Confirmation of guideline-defined hepatitis C screening strategies within the 'Check-Up35+' examination in the primary care setting.

BACKGROUND AND AIMS: Screening strategies for undiagnosed infections are fundamental for hepatitis C virus (HCV) elimination. We previously investigated HCV prevalence and screening strategies in an urban primary care setting. IV drug abuse, blood transfusion before 1992, immigration, or elevated ALT were identified as risk factors in a post hoc analysis and diagnosed 83% of unknown HCV-RNA-positive cases by screening only 26% of the population. We aimed to validate prospectively the proposed screening algorithm in two independent urban and rural cohorts and to analyse for potential differences. METHODS: Anti-HCV and ALT were included in a routine check-up together with a questionnaire covering risk factors. HCV-RNA was analysed in anti-HCV-positive individuals. RESULTS: In urban and rural areas, 4323 and 9321 individuals were recruited. The anti-HCV prevalence was 0.56% and 0.49%, and 0.1% of patients were HCV-RNA-positive in both regions. Fifty-two anti-HCV positive patients including eight HCV-RNA-positive cases were unaware of the infection (number needed to screen to detect one unknown anti-HCV-positive individual: 262). At least one of the three aforementioned risk factors or elevated serum ALT was present in 3000 patients (22%). Restricting HCV screening to only those with risk factors, 52% and 75% of all anti-HCV and HCV-RNA-positive undiagnosed patients were identified (number needed to screen: 111). CONCLUSIONS: We confirm prospectively the efficiency of a risk-based HCV screening. The risk-based algorithm should be evaluated in other countries with similarly low HCV prevalence as in Germany to achieve WHO HCV elimination goals.

Laboratory reform counteracts the WHO hepatitis C elimination strategy in Germany.

The World Health Organization and the German government have announced an initiative to eliminate chronic hepatitis C until the year 2030. To reach this goal, one important step is adequate screening and detection of so far undiagnosed infections. The most common initial test is anti-HCV. This parameter was extra-budgetary reimbursed by statuary healthcare insurances in the past. However, this policy has changed after a nationwide laboratory reform which should reduce the laboratory costs of patients insured in the statuary healthcare insurances. We therefore analysed the impact of the laboratory reform on the order of anti-HCV tests in 510 656 anonymized patient data sets before and after the initiation of the reform. The number of anti-HCV tests declined by 9.4% in quarters I-III 2018 in comparison with the same time period of the year 2017. The number of HBsAg tests declined by 7.4%, indicating that the reduced anti-HCV laboratory orders are not parameter-specific, but most likely a surrogate of the intention of the laboratory reform to generally lower the demands of blood samples and laboratory costs. Thus, the scenario is an important example, how political decisions of the medical self-government influence the screening setting for viral hepatitis: if the current policy is not changed, the laboratory reform directly counteracts the WHO hepatitis C elimination strategy in Germany.

Budget impact analysis on the introduction of a guideline based hepatitis B and C screening into a routine check-up in the German primary care setting.

OBJECTIVES: Systematic screening for chronic hepatitis B and C does not yet exist in Germany. Therefore, the implementation of a screening approach within a preventive medical examination performed by primary care physicians ('Check-Up 35+') was evaluated in a recent prospective multicenter study. The present analysis estimates the financial consequences for the statutory health insurance by budget impact analysis. MATERIALS AND METHODS: A Markov cohort model was developed consisting of 21 health states. Four different screening scenarios derived from the previous multicenter study were compared to usual care, a strategy without screening for hepatitis. Actual cost data for Germany were calculated and systematic literature searches for all input parameters were performed. RESULTS: The base case results in incremental costs for the screening strategies compared to no hepatitis screening of 165-227 € per patient in a 20-year horizon. Two main parameters influence the financial consequences: (A) detection and treatment increase the costs in the beginning. (B) Screening avoids hepatitis induced end-stage liver disease. The initial higher costs exceed the later savings. Sensitivity analyses demonstrate a strong impact of medication costs for the treatment of additionally detected hepatitis infections on the outcome. This finding is robust to sensitivity analysis. CONCLUSIONS: The screening strategy proposed here implies additional costs for the statutory health insurance, however, a decision regarding its usefulness must consider criteria other than cost. For example, the high burden of disease due to liver cirrhosis and liver carcinoma should be considered. Therefore, an additional cost-effectiveness-analysis should be conducted.

Prevalence of elevated ALT values, HBsAg, and anti-HCV in the primary care setting and evaluation of guideline defined hepatitis risk scenarios.

BACKGROUND & AIMS: Prevalence data for hepatitis B and C and an evaluation of a guideline based screening in the primary care setting are not yet available. We therefore implemented a hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus (HCV) screening and developed guideline based screening strategies. METHODS: HBsAg, anti-HCV, and alanine aminotransferase (ALT) were included in a routine check-up together with a questionnaire covering 16 guideline adapted risk scenarios. Significant risk factors were identified by stepwise logistic regression. RESULTS: 51 private practices screened 21,008 patients. The HBsAg, anti-HCV, and HCV-RNA prevalence was 0.52%, 0.95%, and 0.43%, respectively. Infections were previously unknown in 85% and 65% of HBsAg and anti-HCV positive individuals, respectively. Sexual risk factors were under-reported, while the following scenarios were significantly associated with viral infections (Odds ratio [95% confidence interval]). HBV: Immigration (4.4 [2.9, 6.7]), infection in household (2.5 [1.2, 4.5]), male gender (1.6 [1.1, 2.4]). Male immigrants had a 2.1% HBsAg prevalence and 80% were unaware of the infection. HCV: IV drug use (384 [233, 644]), blood transfusion before 1992 (5.3 [3.5, 7.9]), immigration (2.4 [1.5, 3.6]). Presence of either one of the HBV related guideline defined risk scenarios or elevated ALT identified 82% of previously undiagnosed patients. Presence of one of the three significant HCV risk factors or elevated ALT levels diagnosed 83% of unknown HCV-RNA positive cases by screening only 26% of the population. CONCLUSIONS: Undiagnosed hepatitis B and C infections frequently exist in the primary care setting. Easy to apply guideline defined risk scenarios help to diagnose previously unknown infections.

