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Guideline Summary
Guideline Title
Diagnosis, management, and treatment of hepatitis C: an update.
Bibliographic Source(s)
Ghany MG, Strader DB, Thomas DL, Seeff LB, American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. [419 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Strader DB, Wright T, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C. Hepatology 2004 Apr;39(4):1147-71.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • September 25, 2013 – Arzerra (ofatumumab) and Rituxan (rituximab) External Web Site Policy: The U.S. Food and Drug Administration (FDA) approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.

Scope

Disease/Condition(s)

Hepatitis C

Guideline Category
Diagnosis
Evaluation
Management
Risk Assessment
Screening
Treatment
Clinical Specialty
Family Practice
Gastroenterology
Infectious Diseases
Internal Medicine
Pediatrics
Preventive Medicine
Intended Users
Physicians
Guideline Objective(s)

To provide clinicians with approaches to the diagnosis, management, and prevention of hepatitis C virus (HCV) infection

Target Population

Screening

  • Persons who have injected illicit drugs in the recent and remote past, including those who injected only once and do not consider themselves to be drug users
  • Persons with conditions associated with a high prevalence of hepatitis C virus (HCV) infection, including:
    • Persons with human immunodeficiency virus (HIV) infection
    • Persons with hemophilia who received clotting factor concentrates prior to 1987
    • Persons who have ever been on hemodialysis
    • Persons with unexplained abnormal aminotransferase levels
  • Prior recipients of transfusions or organ transplants prior to July 1992, including:
    • Persons who were notified that they had received blood from a donor who later tested positive for HCV infection
    • Persons who received a transfusion of blood or blood products
    • Persons who received an organ transplant
    • Children born to HCV-infected mothers
    • Health care, emergency medical, and public safety workers after a needle stick injury or mucosal exposure to HCV-positive blood
    • Current sexual partners of HCV-infected persons

Counseling/Treatment

Hepatitis C virus-infected adults and children

Interventions and Practices Considered

Screening/Diagnosis

  1. Risk assessment
  2. Counseling on how to avoid hepatitis C virus (HCV) transmission
  3. Laboratory testing including testing for HCV antibodies, HCV ribonucleic acid (RNA), HCV genotyping
  4. Assay interpretation
  5. Liver biopsy and noninvasive tests of fibrosis

Treatment/Management

  1. Pegylated interferon (peginterferon) alfa and ribavirin
  2. Duration of treatment based on HCV genotype
  3. Management of adverse events (acetaminophen, nonsteroidal anti-inflammatory drugs, antidepressants, growth factors)
  4. Timing and duration of assessment of response
  5. Extended therapy as indicated
  6. Considerations (e.g., age, dose adjustments) for special patient groups:
    • Patients with normal alanine aminotransferase (ALT) levels
    • Children, including age at initial testing and treatment
    • Patients with human immunodeficiency virus (HIV) coinfection, including adjustments to anti-HIV medication
    • Patients with kidney disease, including use of rituximab, cyclophosphamide plus methylprednisolone, or plasma exchange followed by interferon-based treatment (as indicated)
    • African-American
    • Compensated or decompensated cirrhosis, including considerations for liver transplantation and growth factors for treatment-associated anemia and leukopenia
    • Patients with solid organ transplantations (heart, lung, kidney)
    • Retreatment of persons who failed to respond to previous treatment (e.g., persons previously treated using non-pegylated interferon)
  7. Treatment of acute HCV
  8. Treatment of active injection drug users
    • Individualized decisions to treat persons who currently use illicit drugs or who are on methadone maintenance program
    • Continued support from drug abuse and psychiatric counseling services
  9. Treatment of patients with concomitant psychiatric disorders with currently approved regimens and support of multi-disciplinary team that includes psychiatric counseling services

General Management Issues

  1. Vaccination against hepatitis A and B
  2. Abstention from alcohol consumption
  3. Monitoring of patients with HCV related cirrhosis for development of hepatocellular carcinoma
Major Outcomes Considered

