BRUSSELS, May 21 /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."
-- 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.
For more information please contact Joan Tallada at email@example.com or Tracy Swan at firstname.lastname@example.org. Tel: +32-2644-4210