- Email: [email protected]
P0777 : Sofosbuvir-based treatment under real life conditions in Germany (The sofger trial)
POSTERS P0777 SOFOSBUVIR-BASED TREATMENT UNDER REAL LIFE CONDITIONS IN GERMANY (THE SOFGER TRIAL) P. Buggisch1 , C. Sarrazin2 , S. Mauss3 , H. Hinrichsen4 , K.-G. Simon5 , J. Vermehren2 , D. Hueppe6 , J. Petersen1 . 1 Leberzentrum Hamburg, IFI, Hamburg, 2 Johann Wolfgang Goethe University Hospital, Frankfurt, 3 Center for HIV and Gastroenterology, Duesseldorf, 4 Center for Gastroenterology, Kiel, 5 Center for Gastroenterology, Leverkusen, 6 Center for Gastroenterology, Herne, Germany E-mail: Buggisch@ifi-medizin.de Background and Aims: The approval of direct-acting antivirals (DAA) in Germany starting with Sofosbuvir (SOF) in January 2014, Simeprevir (SIM) in May 2014 and Daclatasvir (DCV) in August changed the landscape of HCV-therapy. Recommendations in Germany (BNG/DGVS) were rapidly changed accordingly: first in favour for triple therapy with PEG-IFN, Ribavirin (Riba), SOF, later on for dual therapy with SOF/Riba (GT 2) and SIM/SOF (limited to special cases), and DCV/SOF. Aim of this study was to evaluate the change of treatment modalities following the implementation of recommendation as well as the safety and efficacy of the SOF based therapies under real life conditions. Methods: In this non-interventional, prospective, multi-center study conducted by the Association of German Gastroenterologists in private practice (BNG) (5 centers) and one academic based center (Frankfurt), SOF-based therapies are currently being evaluated in Germany. Demographic, clinical, virology data and adverse events are collected throughout treatment and post-treatment. This interim analysis shows data about patients with SOF-based treatments from January to October 2014. Results: 556 patients (319 male, 237 female) received SOF-based treatments. 339 pts with genotype 1 (152 1a, 187 1b), 61 genotype 2, 111 genotype 3, 45 genotype 4. Treatment-naive were 186, 352 had previous treatment (relapse 187, nonresponse 158, 18 unknown), 57% of patients had fibrosis F3–4. 58 pts received SOF/Riba for 12 weeks (all G2), 52 SOF+Riba for 24 weeks. 158 received triple therapy 12 weeks, 181 SOF+DCV +/− Riba (mainly F4, some in compassionate use), 5 SOF+SIM, 102 SIM/SOF. Within 5 months the landscape switched to mostly IFN-free regimen. SVR 12 data in the Triple-therapy group are available so far from 132 patients: 121 SVR12, 7 relapses, 4 pts were lost to follow up. 4 patients with IFN based therapy had to stop treatment because of IFN side effects. Anemia and fatigue were the most reported AEs. No severe side effects occurred. There were 4 deaths (out of 556) reported due to complications of cirrhosis. More SVR 12 data and detailed results for the different treatments will be available at the meeting. Conclusions: SOF-based triple therapies under real life conditions seems to have comparable results to clinical trials. Following recommendations, there was a fast switch to IFN-free therapies in Germany in 2014. There is a clear trend to treat advanced patients first, but almost 40% were treated without advanced fibrosis. Adverse events and treatment discontinuations were low. P0778 THE EFFECT OF HCV ANTIVIRAL THERAPY ON FIBROSIS PROGRESSION M. Lu1 , J. Li1 , L.B. Rupp1 , S.D. Holmberg2 , A.C. Moorman2 , P.R. Spradling2 , E. Tehale2 , F. Xu2 , J.A. Boscarino3 , V. Vijayadeva2 , M.A. Schmidt4 , L.E. Lamerato1 , S. Gordon1 . 1 Henry Ford Health System, Detroit, 2 Centers for Disease Control, Atlanta, 3 Geisinger Health System, Danville, 4 Kaiser-Permanente Northwest, Portland, United States E-mail: [email protected]
(SVR), on fibrosis progression as measured by FIB4 trajectory among patients in the Chronic Hepatitis Cohort Study (CHeCS), a longitudinal observational study that draws patients from 4 large US health systems. Methods: The index date was defined as date of HCV diagnosis or initial treatment, whichever was later. Patients were excluded if they were ever enrolled in an HCV treatment clinical trial, were co-infected with HBV, had received a liver transplant prior to the index date, or were receiving ongoing HCV treatment at end of follow-up. FIB4 scores were derived from routine testing and summarized as median values in 90-day intervals for up to six years after the index date. Only patients with two or more summarized FIB4 scores in addition to index date were included. Multilevel regression for