Long-Term Follow-up of HCV Infected Stem Cell Transplant Patients and Effects of Antiviral Therapy.

Abstract 1141

Poster Board I-163

Hepatitis C virus (HCV) infection has been reported to be an important cause for serious liver disease including cirrhosis and liver failure after hematopoietic stem cell transplantation (HSCT). This study was initiated by the EBMT in 1993 and recruited patients to 1996 with the aims to prospectively follow a cohort of HCV infected patients and study late effects and responses to antiviral therapy. The requirements for participation were for a center to report all HCV infected HSCT patients having survived for at least 6 months and to be willing to report baseline and follow-up data approximately every five years. Initially, 236 patients were registered. However, no follow-up information was reported on 41 patients. Thus, 195 patients from 12 centers were included in this analysis. The diagnosis, clinical follow-up, and antiviral therapy were made according to each center's routines. Kaplan-Meier curves were calculated for overall survival. Cumulative incidences were calculated for death from liver failure with death from other causes as the competing risk and for development of severe liver complications including death from liver failure, liver transplantation, and biopsy verified cirrhosis with death occurring without the diagnosis of severe liver complication as the competing event. Uni- and multivariable logistic regression was performed with the aim to determine risk factors for severe liver complications.

134 patients had undergone allogeneic and 61 autologous HSCT. The median follow-up from HSCT is currently 16.3 years and the maximum 27.1 years. 33 of 195 patients have died of which seven died from liver complications. The survival probability at 20 years after HSCT was 81.4% and the cumulative incidence for death in liver complications was 4.1% (3.3% in allogeneic and 6.5% in autologous HSCT recipients). 120/195 patients had a least one liver biopsy performed during follow-up. The cumulative incidence of severe liver complications (death from liver failure, liver transplantation, cirrhosis) was 7.6% at 15 years and 11.3% at 20 years after HSCT. 85 patients have been treated with interferon based therapy; 43 in combination with ribavirin. 16 patients have been treated more than once. At last follow-up, 42 patients had become PCR negative of whom seven had relapsed, 25 did not respond, two were not yet evaluated, and for 16 the PCR status was unknown. The sustained virological response rate among all treated patients was 40%. The rates of severe side effects were comparable to other patient populations and no patient developed exacerbations of GVHD. Patients who received antiviral therapy had a trend towards a decreased risk of severe liver complications (p=.058). HCV infection is associated with morbidity and mortality in long-term survivors after HSCT. Antiviral therapy might reduce the risk for severe complications and can be given safely with similar rates of side effects and antiviral response as in non-HSCT patients.