European Researchers, Regulators, the Pharmaceutical Industry and Activists Demand Better Treatment for People With Hepatitis C and HIV

Brussels (ots/PRNewswire) - A unique joint declaration by AIDS
activists, doctors, researchers, pharmaceutical companies and members
of regulatory agencies has been issued demanding the urgent
development of better treatment options for people co-infected with
the HIV and hepatitis C (HCV) viruses.

The statement came out of a conference on co-infection that took
place in Sitges last month, organised by the European AIDS Treatment
Group (EATG).

The Sitges Declaration demands that HIV/HCV co-infected people are
included in trials when any new HCV drug is being developed. It calls
on government and drug regulatory agencies to develop urgently a set
of standards that would expedite drug trials in co-infected people
and to develop the best tools for monitoring liver disease.

The statement says: "The patient perspective must be considered
part of the HCV drug development process.

"Studies should include people with the most urgent need for new
HCV therapies."

Specifically, the declaration calls for community participation
in:

- The development of regulatory guidance for HCV drug development:
ringing the lessons learned in the race to develop antiretroviral
drugs for HIV to the development of treatments for a similar
infectious disease.

- The development of industry-sponsored clinical trials: using the
experience of the community of co-infected people to inform the
design of trials and the work of the Data and Safety Monitoring
Boards (DSMBs) of those trials.

- The development of research networks: building new research
networks, public-private partnerships, investigator-initiated studies
and registries of data from multi-center collaborations to accelerate
the development of therapies and evaluate innovative treatment
methods.

The Declaration says that trials of novel HCV therapies in HIV/HCV
co-infected people should begin before approval is granted for their
use in HCV mono-infection.

Trials in co-infected people should start once dose-response
results in mono-infected people from Phase IIB studies are known, and
when there are indications from toxicology, pharmacokinetic and
drug-drug interaction studies that the agent under investigation will
not have the potential for significant toxicities relevant to HIV or
its treatment.

The Declaration adds that:

- Studies should not just be conducted of drugs to cure or
treat HCV infection but also to slow or reverse liver fibrosis.

- There should be further research into non-invasive methods of
assessing liver damage.

- Trials should include enough women to assess gender-specific
effects.

- Trials should include interaction studies with opiate
substitutes such as methadone, buprenorphine, naltrexone and
prescribed heroin.

- Paediatric research should be accelerated.

- Better access must be provided to liver transplants for those
for whom the development of new therapies will come too late.

Wim Vandevelde, Chairperson of the EATG, said: "The Declaration
was issued to address the problem that HCV drugs get trialed on HCV
mono-infected people first and HIV/HCV co-infected people get
neglected."

He added: "This is a first. There's never been a similar statement
signed not only by activists and researchers but by nearly all the
drug companies."

EATG's and gTt's Joan Tallada was the conference co-director,
together with Tracy Swan from the Treatment Action Group (NYC). He
said: "HCV-related liver disease is now by some way the leading cause
of death in people with HIV here in Spain, and will become so in
Eastern Europe too.

We have not seen such a collaboration of different stakeholders
before in issuing a consensus statement like this. The bottom-line
message is that no HCV treatment must get approved before trials have
taken place in co-infected as well as singly-infected people too.
Safety and toxicity issues are so different in people with HIV, and
interactions with HIV drugs, that we can't tolerate HCV drugs going
on the market which are going to be ineffective or even harmful for
people also taking HIV treatment."

Background

- Liver disease due to hepatitis C, especially amongst people with
HIV, is a huge and growing problem in Europe. The proportion of
people with HIV who also have hepatitis C ranges from 9% in the UK to
20% in France, nearly 50% in Spain and Italy, and 75% in Russia.
Although most of this is so far associated with injecting drug use,
there are accelerating rates of sexually-transmitted HCV co-infection
in gay men too.

- People with HIV and HCV develop liver damage 3-4 times faster
than people with HCV alone, and are likely to develop liver failure
within 10-20 years. Given that Europe is the world's epicentre for an
epidemic of fairly recently-acquired HIV/HCV coinfection,
liver-related mortality can only go up in future years unless
effective and convenient treatments are found quickly.

- Last year the World Health Organisation (WHO) said: "In Europe,
the prevalence of hepatitis C virus (HCV) infection in HIV-infected
patients is particularly high - and still rising, in contrast to the
rest of the world. Yet only a minority of HCV/HIV-co-infected
patients is treated for their hepatitis. The compounding effect of
co-infection makes the care for these patients a major challenge."

- The largest trial so far conducted of the standard treatment for
HCV in co-infected people, the APRICOT trial of pegylated interferon
and ribavirin, found that it produced a Sustained Viral Response
(SVR), that is, a clearance of hepatitis C from the body, in only 40%
of people with HIV/HCV coinfection, and only 30% of people with
genotype 1, the most common and virulent strain of HCV. This is why
the best hope for most co-infected people is early access to
experimental GCV drugs.

European AIDS Treatment Group: www.eatg.org

About the EATG.

Founded in 1991 as a co-operative structure of people from
different nationalities and communities affected by HIV in Europe the
EATG is a non- profit organisation registered under German law, with
its secretariat in Brussels, Belgium. Since its establishment the
EATG has been at the forefront of the development of the civil
society response to the HIV/AIDS epidemic in Europe. The EATG has
members from 30 different European countries, who are involved in 58
local NGOs and related to 36 community networks. The mission of the
EATG is to enable people with HIV or at risk of HIV infection and
their advocates to provide significant input into the process of
developing, testing and approving HIV treatments; to advocate for
best practices of care and treatment for all persons living with
HIV/AIDS; to advocate for the rapid introduction of existing and new
HIV treatments; to promote the availability of appropriate
information about HIV treatments for people with HIV, their health
care providers, and health policy makers; to advocate for changes in
legislation and patent law as well as for the medical evaluation of
generic medicines; and to advocate for changes in legislation and
policies affecting the health, rights and quality of life of people
with HIV. In reaching its objectives the EATG has committed itself to
be democratic, accountable, transparent and accessible to people
living with HIV and their advocates, taking into account diversity of
gender, religion, culture and beliefs. The EATG is funded with both
public grants and private donations.

ots Originaltext: European Aids Treatment Group
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information please contact Joan Tallada at joan@gtt-vih.org
or Tracy Swan at tracyswan@verizon.net. Tel: +32-2644-4210