Initial Treatment Box. Summary of Recommendations for Patients Who are Initiating Therapy for HCV Infection or Who Experienced Relapse after Prior PEG/RBV Therapy, by HCV Genotype

Summary of Recommendations for Patients Who Are Initiating Therapy for HCV Infection by HCV Genotype

 

Genotype 1a Treatment-Naïve 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 treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis and in whom no baseline NS5A RASs§ 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 treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis. Rating: Class I, Level A. An 8-week duration is Recommended for treatment-naïve patients without cirrhosis who are non-black, HIV-uninfected, and whose HCV RNA level is <6 million IU/mL. Rating: Class I, Level B
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) as part of an extended-release regimen or plus twice-daily dosed dasabuvir (250 mg), with weight-based ribavirin for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1a infection who do not have cirrhosis.
    Rating: Class I, Level B

§ Includes G1a substitutions 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 Treatment-Naïve 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 treatment-naïve patients with HCV genotype 1a infection who havecompensated cirrhosis and in whom no baseline NS5A RASs§ 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 treatment-naïve patients with HCV genotype 1a infection who havecompensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1a infection who havecompensated cirrhosis.
    Rating: Class I, Level A

For decompensated cirrhosis, please refer to the appropriate section.

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

 

Genotype 1a Treatment-Naïve 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 but have baseline NS5A RASs§ for elbasvir.
    Rating: Class IIa, Level B

§ Includes G1a substitutions at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.
Genotype 1a Treatment-Naïve 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) with dasabuvir (600 mg) as part of an extended-release regimen or plus twice-daily dosed dasabuvir (250 mg), with weight-based ribavirin for 24 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 1a infection who have compensated cirrhosis.
    Rating: Class I, Level A
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 1a infection who have compensated cirrhosis and in whom no Q80K substitution is detected.
    Rating: Class II, Level B
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 24 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 1a infection who have compensated cirrhosis.
    Rating: Class IIa, Level B
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) with weight-based ribavirin for 16 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 1a infection who have compensated cirrhosis and have baseline NS5A RASs§ for elbasvir.
    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.
* 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 substitutions at amino acid positions 28, 30, 31, or 93. Amino acid substitutions that confer resistance.

 

Genotype 1b Treatment-Naïve 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 treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis. Rating: Class I, Level A. An 8-week duration is Recommended for treatment-naïve patients without cirrhosis who are non-black, HIV-uninfected, and whose HCV RNA level is <6 million IU/mL. Rating: Class I, Level B
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) as part of an extended-release regimen or plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily simeprevir (150 mg) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who do not have cirrhosis.
    Rating: Class I, 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 Treatment-Naïve 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 treatment-naïve patients with HCV genotype 1b infection who havecompensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who havecompensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) as part of an extended-release regimen or plus twice-daily dosed dasabuvir (250 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who have compensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1b infection who havecompensated cirrhosis.
    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 Treatment-Naïve Patients with Compensated Cirrhosis– Alternative
Alternative 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 an Alternative regimen for treatment-naïve patients with HCV genotype 1b infection who have compensated cirrhosis.
    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 treatment-naïve patients with HCV genotype 1b infection who have compensated cirrhosis.
    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 Treatment-Naïve Patients Without Cirrhosis – Recommended

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

Genotype 2 Treatment-Naïve Patients Without Cirrhosis – Alternative

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 2 infection who do not have cirrhosis.
    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 antiretoviral therapy.

 

Genotype 2 Treatment-Naïve Patients with Compensated Cirrhosis– Recommended

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 2 infection who havecompensated cirrhosis.
    Rating: Class I, Level A

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Genotype 2 Treatment-Naïve Patients with Compensated Cirrhosis– Alternative

  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 16 weeks to 24 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 2 infection who have compensated cirrhosis.
    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 antiretoviral therapy.

 

Genotype 3 Treatment-Naïve 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 treatment-naïve patients with HCV genotype 3 infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 3 infection who do not have cirrhosis.
    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 antiretoviral therapy.

 

Genotype 3 Treatment-Naïve 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) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 3 infection who havecompensated cirrhosis.
    Rating: Class I, Level A
  • Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 24 weeks with or without weight-based ribavirin is a Recommended regimen for treatment-naïve patients with HCV genotype 3 infection who have compensated cirrhosis.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.

RAS testing for Y93H is recommended for cirrhotic patients and ribavirin should be included in regimen if present.

* 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 antiretoviral therapy.

 

Genotype 4 Treatment-Naïve 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) and weight-based ribavirin for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection who do not have cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection who do not have cirrhosis.
    Rating: Class IIa, Level B
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection who do not have cirrhosis.
    Rating: Class IIa, Level B 

Genotype 4 Treatment-Naïve 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) and weight-based ribavirin for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection, who have compensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection, who havecompensated cirrhosis.
    Rating: Class I, Level A
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection, who havecompensated cirrhosis.
    Rating: Class IIa, Level B
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 4 infection, who havecompensated cirrhosis.
    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 5/6 Treatment-Naïve Patients with and Without Cirrhosis – Recommended

  • Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 5 or 6 infection regardless of cirrhosis status.
    Rating: Class I, Level B
  • Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 5 or 6 infection, regardless of cirrhosis status.
    Rating: Class IIa, Level B

Changes made April 12, 2017.

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