We are pleased to announce a new member to the HCV Guidance Panel! Andrew Reynolds is the Hepatitis C Education Manager of Project Inform, and joins the Panel as a Community Representative.

A correction has been made to a typographical error in the description of the ION-4 study, in the ‘Unique Populations: Patients with HIV/HCV Section’ with regard to not recommending a shortened ledipasvir/sofosbuvir treatment course for HIV/HCV coinfected individuals.

A recent FDA alert warns against combining amiodarone with ledipasvir/sofosbuvir or with sofosbuvir taken in combination with another direct acting antiviral. This interaction has been added to the ‘Drug Interaction With Direct-Acting Antivirals and Selected Concomitant Medications’ table in the Initial Treatment section.

The Coinfection section of the HCV Guidance has been updated to incorporate new data from the 2015 Conference on Retroviruses and Opportunistic Infections held from February 23-26, 2015.  Abstracts and webcasts from the conference can be accessed from the IAS-USA website.

The following statement has been released with regard to the Cost-Effectiveness of Treatment section currently in development:

Hepatitis C Guidance Website to Develop Section on Cost-Effectiveness of Treatment

HCVguidelines.org, a website developed by the American Association of the Study for Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) in collaboration with International Antiviral Society-USA (IAS-USA) to provide up-to-date guidance on the treatment of hepatitis C (HCV), will be updated with a section on cost-effectiveness of treatment. The recent availability of new, direct-acting antivirals for the treatment of hepatitis C (HCV) offers the prospect of cure for the great majority of patients with HCV. The high costs of these new therapies have been the subject of much discussion, and IDSA and AASLD are concerned that the pricing of these drugs may put such therapy out of reach for many patients in need. This new section of the guidance will examine the cost-effectiveness of treatment to help clinicians advise and educate their patients, which is the purpose of the guidance. The new section will not, however, make recommendations regarding the pricing of these therapies for the treatment of HCV. We remain hopeful that the various stakeholders can work together to maximize patient access to optimal care. The development of this cost effectiveness analysis has been initiated and the section will be released as expeditiously as feasible.

The AASLD and IDSA in collaboration with IAS–USA HCV Guidance Panel is seeking an additional community representative to serve on the panel that drafts the Recommendations for Testing, Managing, and Treating Hepatitis C. Community representatives serve a 2 to 3 year term, similar to the scientific panel members, and are expected to serve on at least one subcommittee and to participate actively in all subcommittee and full committee teleconferences. In-person meetings are not expected to occur more than once annually. This is a volunteer position; panel members do not receive a stipend or travel expenses, although assistance with travel may be provided in appropriate circumstances.

Ideal applicants will either have had HCV infection in the past or present, or been active in community organizations representing persons with HCV infection or those at high risk for HCV infection. The chosen applicant must comply with conflict of interest standards of the panel.

Interested individuals should forward a short letter of interest, a curriculum vitae or resume, and a completed conflict of interest disclosure form to: hcvguidelines@iasusa.org by February 15, 2015. Applicants will be screened by a nomination committee and select individuals will be interviewed by phone before final decisions are made.

Additional revisions have been made to Unique Patient Populations: Patients With Decompensated Cirrhosis, sharpening the focus to patients with decompensated cirrhosis only. For guidance on patients with compensated cirrhosis, please refer to Initial Treatment of HCV Infection

The Initial, Retreatment, Monitoring, and Unique Populations (HIV/HCV Coinfection, Cirrhosis, Post-Liver Transplantation, and Renal Impairment) sections have been extensively revised based on newly available therapies and data.

The introductory statement of When and In Whom to Initiate Therapy has been revised to reiterate that treatment will benefit almost all patients in all stages of chronic infection and that urgent initiation of therapy is needed in patients with certain conditions.

The panel is meeting and currently reviewing data to update the Guidance based on the US FDA approval of ledipasvir/sofosbuvir. The updated Guidance will be posted in early December.