Recent Announcements

ION-4 Study Correction in Coinfection

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.

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DDI with Amiodarone

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.

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Coinfection Section Updated

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.

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Official Press Release – Developing Section on Cost-Effectiveness of Treatment

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
 
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Community Representative Nominations for the HCV Guidance Panel Needed

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.

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Unique Patient Populations: Patients With Decompensated Cirrhosis

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

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Guidance Sections Updated

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.

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Updated When and In Whom to Initiate Therapy

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.

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US FDA Approval of Ledipasvir/Sofosbuvir

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.

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Updated Introductory Statement of When and In Whom to Initiate Therapy

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.

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