In 2016, the World Health Organization (WHO) decided on an initiative to identify 90% of the world's existing hepatitis B and C virus infections by 2030, treat 80% and reduce the mortality by 65%. In 2016, the federal government endorsed these goals. From Oct 1, 2021, the G-BA included a one-time screening for hepatitis B and C in the health examination (GU) for people aged 35 and over who have statutory health insurance. The previous participation rates in the GU were evaluated and the effectiveness of the program is documented using the reporting data on hepatitis B and C of Robert Koch Institute (RKI).Notifications from Central Institute of Statutory Health Insurance (ZI) and Scientific Institute of the local health insurance companies (WIdO) were compiled with regard to the GU, the reporting data from the RKI were collected and analyzed using SURVSTAT@RKI 2.0 as well as billing data from the Association of Statutory Health Insurance Physicians (KBV).Between 2007 and 2021, around 83% of all insured persons took part in a GU at least once. From the fourth quarter of 2021, the number of newly diagnosed cases of hepatitis B and C increased. In 2022, the increase for hepatitis B was 91.9% and for hepatitis C 68%. This trend continued in 2023, with new diagnoses of hepatitis B increasing by 160% (to 22,795 cases) and hepatitis C increasing by 121% (to 10,508 cases) compared to 2021. The analysis of the KBV billing data showed that the increase in new diagnoses shows a strong correlation between the number of new diagnoses within the GU and the total number of diagnoses.The decision of the Federal Joint Committee (G-BA) to include hepatitis B and C screening in the GU seems to be a success in detecting previously undetected cases of the disease. Based on the billing data from the KBV, a high level of agreement could be demonstrated between the number of new diagnoses within the GU and the increase in the total number of diagnoses. The goals of the WHO may be achievable.
While direct-acting antivirals (DAAs) cure chronic hepatitis C virus (HCV) infection in almost all patients, some patients remain at risk of liver disease despite HCV cure. In order to identify risk factors indicating liver-related morbidity and death after viral cure, we included 6982 patients from the national multicenter real-world German Hepatitis C Registry with regular follow-up visits for up to 7 years after DAA therapy. Definitions for normal liver function tests (in women/men) were alanine aminotransferase (ALT; ≤35/≤50 U/L), ALT according to American Association for the Study of Liver Diseases (AASLD; ≤19/≤30 U/L), and gamma-glutamyltransferase (GGT; ≤40/≤60 U/L). In our cohort, 97.4% of patients achieved sustained virologic response (SVR). At 24 weeks after SVR (SVR24), elevated ALT occurred in 657/6982 (9.4%), elevated ALT (AASLD) in 2609/6982 (37.4%), and elevated GGT in 1777/6982 (25.5%) patients. Risk factors for increased ALT at SVR24 were obesity, alcohol, cirrhosis, elevated baseline ALT, and non-SVR. Increased GGT at SVR24 was significantly (p < 0.05) and independently associated with male sex (odds ratio [OR], 2.12), higher body mass index (OR, 1.04), age >50 years (OR, 1.60), liver cirrhosis (OR, 3.97), alcohol consumption (OR, 2.99), diabetes (OR, 1.63), non-SVR (OR, 8.00), and elevated GGT at baseline (OR, 17.12). In multivariate regression analysis, elevated GGT at SVR24, particularly in combination with cirrhosis, was the best predictor for hepatic decompensation, hepatocellular carcinoma development, and death, followed by elevated ALT (AASLD) and standard ALT, which predicted hepatic decompensation. Despite successful HCV therapy, elevated GGT at SVR24 and to a lesser extent ALT are predictive of the future clinical outcome and linked with liver-associated comorbidities. This may highlight the relevance of nonalcoholic fatty liver disease, diabetes mellitus, alcohol, and cirrhosis for the clinical outcome in a vulnerable population, even after HCV cure.
