NYSDOH AIDS Institute Hepatitis C Virus Infection Guideline Committee
The New York State Department of Health (NYSDOH) AIDS Institute (AI) protects and promotes the health of New York State’s diverse population through disease surveillance and the provision of quality services for prevention, health care, and psychosocial support for those affected by HIV/AIDS, sexually transmitted diseases, viral hepatitis and related health concerns. In addition, the NYSDOH AI promotes the health of LGBT populations, substance users, and the sexual health of all New Yorkers. In response to the availability of effective new treatments for HCV, the AIDS Institute convened the Hepatitis C Virus Infection Guideline Committee in 2014 to develop a New York State guideline for the clinical care of HCV infection.
The members of the HCV committee (see Figure A1: HCV Committee Leaders, Members, and External Reviewers) were appointed by the NYSDOH AI to ensure representation of clinical practice in all major regions of the state, relevant medical disciplines and sub-specialties, key NYS agencies, community stakeholders, and patient advocates. Individuals confirmed as Committee members are required to disclose any potential conflicts of interest; disclosures are reviewed and approved by the NYSDOH AIDS Institute Office of the Medical Director (see Funding and Financial Disclosure of Potential Conflicts of Interest).
Committee members actively participate in guideline development, including evidence review, drafting of recommendations and text, manuscript review, consensus approval of all recommendations, and rating of recommendations.
The HCV Planning Group of committee leaders refined the manuscript, facilitated consensus approval of all recommendations, addressed feedback from external peer and consumer reviewers, and elicited input from other key AI guideline committees, including the Medical Care Criteria Committee (Adult HIV guidelines) and the Perinatal Transmission Prevention Committee.
Johns Hopkins University (JHU) Editorial Role
The JHU editorial team coordinated, guided, and documented all Committee activities, and edited the guideline material for clarity, flow, and style.
HCV Planning Group (Members of the full committee and reviewers are listed below)
- Joshua S. Aron, MD, Co-Chair
- Christine A. Kerr, MD, Co-Chair
- David Bernstein, MD, FACG, AGAF, FACP, Contributing Committee Member
- Colleen Flanigan, RN, MS, AIDS Institute Hepatitis Bureau Director
- Charles J. Gonzalez, MD, AIDS Institute Deputy Medical Director
- Christopher J. Hoffmann, MD, MPH, JHU Principal Investigator
JHU Editorial Team
- Mary Beth Hansen, MA, JHU Project Director
- Christina Norwood, MS, ELS, Senior Medical Editor
- Jen Ham, MPH, JHU Medical Editor; Lead Editor
- Hanna Gribble, MA, JHU Medical Editor
- Celine Daly, MD, JHU, Contributing Editor
- Jesse Ciekot, Program Coordinator
|Figure A1. Hepatitis C Virus Infection Guideline Committee: Leadership, Contributing Members, Liaisons, and Guideline Reviewers|
Agency, Consumer, and Program Liaisons
AIDS Institute Staff
AIDS Institute HIV Clinical Guidelines Program Committee Reviewers
External Peer Reviewers
*These individuals participated in the early development of the HCV guideline but were no longer in their positions, or were not able to serve as liaisons, at the conclusion of the project.
Funding and Disclosure of Potential Conflicts of Interest
The Treatment of Chronic Hepatitis C Virus (HCV) with Direct-Acting Antivirals (DAAs) guideline was developed using New York State funds awarded as a grant to the Johns Hopkins University School of Medicine, Division of Infectious Diseases, from the New York State Department of Health AIDS Institute.
Conflicts of Interest
All active committee members, invited consultants and coauthors, peer reviewers, and program staff are required to disclose financial relationships with commercial entities, including gifts that may be actual conflicts of interest or may be perceived as conflicts. These individuals must disclose financial relationships annually, for themselves, their partners/spouses, and their organization/institution. On their annual disclosures, committee members are asked to report for the previous 12 months and the upcoming 12 months.
No conflicts were reported by the Committee Chair and Co-Chair, the majority of Committee members, and all NYSDOH AI and JHU program staff. Figure A2, below, lists the conflicts reported by eight Committee members.
Management of Potential Conflicts of Interest
All reported financial relationships with commercial entities are reviewed by the NYSDOH AI guidelines program to assess the potential for undue influence on guideline recommendations made by the Committee. For the Committee members reporting conflicts, it was determined that: 1) in this guideline, no individual drug or device is recommended over another; and 2) individual committee members reported concurrent conflicts with competing pharmaceutical companies.
Any potential for undue influence is also mitigated by the consensus process. All guideline recommendations received consensus approval of the full HCV Committee. The Committee Chairs and the NYSDOH AI Medical Director, none of whom reported conflicts of interest, performed the final review and approve the guideline.