  • Sensitivity and specificity of diagnostic tests
  • Risk factors for hepatitis C virus (HCV) infection transmission
  • Predictors of treatment response
  • Efficacy and safety of treatment
  • Rate of early virological response (EVR) to treatment
  • Rate of sustained virological response (SVR) to treatment
  • Treatment discontinuation rate
  • Morbidity and mortality
  • Effect of HCV infection on comorbidities
  • Costs of treatment

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Medline search up to September 2008

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

Level A Data derived from multiple randomized clinical trials or meta-analyses

Level B Data derived from a single randomized trial, or nonrandomized studies

Level C Only consensus opinion of experts, case studies, or standard-of-care

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The recommendations are based on the following : (1) a formal review and analysis of the recently published world literature on the topic; (2) the American College of Physicians' Manual for Assessing Health Practices and Designing Practice Guidelines; (3) guideline policies, including the American Association for the Study of Liver Diseases' (AASLD) Policy on the Development and Use of Practice Guidelines and the American Gastroenterological Association's Policy Statement on the Use of Medical Practice Guidelines; and (4) the experience of the authors in regard to hepatitis C.

Rating Scheme for the Strength of the Recommendations

Grading System for Recommendations

Class I Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation procedure or treatment is beneficial, useful, and effective

Class II Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a diagnostic evaluation, procedure, or treatment

Class IIa Weight of evidence/opinion is in favor of usefulness/efficacy

Class IIb Usefulness/efficacy is less well established by evidence/opinion

Class III Conditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure/treatment is not useful/effective and in some cases may be harmful

Cost Analysis

The guideline developers reviewed published cost analyses.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

This document has been approved by the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America, and the American College of Gastroenterology. This update of a previously published practice guideline was produced in collaboration with the Practice Guidelines Committee of the AASLD which provided extensive peer review of the manuscript.

Recommendations

Major Recommendations

The grading system for the class of recommendations (I, II, IIa, IIb, III) and the levels of evidence (A–C) are defined at the end of the "Major Recommendations" field.

Testing and Counseling

Testing

  1. As part of a comprehensive health evaluation, all persons should be screened for behaviors that place them at high risk for hepatitis C virus (HCV) infection. (Class I, Level B)
  2. Persons who are at risk should be tested for the presence of HCV infection (see below). (Class I, Level B)

    Persons for Whom HCV Screening Is Recommended

    • Persons who have injected illicit drugs in the recent and remote past, including those who injected only once and do not consider themselves to be drug users
    • Persons with conditions associated with a high prevalence of HCV infection, including:
      • Persons with human immunodeficiency virus (HIV) infection
      • Persons with hemophilia who received clotting factor concentrates prior to 1987
      • Persons who have ever been on hemodialysis
      • Persons with unexplained abnormal aminotransferase levels
    • Prior recipients of transfusions or organ transplants prior to July 1992, including:
      • Persons who were notified that they had received blood from a donor who later tested positive for HCV infection
      • Persons who received a transfusion of blood or blood products
      • Persons who received an organ transplant
    • Children born to HCV-infected mothers
    • Health care, emergency medical, and public safety workers after a needle stick injury or mucosal exposure to HCV-positive blood
    • Current sexual partners of HCV-infected persons*

    Note: Adapted from Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Recomm Rep 1998;47(RR-19):1–39.

    *Although the prevalence of infection is low, a negative test in the partner provides reassurance, making testing of sexual partners of benefit in clinical practice.

Counseling

  1. Persons infected with HCV should be counseled on how to avoid HCV transmission to others (refer to Table 3 in the original guideline document for more information) (Class I, Level C).

Diagnosis of Acute and Chronic HCV Infection and Interpretation of Assays

  1. Patients suspected of having acute or chronic HCV infection should first be tested for anti-HCV. (Class I, Level B)
  2. HCV ribonucleic acid (RNA) testing should be performed in:
    1. Patients with a positive anti-HCV test (Class I, Level B)
    2. Patients for whom antiviral treatment is being considered, using a sensitive quantitative assay (Class I, Level A)
    3. Patients with unexplained liver disease whose anti-HCV test is negative and who are immune-compromised or suspected of having acute HCV infection (Class I, Level B)
  1. HCV genotype should be determined in all HCV-infected persons prior to interferon-based treatment in order to plan for the dose and duration of therapy and to estimate the likelihood of response (Class I, Level A).

