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Summary of Recommendations for Patients in Whom Previous Treatment Has Failed
 

Genotype 1a PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed, and in whom no baseline NS5A RAVs§ for elbasvir are detected.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dasabuvir (250 mg) and weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level B

     

§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 1a PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed, and in whom no baseline NS5A RAVs§ for elbasvir are detected.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

 

For decompensated cirrhosis, please refer to the appropriate section.
§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

 

 

Genotype 1a PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Alternative
 

  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) with weight-based ribavirin for 16 weeks is an Alternative regimen for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed, and who have baseline NS5A RAVs§ for elbasvir.
    Rating: Class IIa, Level B

     

§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

 

Genotype 1a PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Alternative
Alternative regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) and weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is an Alternative regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) with weight-based ribavirin for 16 weeks is an Alternative regimen for patients with HCV genotype 1a infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed, and who have baseline NS5A RAVs§ for elbasvir.
    Rating: Class I, Level B

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1a infection, who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class IIa, Level B

     
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1a infection with compensated cirrhosis who are negative for the Q80K variant by commercially available resistance assay, in whom prior PEG-IFN/ribavirin treatment has failed. Other Recommended or Alternative regimens should be used for patients with compensated cirrhosis and HCV genotype 1a infection in whom the Q80K variant is present.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.
Please see statement on FDA warning regarding the use of PrOD or PrO in patients with cirrhosis.

§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 1b PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who do not have cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class IIa, 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 1b PEG-IFN/Ribavirin Treatment-Experienced with Compensated Cirrhosis- Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

 

For decompensated cirrhosis, please refer to the appropriate section.
Please see statement on FDA warning regarding the use of PrOD or PrO in patients with cirrhosis.

 

Genotype 1b PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Alternative
Alternative regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is an Alternative regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1b infection, who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class IIa, Level B

     
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1b infection who have compensated cirrhosis, in whom prior PEG-IFN/ribavirin treatment has failed.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.
* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 1 Sofosbuvir plus Ribavirin with or Without PEG-IFN Treatment-Experienced Patients - Recommended
 

  • No Cirrhosis:
    Daily fixed-dose combination of ledipavir (90 mg)/sofosbuvir (400 mg) with weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom a previous sofosbuvir plus ribavirin-containing regimen with or without PEG-IFN has failed.
    Rating: Class IIa, Level B
     
  • Compensated Cirrhosis:
    Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom a previous sofosbuvir plus ribavirin-containing regimen with or without PEG-IFN has failed.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Genotype 1 HCV Nonstructural Protein 3 (NS3) Protease Inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

     
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) with weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed. Genotype 1a patients who have baseline NS5A RAVs§ for elbasvir should have this treatment extended to 16 weeks.
    Rating: Class IIa, 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

 

Genotype 1 HCV Nonstructural Protein 3 (NS3) Protease Inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

     
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) plus weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1 infection, regardless of subtype, who have compensated cirrhosis, in whom a prior treatment with an HCV protease inhibitor plus PEG-IFN/ribavirin has failed. Genotype 1a patients who have baseline NS5A RAVs§ for elbasvir should have this treatment extended to 16 weeks.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.
* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

§ Includes G1a polymorphisms at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

 

Genotype 1 Simeprevir plus Sofosbuvir Treatment-Experienced Patients - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Deferral of treatment is recommended, pending availability of data, for patients with HCV genotype 1 infection, regardless of subtype, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed (no prior NS5A treatment), who do not have cirrhosis, and do not have reasons for urgent retreatment.
    Rating: Class IIb, Level C

     
  • Testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended for patients with HCV genotype 1 infection, regardless of subtype, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed (no prior NS5A treatment), who have compensated cirrhosis, or have reasons for urgent retreatment. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below.
    Rating: Class II, Level C

     
  • When using nucleotide-based (eg, sofosbuvir) dual DAA therapy a treatment duration of 24 weeks is recommended, and weight-based ribavirin, unless contraindicated, should be added.
    Rating: Class II, Level C

     
  • If available, nucleotide-based (eg, sofosbuvir) triple or quadruple DAA regimens may be considered. In these settings treatment duration ranges from 12 weeks to 24 weeks (see text), and weight-based ribavirin, unless contraindicated, are recommended.
    Rating: Class II, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Recommended for Genotype 1 HCV NS5A Inhibitor Treatment-Experienced Patients
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Deferral of treatment is recommended, pending availability of data for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, who do not have cirrhosis, and do not have reasons for urgent retreatment.
    Rating: Class IIb, Level C