All external reviewers, including peer reviewers and representatives from other NYSDOH AI Clinical Guidelines committees, were also required to submit conflict of interest/financial disclosure information, which were similarly screened. Three reviewers reported conflicts, which are listed in Figure A2.
|Figure A2. Reported Conflicts of Interest/Financial Disclosure Results|
|Committee/Guideline Role||Relationships disclosed for the previous and upcoming 12 months|
|Committee and Planning Group Member||
|Committee Member||Consultant to: Gilead Sciences, Merck Pharmaceuticals, AbbVie|
|Committee Member||Research support from: BMS, Gilead, and Merck|
|NYSDOH AI Medical Care Criteria Committee Reviewer||
|External Peer Reviewer||Consultant to: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck|
|External Peer Reviewer||
Evidence Collection and Review
The NYSDOH AI guideline development process is based on a systematic search and analysis of the published evidence. Figure A1, below, illustrates the evidence review and selection process.
|Figure A1. Evidence Collection and Review Processes|
|Step 1||HCV Committee defines the goal of the guideline: To provide evidence-based clinical recommendations for primary care management of chronic hepatitis C infection, including screening, diagnosis, pretreatment assessment, treatment options, and post-treatment monitoring|
|Step 2||With individual authors, JHU editorial staff conducts a systematic literature search in PubMed using MESH terms. All searches limited to studies that 1) were published in the 5 years prior to the date of the literature search (see Table A3); 2) involved only human subjects; and 3) were published in English|
|Step 3||Authors review studies identified in searches; specific exclusion criteria include: 1) Studies involving interferon (IFN) treatment for chronic HCV infection; 2) Studies of HCV-associated comorbidities except those influencing HCV treatment decisions|
|Step 4||Authors and editorial staff conduct additional searches using PubMed and online databases to identify:
|Step 5|| Development of guideline recommendations
|Step 6|| Ongoing Update Process
Recommendation Development and Rating Process
The clinical recommendations presented in this guideline were developed by consensus based on a synthesis of the current evidence collected through the systematic search described above. If no data were available, the recommendations are based on expert opinion, and this status is indicated in the rating and in the text.
The Planning Group met via monthly teleconferences over 18 months to finalize the guideline and reach consensus on recommendations and rationale. Once consensus among the Planning Group members was reached, the guideline was reviewed by the full HCV Committee, including consumer liaisons, and consensus was reached on all recommendations. These deliberations were conducted by teleconference; committee members were invited to submit comments in writing as well. Full committee review discussions were recorded, and recordings were reviewed carefully to ensure that all decisions and changes were captured and integrated into the manuscript.
Members of the Planning Group then individually reviewed the evidence for each recommendation and assigned a two-part rating (see Table A3). The individual ratings were compiled into a report distributed to all raters, and conference call discussions were held to deliberate ratings for which consensus was needed. Once all raters agreed on the interpretation of evidence and ratings for all recommendations, the guideline was sent to the NYSDOH AI for review and approval.
|Figure A3. AIDS Institute HIV Clinical Guidelines Program Recommendations Rating Scheme|
|Strength of Recommendation||Quality of Supporting Evidence|
|A = Strong||1 = At least 1 randomized trial with clinical outcomes and/or validated laboratory endpoints|
|B = Moderate||2 = One or more well-designed, nonrandomized trial or observational cohort study with long-term clinical outcomes|
|C = Optional||3 = Expert opinion|
Five external peer reviewers recognized for their experience and expertise in the treatment of chronic HCV infection were identified by program leaders (see Figure A1: HCV Committee Leadership, Members, and External Reviewers). These individuals submitted a financial disclosure statement for the purpose of identifying potential conflicts of interest before participating as peer reviewers. Disclosure information is included in Figure A2: Conflicts of Interest/Financial Disclosure Results.
Peer reviewers were asked to review the guideline for accuracy, balance, clarity, and practicality of the recommendations for primary care providers. The Planning Group addressed peer review feedback; any conflicting opinions were resolved by the Committee chairs.
Members of NYSDOH AI Medical Care Criteria Committee (Adult HIV Guidelines Committee) and the Perinatal Transmission Prevention Committee also provided reviews.
Members of the HCV Committee will monitor developments in the field of HCV treatment in an ongoing structured manner to maintain guideline currency. Once the guidelines are published on the program website: www.hivguidelines.org, any updates will be made to the HTML document as needed as treatment of chronic HCV with DAAs is a rapidly evolving field.
Notification of newly published studies will be automated, and the Planning Group will review new data at least every 4 months. Newly published data that provide support for existing recommendations will be cited in the text, and the studies will be added to the reference list(s).
If newly published data prompt a revision to recommendations or rationale, the Planning Group will propose appropriate edits and determine whether the changes warrant full committee review and approval. If full committee review is required, a conference call will be convened for that purpose.
If a new medication or formulation is approved, the Planning Group will be convened via conference call to examine the data, consider inclusion in the guideline, and determine the need for full committee review and approval.
The full guideline will be reviewed and updated on the 4th anniversary of publication to prepare for publication of an updated guideline on or before the 5th anniversary of publication.