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Management of Hepatitis C Infection

Stefan Zeuzem, MD
Program Director
Jordan J. Feld, MD, MPH
Hemant Shah, MD, MScCH HPTE
Released: June 17, 2019

Treatment Strategies

Genotype 1 Patients
The AASLD and the IDSA regularly update their guidance on the treatment of HCV infection.[54] Recommended treatment options for patients with genotype 1 HCV who are treatment naive differ according to cirrhosis status and subgenotype (Table 29).

Treatment may be considered in consultation with an expert in patients with severe renal impairment (creatinine clearance < 30 mL/min) or those with end-stage renal disease for whom urgent treatment is needed and kidney transplantation is not an immediately available option.. The AASLD/IDSA HCV guidance includes specific recommendations for this population. Use of HCV therapies in patients with HCV/HIV coinfection requires consideration of potential drug–drug interactions with antiretroviral therapy. Treatment switches, where needed, should be managed in collaboration with the patient’s HIV clinician. Expert consultation may be needed.

Table 29. Summary of AASLD/IDSA Recommendations for Treatment of Therapy-Naive Patients With Genotype 1 HCV Infection[54]

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Recommendations for genotype 1 HCV–infected patients in whom previous therapy has failed are summarized in Table 30. Recommendations differ according to subgenotype, cirrhosis status, and treatment experience, specifically the type of regimen on which failure occurred.

Table 30. Summary of AASLD/IDSA Recommendations for Treatment of Patients With Genotype 1 HCV Infection in Whom Previous Therapy Has Failed[54]

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Guidance from the AASLD/IDSA also states that in the presence of mixed infection (> 1 HCV genotype), treatment data are limited and when treatment is necessary, the choice of antiviral therapy and duration should maximize efficacy against all genotypes detected. Expert consultation should be sought when choice of therapy is unclear.

The EASL periodically updates their guidelines on HCV treatment.[88] The current guidelines include multiple DAA-based treatment options for treatment-naive, peginterferon/ribavirin with or without sofosbuvir-experienced patients and sofosbuvir plus ribavirin–experienced patients with genotype 1 HCV infection based on subgenotype, treatment experience, and cirrhosis status (Table 31).

Table 31. Summary of EASL Recommendations for Treatment-Naive and Peginterferon/Ribavirin With or Without Sofosbuvir or Sofosbuvir + RibavirinExperienced Patients With Genotype 1 HCV Infection With or Without Compensated Cirrhosis*

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The EASL guidelines panel also provides recommendations on management of patients who experience treatment failure with DAA-containing (protease inhibitor and/or NS5A inhibitor) regimens (Table 32). The panel notes that HCV resistance testing is useful in this setting and that clinicians working within the context of a multidisciplinary team, including virologists and experienced treaters, can select a retreatment regimen based on probabilities of response with the observed resistance profile.

Table 32. Summary of EASL Recommendations for Retreatment of Patients Who Experience Treatment Failure With Protease Inhibitor and/or NS5A InhibitorContaining Regimens

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In 2014, the World Health Organization (WHO) released first-ever guidelines on the management of HCV infection, which were revised in 2016.[109] The guidelines recommend sofosbuvir plus daclatasvir or ledipasvir/sofosbuvir for 12 weeks in patients with genotype 1 HCV infection who do not have cirrhosis. For patients with compensated cirrhosis and genotype 1 HCV infection, the following regimens are recommended: sofosbuvir plus daclatasvir for 24 weeks, ledipasvir/sofosbuvir for 24 weeks, sofosbuvir plus daclatasvir and ribavirin for 12 weeks, or ledipasvir/sofosbuvir plus ribavirin for 12 weeks.

How Should Treatment Guidelines Be Used?

Although the available treatment guidelines generally agree, there are situations where recommendations differ. In such settings, it is worthwhile to read the text of each guideline carefully to determine why decisions were made, which will hopefully help inform the decision at hand. In some instances, the different recommendations relate to availability of agents in different parts of the world, and in some cases, they are based on slightly different interpretations of available data. With the rapid changes in the field, the intention is to regularly update all of the various guidelines with online versions. Although the guidelines will be published, the online versions will reflect more recent changes and are therefore generally preferable. The guidelines offer insights beyond the medication labels, including updated information on drug–drug interactions as well as how to interpret preliminary data, which may not have resulted in a change in the labels by regulatory bodies.

