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Real-world data on the management of patients with primary biliary cholangitis (PBC) are so far scarce in Germany. Therefore, we aimed to establish a nationwide registry and describe the clinical characteristics and therapy of PBC patients.Three different cohorts defined as ursodeoxycholic acid (UDCA) responders, as inadequate responders according to Paris II criteria, and as newly diagnosed patients were prospectively recruited.This manuscript includes the baseline data of the project.In total, 33/77 (43%) contacted centres (58% of university hospitals, 38% of non-university hospitals, and 24% of private practices) recruited 515 patients including 204 UDCA responders, 221 inadequate responders to UDCA, and 90 newly diagnosed patients.All patients were treated with UDCA; however, a UDCA dosage below the recommended dosage of 13 mg/kg/d was observed in 38.5% of individuals after 12 months of treatment. UDCA dosages were lower in nonacademic compared to academic centres.Only 75/219 (38.5%) of inadequate responders to UDCA received a second-line therapy with obeticholic acid (OCA) and/or bezafibrate (BZF). OCA (13% vs. 4.5%) and BZF (14% vs. 6.5%) were significantly more often prescribed by academic vs. nonacademic centres.Pruritus (27% vs. 15.5%), fatigue (23% vs. 4.5%), and sicca syndrome (14% vs. 1%) were significantly more often reported by academic centres.The German PBC registry could be established, which indicates suboptimal therapy in a relevant proportion of patients and shows significant differences between academic and nonacademic centres. Results are fundamental to improving clinical management at different levels of care., Competing Interests: JW: Lecturer and advisory board member for Intercept/Advanz Pharma, GSK, Ipsen TM: Ssupported by the German Research Foundation Grants MU 2864/1-3 and MU 2864/3- 1.KS: Receipt of speaker´s honoraria or advisory board: Gilead, Intercept/Advanz Pharma, Abbvie, Falk, Novo Nordisk HB: Consultant: Intercept/Advance Pharma, Ipsen GD: Consultant / speaker: AbbVie, Advanz/Intercept, Alexion, Falk Foundation, Gilead, Novartis, Orphalan, Univar PAR: Consulting and lectures fees: Astra Zeneca, BMS, Boston Scientific, CSL Behring, Gilead, Pfizer, Abbvie, Norgine JMS: Consultant: Astra Zeneca, Apollo Endosurgery, Bayer, Boehringer Ingelheim, BMS, Gilead Sciences, GSK, Intercept Pharmaceuticals, Ipsen, Inventiva Pharma, Madrigal, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Siemens Healthineers. Research Funding: Gilead Sciences, Boehringer Ingelheim, Siemens Healthcare GmbH. Stock Options: AGED diagnostics, Hepta Bio. Speaker Honorarium: Boehringer Ingelheim, Echosens, MedPublico GmbH, Novo Nordisk, Madrigal Pharmaceuticals, Histoindex, MedPublico GmbH SZ: Speakers bureau and/or consultancy: Abbvie, BioMarin, Boehringer Ingelheim, Gilead, GSK, Intercept, Ipsen, Janssen, Madrigal, MSD/Merck, NovoNordisk, SoBi, Theratechnologies KGS: Consultant: Advance Pharma, Speaker Honorarium: AbbVie, GileadJT has received speaking and/or consulting fees from Versantis, Gore, Boehringer-Ingelheim, Falk, Grifols, Genfit and CSL Behring. WPH: Consultant or Speaker Honorarium: Intercept /Advanz, Ipsen, NovoNordisk, Gilead, Abbvie, Norgine CS: Consultant, Study support or Speaker Honorarium: Calliditas, Falk, Intercept/Advanz, Ipsen, Mirum ER: Receipt of honoraria or consultation fees/advisory board: Abbvie, Amgen, Intercept, Medac, Merz, Norgine, Falk Foundation, Gilead, Pfizer, Repha, Takeda AEK: Research grant: Intercept. Speakers bureau: Abbvie, Advanz, AOP Orphan, Bayer, BMS, CMS, CymaBay, Falk, Gilead, GSK, Intercept, Ipsen, Newbridge, Novartis, Lilly, Mirum, MSD, Roche, Zambon. Consultant: Abbvie, Advanz, Alentis, AlphaSigma, AstraZenca, Avior, Bayer, BioNTech, CymaBay, Eisai, Escient, Falk, FMC, Gilead, GSK, Guidepoint, Intercept, Ipsen, Mirum, Medscape, MSD, Myr, Roche, Takeda, Viofor