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Published on Recommendations for Testing, Managing, and Treating Hepatitis C (http://www.hcvguidelines.org) Home > Initial Treatment of HCV Infection > Initial Treatment Box. Summary of Recommendations for Patients Who Are Initiating Therapy for HCV Infection 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 have compensated 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 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 1a infection who have compensated 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 have compensated 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 have compensated 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 have compensated 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 have compensated 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 have compensated cirrhosis.¶ Rating: Class I, Level A Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 24 weeks with or without weightbased 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 treatmentnaïve 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 have compensated 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 have compensated 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 have compensated 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 > Click Here to Review Regimens Not Recommended in HCV Treatment < Changes made April 12, 2017. Source URL: http://www.hcvguidelines.org/full-report/initial-treatment-box-summary-recommendations-patients-who-are-initiating-thera py-hcv