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MASAC Recommendations for the Treatment of Chronic HCV Infection in Individuals with Hemophilia and Other Bleeding Disorders

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MASAC Recommendation: 224

MASAC Recommendations for the Treatment of Chronic HCV Infection in Individuals with Hemophilia and Other Bleeding Disorders

Date: 
June 5, 2014
Revisions: 
203; 200; 193
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MASAC Document171.29 KB
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    The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) on April 13, 2014, and adopted by the NHF Board of Directors on June 5, 2014.

     

    Hepatitis C (HCV) infection is a chronic infection that can lead to cirrhosis, liver failure, and hepatocellular carcinoma. Given the high rate and long duration of HCV infection in individuals with hemophilia and other bleeding disorders, the availability of new drugs including polymerase inhibitors and protease inhibitors has dramatically changed the landscape for treatment. New oral non-interferon regimens (direct acting agents, DAA) are currently approved and will continue to evolve with expectations of >95% sustained virologic responses (SVR) after 12-24 weeks of daily oral therapy. These new drugs are highly effective in trials performed in non-bleeding disorder patients that include individuals with all HCV genotypes, HIV co-infected individuals, and cirrhotic patients as well as patients with other co-morbidities.

     

    RECOMMENDATIONS

     

    1.   MASAC strongly recommends that all bleeding disorder patients with HCV infection discuss HCV therapy with their HTC physicians, hepatologists and primary care physicians.

    2.   MASAC encourages access to hepatitis C trials for all patients with bleeding disorders with attention to potential bleeding risks and drug interactions.

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

    4.   MASAC encourages HCV patients who have been treated with new HCV drugs and cured of their viral infection to continue to be followed by their physician for any chronic liver changes.

    REFERENCES

    1. Jacobson IM et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. New Engl J Med 2013; 368(20): 1867-77.

    2. Lawitz E et al. Sofosbuvir for previously untreated chronic hepatitis C infection. New Engl J Med 2013; 368(20): 1878-87.

    3. Kowdley KV et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. New Engl J Med 2014; 370(20): 1879-88.

    4. Afdhal N et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New Engl J Med 2014; 370(20): 1889-98.

    5. Zeuzem S et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. New Engl J Med 2014; 370(21): 1993-2001.

    6. TJ, Ghany MG. Therapy of hepatitis C—back to the future. N Engl J Med. 2014; 370(21): 2043-7
    7. http://www.hcvguidelines.org/full-report-view, accessed June 3, 2014.

       

    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 2014 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.