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EASL 2013 Ivan Gardini MY PERSONAL VIETNAM MY PERSONAL VIETNAM 20 YEARS OF CHRONIC HEPATITS 5 TREATMENTS FAIELD 3 2 CIRRHOSIS LIVER TRANSPLANT A virus that has stolen 20 years of my life Kidnapping mind, body and spirit First transplant, cirrhosis due HCV: December 1997, 34 year old Second transplant, due to HCV recurrency: July 2009, 46 years old Post OLT diagnosis beginning 2011 CHOLESTATIC AND AGGRESSIV HCV RECURRENCY NO RE-TRANSPLANT= 24-36 MONTHS LEAVING CLINICAL PROFILE beginning 2011 PARTIAL RESPONDER IL28 CT WIDESPREAD CIRRHOSIS 93.000 PLATELET (Limits for compassionate use: 90.000) DIABETIC IMMUNOSOPPRESSIVE TREATMENT MAINTENANCE THERAPY INF PEG + RIBA Copie/mL INF PEG alfa + RBV February 2011 INF PEG alfa + RBV Lead in: 18 weeks Copie/mL boceprevir Febbraio 11 Maggio 11 INF PEG alfa + RBV + BOCEPREVIR Week 2 4 log decrease Copie/mL boceprevir boceprevir February 11 May 11 INF PEG alfa INF+ALFA RBV + BOCEPREVIR RBV SOC + BOC Week 4 5 log decrease Copie/mL boceprevir boceprevir Febbraio 11 Maggio 11 INF PEG alfa INF+ALFA RBV + BOCEPREVIR RBV SOC + BOC Week 6 HCV RNA negative Copie/mL boceprevir boceprevir February 11 May 11 INF PEG alfa INF+ALFA RBV + BOCEPREVIR RBV SOC + BOC – 48 WEEKS May 11 May 12 LAST HCV RNA (FEBRUARY 2013) SVR 36 ! WAS IT EASY? NO Side effects 2 SYNCOPES Anemia = Erithropoietina used Neutropenia =growing factor used Asthenia Disguesya Diarrhea Pruritis WHICH SENSATION? AFTER 186 interferon INJECTIONS 6.714 Ribavirin and other PILLS AND MANY OTHER MEDICATIONS PURCHASED THE RETURN TICKET FROM HELL DAAs EARLY ACCESS with compassionate use may SAVE LIFES And patients are Back to life Back to life: In a DISCO with my daughters Each year, 5 – 7% of patients with compensated cirrhotics progress to decompensated cirrhosis (D’amico et al J Hepatol. 2006 Jan;44(1):217-31). In these patients, all drug regimes based on pegylated interferon, ribavirin and other DAAs cannot be used due to the severe side effects and contraindications. Inevitably those people will eventually face liver cancer, liver transplant or death, which dramatically increases the patients suffering as well as social and economical costs. WARNING REGISTRATIVE TRIALS, CLINICAL TRIALS, EXPANDED ACESS PROGRAMS AND ALSO COMPASSIONATE USE HAVE SEVERAL EXCLUSION CRITERIA THAT MEAN CLOSE THE DOOR TO THE PATIENTS MOST IN URGENT NEED FOR THOSE PATIENTS THE QUESTION IS: WAIT FOR TOTAL SAFETY DATA OR OPEN A RISKLY WINDOW TO THE EARLY ACCESS ? WHAT WE ASK FOR IS…. To remove from compassionate use protocols most of the exclusion criteria that may lead to exclude patients with HCV advanced disease. This regards the compassionate use and the named patient basis programs The right of the patients to have curative choices even taking some risks, with European regulatory agencies to issue opinions on the subject An european register for the results of curative DAAs combinations given by compassionate use a common legislation approach of Member States particularly on Compassionate use programmes for hcv patients