Page 27 - EASL Recommendations on Treatment of Hepatitis C 2015 - Full version
P. 27
Clinical Practice Guidelines
Recommendations
• Patients who failed after PegIFN-α and ribavirin combination of sofosbuvir and daclatasvir (genotypes
combination treatment must be retreated like 2, 3, 5 and 6) or with the combination of sofosbuvir and
treatment-naïve patients, according to the above ledipasvir (genotypes 5 and 6) (B2)
recommendations by HCV genotype (A1)
• Patients infected with genotype 1 or 4 who failed on a
• Patients infected with HCV genotype 1 who failed after regimen containing sofosbuvir and simeprevir should
a triple combination regimen of PegIFN-α, ribavirin and be retreated with a combination of sofosbuvir with
either telaprevir or boceprevir should be retreated with daclatasvir or ledipasvir (B2)
the IFN-free combination of sofosbuvir and ledipasvir,
or sofosbuvir and daclatasvir, with ribavirin for 12 weeks • Patients who failed on a regimen containing sofosbuvir
(A1) and daclatasvir or sofosbuvir and ledipasvir should
be retreated with a combination of sofosbuvir and
• Recommendations for retreatment after failure of simeprevir (genotype 1 and 4). Patients infected
second-wave DAA-based anti-HCV regimens are based with other genotypes should be retreated with the
on indirect evidence and subject to change when more combination of sofosbuvir and daclatasvir (genotypes
data become available (A1) 2, 3, 5 and 6) or with the combination of sofosbuvir and
ledipasvir (genotypes 5 and 6) for 24 weeks (B2)
• Patients who failed on a second-wave DAA-containing
regimen, with or without PegIFN-α, with or without • Patients infected with genotype 1 who failed on the
ribavirin, should be retreated with an IFN-free regimen triple combination of ritonavir-boosted paritaprevir,
for 12 weeks with weight-based ribavirin. Extending ombitasvir and dasabuvir should be retreated with
therapy to 24 weeks with ribavirin may be considered, a sofosbuvir-based regimen, e.g. sofosbuvir and
especially in patients with advanced liver disease, simeprevir, sofosbuvir and daclatasvir or sofosbuvir and
including extensive fibrosis (F3) and cirrhosis (F4) (B2) ledipasvir (B2)
• Patients who failed on sofosbuvir alone or sofosbuvir • Patients infected with genotype 4 who failed on the
plus ribavirin or sofosbuvir plus PegIFN-α and ribavirin double combination of ritonavir-boosted paritaprevir and
can be retreated with a combination of sofosbuvir plus ombitasvir should be retreated with a sofosbuvir-based
simeprevir (genotype 1 or 4), sofosbuvir plus daclatasvir regimen, e.g. sofosbuvir and simeprevir, sofosbuvir and
(all genotypes) or sofosbuvir plus ledipasvir (genotypes daclatasvir or sofosbuvir and ledipasvir (B2)
1, 4, 5 or 6), or with ritonavir-boosted paritaprevir,
ombitasvir and dasabuvir (genotype 1), or with ritonavir- • Alternatively, patients without an urgent need for
boosted paritaprevir and ombitasvir (genotype 4) (B2) treatment can wait until more data and/or alternative
therapeutic options become available (A1)
• Patients infected with HCV genotype 1 or 4 who failed
on a regimen combining PegIFN-α, ribavirin and • The efficacy and safety of a triple combination regimen
simeprevir should be retreated with a combination of including sofosbuvir, an NS3 protease inhibitor and
sofosbuvir with daclatasvir or ledipasvir (B2) an NS5A protease inhibitor in patients who failed on a
DAA-containing regimen is unknown (B2)
• Patients who failed on a regimen combining PegIFN-α,
ribavirin and daclatasvir should be retreated with • The utility of HCV resistance testing (i.e. the
a combination of sofosbuvir and simeprevir (if they determination of the sequence of the DAA target region)
are infected with genotype 1 or 4). Patients infected prior to retreatment in patients who failed on any of the
with other genotypes should be retreated with the DAA-containing treatment regimens is unknown (B2)
Treatment of patients with severe liver disease benefits and the effect of this treatment on portal pressure have
not been reported.
Patients with decompensated cirrhosis without an indication for liver
transplantation A study assessed the safety and efficacy of the fixed-dose
combination of sofosbuvir and ledipasvir with ribavirin for 12
The main goal of anti-HCV therapy in patients with decompen- or 24 weeks in patients with decompensated cirrhosis (Child-
sated cirrhosis not on a transplant waiting list is to achieve Pugh score up to 12) infected with HCV genotype 1 or 4 [89].
improvement in liver function and survival. A 48-week regimen The SVR rates were 87% (45/52) and 89% (42/47) after 12 and
of sofosbuvir and ribavirin is being assessed in patients with cir- 24 weeks of treatment, respectively; treatment was equally effec-
rhosis and portal hypertension [88]. Preliminary results demon- tive in patients with Child-Pugh B and Child-Pugh C cirrhosis.
