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.