Appraising the 2014 Appraising the 2014 AASLD and IDSA AASLD and IDSA

Guidelines on HCV Guidelines on HCV Testing and Linkage to Testing and Linkage to

CareCare TARIK IBRAHIM ZAHERTARIK IBRAHIM ZAHER

Professor of Tropical Medicine, Professor of Tropical Medicine, Zagazig UniversityZagazig University

ClassificationClassification Class I:Class I:Conditions for which there is evidence and/or general Conditions for which there is evidence and/or general

agreement that a given diagnostic evaluation, procedure, or agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful, and effectivetreatment is beneficial, useful, and effective

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

Class IIa:Class IIa:Weight of evidence and/or opinion is in favor of Weight of evidence and/or opinion is in favor of usefulness and efficacyusefulness and efficacy

Class IIb:Class IIb:Usefulness and efficacy are less well established by Usefulness and efficacy are less well established by evidence and/or opinionevidence and/or opinion

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

Level of EvidenceLevel of Evidence Level A:Level A:Data derived from multiple Data derived from multiple

randomized clinical trials, meta-analyses, randomized clinical trials, meta-analyses, or equivalentor equivalent

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

Level C:Level C:Consensus opinion of experts, Consensus opinion of experts, case studies, or standard of carecase studies, or standard of care

HCV testing is HCV testing is recommended at least recommended at least once for persons born once for persons born between 1945 and 1965. between 1945 and 1965.

Rating: Rating: Class I, Level BClass I, Level B

Other persons should be Other persons should be screened for risk factors screened for risk factors for HCV for HCV infectioninfection, and , and one-time testing should one-time testing should be performed for all be performed for all persons with behaviors, persons with behaviors, exposures, and conditions exposures, and conditions associated with an associated with an increased risk of HCV increased risk of HCV infectioninfection..

1-Risk behaviors1-Risk behaviors• Injection-drug use (current or ever, Injection-drug use (current or ever,

including those who injected once)including those who injected once)• Intranasal illicit drug use.Intranasal illicit drug use.

2-Risk exposures2-Risk exposures• Long-term hemodialysis (ever)Long-term hemodialysis (ever)• Getting a tattoo in an unregulated settingGetting a tattoo in an unregulated setting• Healthcare, emergency medical, and public safety Healthcare, emergency medical, and public safety

workers after needle sticks, sharps, or mucosal workers after needle sticks, sharps, or mucosal exposures to HCV-infected bloodexposures to HCV-infected blood

• Children born to HCV-infected womenChildren born to HCV-infected women• Were ever incarceratedWere ever incarcerated• Prior recipients of transfusions or organ transplants, Prior recipients of transfusions or organ transplants,

including persons who:including persons who: were notified that they received blood from a donor who were notified that they received blood from a donor who

later tested positive for HCV infectionlater tested positive for HCV infection received a transfusion of blood or blood components, or received a transfusion of blood or blood components, or

underwent an organ transplant before July 1992underwent an organ transplant before July 1992 received clotting factor concentrates produced before 1987received clotting factor concentrates produced before 1987

3-Other medical conditions3-Other medical conditions• HIV infectionHIV infection• Unexplained chronic liver disease and Unexplained chronic liver disease and

chronic hepatitis including elevated chronic hepatitis including elevated alanine aminotransferase levelsalanine aminotransferase levels

Rating: Rating: Class I, Level BClass I, Level B

An anti-HCV test is An anti-HCV test is recommended for HCV recommended for HCV testing, and if the testing, and if the result is positive, result is positive, current infection should current infection should be confirmed by a be confirmed by a sensitive RNA test.sensitive RNA test.

Rating:Rating: Class I, Level A Class I, Level A

FDA-approved, Commercially FDA-approved, Commercially Available Anti-HCV Screening Available Anti-HCV Screening

AssaysAssays Abbott HCV EIA 2.0(Abbott HCV EIA 2.0(EIA) (Manual)EIA) (Manual) Advia Centaur HCV(Advia Centaur HCV(CIA )(Automated)CIA )(Automated) ARCHITECT Anti-HCV(ARCHITECT Anti-HCV(CMIA) (Automated)CMIA) (Automated) AxSYM Anti-HCV(AxSYM Anti-HCV(MEIA) (Automated)MEIA) (Automated) OraQuick HCV Rapid Antibody OraQuick HCV Rapid Antibody

