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MASAC Recommendation #213
 

MASAC RECOMMENDATIONS FOR TREATMENT OF CHRONIC HCV INFECTION IN INDIVIDUALS WITH HEMOPHILIA AND OTHER RARE BLEEDING DISORDERS

 

MASAC Document #213

(Replaces #203, #200, #193)

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The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) on November 10, 2012, and adopted by the NHF Board of Directors on November 11, 2012.

 

Given the high rate and long duration of hepatitis C (HCV) infection in individuals with hemophilia and other bleeding disorders, the availability of new drugs for treatment of HCV, including antiviral, protease inhibitor (PI), and other direct acting agents (DAA), is greatly anticipated. Recommendations regarding the use of such drugs is based on randomized trials in non-hemophilic individuals with HCV mono-infection and genotype 1. There may be insufficient data to address potential safety, bleeding, and drug interaction issues for those with hemophilia with advanced liver disease and/or HIV co-infection, or comorbidities that are associated with poor response to therapy. Further, there should be access to HCV clinical trials in persons with bleeding disorders.

 

Recommendations:

1.     MASAC encourages access to hepatitis C clinical trials, including those of direct-acting antiviral agents (DAAs), for patients with bleeding disorders, with attention to potential bleeding risks and drug interactions.

2.     MASAC encourages the FDA to develop post-licensure surveillance of new anti-HCV drugs in collaboration with HTCs through CDC and ATHN data collection and manufacturers through post licensure marketing to assist in the recognition and reporting of adverse effects and to assure the collection of safety data.

 

 

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends particular treatment for specific individuals and in all cases recommends that you consult your physician or local treatment center before pursuing any course of treatment.

 

Copyright 2012 National Hemophilia Foundation. To facilitate the dissemination of these medical recommendations, reproduction of any material in this publication in whole or in part will be permitted provided: 1) a specific reference to the MASAC recommendation number and title is included and 2) the reproduction is not intended for use in connection with the marketing, sale or promotion of any product or service. NHF reserves the right to make the final determination of compliance with this policy. For questions or to obtain a copy of the most recent recommendations, please contact the NHF Director of Communications at 1-800-42-HANDI or visit the NHF website at www.hemophilia.org.