Genotype 2 Patients

The AASLD and the IDSA regularly update their guidelines on the treatment of HCV infection.[54] Glecaprevir/pibrentasvir and sofosbuvir/velpatasvir are the recommended options for initial treatment of patients with genotype 2 HCV infection, regardless of cirrhosis status, although duration of treatment may be different. These 2 regimens are also recommended for patients with previous failure on peginterferon/ribavirin, regardless of cirrhosis status, and elbasvir/grazoprevir is added for those without cirrhosis (Table 33). Sofosbuvir/velpatasvir and daclatasvir plus sofosbuvir are both recommended regimens for patients with nonresponse to previous sofosbuvir plus ribavirin. Sofosbuvir/velpatasvir/voxilaprevir is the only regimen recommended for genotype 2 HCV–infected patients with sofosbuvir and NS5A inhibitor experience.

Treatment may be considered in consultation with an expert in patients with severe renal impairment (creatinine clearance < 30 mL/min) or those with end-stage renal disease for whom urgent treatment is needed and kidney transplantation is not an immediately available option. The AASLD/IDSA HCV guidance includes specific recommendations for this population. Use of HCV therapies in patients with HCV/HIV coinfection requires consideration of potential drug–drug interactions with antiretroviral therapy. Treatment switches, where needed, should be managed in collaboration with the patient’s HIV clinician. Expert consultation may be needed.

Table 33. Summary of AASLD/IDSA Recommendations for Treatment of Patients With Genotype 2 HCV Infection[54]

Close

Guidance from the AASLD/IDSA also states that in the presence of mixed infection (> 1 HCV genotype), treatment data are limited and when treatment is necessary, the choice of antiviral therapy and duration should maximize efficacy against all genotypes detected. Expert consultation should be sought when choice of therapy is unclear.

The EASL periodically updates its guidelines on HCV treatment.[88] The guidelines panel recommends sofosbuvir/velpatasvir for 12 weeks or glecaprevir-pibrentasvir:glecaprevir/pibrentasvir for 8 weeks if no cirrhosis is present or 12 weeks if compensated cirrhosis is present for patients with genotype 2 HCV infection with or without compensated cirrhosis who are treatment naive, experienced with peginterferon/ribavirin with or without sofosbuvir, or experienced with sofosbuvir plus ribavirin.

The EASL guidelines panel also provides recommendations on management of patients who experience treatment failure with DAA-containing (protease inhibitor and/or NS5A inhibitor) regimens (Table 32). The panel notes that HCV resistance testing is useful in this setting and that clinicians working within the context of a multidisciplinary team, including virologists and experienced treaters, can select a retreatment regimen based on probabilities of response with the observed resistance profile.

In 2014, the World Health Organization released first-ever guidelines on the management of HCV infection, which were revised in 2016.[109] The guidelines include a recommendation for the use of sofosbuvir in combination with ribavirin for 12 weeks in patients with genotype 2 HCV infection.

Genotype 3 Patients

The AASLD and the IDSA regularly update their guidelines on the treatment of HCV infection.[54] Glecaprevir/pibrentasvir and sofosbuvir/velpatasvir are the recommended options for treatment-naive patients with genotype 3 HCV infection whereas sofosbuvir plus daclatasvir is an alternative choice. These same 3 drug combinations plus sofosbuvir/velpatasvir/voxilaprevir are used for patients who have experienced failure of earlier therapies (Table 34).

Treatment may be considered in consultation with an expert in patients with severe renal impairment (creatinine clearance < 30 mL/min) or those with end-stage renal disease for whom urgent treatment is needed and kidney transplantation is not an immediately available option. The AASLD/IDSA HCV guidance includes specific recommendations for this population. Use of HCV therapies in patients with HCV/HIV coinfection requires consideration of potential drug–drug interactions with antiretroviral therapy. Treatment switches, where needed, should be managed in collaboration with the patient’s HIV clinician. Expert consultation may be needed.

Table 34. Summary of AASLD/IDSA Recommendations for Treatment of Patients With Genotype 3 HCV Infection[54]

Close

Guidance from the AASLD/IDSA also states that in the presence of mixed infection (> 1 HCV genotype), treatment data are limited and when treatment is necessary, the choice of antiviral therapy and duration should maximize efficacy against all genotypes detected. Expert consultation should be sought when choice of therapy is unclear.

The EASL periodically updates their guidelines on HCV treatment.[88] The current guidelines include 3 recommended treatment options for treatment-naive, peginterferon/ribavirin with or without sofosbuvir–experienced patients or sofosbuvir plus ribavirin–experienced patients with genotype 3 HCV infection (Table 35). These options include sofosbuvir/velpatasvir for 12 weeks in patients without cirrhosis, sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in patients with compensated cirrhosis, and glecaprevir-pibrentasvir:glecaprevir/pibrentasvir with duration of treatment based on treatment experience and cirrhosis status.

