Download Initial Treatment Box. Summary of Recommendations for Patients

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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.
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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
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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.
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■
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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
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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.
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■
■
■
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.
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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
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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