MR: Consultant, or Speaker Honorarium: Intercept/Advanz, Gilead, Abbvie AT: Speaker Honorarium: Intercept/Advanz VK: Consultant Astra Zeneca, Speaker’s Honoraria from AbbVie, Gilead, Falk, Mirum, Albireo/Ipsen, Merck, MedUpdate GmbH, Sanofi, CSL Behring ER: Receipt of honoraria or consultation fees/advisory board: Abbvie, Amgen, Intercept, Medac, Merz, Norgine, Falk Foundation, Gilead, Pfizer, Repha, Takeda FT: Research grant: Allergan, BMS, Inventiva, Gilead. Speakers bureau: Gilead, Abbvie, Falk, Merz, Orphalan, Advanz. Consultant: Allergan, AstraZeneca, Gilead, Abbvie, Alnylam, BMS, Intercept / Advanz, Inventiva, Pfizer, Novartis, Novo Nordisk, Sanofi. CT: Receipt of honoraria or consultation fees/advisory board: Intercept/Advanz Pharma TB: Receipt of grants/research supports: Abbvie, BMS, Gilead, MSD/Merck, Humedics, Intercept, Merz, Norgine, Novartis, Orphalan, Sequana Medical; Receipt of honoraria or consultation fees/advisory board: Abbvie, Alexion, Albireo, Bayer, Gilead, GSK, Eisai, Enyo Pharma, HepaRegeniX GmbH, Humedics, Intercept, Ipsen, Janssen, MSD/Merck, Novartis, Orphalan, Roche, Sequana Medical, SIRTEX, SOBI, and Shionogi; Participation in a company sponsored speaker’s bureau: Abbvie, Advance Pharma, Alexion, Albireo, Bayer, Gilead, Eisai, Falk Foundation, Intercept, Ipsen, Janssen, MedUpdate GmbH, MSD/Merck, Novartis, Orphalan, Sequana Medica, SIRTEX, and SOBI Nothing to disclose: AF, RG, UN, TB, AW, MH, RG, CB, TTW, RB, HG, ND, MM, PM, JUM, AK, KP, NKB, (Thieme. All rights reserved.)

Background:  Hepatitis C virus (HCV) genotype (GT) 1 is the most common HCV GT in Western and Central Europe. The main focus of this present work is to analyze the change of baseline characteristics of 17 093 HCV-patients with genotype 1a/1b with antiviral therapy in Germany between 2004 and 2018. We analyzed five periods: (i) 2004-2007, (ii) 2008-2010, (iii) 2010-2013, (iv) 2014-2016, (v) 2017-2018., Methods:  The present analysis is based on five German non-interventional registry studies and comprises data on 17 093 HCV-GT1 patients documented between 2004 and 2018 [ML17071, ML19464, ML21645, ML25724 (Peginterferon alfa-2a ® non-interventional study [PAN]) and the German Hepatitis C-Registry (DHC-R)., Findings:  Overall, 7662 patients were infected with HCV GT1a and 9431 patients with HCV GT1b. GT1a patients were younger (46.5 years vs. 51.2 years) and more often male (70 % vs. 52 %). Previous or ongoing drug abuse was documented more frequently for GT1a patients throughout the study periods with highest frequencies in the most recent period (2017-2018; 44 % for GT1a and 10.3 % for GT1b). Metabolic comorbidities, such as those who are overweight and those with diabetes mellitus, were associated with HCV GT1b-infected women. The GT1a ratio increased from 33.6 % (2004-2007) to 50 % (2017-2018). A relevant change in the GT1a/1b ratio was observed over time in men (2004-2007: 38 %/63 %; 2017-2018: 59 %/41 %). In contrast, only 30 % of women had GT1a infection throughout all study periods without relevant changes. There were no regional differences within Germany in HCV GT1a/1b distribution despite a higher proportion of GT1b-infected women in East Germany in 2004-2007 (86 %)., Conclusion:  A marked increase of GT1a infection associated with drug use was observed in men, but not women, in Germany between 2004 and 2018. The present data show a fundamental change in HCV epidemiology, which has an impact on therapy management and general care of hepatitis C patients in Germany., Competing Interests: Karl-Georg Simon hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie GmbH & Co.KG, Falk Pharma, Gilead Sciences GmbH, MSD Sharp & Dohme GmbH.Yvonne Serfert hat keine Interessenkonflikte.Peter Buggisch hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie, Gilead, MSD.Stefan Mauss hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie, Gilead, MSD.Klaus