Utility of the Liver Biopsy and Noninvasive Tests of Fibrosis

  1. A liver biopsy should be considered in patients with chronic hepatitis C infection if the patient and health care provider wish information regarding fibrosis stage for prognostic purposes or to make a decision regarding treatment. (Class IIa, Level B)
  2. Currently available noninvasive tests may be useful in defining the presence or absence of advanced fibrosis in persons with chronic hepatitis C infection, but should not replace the liver biopsy in routine clinical practice. (Class IIb, Level C)

Assessment Prior to Treatment and Monitoring During and After Therapy

  1. Treatment decisions should be individualized based on the severity of liver disease, the potential for serious side effects, the likelihood of treatment response, the presence of comorbid conditions, and the patient's readiness for treatment. (Class IIa, Level C)
  2. For patients in whom liver histology is available, treatment is indicated in those with bridging fibrosis or compensated cirrhosis provided they do not have contraindications to therapy (Class I, Level B).
  3. The optimal therapy for chronic HCV infection is the combination of peginterferon alfa and ribavirin. (Class I, Level A)
  4. HCV RNA should be tested by a highly sensitive quantitative assay at the initiation of or shortly before treatment and at week 12 of therapy. (Class I, Level A)

Genotypes 1 and 4 HCV Infection

  1. Treatment with peginterferon plus ribavirin should be planned for 48 weeks; the dose for peginterferon alfa-2a is 180 micrograms subcutaneously per week together with ribavirin using doses of 1,000 mg for those <75 kg in weight and 1,200 mg for those >75 kg; the dose for peginterferon alfa-2b is 1.5 micrograms/kg subcutaneously per week together with ribavirin using doses of 800 mg for those weighing <65 kg; 1,000 mg for those weighing >65 kg to 85 kg, 1,200 mg for >85 kg to 105 kg, and 1,400 mg for >105 kg. (Class I, Level A)
  2. Treatment may be discontinued in patients who do not achieve an early virologic response (EVR; >2 log reduction in HCV RNA at week 12 of treatment. (Class I, Level A)
  3. Patients who do not achieve a complete EVR (undetectable HCV RNA at week 12 of treatment) should be re-tested at week 24, and if HCV RNA remains positive, treatment should be discontinued. (Class I, Level A)
  4. For patients with genotype 1 infection who have delayed virus clearance (HCV RNA test becomes negative between weeks 12 and 24), consideration should be given to extending therapy to 72 weeks. (Class IIa, Level B)
  5. Patients with genotype 1 infection whose treatment continues through 48 to 72 weeks and whose measurement of HCV RNA with a highly sensitive assay is negative at the end of treatment should be retested for HCV RNA 24 weeks later to evaluate for a sustained virological response (SVR; HCV RNA negative 24 weeks after cessation of treatment). (Class I, Level A)

Genotype 2 or Genotype 3 HCV Infection

  1. Treatment with peginterferon plus ribavirin should be administered for 24 weeks, using a ribavirin dose of 800 mg. (Class I, Level A)
  2. Patients whose treatment continues through 24 weeks and whose measurement of HCV RNA with a highly sensitive assay is negative, should be retested for HCV RNA 24 weeks later to evaluate for an SVR. (Class I, Level A)
  3. Patients with HCV-related cirrhosis who achieve an SVR, regardless of the genotype, should continue to be monitored at 6 to 12 month intervals for the development of HCC. (Class IIa, Level C)

