ISG Winter Meeting 2015
Second Prize Clinical Science
Trinity College Dublin / St. James's Hospital, Dublin
Real-world outcomes from the national HCV treatment registry
E Gray, A. O’Leary, C Bergin, G. Courtney, M. Cannon, O. Crosbie, C. deGascun, E. Feeney, D Houlihan, B. Kelleher, JS. Lambert, J. Lee, P. Mallon, S. McConkey, A. McCormick, S. McKiernan
School of Medicine, Trinity College, Dublin, Ireland; National Centre for Pharmacoeconomics; St James’ Hospital, Dublin, Ireland; Irish Hepatitis C Outcomes and Research Network
The Irish Hepatitis C Outcomes and Research Network (ICORN) national HCV treatment registry was established in 2012 to prospectively collect clinical and economic outcomes for patients treated for HCV infection with regimens containing directacting antiviral agents (DAAs) in the post-reimbursement setting. Patients treated in seven hospitals across hepatology, gastroenterology and infectious disease disciplines were included in this national registry.
To report the clinical outcomes for patients treated with interferon-based or interferon-free regimens in the Irish real-world clinical setting, for whom final outcomes have been achieved.
All patients consented for participation in the registry were included. Demographic data, relapse rates, discontinuation rates and sustained viral response (SVR) rates are captured during treatment and follow-up, and entered into a secure electronic platform.
Between June 2012 and September 2015, 668 patients commenced treatment with interferon-based (n=330) and interferon-free regimens (n=338), and were enrolled in the registry. Genotype 1 accounted for 87% of the total cohort, and GT3 11%. Outcome data is currently available for 264 interferon-based and 100 interferon-free patients. The overall SVR24 rate among GT1 patients, of whom 25% were cirrhotic, treated with interferon-based regimens was 68% (179/264); 73% (132/180), 55% (42/76) and 63% (5/8) in patients prescribed telaprevir (TPV) with pegylated interferon and ribavirin (PR), boceprevir (BOC)/PR and simeprevir (SIM)/PR respectively. The overall discontinuation rate was 31% with a relapse rate of 5%. The median age for 100 patients (62% male) with advanced liver disease (CPT ≥7, and/or evidence of decompensation) treated with sofosbuvir/ledipasvir and ribavirin (SOF/LDV/RBV) was 49 years (range 34-79). One third were reported to have had an episode of decompensation. The genotypic profile was 70% GT1, and 23% GT3. The SVR12 rate in this cohort was 80% and 34% in GT1 and GT3 respectively (Table 1). Eleven patients (12%) prematurely discontinued therapy, of whom 7 patients died on treatment. Sixteen patients relapsed following treatment, primarily driven by a high rate in GT3 (10/23). Two further relapses were obtained in patients with genotype 4 and of a mixed profile.
Robust observational Irish data is essential for evaluating and understanding the true effectiveness of newer treatment regimens for hepatitis C and provide valuable information for Irish health policy makers and decision makers regarding allocation of resources. Results from this national dataset are comparable to other European and international studies.