H. W. Boeker hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie, Gilead.Hartwig Klinker hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie, BMS, Gilead, Janssen, MSDTobias Müller hat keine Interessenkonflikte.Uta Merle hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: CSL-Behring, FALK.Dietrich Hüppe hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie GmbH & Co. KG, Falk Pharma, Ferring Arzneimittel GmbH.Michael P. Manns hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: AbbVie, BMS, Gilead, Merck (MSD)Heiner Wedemeyer hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: Abbott, AbbVie, Altimmune, Biotest, BMS, BTG, Dicerna, Gilead, Janssen, Merck/MSD, MYR GmbH, Novartis, Roche, Siemens, Transgene., (Thieme. All rights reserved.)

Despite the high effectiveness of direct-acting antivirals for the treatment of hepatitis C, a small proportion of patients do not respond to approved regimens. The combination regimen of SOF/VEL/VOX was recently approved for patients with failure to prior NS5A-based treatment. In this German real-world cohort including patients with cirrhosis (27.3 %) and previous decompensation events, 12 weeks of SOF/VEL/VOX resulted in high virologic response rates irrespective of disease severity and prior DAA regimen. Adverse events were mostly mild or moderate and comparable to those seen in the approval studies., Competing Interests: Johannes Vermehren: sponsored lectures (national oriInternational): AbbVie, Gilead, Intercept, Merck. Markus Cornberg: sponsored lectures (national or international): AbbVie, Gilead, Merck/MSD, Siemens Healthcare, Falk Foundation e. V.; other: advisory committee or review panel: Merck/MSD, AbbVie, Spring. Albrecht Stoehr: grants: Abbvie, Bristol-Myers-Squibb, Gilead, Janssen, MSD, ViiV; sponsored lectures (national or international): AbbVie, Bristol-Myers-Squibb, Gilead, Janssen, MSD, ViiV; other: advisory boards: AbbVie, Bristol-Myers-Squibb, Gilead, Janssen, MSD, ViiV. Hartwig Klinker: grants: Abbvie, BMS, Gilead, Janssen, MSD; sponsored lectures (national or international): AbbVie, BMS, Gilead, Janssen, MSD; other: advisory boards: AbbVie, BMS, Gilead, Hexal, Janssen, MSD. Karl-Georg Simon: sponsored lectures (national or international): AbbVie, FALK, Gilead, MSD; other: advisory committee or review panel: AbbVie, MSD. Gerlinde Teuber: sponsored lectures (national or international): AbbVie, Gilead Sciences, Intercept, MSD; other: advisory committee or review panel: AbbVie, Gilead. Katja Deterding: sponsored lectures (national or international): AbbVie, Gilead, Merck/MSD; other: advisory committee: Gilead, AbbVie. Julian Schulze zur Wiesch: sponsored lectures: Gilead, MSD, AbbVie. Maria-Christina Jung: nothing to disclose. Yvonne Serfert: nothing to disclose. Michael P. Manns: grants: AbbVie, BMS, Janssen, Gilead, Merck (MSD); sponsored lectures (national or international): AbbVie, BMS, Janssen, Gilead, Merck (MSD); consultant: AbbVie, BMS, Janssen, Gilead, Merck (MSD). Stefan Zeuzem: consultancies and lecture honoria: AbbVie, Gilead, Intercept, Janssen, Merck/MSD. Heiner Wedemeyer: reports personal fees from Transgene, MSD, Roche, Gilead, Abbott, BMS, Falk, AbbVie, Novartis, GSK, Roche Diagnostics, Eiger, ITF, and MyrGmbH; grants/research support from MSD, Novartis, Gilead, Roche, Abbott, and Roche Diagnostics. Christoph Sarrazin: grants: Abbott, Gilead, Janssen, Qiagen, Roche, Siemens; sponsored lectures (national or international): Abbott, AbbVie, Achillion, BMS, Gilead, Janssen, Merck/MSD, Qiagen, Roche, Siemens; other: advisory boards: Abbott, AbbVie, BMS, Gilead, Janssen, Merck/MSD, Roche., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background:  Virologic failure to approved combinations of direct antiviral agents (DAA) in patients with chronic hepatitis C virus (HCV) infection is rare. Mostly it involves difficult to treat patients with advanced