Retreatment of Persons Who Failed to Respond to Previous Treatment

  1. Retreatment with peginterferon plus ribavirin in patients who did not achieve an SVR after a prior full course of peginterferon plus ribavirin is not recommended even if a different type of peginterferon is administered. (for relapsers, Class III, Level C; for non-responders, Class III, Level B)
  2. Retreatment with peginterferon plus ribavirin can be considered for non-responders or relapsers who have previously been treated with non-pegylated interferon with or without ribavirin, or with peginterferon monotherapy, particularly if they have bridging fibrosis or cirrhosis. (Class IIa, Level B)
  3. Maintenance therapy is not recommended for patients with bridging fibrosis or cirrhosis who have failed a prior course of peginterferon and ribavirin. (Class III, Level B)

Special Patient Groups

Treatment of Persons with Normal Serum Aminotransferase Values

  1. Regardless of the serum alanine aminotransferase levels, the decision to initiate therapy with pegylated interferon and ribavirin should be individualized based on the severity of liver disease by liver biopsy, the potential of serious side effects, the likelihood of response, and the presence of comorbid conditions. (Class I, Level B)
  2. The treatment regimen for HCV-infected persons with normal aminotransferase levels should be the same as that used for persons with elevated serum aminotransferase levels. (Class I, Level B)

Diagnosis and Treatment of HCV-Infected Children

  1. The diagnosis and testing of children suspected of  being infected with chronic HCV should proceed as with adults. (Class I, Level B)
  2. Routine testing for anti-HCV at birth of children born to HCV-infected mothers is not recommended because of the high rate of positive antibody due to passive transfer from the mother. Testing for anti-HCV may be performed at 18 months of age or older. (Class I, Level B)
  3. Testing for HCV RNA may be considered at 1 to 2 months of age in infants born to HCV-infected mothers if early diagnosis is desired. (Class II, Level B)
  4. Children aged 2-17 years who are infected with HCV should be considered appropriate candidates for treatment using the same criteria as that used for adults. (Class IIa, Level B)
  5. Children should be treated with pegylated interferon alfa-2b, 60 micrograms/m2 weekly in combination with ribavirin, 15 mg/kg daily for a duration of 48 weeks. (Class I, Level B)

Diagnosis, Natural History, and Treatment of Persons with HIV Coinfection

  1. Anti-HCV testing should be performed in all HIV-infected persons. (Class 1, Level B)
  2. HCV RNA testing should be performed to confirm HCV infection in HIV-infected persons who are positive for anti-HCV, as well as in those who are negative and have evidence of unexplained liver disease. (Class I, Level B)
  3. Hepatitis C should be treated in the HIV/HCV-coinfected patient in whom the likelihood of serious liver disease and a treatment response are judged to outweigh the risk of morbidity from the adverse effects of therapy. (Class I, Level A)
  4. Initial treatment of hepatitis C in most HIV-infected patients should be peginterferon alfa plus ribavirin for 48 weeks at doses recommended for HCV mono-infected patients (see recommendation 13). (Class I, Level A)
  5. When possible, patients receiving zidovudine (AZT) and especially didanosine (ddI) should be switched to an equivalent antiretroviral agent before beginning therapy with ribavirin. (Class I, Level C)
  6. HIV-infected patients with decompensated liver disease (Child-Turcotte-Pugh [CTP] Class B or C) should not be treated with peginterferon alfa and ribavirin and may be candidates for liver transplantation. (Class IIa, Level C)

