Luís Mendão European AIDS Treatment Group, GAT/H-CAB ELPA Symposium Compassionate use programs for hepatitis C patients with advanced disease Saturday, April 27 th 2013 EASL Amsterdam HCV compassionate use programs for co- infection HIV/HCV Working together (fast and well) to save lives

ELPA Symposium Personal Disclosure I’m an HIV/HCV patient, male, heavy smoker, old (largely over 50), diabetic, lipodystrophic, with NAFLD, cirrhotic (still compensated?), null responder to PEG/Riba, HCV genotype 1a, CT. I’m under successful cART for 17 years; I’m on hydrocortone because of Addison’s disease. So I might be a little biased towards interferon free regimens and not fitting the usual criteria to clinical trials and I’m convinced I could take the risk. The drugs I need will not be normally available in my hospital for the next (at least 3 years)

ELPA Symposium Thank you to ELPA for the invitation and for the commitment on access for patients with advanced liver disease and other co-morbs. I think we share that there is a Revolution going on on HCV treatment/cure. The collaboration between informed treatment “activist” patients and patient organizations across Europe and the US, did contribute to change radically the regulatory pathways for approval off new drugs and new clinical trial design to be accepted. Now we need to work in order to translate the ongoing progress In the safest access to those in most urgent need.

ELPA Symposium Are people with HIV/HCV a separate group from those with no HIV? Only partially- usually we progress faster, the rates of cure are smaller, to use HCV drugs we need specific DDI information but we have as the others easy to treat, “healthy” people, and we came with all stages of disease. Thought we are less than 10% of all HCV patients, due to the faster progression we have a disproportionate number of people with advanced disease.

ELPA Symposium After (and if) the DDI are solved, coinfection should not be an exclusion criteria for: early access programs. clinical studies on cirrhotic (compensated or decompensated), on pre and post transplanted, compassionate use programmes name based access.

ELPA Symposium Provocative statements HCV is now an easy to cure viral infection We have on phase 2 and phase 3 clinical trials a set of drugs that could, used in right way, cure virtually all HCV patients. Viral eradication is beneficial for all patients with advanced disease. The very heterogeneous groups of people with advanced disease need to be referred and have access to reference clinicians and centers.

ELPA Symposium What do we need now? We need regulators to issue guidance on compassionate needed and acceptable programmes. We need companies to not hold access of their drugs on compassionate and name based use that regulators, physicians and patients agree on the risk benefit. We need commitment and guidance from clinical societies and the best among the researchers and physicians. We need to work together fast and well and have consensus written positions

ELPA Symposium We need Access to drug combinations from different companies. Best compassionated programmes for decompensated and pre transplant without interferon

ELPA Symposium I would like to thank (though unfair with so many others) Ivan, Maxime, Jules and Tracy