strated excellent on treatment responses and slight There was a clear effect of viral clearance on liver function, with
improvements in liver function tests. The long-term clinical significant improvements in bilirubin, albumin and INR values
and, as a result, in MELD and Child-Pugh scores. Improvement
26
Recommendations
• Patients who failed after PegIFN-α and ribavirin combination of sofosbuvir and daclatasvir (genotypes
combination treatment must be retreated like 2, 3, 5 and 6) or with the combination of sofosbuvir and
treatment-naïve patients, according to the above ledipasvir (genotypes 5 and 6) (B2)
recommendations by HCV genotype (A1)
• Patients infected with genotype 1 or 4 who failed on a
• Patients infected with HCV genotype 1 who failed after regimen containing sofosbuvir and simeprevir should
a triple combination regimen of PegIFN-α, ribavirin and be retreated with a combination of sofosbuvir with
either telaprevir or boceprevir should be retreated with daclatasvir or ledipasvir (B2)
the IFN-free combination of sofosbuvir and ledipasvir,
or sofosbuvir and daclatasvir, with ribavirin for 12 weeks • Patients who failed on a regimen containing sofosbuvir
(A1) and daclatasvir or sofosbuvir and ledipasvir should
be retreated with a combination of sofosbuvir and
• Recommendations for retreatment after failure of simeprevir (genotype 1 and 4). Patients infected
second-wave DAA-based anti-HCV regimens are based with other genotypes should be retreated with the
on indirect evidence and subject to change when more combination of sofosbuvir and daclatasvir (genotypes
data become available (A1) 2, 3, 5 and 6) or with the combination of sofosbuvir and
ledipasvir (genotypes 5 and 6) for 24 weeks (B2)
• Patients who failed on a second-wave DAA-containing
regimen, with or without PegIFN-α, with or without • Patients infected with genotype 1 who failed on the
ribavirin, should be retreated with an IFN-free regimen triple combination of ritonavir-boosted paritaprevir,
for 12 weeks with weight-based ribavirin. Extending ombitasvir and dasabuvir should be retreated with
therapy to 24 weeks with ribavirin may be considered, a sofosbuvir-based regimen, e.g. sofosbuvir and
especially in patients with advanced liver disease, simeprevir, sofosbuvir and daclatasvir or sofosbuvir and
including extensive fibrosis (F3) and cirrhosis (F4) (B2) ledipasvir (B2)
• Patients who failed on sofosbuvir alone or sofosbuvir • Patients infected with genotype 4 who failed on the
plus ribavirin or sofosbuvir plus PegIFN-α and ribavirin double combination of ritonavir-boosted paritaprevir and
can be retreated with a combination of sofosbuvir plus ombitasvir should be retreated with a sofosbuvir-based
simeprevir (genotype 1 or 4), sofosbuvir plus daclatasvir regimen, e.g. sofosbuvir and simeprevir, sofosbuvir and
(all genotypes) or sofosbuvir plus ledipasvir (genotypes daclatasvir or sofosbuvir and ledipasvir (B2)
1, 4, 5 or 6), or with ritonavir-boosted paritaprevir,
ombitasvir and dasabuvir (genotype 1), or with ritonavir- • Alternatively, patients without an urgent need for
boosted paritaprevir and ombitasvir (genotype 4) (B2) treatment can wait until more data and/or alternative
therapeutic options become available (A1)
• Patients infected with HCV genotype 1 or 4 who failed
on a regimen combining PegIFN-α, ribavirin and • The efficacy and safety of a triple combination regimen
simeprevir should be retreated with a combination of including sofosbuvir, an NS3 protease inhibitor and
sofosbuvir with daclatasvir or ledipasvir (B2) an NS5A protease inhibitor in patients who failed on a
DAA-containing regimen is unknown (B2)
• Patients who failed on a regimen combining PegIFN-α,
ribavirin and daclatasvir should be retreated with • The utility of HCV resistance testing (i.e. the
a combination of sofosbuvir and simeprevir (if they determination of the sequence of the DAA target region)
are infected with genotype 1 or 4). Patients infected prior to retreatment in patients who failed on any of the
with other genotypes should be retreated with the DAA-containing treatment regimens is unknown (B2)
Treatment of patients with severe liver disease benefits and the effect of this treatment on portal pressure have
not been reported.
Patients with decompensated cirrhosis without an indication for liver
transplantation A study assessed the safety and efficacy of the fixed-dose
combination of sofosbuvir and ledipasvir with ribavirin for 12
The main goal of anti-HCV therapy in patients with decompen- or 24 weeks in patients with decompensated cirrhosis (Child-
sated cirrhosis not on a transplant waiting list is to achieve Pugh score up to 12) infected with HCV genotype 1 or 4 [89].
improvement in liver function and survival. A 48-week regimen The SVR rates were 87% (45/52) and 89% (42/47) after 12 and
of sofosbuvir and ribavirin is being assessed in patients with cir- 24 weeks of treatment, respectively; treatment was equally effec-
rhosis and portal hypertension [88]. Preliminary results demon- tive in patients with Child-Pugh B and Child-Pugh C cirrhosis.
strated excellent on treatment responses and slight There was a clear effect of viral clearance on liver function, with
improvements in liver function tests. The long-term clinical significant improvements in bilirubin, albumin and INR values
and, as a result, in MELD and Child-Pugh scores. Improvement
26