Treatment of Patients with Kidney Disease

  1. All persons with chronic kidney disease awaiting renal replacement therapy, namely hemodialysis or kidney transplantation, should be screened for hepatitis C in order to plan for management and treatment. (Class I, Level B)
  2. The decision to perform a liver biopsy in patients with kidney disease should be individualized based upon the clinical assessment for the need for therapy and the need to establish the severity of the liver disease. (Class IIa, Level C)
  3. Persons with chronic HCV infection and mild kidney disease (glomerular filtration rate [GFR] >60 mL/minute) can be treated with the same combination antiviral therapy as that used in persons without kidney disease. (Class IIa, Level C)
  4. Persons with chronic HCV infection and severe kidney disease not undergoing hemodialysis can be treated with reduced doses of both peginterferon (alpha- 2a, 135 micrograms/week; alpha-2b, 1 microgram/kg/week) and ribavirin (200-800 mg/day) with careful monitoring for adverse effects. (Class IIa, Level C)
  5. Treatment of HCV in patients on dialysis may be considered with either standard interferon (2a or 2b) in a dose of 3 mU 3 times a week (t.i.w.) or reduced dose pegylated interferon 2a, 135 micrograms/week or 2b 1 microgram/kg/week. (Class IIa, level C) Ribavirin can be used in combination with interferon in a markedly reduced daily dose with careful monitoring for anemia and other adverse effects. (Class IIb, level C)
  6. Treatment is not recommended for patients with chronic HCV infection who have undergone kidney transplantation, unless they develop fibrosing cholestatic hepatitis. (Class III, Level C)
  7. Patients with cryoglobulinemia and mild to moderate proteinuria and slowly progressive kidney disease can be treated with either standard interferon or reduced doses of pegylated interferon alfa and ribavirin. (Class IIa, Level C)
  8. Patients with cryoglobulinemia and marked proteinuria with evidence of progressive kidney disease or an acute flare of cryoglobulinemia can be treated with rituximab, cyclophosphamide plus methylprednisolone, or plasma exchange followed by interferon- based treatment once the acute process has subsided. (Class IIa, Level C)

Treatment of African Americans

  1. African Americans infected with HCV who are appropriate treatment candidates should be treated with the current optimal regimen consisting of pegylated interferon and ribavirin. (Class I, Level A)
  2. African Americans with baseline neutropenia (absolute neutrophil count [ANC] <1500 mm3) should not be excluded from hepatitis C treatment. (Class IIa, Level B)

Treatment of Persons with Compensated and Decompensated Cirrhosis

  1. Patients with HCV-related compensated cirrhosis (CTP class A), can be treated with the standard regimen of pegylated interferon and ribavirin but will require close monitoring for adverse events. (Class I, Level A)
  2. Patients with HCV-related decompensated cirrhosis should be referred for consideration of liver transplantation. (Class I, Level B).
  3. Interferon-based therapy may be initiated at a low dose in patients with  decompensated cirrhosis (CTP class B and C), as long as treatment is administered by experienced clinicians with vigilant monitoring for adverse events preferably in patients who have already been accepted as candidates for liver transplantation. (Class IIb, Level B)
  4. Growth factors can be used for treatment-associated anemia and leukopenia to improve quality of life and may limit the need for antiviral dose reductions in patients with decompensated cirrhosis. (Class IIb, Level C)

Treatment of Patients After Solid Organ Transplantation

  1. Treatment of HCV-related disease following liver transplantation should be initiated in appropriate candidates after demonstration of recurrent histologic disease but should be undertaken with caution and under the supervision of a physician experienced in transplantation. (Class IIa, Level A)
  2. Peginterferon alfa either with or without ribavirin should be the preferred regimen when treating patients with hepatitis C after liver transplantation. (Class IIa, Level B)
  3. Interferon-based therapy should not be used in recipients of heart, lung, and kidney grafts, except for patients who develop fibrosing cholestatic hepatitis. (Class III, Level C).

Treatment of Persons with Acute Hepatitis C

  1. Patients with acute HCV infection should be considered for interferon-based anti-viral therapy. (Class I, Level B)
  2. Treatment can be delayed for 8 to 12 weeks after acute onset of hepatitis to allow for spontaneous resolution. (Class IIa, Level B)
  3. Although excellent results were achieved using standard interferon monotherapy, it is appropriate to consider the use of peginterferon because of its greater ease of administration. (Class I, Level B)
  4. Until more information becomes available, no definitive recommendation can be made about the optimal duration needed for treatment of acute hepatitis C; however, it is reasonable to treat for at least 12 weeks, and 24 weeks may be considered. (Class IIa, Level B)
  5. No recommendation can be made for or against the addition of ribavirin and the decision will therefore need to be considered on a case-by-case basis. (Class IIa, Level C)

