Research agenda and access to experimental hepatitis-C drugs for people co-infected with HIV

Opening access, saving lives - The crucial work to accelerate access to new HCV drugs for people living with HIV and Hepatitis C, Joan Tallada

Rationale

In parts of Southern Europe — Italy, Spain, France, and Portugal — liver failure is now the leading cause of death among HIV-positive people.

Several factors contribute:

• Hepatitis C is prevalent among people living with HIV; 30 to 70% are co-infected, depending on the geographical area.
• HIV accelerates hepatitis C disease progression.
• Current HCV treatment is less likely to eradicate hepatitis C virus in HIV-positive people, vs. those with HCV alone, particularly in genotype 1 (14-29%).
• In co-infected people, HCV therapy is associated with significant side effects and poor tolerability.

More effective, less toxic HCV therapies are urgently needed for all co-infected people. However, safety and efficacy studies in confected people are not required for approval of new HCV therapies. Often, data on HCV treatment in co-infected people appears years after HCV drugs are approved. This is an unacceptable situation, and must be addressed.

Access to experimental HCV treatments in co-infected people should be broadened by:

• Performing PK studies in persons with advanced liver disease as soon as it is safe to do so,
• Performing drug interaction studies with agents commonly used to treat HIV and associated complications and new HCV therapies during Phase II studies,
• Initiating safety and efficacy studies in co-infected people upon completion of Phase II studies,
• Launching expanded access programs for HCV therapies, prior to their approval—these may be the only hope for some people.

Expanding access to HCV therapy presents scientific and ethical challenges, and requires a multi-party discussion of the risks and benefits involved. This meeting will increase awareness of the problem, and may yield specific recommendations for action from regulators, industry and the community.

Goals

• A productive dialogue with stakeholders from community, regulators, and industry, to better the mutual understanding of risks and benefits involved with broadening access to HCV experimental drugs.
• Broaden access to experimental HCV therapies by promoting regulatory changes and company commitment, and through increasing provider and community awareness.
• Promoting the creation of an international network of HIV/HCV co-infection activists.

Description
A complete two-day symposium for approximately 50 participants, including healthcare providers, academia, company representatives, regulatory experts, health authorities, activists and people living with HIV/HCV.

Local Spanish community will be also invited and simultaneous translation provided, in order to ensure local impact and mobilisation.

Programme
Topics include:

• Current limitations of HCV therapy in co-infected people and rationale for expanding access to HCV drugs for co-infected people.
• HCV drug pipeline.
• Regulations on drug clinical development.
• Proposals/groundwork for broadening access: Research and development in HIV/HCV co-infection (interaction studies, when to launch treatment trials, EAP critieria).

See final meeting programme below.

Location: Sitges, Spain

Downloads - meeting slides

1. Training session: ”The basics of drug development – the case for HCV“
   Overview of drug development — what happens in phase I, phase II, phase III and post-marketing

   Svilen Konov (London, UK) and Tracy Swan (New York, USA)

2. Epidemiology and natural history of HIV/HCV co-infection

   Miguel de Melo, TRT-5, Paris, France

3. Natural history of liver disease in HCV-HIV co-infected patients: end-stage and post-transplantation

   Josep Maria Miró, Hospital Clínic, Barcelona, Spain

4. Overview of drug development: regulatory agencies

   FDA HCV trial design meeting: a report

   Tracy Swan, Treatment Action Group, NYC, USA

   EMEA perspective

   Olle Karlström, Stockholm, Sweden

   Spanish Agency of Drug and Health Products

   Fernando de Andrés, Madrid, Spain

5. HCV : The path of least resistance in drug development

   Raymond Schinazi, Emory University / Veteran Affairs Department, Atlanta, USA

6. Early access to HCV drugs: interactions, safety, efficacy

   Bruce Polsky, St. Luke’s Hospital, NYC, USA

7. Limitations of current HCV treatment in co-infected populations: overview from the experience

   Bruce Polsky, St. Luke’s Hospital, New York, USA
   Massimo Puoti, Universitàdegli Studi di Brescia, Italy
   Carmen Tarrades, UK-CAB, UK
   Diego García-Morcillo, FEAT, Spain

Declaration

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