liver disease and prior interferon-experience. Before approval of VOX/VEL/SOF, a restricted number of patients received rescue treatment, and the choice of DAA combinations for re-treatment were selected on an individual basis. In the present analysis, patient characteristics and rescue-regimens after virologic failure mainly based on first generation DAAs are described., Patients and Methods:  Data were obtained from the German Hepatitis C-Registry (DHC-R), which is a national multicenter real-world cohort currently including about 16 500 patients recruited by more than 250 centers. The present analysis is based on 6683 patients who initiated a DAA therapy and for whom follow-up data (per-protocol analysis) were available., Results:  Among the patients, 188 (2.8 %) experienced a virologic relapse. Compared to SVR-patients, relapse patients were significantly more often male (77.7 % versus 56.9 %, respectively, p < 0.001), showed cirrhosis significantly more (48.4 % versus 28.1 %, respectively, p < 0.001) and a prior interferon-containing therapy (46.3 % versus 39.0 %, respectively, p = 0.049). The majority of patients who relapsed were infected with genotype 1 (47.4 %) followed by genotype 3 (29.8 %), and 95 relapse patients started DAA re-treatment. Characteristics of patients with rescue-treatment are similar to these of patients with relapse after initial DAA treatment. Thirty-one of 39 patients with complete follow-up data achieved SVR (79.5 %), and 8 patients had a relapse again (20.5 %). Patients who received rescue treatment including a new DAA class according to guidelines, except patients who received VOX/VEL/SOF, showed higher SVR rates than the entire group (21/25, 84 %). All patients who received VOX/VEL/SOF achieved SVR (n = 4, 100 %)., Conclusions:  Patients with failure with DAA combination therapies are a difficult but urgent to treat population with the frequent presence of cirrhosis and prior treatment failure with interferon-based therapies. Rescue therapy with inclusion of a new DAA class leads to high SVR rates, but multiple targeted therapy with VOX/VEL/SOF seems to be most effective., Competing Interests: Annika Schmitt: consulting: AbbVieRainer Günther: has nothing to discloseStefan Mauss: sponsored lectures (national or international): Gilead, AbbVie, MSD; advisory committee or review panel: Gilead, AbbVie, MSDKlaus H.W. Boeker: speaking and teaching: AbbVie, Gilead, MSDPeter Buggisch: advisory committee or review panel: AbbVie, Gilead, MSD, Intercept; speaking and teaching: AbbVie, Gilead, Falk, Merz, MSD, NorgineHeribert Hillenbrand: has nothing to discloseChristine John: has nothing to discloseHartwig Klinker: advisory committee or review panel: AbbVie, BMS, Gilead, Hexal, Janssen, MSD, Shionogi; grant/research support: AbbVie, Arrowhead, BMS, Janssen, Gilead, MSD, Novartis; speaking and teaching: AbbVie, BMS, Gilead, Janssen, MSDAnita Pathil: consultant: AbbVie; sponsored lectures (National or International): AbbVie, BMS, Gilead, JanssenKarl-Georg Simon: advisory committee or review panel: AbbVie, Gilead, MSD; speaking and teaching: AbbVie, FALK, Gilead, MSDYvonne Serfert: has nothing to discloseClaus Niederau: grants: AbbVie, Falk, Genzyme, Gilead, MSD, Novartis, Shire; consultant: AbbVie, Alexion, Genzyme, Gilead, Janssen, MSD, Shire; sponsored lectures: (National or International): AbbVie, Alexion, Biogen, BMS, Falk, Genzyme, Gilead, Janssen, MSD, Novartis, ShireJohannes Vermehren: sponsored lectures (national or international): AbbVie, Gilead, Intercept, Merck.Heiner Wedemeyer: personal fees from Transgene, MSD, Roche, Gilead, Abbott, BMS, Falk, AbbVie, Novartis, GSK, Roche Diagnostics, Eiger, ITF, and MyrGmbH; grants/research support from MSD, Novartis, Gilead, Roche, Abbott, and Roche Diagnostics.Christoph Sarrazin: speaker and consultation for AbbVie, Gilead, MSD/Merck, (© Georg Thieme Verlag KG Stuttgart · New York.)