The number of patients diagnosed with hepatitis C virus (HCV) is markedly higher than the number initiating treatment indicating gaps in the care cascade, likely centred around reaching at-risk populations. Understanding changing characteristics of patients with HCV allows for targeted programs that increase linkage to care. We investigated changes in demographic and clinical characteristics of patients registered in the German Hepatitis C-Registry (DHC-R) from 1 January 2014 to 31 December 2019. The DHC-R is an ongoing, noninterventional, multicentre, prospective, observational cohort registry including 327 German centres. Patient characteristics were analysed over time in 7 phases for all patients completing a screening visit. Overall, 14,357 patients were enrolled. The percentage of treatment-naïve/non-cirrhotic patients increased from 34.4% in phase 1 (1 January-31 December 2014) to 68.2% in phase 7 (1 August-31 December 2019). The proportion of migrants, alcohol users, people who inject drugs, and those receiving opiate substitution therapy increased in later registry phases. Most patients (60.1%) were receiving comedication at baseline. The most prescribed comedications were drugs used to treat opioid dependence which increased from 9.2% in phase 1 to 24.0% in phase 7. The patients' mean age decreased from 52.3 years in phase 1 to 48.7 years in phase 7. From 2014 to 2019, the proportion of at-risk patients enrolling in the registry increased. To eliminate viral hepatitis as a major public health threat, a continued commitment to engaging underserved populations into the HCV care cascade is needed.
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.
Background and aims Direct acting antivirals against hepatitis C improve the short-term outcome of patients with chronic hepatitis C. The long-term clinical course after interferon-free treatment of chronic hepatitis C has rarely been studied in large real-world cohorts. We here present data on 10,448 patients being followed for up to 7 years after DAA therapy in the German Hepatitis C-Registry.
Background Healthcare services were faced with unprecedented challenges due to the COVID-19 pandemic and its associated lockdown regulations. In order to analyse the influence of the pandemic on the healthcare of patients with chronic hepatitis C in Germany, we carried out a structured questionnaire among all centres participating in the German Hepatitis C-Registry (DHC-R). Methods 320 centres of the DHC-R were invited to participate in an online survey. Of these, 74 centres had included >= 5 patients in the last 12 months. Findings A fully answered questionnaire was sent back by 64 centres. Due to the lockdown regulations, 11 % of the centres had stopped their regular consultation between March and May 2020; 58 % had reduced the consultations and 32 % did not change the consultations. More than 50 % of the appointment cancellations were done by the patients. 52 % of the centres offered a new or additional telephone consultation and 17 % offered a new video consultation. Between March and May 2020, the number of patients newly treated with antivirals was markedly lower when compared with the same period in 2019. All centres had returned to their usual consultation procedures in July 2020. Almost 80 % indicated that there were no significant limitations in patient's healthcare. However, 22 % of the centres stated that liver decompensation was diagnosed late and 9.4 % stated that diagnosis of hepatocellular carcinoma was delayed. An adequate amount of personal protective equipment (including disinfectants) was available in 56 % of the centres. Official information by public healthcare authorities was considered sufficient by 63 % of the centres. Summary Diagnosis, therapy and monitoring of patients with chronic hepatitis C were impaired during the COVID-19 pandemic. Nevertheless, the majority of the centres did not see healthcare problems for these patients in the medium and long term. However, the fact that the diagnosis of liver decompensations with potential lethal consequences was delayed in a considerable number of patients causes major concern.
GOALS AND BACKGROUND:International guidelines recommend prioritized treatment initiation in hepatitis C virus (HCV)-infected patients with advanced liver disease. We aimed to evaluate whether the widespread usage of direct acting antivirals (DAAs) has led to a decrease in late presentation for care. STUDY:Data derived from the multicenter German Hepatitis C Cohort (GECCO) was analyzed. Treatment naive HCV-infected patients initiating DAA-based treatment between January 2014 and September 2017 were included. Advanced liver disease was defined by aspartate aminotransferase to platelet ratio index score ≥1.5, METAVIR≥F3, or FibroScan ≥9.5 kPa. Period prevalence and risk factors for late presentation were evaluated. RESULTS:Six hundred fifty-three HCV-monoinfected and 210 HIV/HCV-coinfected patients (mean age, 48.6±12.7 y; 65.5% male) were included. Overall 32.5% of patients had advanced liver disease. In 2014 39.4% of patients presented with advanced liver disease, decreasing to 30.1%, 34.4%, and 26.4% in the years 2015, 2016, and 2017 (P=0.057), respectively. Patients with and without advanced liver disease differed in age (P<0.0001), CD4 ≤350/µL (P=0.027), genotype (P=0.005), transmission route (P=0.047), body mass index (P<0.001), and time since diagnosis (P=0.007). In the multivariable binary logistic regression analysis GT3, age above 45 years and being diagnosed >2 years ago were positively and HCV transmission through men who have sex with men was negatively associated with advanced liver disease. CONCLUSIONS:Overall 32.5% of patients presented with advanced liver disease. We observed a trend toward a lower proportion of patients starting treatment late.GT3, age, years since HCV diagnosis and HCV transmission route were identified as risk factors for presentation with advanced liver disease.