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MASAC Revised Recommendation Regarding Treatment of HCV in HIV Coinfected Individuals with Hemophilia and Other Inherited Bleeding Disorders

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MASAC Recommendation: 90

MASAC Revised Recommendation Regarding Treatment of HCV in HIV Coinfected Individuals with Hemophilia and Other Inherited Bleeding Disorders

Date: 
October 25, 1998
  • MASAC recognizes that the optimal treatment options for chronic hepatitis C in individuals with hemophilia and related bleeding disorders who are coinfected with HIV remain to be established. This is critical because coinfection has been correlated with more rapid progression of HCV, leading to liver failure and significant mortality in this population. Therefore, MASAC strongly recommends that all efforts be made to treat all HCV/HIV coinfected individuals in the bleeding disorders population as recommended by the NIH Consensus Development Statement: Management of Hepatitis C. While formal clinical trials are preferable, if these are unavailable, patients and their healthcare providers should evaluate the risks and benefits of standard therapy. Individuals not treated in research protocols should have the same laboratory and clinical data collected longitudinally as those within clinical trials so that the natural history of this disease can be studied.

    MASAC recommends that currently available data collection mechanisms such as the Uniform Data Collection (UDC) of the CDC should be expanded in order to acquire more detailed information on all HCV-infected individuals with hemophilia including:

    1. the demographics of HCV infection and co-infection with other blood-borne viruses within the hemophilia population

    2. the approaches to diagnosis and treatment of HCV-related liver disease and analysis of outcomes

    3. the criteria used for performing liver biopsies in these individuals with an analysis of the techniques employed, complication rates, and histologic results

    4. treatments used, dosage, duration, toxicity, outcome, and other drugs used concomitantly (e.g., protease inhibitors).

    MASAC recognizes the need for increased access of the HIV/HCV coinfected hemophilia population to clinical trials and strongly encourages pharmaceutical companies developing and marketing drugs for the therapy of HCV to expand current trials to include HIV/HCV coinfected hemophilia patients. In concert with MASAC, the Hemophilia Research Society of North America, and the Centers for Disease Control and Prevention, manufacturers should develop and initiate new therapeutic protocols for treating these patients.

    Individuals with hemophilia make up one of the major groups with HIV/HCV coinfection, yet little is known about the impact of HIV on HCV-associated liver disease and its treatment. As improvements occur in immune system function and in survival of HIV-infected individuals treated with highly active antiretroviral therapy (HAART), e.g. combination protease inhibitor/antiretroviral therapy, members of the hemophilia community who previously would have died from AIDS and HIV infection are now dying from progression of liver disease. Although HIV may speed progression of hepatitis C-associated chronic liver disease, and protease inhibitor antiretroviral therapy may cause hepatotoxicity, little is known about the impact of HIV infection and its treatment on HCV-associated liver disease. Furthermore, patients with coinfection may have poorer response to antiviral treatment for HCV disease. If liver disease progression occurs, liver transplantation is currently contraindicated, yet little is known regarding the potential safety of this procedure when given with HAART. Because we do not understand the natural history of HIV/HCV coinfection, because current treatment is suboptimal, and because comorbidities may exist, we strongly support research studies into the epidemiology, natural history, and treatment of HIV/HCV coinfection. The hemophilia community should work to make such studies an NIH funding priority and to promote advocacy for individuals with hemophilia in national liver organizations, organ procurement regulatory authorities, and pharmaceutical companies (to develop pharmaceutical-sponsored research studies).