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Summary of Recommendations for Patients with Decompensated Cirrhosis

 

Recommended for All Patients with HCV Infection Who Have Decompensated Cirrhosis

Recommended Regimens for Patients with HCV Genotype 1, 4, 5, or 6 Infection Who Have Decompensated Cirrhosis (Moderate or Severe Hepatic Impairment; CTP Class B or C) Who May or May Not Be Candidates for Liver Transplantation, Including Those with Hepatocellular Carcinoma
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) with weight-based ribavirin|| for 12 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 or 4 infection who have decompensated cirrhosis.
    Rating: Class I, Level B

 

|| Low initial dose of ribavirin (600 mg) is recommended for patients with CTP class C.

*The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information for daclatasvir.

Only available data for genotype 6 are in patients with compensated cirrhosis.

Only available data for genotype 5 and 6 are in small number of patients with compensated cirrhosis.

 

Recommended Regimens for Patients with HCV Genotype 1, 4, 5, or 6 Infection Who Have Decompensated Cirrhosis and Are Ribavirin Ineligible
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis and are ribavirin ineligible.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 1 or 4  infection who have decompensated cirrhosis and are ribavirin ineligible.
    Rating: Class II, Level C

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis and are ribavirin ineligible.
    Rating: Class II, Level C

 

*The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information for daclatasvir.

Only available data for genotype 6 are in patients with compensated cirrhosis.

Only available data for genotype 5 and 6 are in small number of patients with compensated cirrhosis.

 

Recommended Regimens for Patients with HCV Genotype 1, 4, 5, or 6 Infection Who Have Decompensated Cirrhosis and in Whom Prior Sofosbuvir-based or NS5A-based Treatment Has Failed

Recommended regimens are listed in groups by level of evidence, then alphabetically.
 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 24 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis and in whom prior sofosbuvir-based treatment has failed.
    Rating: Class II, Level C

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) with weight-based ribavirin|| for 24 weeks is a Recommended regimen for patients with HCV genotype 1, 4, 5, or 6 infection who have decompensated cirrhosis and in whom prior sofosbuvir-based or NS5A-based treatment has failed.
    Rating: Class II, Level C

     

|| Low initial dose of ribavirin (600 mg) is recommended for patients with CTP class C.

Only available data for genotype 6 are in patients with compensated cirrhosis.

Only available data for genotype 5 and 6 are in small number of patients with compensated cirrhosis.

 

Recommended Regimens for Patients with HCV Genotype 2 or 3 Infection Who Have Decompensated Cirrhosis (Moderate or Severe Hepatic Impairment; CTP Class B or C) and Who May or May Not Be Candidates for Liver Transplantation, Including Those with Hepatocellular Carcinoma

 

  • Daily fixed-dose combination sofosbuvir (400 mg)/velpatasvir (100 mg) with weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 2 or 3 infection who have decompensated cirrhosis and who may or may not be candidates for liver transplantation including those with hepatocellular carcinoma.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 2 or 3 infection who have decompensated cirrhosis and who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.
    Rating: Class II, Level B

 

*The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information for daclatasvir.

Changes made April 12, 2017.