Treatment of Active Injection Drug Users

  1. Treatment of HCV infection can be considered for persons even if they currently use illicit drugs or who are on a methadone maintenance program, provided they wish to take HCV treatment and are able and willing to maintain close monitoring and practice contraception. (Class IIa, Level C)
  2. Persons who use illicit drugs should receive continued support from drug abuse and psychiatric counseling services as an important adjunct to treatment of HCV infection. (Class IIa, Level C)

Treatment of Persons with Psychiatric Illnesses

  1. Patients with HCV infection and concomitant mental and psychiatric disorders can be considered for treatment using the currently approved regimens. (Class IIa, Level C)
  2. Treatment of hepatitis C infection in patients with psychiatric disorders should be undertaken only with the support of a multi-disciplinary team that should include psychiatric counseling services. (Class IIa, Level C)

General Management Issues

  1. All persons with chronic HCV infection who lack antibodies to hepatitis A and B should be offered vaccination against these two viral infections. (Class IIa, Level C)
  2. Persons with chronic HCV infection should be advised to abstain from alcohol consumption. (Class IIb, Level C)
  3. No recommendation can be made for the use of herbal products. There is no current evidence that herbal products have a role in the treatment of patients with acute or chronic HCV infection. (Class III, Level C)

Definitions:

Levels of Evidence

Level A Data derived from multiple randomized clinical trials or meta-analyses

Level B Data derived from a single randomized trial, or nonrandomized studies

Level C Only consensus opinion of experts, case studies, or standard-of-care

Grading System for Recommendations

Class I Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation procedure or treatment is beneficial, useful, and effective

Class II Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a diagnostic evaluation, procedure, or treatment

Class IIa Weight of evidence/opinion is in favor of usefulness/efficacy

Class IIb Usefulness/efficacy is less well established by evidence/opinion

Class III Conditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure/treatment is not useful/effective and in some cases may be harmful 

Clinical Algorithm(s)

The original guideline document contains algorithms for:

  • Managing and Treating Patients with Chronic Hepatitis C Virus (HCV) Infection, Genotype 1
  • Managing and Treating Patients with Chronic HCV Infection, Genotype 2 or 3

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The guidelines are based on review of the published literature and the personal experience of the authors. The type of evidence is specifically stated for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Improved diagnosis and treatment of hepatitis C virus (HCV) infection and prevention of HCV infection complications

Potential Harms

Adverse Events of Immunoassays

False positive or false negative results of enzyme immunoassays

Adverse Events of Medication

The most common adverse events in clinical trials were influenza-like side effects such as fatigue, headache, fever and rigors, which occurred in more than half of the patients, and psychiatric side effects (depression, irritability, and insomnia), which occurred in 22% to 31% of patients. Refer to the original guideline document for more information regarding adverse effects of medications.

Liver biopsy is not without risks (including pain, bleeding and perforation of other organs); it is subject to sampling error, it requires special expertise for interpreting the histopathology, it adds cost to medical care, and it is anxiety-provoking for the implicated person.

Contraindications

Contraindications

Characteristics of persons for whom therapy is currently contraindicated:

  • Major, uncontrolled depressive illness
  • Solid organ transplant (renal, heart, or lung)
  • Autoimmune hepatitis or other autoimmune condition known to be exacerbated by peginterferon and ribavirin
  • Untreated thyroid disease
  • Pregnant or unwilling to comply with adequate contraception
  • Severe concurrent medical disease such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes, chronic obstructive pulmonary disease
  • Age less than 2 years
  • Known hypersensitivity to drugs used to treat hepatitis C virus (HCV)

Qualifying Statements

Qualifying Statements

  • These recommendations suggest preferred approaches to the diagnostic, therapeutic, and preventive aspects of care. They are intended to be flexible, in contrast to standards of care, which are inflexible policies to be followed in every case.
  • This guideline represents currently acceptable recommendations; it is recognized that reasonable physicians may deviate from the strategy and remain within acceptable standards of treatment.
  • The issue of treatment of chronic hepatitis C is in constant flux. There is highly active clinical research in this area, and new information appears with increasing frequency. Presented here is the current state of the art for management and treatment of persons with chronic hepatitis C. However, these recommendations will need to be revised and updated in the future as additional critical and pivotal information becomes available.
  • The views expressed in these guidelines do not necessarily represent the views of the Department of Health and Human Services, the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, or the United States Government.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
Mobile Device Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Ghany MG, Strader DB, Thomas DL, Seeff LB, American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. [419 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2004 Apr (revised 2009 Apr)
Guideline Developer(s)
American Association for the Study of Liver Diseases - Nonprofit Research Organization
Source(s) of Funding

