Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010
BASELINE CHARACTERISTICS AND ON-TREATMENT PREDICTORS OF RESPONSES FROM REAL-WORLD PATIENT COHORTS: INTERIM RESULTS OF THE MULTINATIONAL PROPHESYS COHORTS
P. Ferenci1*, M.L. Shiffman2, M. Puoti3, A. Orlandini4, F.A. Caruntu5, D. Ouzan6, M. Bozic7, M. Bourliere8, G.F. Silva9, J. Schuller10, J.-P. Mulkay11, A. Horban12, D. Messinger13, A. Tietz14, A. Mangia15
1Medical University of Vienna, Vienna, Austria, 2Bon Secours Health System, Liver Institute of Virginia, Newport News, VA, USA, 3University of Brescia, Brescia, 4Unit of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy, 5Matei Bals Infectious Diseases Institute, Bucharest, Romania, 6Institut Arnault Tzanck, Saint-Laurent-du-Var, France, 7Clinical Center of Serbia, Beograd, Serbia, 8Hospital Saint Joseph, Marseille, France, 9Botucatu School of Medicine, Botucatu, Brazil, 10Szent Laszlo Hospital, Budapest, Hungary, 11Hôpital Saint Pierre, Bruxelles, Belgium, 12Medical University Clinic of Infectious Diseases, Warsaw, Poland, 13IST GmbH, Mannheim, Germany, 14Roche, Basel, Switzerland, 15Hospital Casa Sollievo della Sofferenza, Rotondo, Italy. *email@example.com
Background: The concept of response-guided therapy in CHC has been developed retrospectively from the results of randomised controlled trials. Prospective real-world data testing the impact of this concept are lacking. PROPHESYS comprises three separate, non-interventional cohort studies of patients receiving combination treatment for CHC. Data are collected only from mono-infected, naive patients whose treatment is prescribed in accordance with the local label. According to country-specific requirements, PROPHESYS 1 follows patients prescribed the combination of peginterferon alfa-2a (40KD)/ribavirin. PROPHESYS 2 and 3 include combination therapy with peginterferon alfa-2a (40KD)/ribavirin or with peginterferon alfa-2b (12KD)/ribavirin.
Methods: This interim analysis included data from patients who initiated treatment on/before 31/01/2009 and had baseline and week 12 HCV-RNA results. RVR and cEVR were defined as undetectable HCV-RNA (< 15IU/mL) by weeks 4 and 12, respectively, and pEVR was defined as ≥2 log decrease but still detectable (≥15IU/mL) HCV-RNA at week 12. MLR analysis explored baseline factors associated with RVR and/or cEVR.
Results: A total of 5292 patients were treated with peginterferon alfa-2a or with peginterferon alfa-2b, both in combination with ribavirin. Baseline characteristics and on-treatment responses are presented in the table. Among G1/4 patients, according to MLR, baseline factors significantly (p< 0.05) associated with higher rates of viral clearance by week 12 (RVR or cEVR) included younger age, lower HCV-RNA, lower BMI, race (Asian rates higher than Caucasian, and Caucasian rates higher than Black or other), absence of cirrhosis, higher platelets, higher ALT ratio and prescription of peginterferon alfa-2a. For G2/3 patients, factors associated with RVR and cEVR included younger age, higher platelets and genotype 3.
Conclusion: Patient demographics differed markedly by genotype. Rates of RVR and cEVR were similar to or even higher than those reported in Phase III clinical trials. Baseline factors strongly associated with rapid and/or early viral clearance were also similar to those previously reported in randomised clinical trials. The results of this real-world analysis provide insights into subgroups of patients who may be future candidates for shortened treatment with triple combination therapy.