Background:  The urgent need in HCV-infected patients with liver disease mandated the rapid implementation of IFN-free DAA combination therapies following their regulatory approval in 2014 and 2015 without full knowledge of the optimal combinations and regimens. Investigating the evolution of the DAA utilization patterns and treatment outcomes could provide learnings for future situations., Methods:  This was an analysis of a prospective observational database from the German Hepatitis C Registry (DHC-R) covering a period from May 2014 to September 2015. Adult patients had evidence of chronic HCV GT1 or GT4 infection and were treated with an IFN-free combination regimen of simeprevir (SMV) + sofosbuvir (SOF) or other IFN-free regimens: daclatasvir + sofosbuvir (DCV + SOF), ledipasvir/sofosbuvir (SOF/LDV), paritaprevir/r + ombitasvir ± dasabuvir (PrOD), with or without ribavirine (R)., Results:  A total of 5496 subjects were followed during the period. During this period, clinical recommendations and treatment patterns evolved rapidly in response to new evidence from clinical trials and clinical routine and regulatory approval of additional regimens. High SVR12 rates were seen in this cohort, even in hard-to-treat patient subgroups. In the multivariate analysis, gender, age, advanced cirrhosis, and intensified treatment for cirrhotics were associated with treatment outcome., Conclusion:  Despite limited knowledge of the optimal utilization of the newly approved DAA combinations and treatment durations as well as their comparative efficacy and safety profiles, high SVR rates were achieved regardless of the DAA combination. These outcomes were facilitated by the rapid adaptation of clinical recommendations. Future situations with high unmet medical need may follow a similar approach., Competing Interests: CS has received speaker and consultancy fees from Abbvie, Abbott, BMS, Gilead, Janssen, Merck and Siemens.PB has received speaker and consultancy fees from AbbVie, Falk, Gilead, Merz Pharma and MSD.SM has received speaker and consultancy fees from AbbVie, Gilead, Janssen and MSD.TM has received speaker and consultancy fees from AbbVie, Falk, Intercept, Gilead, MSD, Novartis and Roche.TZ has received speaker and consultancy fees from AbbVie, Astellas, BMS, Boehringer Ingelheim, Gilead Sciences, Janssen, MSD, Novartis, and Roche.HK has received speaker and consultancy fees from AbbVie, BMS, Gilead, Hexal, Janssen and MSD.AP has received speaker and consultancy fees from Janssen, Gilead, AbbVie und BMS.MS is an employee of Janssen.CN is an employee of Janssen.ILD is an employee of Janssen.KGS has received speaker and consultancy fees from AbbVie, BMS, Janssen, Falk, Gilead, Norgine, Merz, MSD., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims:  Disease activity, but also demographics, lifestyle, and comorbidities, may influence alanine aminotransferase (ALT) levels in hepatitis C virus (HCV)-infected patients. Direct-acting antiviral agents (DAA) achieve virological cure in > 90 % of patients, regardless of HCV genotype and fibrosis stage. This allows assessing determinants for ALT levels before and after elimination of HCV., Methods:  Our prospective cohort included HCV- and HIV/HCV-infected patients treated with DAA at 9 German centers (GECCO cohort). We analyzed all consecutive patients with sustained virological response (SVR) at week 12 (SVR12) and/or 24. Normal ALT was defined as ≤ 35 U/L, regardless of sex., Results:  At baseline, 1477 out of 1774 patients (83 %) had ALT > 35 U/L, and 297 (17 %) had ALT ≤ 35 U/L. Baseline ALT > 35 U/L was independently associated with male sex, higher body mass index (BMI), liver cirrhosis, and not being on opioid