American Association for the Study of Liver Diseases

Guideline Committee

Practice Guidelines Committee

Composition of Group That Authored the Guideline

Primary Authors: Marc G. Ghany; Doris B. Strader; David L. Thomas; Leonard B. Seeff

Committee Members: Margaret C. Shuhart, MD, MS, (Committee Chair); Gary L. Davis, MD (Board Liaison); Kiran Bambha, MD; Andres Cardenas, MD; MMSc.; Timothy J. Davern, MD; José Franco, MD; Steven-Huy B. Han, MD; Stephen A. Harrison, MD; Charles D. Howell, MD; Simon C. Ling, MBChB, MRCP; Lawrence U. Liu, MD; Paul Martin, MD; Robert S. O'Shea, MD; Nancy Reau, MD; Bruce A. Runyon, MD; Jayant A. Talwalkar, MD, MPH; John B. Wong, MD; Colina Yim, RN, MN

Financial Disclosures/Conflicts of Interest

Drs. Marc Ghany, Leonard Seeff, and Doris Strader have no financial relationships to declare. Dr. David Thomas was on the Advisory Board of Merck, Sharpe and Dohme at the time of writing but has since resigned from this position.

Guideline Endorser(s)
American College of Gastroenterology - Medical Specialty Society
Infectious Diseases Society of America - Medical Specialty Society
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Strader DB, Wright T, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C. Hepatology 2004 Apr;39(4):1147-71.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Association for the Study of Liver Diseases Web site External Web Site Policy.

Print copies: Available from the American Association for the Study of Liver Diseases, 1729 King Street, Suite 200; Alexandria, VA 22314; Phone: 703-299-9766; Web site: www.aasld.org External Web Site Policy; e-mail: aasld@aasld.org.

Availability of Companion Documents

This guideline is available as a Personal Digital Assistant (PDA) download via the APPRISOR™ Document Viewer from www.apprisor.com External Web Site Policy.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI on July 27, 2004. The information was verified by the guideline developer as of August 25, 2004. This summary was updated on May 3, 2005 following the withdrawal of Bextra (valdecoxib) from the market and the release of heightened warnings for Celebrex (celecoxib) and other nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI on June 16, 2005, following the U.S. Food and Drug Administration advisory on COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI on December 5, 2005, following the U.S. Food and Drug Administration advisory on Aranesp, Epogen, and Procrit. This summary was updated by ECRI on January 29, 2007, following the U.S. Food and Drug Administration advisory on erythropoiesis stimulating agents. This summary was updated by ECRI Institute on July 9, 2007, following the FDA advisory on erythropoiesis stimulating agents. This summary was updated by ECRI Institute on November 6, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on February 26, 2008 following the U.S. Food and Drug Administration advisory/voluntary market withdrawal of the liquid formulation of Leukine (sargramostim). This summary was updated by ECRI Institute on March 21, 2008 following the FDA advisory on Erythropoiesis Stimulating Agents. This summary was updated by ECRI Institute on August 15, 2008 following the U.S. Food and Drug Administration advisory on Erythropoiesis Stimulating Agents (ESAs).  This summary was updated by ECRI Institute on November 4, 2009. The information was verified by the guideline developer on December 16, 2009. This summary was updated by ECRI Institute on April 1, 2010 following the U.S. Food and Drug Administration advisory on Erythropoiesis-Stimulating Agents (ESAs). This summary was updated by ECRI Institute on November 21, 2013 following the U.S. Food and Drug Administration advisory on Arzerra (ofatumumab) and Rituxan (rituximab).

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the American Association for the Study of Liver Diseases' copyright restrictions.

Disclaimer

NGC Disclaimer

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