Hepatitis C guidance: AASLD‐IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus

Potential conflict of interest: Listed at the end of the article for all authors. These recommendations have been approved by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Potential conflict of interest: Listed at the end of the article for all authors. All AASLD Practice Guidelines are updated annually. If you are viewing a Practice Guideline that is more than 12 months old, please visit www.aasld.org for an update in the material. Preamble The pace of hepatitis C virus (HCV) drug development in recent years has accelerated dramatically. For patients to benefit from these impressive advances, practitioners need access to the most up‐to‐date data and to advice from experienced experts. Such information and advice can be difficult to access readily given the diverse sources from which information is available and the sometimes lengthy time needed for publication of original articles and scholarly perspectives. Traditional practice guidelines for more established areas of medicine and care often take years to develop and bring to publication. In the new era in hepatitis C treatment, such a process would not be nimble or timely enough to address the needs of patients with HCV infection, practitioners caring for these patients, or payers approving therapies for use. A living document made available in a web‐based system, such as that used by the US Department of Health and Human Services for human immunodeficiency virus (HIV) treatment recommendations (http://aidsinfo.nih.gov/guidelines), was selected as the best model to provide timely recommendations for hepatitis C management. In 2013, the two major membership societies supporting liver and infectious disease specialists (American Association for the Study of Liver Diseases [AASLD] and Infectious Diseases Society of America [IDSA]) joined forces to develop guidance for the management of hepatitis C in this rapidly moving field. The International Antiviral Society‐USA, which has experience in developing treatment guidelines in HIV disease, was invited to join the effort as a collaborating partner responsible for managing the panel and the guidance development process. The goal of the hepatitis C guidance is to provide up‐to‐date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence. This review provides a condensed summary of recommendations from the guidance. The complete guidance, which is updated regularly, is available at www.hcvguidelines.org. Process This was conceived to be a living document that would reside online and undergo real‐time revisions as the field evolved. To lead the process, two cochairs selected by the governing boards of each founding society were joined by a fifth cochair representing the International Antiviral Society‐USA. These cochairs selected 10 panel members from each society. The panel members were chosen to represent expertise in the diagnosis, management, treatment, research, and patient care from the fields of hepatology and infectious diseases. At least 51% of the panelists could have no substantive industry support other than research advisory boards, data safety monitoring boards, or research funding that went to the member's employer. The panel first convened in person in October 2013. Panel members were divided into teams to review available data and to propose preliminary guidance in three areas: (1) testing and linkage to care, (2) initial treatment of HCV infection, and (3) retreatment of patients in whom prior HCV treatment had failed. The treatment section teams also reviewed data for special considerations in patients with hepatitis C, including those with HCV/HIV coinfection, with decompensated cirrhosis, and who had undergone liver transplantation. The teams and cochairs met regularly by conference call. All panel members reviewed and approved the final recommendations. Each society's governing board peer‐reviewed the final recommendations. The first version of the guidance was uploaded (www.hcvguidelines.org) on January 29, 2014. By September 2014, three additional sections were developed: (1) treatment of acute HCV infection, (2) monitoring during and after therapy, and (3) when and whom to treat. In October 2014, the panel reconvened in person to update recommendations to consider data on pending new treatments. The updated recommendations (and appropriate revisions of all current guidance) were uploaded on December 20, 2014. This report was prepared on May 20, 2015. Funding for the guidance itself was provided by the AASLD and the IDSA. No industry funding was solicited or accepted. The Centers for Disease Control and Prevention (CDC) provided separate funding for identifying and reviewing data pertaining to testing and linkage to care. Collecting, Evaluating, and Rating the Evidence The panel, comprising experts in the fields of hepatology and infectious diseases, used an evidence‐based approach to review available information for the guidance. Information sources considered were research published in peer‐reviewed journals or presented at major national or international research conferences; safety warnings from the US Food and Drug Administration (FDA), other regulatory agencies, or the manufacturer; drug interaction data; prescribing information from FDA‐approved products; and registration data for new products under FDA review. An initial search of the literature yielded 3939 unique citations on November 4, 2013. To be considered, articles needed to be published in English from 2010 to the present. Review studies, studies using mice or rats, and in vitro studies were excluded. Panel members monitor the literature and other sources regularly and update the guidance as new evidence warrants. Each recommendation is rated in terms of the level of evidence (depicted by Roman numeral I, II, or III) and the strength of the recommendation (depicted by letter A, B, or C) using a scale (Table 1) adapted from the American College of Cardiology and the American Heart Association Practice Guidelines.1 Table 1 - Rating by Classification and of Evidence Classification for which is evidence that a given or treatment is and for which is evidence a of the and of a or treatment of evidence is in of and and are established by evidence for which is evidence that a or treatment is not and or in be of Evidence from or from a studies, or C of studies, or of care such as for HCV with an or be The FDA has including or For additional and In those for which was a FDA‐approved panel members considered the evidence as to a for A and from the American College of Cardiology and the American Heart Association Practice Guidelines.1 HCV and to the to with HCV in the United States, are that are of those with infection is the first and HCV testing is in on prior and (Table In the HCV testing guidelines in with a recommendation to a HCV to all from of HCV have been This recommendation was by the of the to more than of HCV in the to for of all HCV with a than other A review that of with HCV infection would have been a testing would have been with the The of testing is to that of current Table - of for for HCV the years of and or including those who drug a in an Health care, and safety after or to to of or including who were that from a who for HCV infection a of or or an were HIV infection liver disease and hepatitis including and with the and the US Services a HCV is in in the and other on and that for HCV for HCV be using FDA‐approved such as testing for with or a A current HCV infection or infection that has or a FDA‐approved or testing with a level of or be used to HCV to HCV infection and management. for HCV also be in with a who are or who have been to HCV in the prior months these be An HCV is also needed to in after or for of and testing can be in the testing at www.hcvguidelines.org. All for HCV testing first be for using an FDA‐approved be by testing for HCV Evidence the optimal of testing in at for to HCV is the of testing on the of of the of HCV infection who and who have with who have at least HCV testing is in these HCV testing is for who and for who have with testing be to other at of HCV with HCV be to is of the of which lead to more of liver and the development of with HCV be for HIV and hepatitis as with hepatitis virus or HIV has been with of and additional from and and with and who have are more to have liver disease, which in who are or by a of or or or be to and and with HCV be disease and to to in of current hepatitis C and in treatment have on and patients have access to appropriate care. In the United States, is that of with HCV infection in to practitioners who are and to evaluate such patients and provide treatment is or is that all patients with current hepatitis C and a HCV be to and by a with expertise in the of liver disease and HCV those with or management, including of liver as by a who is prepared to provide management, including of therapy, is for all with current HCV and in to HCV hepatitis C treatment is in all patients and is by a as the of HCV for 12 or more after of is a for of HCV infection and has been to be in studies in more than of patients for at least who are of HCV infection experience including a in liver of in most and of in the and other of liver disease also An is with a more than in the of liver and a in the of and liver of HCV infection also and from including a to of with HCV with and other complete or in to of HCV These in disease to in patients an have of including and Evidence treatment for all those with than 12 to treatment is best in the of the disease and the development of the most of treatment be by at for the to all patients as is most appropriate to first those at of disease and those at for HCV or in whom treatment such of treatment for those in and is including patients with liver disease or or those with Table - of and Disease in HCV to the and for treatment to for or I, A I, or with I, or for treatment to for I, I, virus C liver disease C C to the strength and level of evidence with to of treatment in these Table - of HCV or in May who have with with on of to care who C at of HCV be on to and the of that in patients with the of an In a patients with or by were for more than The was in those who experienced an than in those treatment had or those who were and and for of of other studies benefit treatment is at prior to Antiviral treatment is for all patients with HCV infection, those with to If the to all patients as is most appropriate to those at of disease those with disease An of is in the for treatment, in the of treatment, and the need for more The of is of the most used to disease and In to in more need for therapy, with for and are to with cirrhosis, such as those with evidence of or or not additional the of patients testing to liver is the and when In the is and are patient and such as are to the of in patients with HCV infection such as and of the by and liver No is to have and the of each be The most approach to is to and liver of testing or liver is in to the of the of of HCV This section treatment of patients with hepatitis C who are to of and are approved by the FDA for HCV the initial for patients who are with HCV 1 has been by using are as and the of which to of drug the and For the of and has a interaction with the of and has a interaction with the and other that with the with HCV to have than patients with HCV with 1 HCV infection that be be as For HCV patients, are three of and and For the of and the of for those with those who not have The of is for who than to for those who or The safety of each of these are studies, than of patients treatment and were in with and HCV who were the had after treatment with and than those who not the in these patients, of the other for be for patients with HCV who are are in