substitution. After SVR, > 80 % of patients normalized ALT, and even patients with low baseline ALT further reduced ALT levels. However, ALT remained > 35 U/L in 15 % (221/1477) after SVR12. By multivariate analysis, ALT > 35 U/L at SVR12 was associated with male sex, higher BMI, liver cirrhosis, baseline ALT, HCV genotype 2, and younger age. Obesity, cirrhosis, and ALT were also independent factors associated with ALT > 15 U/L at SVR12 in patients with normal ALT at baseline., Conclusions:  Male sex, advanced liver fibrosis, and obesity are main risk factors for the lack of ALT normalization and/or ALT decline after SVR, indicative of fatty liver disease as a relevant comorbidity in hepatitis C., Competing Interests: Financial disclosures: Florian Berger: noneLukas Buendgens: noneChristoph Boesecke: Speakers bureau: Abbvie, Gilead, Janssen, MSD, ViiV, Advisory board: Abbvie, Gilead, MSD, ViiVStefan Christensen: Speakers bureau: Abbvie, Gilead, Janssen; Advisory board: Abbvie, Gilead, Janssen, MSD, ViiVDietrich Hüppe: Speakers bureau: Abbvie, Gilead, Janssen, MSD; Advisory board: Abbvie, Gilead, Janssen.Patrick Ingiliz: Speakers bureau: Abbvie, Gilead, Janssen, MSD.Thomas Lutz: noneStefan Mauss: Speakers bureau: Abbvie, Gilead, Janssen; Advisory board: Abbvie, Janssen, MSD.Knud Schewe: Fees for consultancy and speaking from AbbVie, Bristol-Myers-Squibb, Gilead, Hexal, ViiV, Janssen, MSD.Karl Georg Simon: Speakers bureau: Abbvie, Gilead, Janssen; Advisory board: Abbvie, Janssen, MSD.Frank Tacke: Fees for consultancy and speaking from AbbVie, Bristol-Myers-Squibb, Gilead, Janssen, MSD. Financial support: none, (© Georg Thieme Verlag KG Stuttgart · New York.)

Background:  More than 250 000 patients suffer from chronic hepatitis C in Germany. Several potent, direct-acting antiviral drugs have been approved since 2014. The aim of the German Hepatitis C-Registry (DHC-R) is to describe the epidemiology and patient care of hepatitis C and to investigate the efficacy and safety of new treatment options in real-world settings., Methods:  The DHC-R is a prospective multicenter non-interventional registry study that includes 327 centers throughout Germany. All approved treatment options have been documented. The current analysis differentiated 4 phases: 2/2014 - 12/2014, 1/2015 - 12/2015, 1/2016 - 7/2017 and 8/2017 - 7/2018., Findings:  Between February 2014 and July 2018, 12 170 patients were included in the registry (61.3 % male), and antiviral treatment was initiated in 11 268. The mean age declined from 52.3 years (phase 1) to 49.3 years (phase 4), while the proportion of patients with previous or ongoing drug abuse increased (26.3 % to 43.1 %). In 2014, 35.1 % of treated patients had liver cirrhosis, which declined to 16.5 % in phase 4. The HCV genotype distribution showed marked fluctuations, with most recent increases in HCV genotype 3 (30 % in phase 4). Per-protocol sustained virological response rates increased from 92.8 % in 2014 to 94.4 % in 2017/18 with excellent tolerability., Summary:  The DHC-R mirrors patient care of chronic hepatitis in the real-world setting in Germany and provides insights into epidemiology developments. It also confirms the high efficacy and safety of novel treatment options., Competing Interests: Dr. Dietrich Hüppe hat in den letzten 3 Jahren Zuwendungen (z. B. Vortragshonorare, Forschungsgelder oder Beraterhonorare) erhalten von: MSD Sharp&Dohme GmbH, Janssen Cilag GmbH, Roche Pharma AG, Bristol-Myers Squibb GmbH&Co. KGaA, Falk Pharma, Boehringer Ingelheim Pharma GmbH & Co. KG, Novartis Pharma Germany GmbH, Norgine GmbH, AbbVie GmbH & Co. KG, Gilead Sciences GmbH, Ferring Arzneimittel GmbH, (© Georg Thieme Verlag KG Stuttgart · New York.)