Meeting Discusses European Access to New Hepatitis C Drugs
Community activists, researchers, and regulatory and pharmaceutical
representatives met this month in Sitges, Spain, to discuss
early and expanded access to direct-acting antiviral agents
for hepatitis C, especially for difficult-to-treat patients
including those with HIV/HCV coinfection and cirrhosis.
is the edited text of an announcement from participating community
organizations describing the meeting and its outcomes.
IV Advances the Discussion of Early
Access to Hepatitis C Treatment
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.
meeting was organised by the European Community Advisory Board
(ECAB) of the European AIDS Treatment Group (EATG; www.eatg.org).
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 Español de Activistas en Tratamientos
(FEAT), and Treatment Action Group (TAG).
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.
participants emphasised the need for early access for "difficult-to-treat"
populations, including 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.
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.
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.
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.
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.
further information, please contact the ECAB chairperson, Wim
Vandevelde (email@example.com) or the Sitges IV project leader Svilen
and others. Sitges IV Advances the Discussion of Early Access
to Hepatitis C Treatment. Community announcement. June 15, 2011.