of for 12 of and for 12 or with or for 12 or for patients with a for the using available In patients with HCV and who have the of the other for is For HCV patients, are three of for 12 for 12 and with or for 12 for patients with for patients with HCV who are are in of for 12 of for 12 with or for 12 or is the for patients with HCV more data are treatment to in HCV patients with is for patients with HCV and for 12 treatment to is for patients with is the most difficult to with available for is the in the United on recent data from a than those with and for the of and for 12 is for the and monitoring of this a for 12 has been is not for patients with HCV and for 12 for and for for For the treatment of patients with HCV 4, three are of with or the in vitro and in of HCV 4, be data are for patients with HCV infection in of for 12 of and for 12 and for and for 12 with or for 12 or data are available to for patients with HCV or on is for patients with HCV or of for 12 and for 12 for patients who are of in of and a are in this and and In patients with cirrhosis, treatment with for than 12 of treatment, supporting the recommendation that HCV patients with of with given for 12 to of in patients with in whom a prior of and or had failed. For patients with who are with and of is patients with who are with of The treatment in this are or For those with in whom a prior has the recommendations for treatment are the as those for patients with cirrhosis, the treatment of can be to 12 and can be for retreatment of patients with 1 HCV in whom and treatment had in HCV of for 12 of and for 12 for 12 HCV of for 12 of for 12 for 12 HCV or of for of of for 12 of of and for or for 12 with or for for patients with a for the using available and for HCV In patients with HCV and who have the of the other for is of and and a and of or The treatment for patients with HCV 1 in whom a prior that or has is for 12 For patients with cirrhosis, were in the than the treatment those patients with have treatment to In a retreatment of patients with treatment with and or were those 12 of and and those of and for 12 is for patients with in whom prior treatment with and and or are data for and treatment on of treatment with be given to this of patients as with and or be for retreatment of patients with 1 HCV in whom a and had in in each for 12 of for of for 12 of of with to be more in with HCV than with and more in those with than in those of is with to and other HCV such as are data for retreatment after a treatment with a of other with is for prior and or prior and to the of data in this to a be appropriate for For patients with liver disease, be given to of retreatment more information is In patients who have and retreatment more treatment with with for is more data are In the of for patients in whom prior treatment with be given to in a For patients with liver disease, be given to of retreatment pending the of In patients who retreatment more on data and the of HCV drug with or is for retreatment of patients with 1 HCV who a in in each on the data available for therapy, is that patients an need for HCV treatment, of additional data are available or consider in a with who have an need for treatment a of with for of who have an need for treatment a of with for 12 of of and are data to retreatment of patients treatment with has failed. of those prior treatment with with for in a of which was by the of those patients with liver disease pending who have or who retreatment undergo for retreatment of patients with HCV 1 For patients an need for treatment, of retreatment is pending the of additional For patients with or an need for testing which to and to be using available For patients with no retreatment with a of with for is For patients who have not have treatment with and with for is For patients who have and to a is with HCV infection who have a prior of for 12 treatment from 12 to in HCV patients with is data also that and for 12 of with for and is an for patients who are no data are available to support a recommendation for patients who have treatment with a be given to of retreatment more information is with HCV infection in whom prior and treatment has be with and for 12 patients to patients with with and for 12 is an for patients in whom prior and treatment who are to with HCV infection who have a prior of for with and for 12 is also those with is for those to This also be in those patients with HCV infection who have a prior of and with HCV infection in whom prior and treatment has and for 12 for patients who are to and for for are to retreatment for patients with HCV for patients in whom retreatment is after prior of and are for 12 and for 12 for patients and for 12 or for with who were with for had than those for 12 for those with cirrhosis, of treatment is for retreatment of patients with who a in of for 12 or of and for 12 for 12 and for 12 for patients who are to and for and data are available to for patients with HCV or in whom prior has failed. on is with HCV or infection in whom prior and treatment has of for 12 and for 12 for patients who are and Antiviral be prior to therapy, during treatment, and of treatment in to the of liver disease and the and safety of HCV The (and are in Table - to Antiviral of with is prior to HCV The are 12 prior to international panel and and is used The testing is at time prior to HCV and HCV in the that a of I, C Table - Antiviral or are as during treatment to and to monitor for and with The testing is and panel are after of treatment and as is 12 for patients for complete for patients is as HCV testing is after of and at 12 of Antiviral drug not be or HCV are not or available during HCV testing can be considered at the end of treatment and or the of I, of is for (1) a in at or (2) in of than at that is by or or by or international in of than at be and at and I, Table - for of of of If HCV is at of treatment, HCV testing is