Test(Test(Immunochromatographic) (Manual)Immunochromatographic) (Manual) Ortho HCV Version 3.0 EIAOrtho HCV Version 3.0 EIA (Manual) (Manual) VITROS Anti-HCV(VITROS Anti-HCV(CIA) (Automated)CIA) (Automated)

Among persons with a negative Among persons with a negative anti-HCV test who are suspected anti-HCV test who are suspected of having liver disease, testing of having liver disease, testing for HCV RNA or follow-up testing for HCV RNA or follow-up testing for HCV antibody is for HCV antibody is recommended if exposure to recommended if exposure to HCV occurred within the past 6 HCV occurred within the past 6 months; testing for HCV RNA can months; testing for HCV RNA can also be considered in persons also be considered in persons who are immunocompromised.who are immunocompromised.

Rating:Rating: Class I, Level C Class I, Level C

Among persons suspected of Among persons suspected of reinfection after previous reinfection after previous spontaneous or treatment-spontaneous or treatment-related viral clearance, initial related viral clearance, initial HCV-RNA testing is HCV-RNA testing is recommended because an recommended because an anti-HCV test is expected to anti-HCV test is expected to be positive. be positive.

Rating:Rating: Class I, Level C Class I, Level C

Quantitative HCV RNA Quantitative HCV RNA testing is recommended testing is recommended prior to the initiation of prior to the initiation of antiviral therapy to antiviral therapy to document the baseline document the baseline level of viremia (ie, level of viremia (ie, baseline viral load).baseline viral load).

Rating:Rating: Class I, Level A Class I, Level A

If found to have positive If found to have positive results for anti-HCV test and results for anti-HCV test and negative results for HCV negative results for HCV RNA by PCR, persons should RNA by PCR, persons should be informed that they do not be informed that they do not have evidence of current have evidence of current (active) HCV infection.(active) HCV infection.

Rating:Rating: Class I, Level A Class I, Level A

Persons with current (active) Persons with current (active) HCV infection should receive HCV infection should receive education and interventions education and interventions aimed at reducing aimed at reducing progression of liver disease progression of liver disease and preventing transmission and preventing transmission of HCV.of HCV.

Rating: Rating: Class IIa, Level BClass IIa, Level B

1-Abstinence from alcohol and, when 1-Abstinence from alcohol and, when appropriate, interventions to facilitate appropriate, interventions to facilitate cessation of alcohol consumption should cessation of alcohol consumption should be advised for all persons with HCV be advised for all persons with HCV infection.infection.

Rating:Rating: Class IIa, level B Class IIa, level B

2-Evaluation for other conditions that may 2-Evaluation for other conditions that may accelerate liver fibrosis, including HBV accelerate liver fibrosis, including HBV and HIV infections, is recommended for and HIV infections, is recommended for all persons with HCV infection.all persons with HCV infection.

Rating:Rating: Class IIb, level B Class IIb, level B

3-Evaluation for advanced fibrosis, using 3-Evaluation for advanced fibrosis, using liver biopsy, imaging(elastography), or liver biopsy, imaging(elastography), or non-invasive markers(e.g.FIB4), is non-invasive markers(e.g.FIB4), is recommended in all persons with HCV recommended in all persons with HCV infection to facilitate an appropriate infection to facilitate an appropriate decision regarding HCV treatment decision regarding HCV treatment strategy and determine the need for strategy and determine the need for initiating additional screening measures initiating additional screening measures (eg, hepatocellular carcinoma [HCC] (eg, hepatocellular carcinoma [HCC] screening).screening).

Rating:Rating: Class I, Level B Class I, Level B

4-Vaccination against hepatitis A and 4-Vaccination against hepatitis A and hepatitis B is recommended for all hepatitis B is recommended for all persons with HCV infection who are persons with HCV infection who are susceptible to these types of viral susceptible to these types of viral hepatitis.hepatitis.

Rating: Rating: Class IIa, Level CClass IIa, Level C

5-All persons with HCV infection 5-All persons with HCV infection should be provided education on how should be provided education on how to avoid HCV transmission to others.to avoid HCV transmission to others.

Rating:Rating: Class I, level C Class I, level C

Evaluation by a practitioner Evaluation by a practitioner who is prepared to provide who is prepared to provide comprehensive management, comprehensive management, including consideration of including consideration of antiviral therapy, is antiviral therapy, is recommended for all persons recommended for all persons with current (active) HCV with current (active) HCV infection.infection.

Rating:Rating: Class IIa, level C Class IIa, level C