     
  • Testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, and who have compensated cirrhosis, or have reasons for urgent retreatment. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below.
    Rating: Class IIb, Level C

     
  • When using nucleotide-based (eg, sofosbuvir) dual DAA therapy a treatment duration of 24 weeks is recommended, and weight-based ribavirin, unless contraindicated, should be added.
    Rating: Class IIb, Level C

     
  • If available, nucleotide-based (eg, sofosbuvir) triple or quadruple DAA regimens may be considered. In these settings treatment duration ranges from 12 weeks to 24 weeks (see text), and weight-based ribavirin, unless contraindicated, are recommended.
    Rating: Class IIb, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Genotype 2 PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
 

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 2 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     

Genotype 2 PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Alternative
 

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is an Alternative regimen for patients with HCV genotype 2 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 2 PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Recommended
 

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 2 infection, who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Genotype 2 PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Alternative
 

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 16 weeks to 24 weeks is an Alternative regimen for patients with HCV genotype 2 infection, who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.

* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 2 Sofosbuvir plus Ribavirin Treatment-Experienced Patients - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 2 infection, regardless of cirrhosis status, in whom prior treatment with sofosbuvir and ribavirin has failed.
    Rating: Class IIa, Level C

     
  • 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 2 infection, regardless of cirrhosis status, in whom prior treatment with sofosbuvir and ribavirin has failed.
    Rating: Class IIa, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.
* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 3 PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 3 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 3 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     

* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

RAV testing for Y93H is recommended and ribavirin should be included in regimen if present.

 

Genotype 3 PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • 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 3 infection, who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level B

     
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 3 infection, who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.
* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 3 Sofosbuvir and Ribavirin Treatment-Experienced Patients - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 3 infection, regardless of cirrhosis status, in whom prior treatment with sofosbuvir and ribavirin has failed.
    Rating: Class IIa, Level C

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) plus weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 3 infection, regardless of cirrhosis status, in whom prior therapy with sofosbuvir and ribavirin has failed.
    Rating: Class IIa, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.

* 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 and the section on HIV/HCV coinfection for patients on antiretroviral therapy.

 

Genotype 4 PEG-IFN/Ribavirin Treatment-Experienced Patients Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) (PrO) and weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients who have HCV genotype 4 infection, who do not have cirrhosis, who experienced virologic relapse after prior PEG-IFN/ribavirin therapy. Genotype 4 patients with prior on-treatment virologic failure (failure to suppress or breakthrough) while on PEG-IFN/ribavirin should be treated with 16 weeks and have weight-based ribavirin added to the treatment regimen.
    Rating: Class IIa, Level B

     
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection, who do not have cirrhosis, in whom prior treatment with PEG-IFN/ribavirin treatment has failed.
    Rating: Class IIa, Level B

     

Genotype 4 PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) (PrO) and weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of sofosbuvir (400 mg)velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection, who have compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class I, Level A

     
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for patients who have HCV genotype 4 infection, who have compensated cirrhosis, and who experienced virologic relapse after prior PEG-IFN/ribavirin therapy. Genotype 4 patients with prior on-treatment virologic failure (failure to suppress or breakthrough) while on PEG-IFN/ribavirin should be treated with 16 weeks and have weight-based ribavirin added to the treatment regimen.
    Rating: Class IIa, Level B

     
  • Daily ledipasvir (90 mg)/sofosbuvir (400 mg) and weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 4 infection with compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed, and who are eligible for ribavirin.
    Rating: Class IIa, Level B

     

For decompensated cirrhosis, please refer to the appropriate section.
Please see statement on FDA warning regarding the use of PrOD or PrO in patients with cirrhosis.
 

 

Genotype 4 PEG-IFN/Ribavirin Treatment-Experienced Patients with Compensated Cirrhosis- Alternative

 

  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is an Alternative regimen for patients with HCV genotype 4 infection with compensated cirrhosis, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

     

For decompensated cirrhosis, please refer to the appropriate section.

 

Genotype 5 or 6 PEG-IFN/Ribavirin Treatment-Experienced Patients with or Without Cirrhosis - Recommended
Recommended regimens are listed in groups by level of evidence, then alphabetically.

 

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 5 or 6 infection regardless of cirrhosis status, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level B

     
  • Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for patients with HCV genotype 5 or 6 infection regardless of cirrhosis status, in whom prior treatment with PEG-IFN/ribavirin has failed.
    Rating: Class IIa, Level C

Changes made July 6, 2016.