after additional of treatment If HCV has by than on testing at of HCV treatment is The of a HCV at that at or is No recommendation to or can be provided at this C who not of of the treatment or who or are after treatment have liver and have the to Such patients be for liver disease, to and considered for in whom treatment be for and of and be considered for treatment when treatment is Such patients have a virus that is to or more of the used at the time of is no evidence to that the of more liver than the of such retreatment with the of to or more with the of testing for the at in patients with HCV infection treatment with and or treatment with in patients with cirrhosis, testing for initial treatment is not data that for in patients treatment with is for those who who to the Disease months to 12 months with a panel, complete and international for with testing months for patients with or for is present. for retreatment as monitoring for HCV drug during or after is not prior to treatment of (1) with HCV infection who are considered for treatment with with and or or (2) with HCV 1 infection who were with an and are considered for who have HCV in the when 12 or more after of treatment are to have an In these patients, hepatitis liver at for liver disease, such as liver or liver with at for developing An of liver with of liver in not patients with an of of patients liver who an care that is for patients who were with patients with liver or who an decompensated liver disease the of during and is who have or to be at for development of after an is than the with liver in most patients who an and from is patients with undergo for of and these be or as in whom an is who have of liver disease with or liver disease, or hepatitis at for of is that such patients be the of liver disease and for liver disease testing is for patients with for HCV infection drug or or HCV in liver of with HCV a new in most patients an testing for HCV be with an that HCV a HCV with or hepatitis infection experience and hepatitis during treatment or This not with hepatitis C HCV testing during treatment or of during treatment is not who an the For patients no additional is with or undergo for with to for is present. in whom are be and as of other of liver disease for patients who have liver after an for HCV or is the patient has for HCV infection or In such a HCV than an is to for HCV or monitoring for HCV infection patients who an and who are treatment is not with HCV who have decompensated or or C) be to a who is experienced in the management of liver disease and HCV treatment in a liver 1 and data support the of in patients with decompensated or patients with HCV 1 or with or C who and as for 12 or had a of and is an appropriate for patients with decompensated who are with HCV 1 or For patients with decompensated who are liver the of on for is of in this is of December 2014, are no data from studies of in patients with decompensated treatment for patients with 1 or HCV and decompensated or or C) who or not be for liver including those with and of as for 12 For patients with or for For patients in whom prior treatment has and of as for and In patients with HCV infection and for liver were with for to At 12 of the patients who had undergone liver had HCV with of HCV patients experienced of whom had HCV for than of the patients with HCV or These data that and can be given to liver with and decompensated treatment for patients with or and decompensated or or C) who or not be for liver including those with and of the and for to HCV Liver 1 and In a of liver with 1 or were to and for 12 or In the and was in of patients with to and was in or C cirrhosis, with no in with all patients the is that to the on other of is an for In a of liver with of HCV for an of of the interaction and are for and In a of with or in liver the was not be with be with with for and patients with HCV 1 or infection in the including those with of with for 12 for patients with HCV 1 or infection in the of for is for those who are or not or For patients with HCV 1 in the including those with cirrhosis, with or for 12 For patients with 1 HCV in the including of and for data are available to treatment of patients with HCV or in the recommendations those in the and patients with HCV in the including those with cirrhosis, and for and patients with HCV in the the and for or C) and initial of as for The approved can be in with are data to of these in disease of with or HCV or in patients with is in managing to and not be given the level is than 10 For patients with to no is when using of or of to or HCV infection in patients with appropriate For patients with HCV 1 and with treatment with the of with or is be given the level is For patients with initial be or other For patients with or who are on initial be to those with HCV infection with HCV/HIV have a of HCV to and liver disease, and HCV with also had to and than those with HCV infection an by the HCV with the of in treatment and patients have not been the treatment recommendations for are the as for those with HCV infection, with of with HIV In testing has been in and is experience with the In the is or on The with the of is of the of are by and be with of other that the of of in the also HIV (and other and additional be when HCV treatment is In when was with and and with of the was with to were and not be used with the have the safety and of in with HCV 1 or who were that and with or are from studies that HCV and as as those with or data in with HCV 1 or infection have the safety and of for 12 and of with or for 12 on treatment of with HCV or support of as are for HIV of and with or were for and was be and the as HIV infection, after and managing with treatment to HCV is not and HCV drug be prior to Drug when be in with the HIV For HIV and HCV not is The are recommendations to drug which need to be considered in and be in those with of this is when