More than 50 community activists, researchers, clinicians, pharmaceutical representatives and regulatory authorities’ representatives met between the 3rd and 5th of June in Sitges, Spain, to discuss early and expanded access to new direct-acting antiviral drugs (DAAs) for people with hepatitis C.
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The meeting was organised by the European Community Advisory Board (ECAB) of the European AIDS Treatment Group (EATG: http://www.eatg.org/).
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Other community groups, working in the field of Hepatitis C, were also represented - The Hepatitis Community Advisory Board (HCAB), the European Liver Patients Association (ELPA), the World Hepatitis Alliance (WHA), Groupe Inter-Associatif "traitements et recherche thérapeutique” (TRT-5), Collectif Hépatites Virales-CHV, Foro Espñañol de Activistas en Tratamientos (FEAT) and Treatment Action Group (TAG).
Direct-acting antivirals will revolutionise treatment of chronic hepatitis C, offering a higher cure rate and the potential for shorter therapy. However, many people do not have access to these drugs until they are approved, regardless of the urgency of their condition. The first two DAAs, boceprevir (Victrelis®) and telaprevir (Incivek®), were recently approved by the U.S. Food and Drug Administration and are awaiting approval from the European Medicines Agency, likely to happen by the end of this year. They are both indicated for use in combination with pegylated interferon plus ribavirin (the current standard of care), but all-oral, interferon-free regimens are under study. These offer hope to people who cannot tolerate, or safely use interferon.
Meeting participants emphasised the need for early access for "difficult-to-treat" populations, including both patients with medical complications such as HIV/HCV coinfection or liver cirrhosis, people who have undergone liver transplantation or are currently on the waiting list, people in marginalised groups such as drug users, and particularly, access to interferon-free regimens for people who need them. The most urgent need is for people with advanced disease who have no other treatment options and cannot wait for full approval of new therapies.
Community members asked investigators and pharmaceutical companies to provide access to difficult-to-treat populations in parallel with Phase 3 clinical trials, and for support from regulatory agencies They want harmonisation of early access regulations and delivery systems that now differ widely among European countries, and called for clearer and more consistent EU rules. Companies should provide drugs at no cost during early access, notwithstanding countries (e.g., France) that currently pay. Community stakeholders must be included in decision making at all levels.
It is critical to study pharmacokinetics, safety, and efficacy in a wide-range of groups that will use these drugs in real world practice. New DAAs must be evaluated for drug-drug interactions with HIV antiretroviral agents, opiate substitution therapy (methadone and buprenorphine), immunosuppressants, antidepressants, and other medications commonly used by people with hepatitis C.
Researchers and companies were urged to share study data as soon as they become available. The industry was also asked to involve community members in development of a robust informed consent process and on Data and Safety Monitoring Boards to oversee ongoing trials.
Currently the EATG plans to meet with some country regulatory agencies in Europe (France, Spain, Italy and others) to discuss a possible harmonisation of regulations and best practices development of early and expanded access programmes. Further to that, the EATG will also follow the issue of pricing at the level of the EU Parliament.
For further information, please contact the ECAB chairperson, Wim Vandevelde (http://www.eatg.org/eatg/Press-Room/Open-letters/bWFpbHRvOndpbUBlYXRnLm9yZw==) or the Sitges IV project leader Svilen Konov (http://www.eatg.org/eatg/Press-Room/Open-letters/bWFpbHRvOnN2aWxlbkBlYXRnLm9yZw==).
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Other community groups, working in the field of Hepatitis C, were also represented - The Hepatitis Community Advisory Board (HCAB), the European Liver Patients Association (ELPA), the World Hepatitis Alliance (WHA), Groupe Inter-Associatif "traitements et recherche thérapeutique” (TRT-5), Collectif Hépatites Virales-CHV, Foro Espñañol de Activistas en Tratamientos (FEAT) and Treatment Action Group (TAG).
Direct-acting antivirals will revolutionise treatment of chronic hepatitis C, offering a higher cure rate and the potential for shorter therapy. However, many people do not have access to these drugs until they are approved, regardless of the urgency of their condition. The first two DAAs, boceprevir (Victrelis®) and telaprevir (Incivek®), were recently approved by the U.S. Food and Drug Administration and are awaiting approval from the European Medicines Agency, likely to happen by the end of this year. They are both indicated for use in combination with pegylated interferon plus ribavirin (the current standard of care), but all-oral, interferon-free regimens are under study. These offer hope to people who cannot tolerate, or safely use interferon.
Meeting participants emphasised the need for early access for "difficult-to-treat" populations, including both patients with medical complications such as HIV/HCV coinfection or liver cirrhosis, people who have undergone liver transplantation or are currently on the waiting list, people in marginalised groups such as drug users, and particularly, access to interferon-free regimens for people who need them. The most urgent need is for people with advanced disease who have no other treatment options and cannot wait for full approval of new therapies.
Community members asked investigators and pharmaceutical companies to provide access to difficult-to-treat populations in parallel with Phase 3 clinical trials, and for support from regulatory agencies They want harmonisation of early access regulations and delivery systems that now differ widely among European countries, and called for clearer and more consistent EU rules. Companies should provide drugs at no cost during early access, notwithstanding countries (e.g., France) that currently pay. Community stakeholders must be included in decision making at all levels.
It is critical to study pharmacokinetics, safety, and efficacy in a wide-range of groups that will use these drugs in real world practice. New DAAs must be evaluated for drug-drug interactions with HIV antiretroviral agents, opiate substitution therapy (methadone and buprenorphine), immunosuppressants, antidepressants, and other medications commonly used by people with hepatitis C.
Researchers and companies were urged to share study data as soon as they become available. The industry was also asked to involve community members in development of a robust informed consent process and on Data and Safety Monitoring Boards to oversee ongoing trials.
Currently the EATG plans to meet with some country regulatory agencies in Europe (France, Spain, Italy and others) to discuss a possible harmonisation of regulations and best practices development of early and expanded access programmes. Further to that, the EATG will also follow the issue of pricing at the level of the EU Parliament.
For further information, please contact the ECAB chairperson, Wim Vandevelde (http://www.eatg.org/eatg/Press-Room/Open-letters/bWFpbHRvOndpbUBlYXRnLm9yZw==) or the Sitges IV project leader Svilen Konov (http://www.eatg.org/eatg/Press-Room/Open-letters/bWFpbHRvOnN2aWxlbkBlYXRnLm9yZw==).
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