Table 35. Summary of EASL Recommendations for Treatment-Naive and Peginterferon/Ribavirin ± Sofosbuvir or Sofosbuvir + Ribavirin–Experienced Patients With Genotype 3 HCV Infection*[88]

Close

The EASL guidelines panel also provides recommendations on management of patients who experience treatment failure with DAA-containing (protease inhibitor and/or NS5A inhibitor) regimens (Table 32). The panel notes that HCV resistance testing is useful in this setting and that clinicians working within the context of a multidisciplinary team, including virologists and experienced treaters, can select a retreatment regimen based on probabilities of response with the observed resistance profile.

In 2014, the World Health Organization released first-ever guidelines on the management of HCV infection, which were revised in 2016.[109] The guidelines include a recommendation for the use of daclatasvir plus sofosbuvir for 12 weeks or sofosbuvir in combination with ribavirin for 24 weeks in patients with genotype 3 HCV infection who do not have cirrhosis and daclatasvir plus sofosbuvir and ribavirin for 24 weeks in those with compensated cirrhosis.

Genotype 4, 5, 6 Patients

The AASLD and the Infectious Diseases Society of America regularly update their guidelines on the treatment of HCV infection.[54] There are 4 recommended regimens for initial treatment of patients with genotype 4 HCV infection and 3 recommended regimens for patients with genotype 5 or 6 HCV infection (Table 36).

Treatment may be considered in consultation with an expert in patients with severe renal impairment (creatinine clearance < 30 mL/min) or those with end-stage renal disease for whom urgent treatment is needed and kidney transplantation is not an immediately available option. The AASLD/IDSA HCV guidance includes specific recommendations for this population. Use of HCV therapies in patients with HCV/HIV coinfection requires consideration of potential drug–drug interactions with antiretroviral therapy. Treatment switches, where needed, should be managed in collaboration with the patient’s HIV clinician. Expert consultation may be needed.

Guidance from the AASLD/IDSA also states that in the presence of mixed infection (> 1 HCV genotype), treatment data are limited and when treatment is necessary, the choice of antiviral therapy and duration should maximize efficacy against all genotypes detected. Expert consultation should be sought when choice of therapy is unclear.

Table 36. Summary of AASLD/IDSA Recommendations for Treatment of Patients With Genotype 4, 5, and 6 HCV Infection[54]

Close

The EASL guidelines on HCV treatment[88] include several recommended treatment options for treatment-naive and treatment-experienced patients with genotype 4 HCV infection (Table 37).

Table 37. Summary of EASL Recommendations for Treatment-Naive and Peginterferon/Ribavirin ± Sofosbuvir or Sofosbuvir + RibavirinExperienced Patients With Genotype 4 HCV Infection*[88]

Close

Three options are recommended by the EASL guidelines panel for patients with genotype 5 or 6 HCV.

Table 38. Summary of EASL Recommendations for Treatment-Naive and Peginterferon/Ribavirin ± Sofosbuvir or Sofosbuvir + RibavirinExperienced Patients With Genotype 5 or 6 HCV Infection*[88]

Close

The EASL guidelines panel also provides recommendations on management of patients who experience treatment failure with DAA-containing (protease inhibitor and/or NS5A inhibitor) regimens (Table 32). The panel notes that HCV resistance testing is useful in this setting and that clinicians working within the context of a multidisciplinary team, including virologists and experienced treaters, can select a retreatment regimen based on probabilities of response with the observed resistance profile.

In 2014, the World Health Organization released their first-ever guidelines on the management of HCV infection, which were revised in 2016.[109] In the absence of cirrhosis, the guidelines recommend sofosbuvir plus daclatasvir or ledipasvir/sofosbuvir for 12 weeks in patients with genotype 4 HCV infection and ledipasvir/sofosbuvir for 12 weeks in patients with genotype 5 or 6 HCV infection. For patients with compensated cirrhosis and genotype 4 HCV infection, the following regimens are recommended: sofosbuvir plus daclatasvir for 24 weeks, ledipasvir/sofosbuvir for 24 weeks, sofosbuvir plus daclatasvir and ribavirin for 12 weeks, or ledipasvir/sofosbuvir plus ribavirin for 12 weeks. For patients with genotype 5 or 6 HCV infection and compensated cirrhosis, the WHO guidance panel recommends ledipasvir/sofosbuvir for 24 weeks or ledipasvir/sofosbuvir plus ribavirin for 12 weeks.

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