Successful hepatitis B and C screening in the health check-up in the German primary care setting.

Background & Aims: A goal of the World Health Organization's global hepatitis strategy is the elimination of chronic hepatitis C virus (HCV) infection by 2030. As part of its strategy, the Federal Joint Committee (Germany) decided to include hepatitis B and C screening in a preventive medical examination, which is performed at the primary care level in Germany. We investigated the results 1 year after implementation of screening between October 2021 and September 2022. Methods: HBsAg/HBV DNA and anti-HCV/HCV RNA screenings were identified by billing categories in 286,192 individuals of 11 ambulatory healthcare centers. Results: Compared to 30,106 HBsAg and 31,266 anti-HCV laboratory requisitions in the year 2018, the number of tests increased to 286,192 during the screening period. Compared to routine care, additional anti-HCV positive tests age dependently increased the tally by 98% (177 plus 170 positive cases in males) and 123% (96 plus 118 positive cases in females) in those aged 35-44 years up to 518% (17 plus 88 positive cases in males) and 514% (29 plus 149 positive cases in females) in those aged 75-84 years. Similar results were observed for HBsAg. Prevalences of HBsAg, anti-HCV and HCV RNA were 0.54%, 0.79% and 0.13%, respectively. Conclusions: A structured hepatitis screening program at the primary care level has been successfully established and leads to age- and-sex-dependent large additional effects compared to routine care. Impact and implications: Strategies to eliminate chronic hepatitis B and C virus infection are country specific and vary between clinical scenarios. Our analysis proves the efficacy of a screening program by primary care physicians compared to routine care in a low-prevalence country. This program should be accompanied by additional efforts in risk populations like people who inject drugs who are under-represented in the current screening approach.

[A comprehensive screening for hepatitis B and C as an effective means of cancer prevention and as a prerequisite for elimination of chronic viral hepatitis - Data and comments on a discussion]. / Ein umfassendes Screening auf Hepatitis B und C ist eine effektive Krebsprävention und die Voraussetzung für die Elimination dieser Infektionen ­ Daten und Anmerkungen zu einer Diskussion.

Since October 2021 in Germany all people with a statutory health insurance aged 35 and older have the right to be tested once for hepatitis B and C in a general preventative examination, regardless of specific risk-factors. This is a milestone on the way of eliminating these infections and also a great contribution to cancer prevention.In the USA the Centers of Disease Control and Prevention in April 2020 recommended a one-time screening for all adults aged 18 and older in addition to testing people with known risk-factors, because a significant part of the affected population cannot be identified with risk-based screening. Corresponding CDC-Recommendations for HBV are currently elaborated. According to available Data this screening strategy combined with a vaccination for HBV is necessary in Germany too to reach the agreed elimination goals till the year of 2030. Furthermore, an offer of such a testing for all adults can be regarded as ethically imperative to prevent as many life-threatening consequences or deaths as possible by effective therapies.

Linkage to care of HbsAg-positive and anti-HCV-positive patients after a systematic screening approach in the German primary care setting.

BACKGROUND: Identification of previously unknown cases is important to lower the burden of chronic hepatitis B and C infection. However, a screening program in the primary care setting has not yet been established. Therefore, a systematic screening project was conducted in 21 008 patients (Wolffram and colleagues). Here, we describe linkage to care of identified HbsAg-positive and anti-hepatitis C virus (HCV)-positive patients. METHODS: General practitioners characterized further medical care by a standardized questionnaire. Data of 48/110 HbsAg-positive and 114/199 anti-HCV-positive patients were available. An APRI index more than 2 or up to 0.5 indicated the presence of cirrhosis or the absence of fibrosis. RESULTS: APRI was calculated in 32/48 hepatitis B virus (HBV) patients (>2: n=1; ≤0.5: n=29) and 34/114 HCV patients (>2: n=4; ≤0.5: n=23). The general practitioners were already aware of the positive HBsAg and anti-HCV-test in 13/48 and 59/114 patients, respectively.For 29/35 newly diagnosed HBV patients and 26/55 HCV patients, further diagnostics were initiated: ultrasound 77 versus 38%, liver biopsy 20 versus 4%, and gastroscopy 20 versus 7%.Antiviral treatment was initiated in 5/35 HBV cases and in 10/55 HCV patients.A family screening was initiated in 22/35 HBV versus 13/55 HCV index patients and showed one additional HbsAg-positive and two anti-HCV-positive cases.Diagnostic procedures differed significantly between anti-HCV-positive and HbsAg-positive patients (P<0.001 for APRI, ultrasound, and family screening; P=0.03 for liver biopsy). CONCLUSION: Diagnostic procedures should be improved for hepatitis C-infected patients. The APRI index was only of limited value in the primary care setting.