longitudinal logFIB4, univariate followed by the multivariable modeling, was used to test the effects of HCV treatment and SVR on FIB4 trajectory over time. All analyses were adjusted using propensity score. Age, sex, FIB4, diabetes, and history of alcohol abuse at baseline were considered in the propensity score calculation. Results: A total of 4,148 patients with confirmed HCV infection were included; 1,403 (34%) were treated (92% with dual ribavirin/ interferon therapy and 5% with triple therapy), of whom 648 (46%) achieved an SVR. The final multilevel regression model showed significant change in FIB4 based on time, as well as interaction terms indicating that the fibrosis trajectory differed based on sex and timing of treatment response. Over time, men demonstrated consistently higher FIB4 levels than women (p < 0.01). For both males and females who achieved SVR, logFIB4 decreased for several years, then leveled off at year 4.5. Non-SVR responders demonstrated slow climbing logFIB4 in the range of 0.5–0.8 for females and 0.7–1.1 for males, while untreated males showed more rapid logFIB4 progression. Conclusions: Eradication of HCV with antiviral therapy appeared to induce a regression of fibrosis, as measured by the FIB4 biomarker over a 6-year timeframe in a large diverse US cohort. Both absence of treatment and unsuccessful treatment were characterized by a progressive increase in fibrosis progression, with untreated males showing more rapid progression.
Figure: Predicted log FIB4 over time.
Background and Aims: The extent to which antiviral therapy for hepatitis C virus (HCV) infection alters the course of fibrosis progression is not well understood. We sought to study the impact of antiviral therapy, with and without sustained viral response S622
Journal of Hepatology 2015 vol. 62 | S263–S864
(SVR), on fibrosis progression as measured by FIB4 trajectory among patients in the Chronic Hepatitis Cohort Study (CHeCS), a longitudinal observational study that draws patients from 4 large US health systems. Methods: The index date was defined as date of HCV diagnosis or initial treatment, whichever was later. Patients were excluded if they were ever enrolled in an HCV treatment clinical trial, were co-infected with HBV, had received a liver transplant prior to the index date, or were receiving ongoing HCV treatment at end of follow-up. FIB4 scores were derived from routine testing and summarized as median values in 90-day intervals for up to six years after the index date. Only patients with two or more summarized FIB4 scores in addition to index date were included. Multilevel regression for longitudinal logFIB4, univariate followed by the multivariable modeling, was used to test the effects of HCV treatment and SVR on FIB4 trajectory over time. All analyses were adjusted using propensity score. Age, sex, FIB4, diabetes, and history of alcohol abuse at baseline were considered in the propensity score calculation. Results: A total of 4,148 patients with confirmed HCV infection were included; 1,403 (34%) were treated (92% with dual ribavirin/ interferon therapy and 5% with triple therapy), of whom 648 (46%) achieved an SVR. The final multilevel regression model showed significant change in FIB4 based on time, as well as interaction terms indicating that the fibrosis trajectory differed based on sex and timing of treatment response. Over time, men demonstrated consistently higher FIB4 levels than women (p < 0.01). For both males and females who achieved SVR, logFIB4 decreased for several years, then leveled off at year 4.5. Non-SVR responders demonstrated slow climbing logFIB4 in the range of 0.5–0.8 for females and 0.7–1.1 for males, while untreated males showed more rapid logFIB4 progression. Conclusions: Eradication of HCV with antiviral therapy appeared to induce a regression of fibrosis, as measured by the FIB4 biomarker over a 6-year timeframe in a large diverse US cohort. Both absence of treatment and unsuccessful treatment were characterized by a progressive increase in fibrosis progression, with untreated males showing more rapid progression.
Figure: Predicted log FIB4 over time.
Background and Aims: The extent to which antiviral therapy for hepatitis C virus (HCV) infection alters the course of fibrosis progression is not well understood. We sought to study the impact of antiviral therapy, with and without sustained viral response S622
Journal of Hepatology 2015 vol. 62 | S263–S864