Policy report exposes procedural and institutional barriers in health
technology and clinical trials in treatments for people living with
both HIV and Hepatitis C
TORONTO, July 24, 2013 /CNW/ - The Canadian Treatment Action Council
(CTAC) has produced "Two Standards of Care: toward treatment equity for people living with
HIV/HCV co-infection", a report discussing the current inequities in the world of
pharmaceutical regulations and clinical trials for people living with
both HIV and Hepatitis C.
The report, which analyzes the two newest Hepatitis C treatments on the
market—boceprevir (Victrelis, Merck) and telaprevir (Incivek,
Vertex)—acknowledges the advancements that have been made in medical
treatments for people living with Hepatitis C, while focusing on the
poor record of large pharmaceutical companies and governmental
regulatory bodies in creating and recommending effective and efficient
drug treatments for those who are suffering from both HIV and Hepatitis
The Two Standards of Care policy report outlines several policy recommendations that could aid
the efficiency and efficacy of the clinical trial process in Canada.
Among them: enforce regulations on Hepatitis C drug development by
regulatory agencies; include people who are considered "hard to treat"
in clinical trials, and expand focus on equity at the Canadian Agency
for Drugs and Technologies in Health.
"Many current clinical trial designs delay including patients who are
harder to treat, and this can include people living with HIV/HCV
co-infection," says Paul Sutton, policy researcher at CTAC. "CTAC's
work in Two Standards of Care is to show how we can minimize clinical trial delays so we can get new,
improved medications to the people who need it as quickly as possible."
The report highlights the enormous length of time between clinical
trials for mono-infected patients (Hepatitis C alone) and co-infected
patients (HIV and Hepatitis C). Due to the high cost for testing drugs
(between $500 million and $2 billion for per drugi ii) most treatments are initially tested on those living with Hepatitis C
alone. What's more, time delays for clinical trials are lengthy—with
co-infected people waiting up to four years upon clinical trial
completion for drugs like, boceprevir. This is only after the drug has
been tested on Hepatitis C mono-infected patients.
CTAC also stresses its concerns with the restriction of access to
ground-breaking treatments for co-infected people by health technology
assessment bodies like the Common Drug Review (CDR). Between late-2011
and early-2012, the CDR decided not to recommend Hepatitis C treatment
medications boceprevir and telaprevir for co-infected patients despite
the fact that there was no evidence saying that the drugs were
harmful. In June 2013, the CDR reversed its decision and recommended
the use of the two drugs for people living with HIV and Hepatitis C.
The 18-month lapse caused a serious delay for co-infected people to
access new and effective treatment.
The official launch date of the Two Standards of Care Report is August 9th, 2013.
CTAC is Canada's national civil society organization addressing access
to treatment, care and support for people living with HIV and HCV. In
operation since 1996, CTAC works to engage community members, service
providers, policymakers and other relevant stakeholders to identify,
develop and implement policy and program solutions.
iAdams C, Brantner V (2006). "Estimating the cost of new drug
development: is it really 802 million dollars?". Health Aff (Millwood) 25 (2): 420-8
iiAdams, Christopher Paul; Brantner, Van Vu (February 2010). "Spending on
new drug development". Health Economics 19 (2): 130-141.
SOURCE: Canadian Treatment Action Council
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