD
1, 4, 5 or 6), or the combination of sofosbuvir and score >20 (A1)
daclatasvir (all genotypes) for 24 weeks without ribavirin
(B1) • The optimal timing of treatment (i.e. before
transplantation or post-transplantation) to maximize
Patients with HCC without an indication for survival is still debatable and requires individual
liver transplantation assessment (B2)
• Due to the limited amount of safety data reported
in patients with decompensated cirrhosis awaiting
liver transplantation, frequent clinical and laboratory
assessment is necessary (B2)
• Although the long-term benefit of antiviral therapy to
reduce the risk of HCC in patients undergoing resection
or ablation for HCV-associated HCC is unknown, these
patients frequently have advanced fibrosis and should
receive appropriate antiviral therapy for their liver
disease, following the guidelines above (B2)
11
triple combination of ritonavir-boosted paritaprevir, transplantation
ombitasvir and dasabuvir should be retreated with
a sofosbuvir-based regimen, e.g. sofosbuvir and • In patients awaiting liver transplantation, antiviral
simeprevir, sofosbuvir and daclatasvir or sofosbuvir and therapy is indicated, because it prevents graft infection
ledipasvir (B2) (A1)
• Patients infected with genotype 4 who failed on the • Treatment should be initiated as soon as possible
double combination of ritonavir-boosted paritaprevir and in order to complete a full treatment course before
ombitasvir should be retreated with a sofosbuvir-based transplantation and assess the effect of viral clearance
regimen, e.g. sofosbuvir and simeprevir, sofosbuvir and on liver function, because significant improvement in
daclatasvir or sofosbuvir and ledipasvir (B2) liver function may lead to delisting selected cases (B1)
• Alternatively, patients without an urgent need for • Patients awaiting liver transplantation should be treated
treatment can wait until more data and/or alternative with an IFN-free regimen, in principle for 12 or 24
therapeutic options become available (A1) weeks, practically up to transplantation, with ribavirin
(A1)
• The efficacy and safety of a triple combination regimen
including sofosbuvir, an NS3 protease inhibitor and • Patients with conserved liver function (Child-Pugh
an NS5A protease inhibitor in patients who failed on a A) in whom the indication for transplantation is HCC
DAA-containing regimen is unknown (B2) can be treated with the combination of sofosbuvir
and ribavirin for 16-20 weeks (genotype 2), with the
• The utility of HCV resistance testing (i.e. the fixed-dose combination of sofosbuvir and ledipasvir
determination of the sequence of the DAA target region) with ribavirin for 12 weeks (genotypes 1, 4, 5 or 6),
prior to retreatment in patients who failed on any of the with the combination of ritonavir-boosted paritaprevir,
DAA-containing treatment regimens is unknown (B2) ombitasvir and dasabuvir with ribavirin for 12 weeks
(genotype 1b) or 24 weeks (genotype 1a), with the
12. Treatment of patients with severe liver combination of ritonavir-boosted paritaprevir and
disease ombitasvir with ribavirin for 12 weeks (genotype 4),
with the combination of sofosbuvir and simeprevir with
Patients with decompensated cirrhosis without ribavirin for 12 weeks (genotypes 1 and 4), or with the
an indication for liver transplantation combination of sofosbuvir and daclatasvir with ribavirin
for 12 weeks (all genotypes) (B1)
• Patients with decompensated cirrhosis (Child-Pugh B
and Child-Pugh C, up to 12 points) not on the waiting • Treatment with PegIFN-α, ribavirin and sofosbuvir for
list for liver transplantation and without concomitant 12 weeks is acceptable in patients with compensated
comorbidities that could impact their survival can (Child-Pugh A) cirrhosis awaiting liver transplantation if
be treated with the combination of sofosbuvir and IFN-free combinations are not available (B2)
ribavirin for 16-20 weeks (genotype 2), the fixed-dose
combination of sofosbuvir and ledipasvir (genotypes • Patients with decompensated cirrhosis (Child-Pugh
1, 4, 5 and 6), or the combination of sofosbuvir and B or C) awaiting liver transplantation can be treated
daclatasvir (all genotypes), with weight-based ribavirin, with the combination of sofosbuvir and ribavirin for 12
for 12 weeks (B1) weeks (genotype 2), with the fixed-dose combination
of sofosbuvir and ledipasvir with ribavirin for 12 weeks
• Patients with decompensated cirrhosis with contra- (genotypes 1, 4, 5 or 6), or with the combination of
indications to the use of ribavirin or with poor tolerance sofosbuvir and daclatasvir with ribavirin for 12 weeks
to ribavirin on treatment should receive the fixed-dose (all genotypes); however, data are limited in patients
combination of sofosbuvir and ledipasvir (genotypes with Child-Pugh C cirrhosis >12 points or with a MELD
1, 4, 5 or 6), or the combination of sofosbuvir and score >20 (A1)
daclatasvir (all genotypes) for 24 weeks without ribavirin
(B1) • The optimal timing of treatment (i.e. before
transplantation or post-transplantation) to maximize
Patients with HCC without an indication for survival is still debatable and requires individual
liver transplantation assessment (B2)
• Due to the limited amount of safety data reported
in patients with decompensated cirrhosis awaiting
liver transplantation, frequent clinical and laboratory
assessment is necessary (B2)
• Although the long-term benefit of antiviral therapy to
reduce the risk of HCC in patients undergoing resection
or ablation for HCV-associated HCC is unknown, these
patients frequently have advanced fibrosis and should
receive appropriate antiviral therapy for their liver
disease, following the guidelines above (B2)
11
