BACKGROUND:Chronic active hepatitis C virus (HCV) infection is a major public health problem and causes liver fibrosis (LF) up to liver cirrhosis (LC). LF can be estimated by non-invasive, easy handling methods. With implementation of new HCV therapies, elimination rates of HCV are near 100%, resulting in less clinical complications and costs. The aim of our study was to evaluate the positive influence of HCV treatment on liver stiffness by non-invasive assessments of LF.METHODS:Sixty-two patients with HCV were treated with antiviral drug regimes. Serological fibrosis scores and ultrasound elastography (acoustic radiation force impulse and shear wave elasticity imaging (ARFI-SWEI)) were used for LF assessment on day 0 and 6 months after therapy.RESULTS:Antiviral treatment was successful in all cases. ARFI-SWEI measurements showed an improvement of all LF stages. Results of serological markers and scores were heterogeneous. Significant positive effects of treatment were seen for aspartate aminotransferase-to-platelet ratio index (APRI) and fibrosis-4 (FIB-4) scores, only. Further Pearson's coefficient showed moderate till very high correlations for ARFI-SWEI and FIB-4/APRI scores.CONCLUSION:Today HCV therapy is able to cure HCV. Positive influences are improvement of LF stages. ARFI-SWEI, APRI and FIB-4 score are useful, easy handling tools to verify positive influence of HCV treatment on LF alone or in combination.
Zusammenfassung Anamnese und klinischer Befund Eine 66-jährige Patientin mit chronischer HBV-Infektion unter antiviraler Therapie stellte sich mit Ikterus und allgemeiner Schwäche 2 Wochen nach einem Infekt der oberen Atemwege vor. Die Therapie setzte die Patientin 6 Monate vor Vorstellung eigenständig ab. Die Leber war leicht vergrößert tastbar, das Abdomen sowie der weitere körperliche Untersuchungsstatus waren unauffällig. Untersuchungen und Diagnose Das Labor zeigte deutlich erhöhte Lebertransaminasen sowie ein erhöhtes Bilirubin. Der Hepatitis-B-Infektionsstatus bestätigte das Bild des chronisch-aktiven Verlaufs (HBsAg positiv), die Virusquantifizierung ergab Werte > 21 Mio. IU/ml. Sonografisch zeigten sich keine Auffälligkeiten. Therapie und Verlauf Die antivirale Therapie wurde wieder aufgenommen mit nachfolgender Besserung der Lebertransaminasen und Abfall der Virusmenge. Nach 22 Wochen Behandlung traten eine Serokonversion (HBsAg negativ) und Ausheilung der Hepatitis ein. Folgerung Im Rahmen eines akuten Schubs einer chronischen Hepatitis B nach Beendigung der antiviralen Therapie ist eine Ausheilung mit Verlust des HBsAg möglich.
HISTORY AND CLINICAL FINDINGS:A 66-year-old women with chronic hepatitis-b and antiviral therapy was presented with icterus and sickness 2 weeks after cold symptoms. The treatment was stopped by patient 6 month before. The liver was enlarged, the abdomen and further body status unsuspicious. FINDINGS AND DIAGNOSIS:The chemical results showed elevated liver enzymes and bilirubin values. The hepatitis-b status revealed signs of chronical course (HBsAg positive), the virus amount was > 21 Mio IU/ml. The sonographic abdominal status was normal. THERAPY AND COURSE:The antiviral therapy was re-established and liver enzymes improved. The virus amount was falling and after 22 weeks antiviral therapy seroconversion (HBsAg negative) and healing up of hepatitis-b was objectified. CONCLUSION:Acute exacerbation of chronic hepatitis-b followed stopping antiviral treatment can lead to healing by loss of HBsAg.
Intramural duodenal hematomas (IDH) have been rarely associated with pancreatic diseases. Conservative treatment is recommended, but course of disease can be life threatening, serious complications may occur (i.e. duodenal perforation) with imperative surgery. The management of diagnostic and treatment in IDH has improved over the years. Computed tomography (CT) and endoscopic ultrasound are excellent tools for diagnosis and follow up of IDH. We report a case of a 31-year-old alcoholic who presented with vomiting, exsiccosis, hypochondriac pain and positive shock index. Esophagogastroduodenoscopy showed gastric outlet obstruction caused by obliterating tumor of bulbus duodeni. Initial suspicion was malign tumor of the duodenum confirmed by native CT and histology. Further diagnostic using EUS-guided aspirate resulted in IDH. By conservative management with nasogastric decompression and digestive rest the patient recovered. In course of disease the hematoma got smaller, but parts were still seen in CT 6 month later.
PurposeThe prevalence of chronic hepatitis B virus- and hepatitis C virus-infections in the general German population has been estimated to be 0.6-0.7 and 0.3-0.4%, respectively. The population of Frankfurt/Main is multicultural and marked by different risks of chronic viral hepatitis. The aim of this prospective study was to define epidemiologic data for hepatitis B and C from consecutive patients of an interdisciplinary emergency unit in Frankfurt.Patients and methodsOver a period of 12 months, 10215 patients of an interdisciplinary emergency unit in Frankfurt/Main were screened for hepatitis B surface-antigen (HBsAg) and hepatitis C virus-antibodies (HCV-Ab). In case of positive HBsAg or HCV-Ab, a quantitative PCR analysis of virus was carried out.ResultsThe prevalence of HBsAg and HCV-Ab in the study population was 1.32% (n=135; group 1) and 2.70% (n=276; group 2), respectively, with a sex ratio close to 1. Quantitative PCR tests of virus load were performed in 72.59% (group 1) and in 82.61% (group 2), with confirmed viremia in 54.08% (group 1) and 41.67% (group 2), and correlated to elevated liver enzymes in 49.05% (group 1) and in 75.78% (group 2) of the cases. The ethnic distribution was 87.09% White (n=8897; group A) versus 12.90% other ethnic groups (n=1318; group B), with a prevalence of HBsAg-positive and HCV-Ab-positive cases of 1.08 and 2.76% (group A) and 2.96 and 2.28% (group B).ConclusionThe results show that in multicultural areas, the prevalence of chronic viral hepatitis is increased. Because of the potential of progressive liver damage in viral hepatitis, field screening in specific populations at high risk for hepatitis should be performed.
The treatment of chronic hepatitis C has considerably changed with the introduction of recent direct acting antivirals. These antivirals have sustained virologic response (SVR) rates above 90% as well as reduced toxicity and treatment duration. Therefore, current German guidelines recommend these interferon-free regimens as first-choice treatment. Nevertheless, recent developments were accompanied by a significant increase in treatment costs, which led to extensive discussions on reasonable pharmaceutical prices. The aim of the current study was to analyze the average treatment costs and costs per patient cured for guideline treatment recommendations. Analyses were stratified according to genotype, treatment status (naive/experienced), and presence/absence of cirrhosis. Costs were separated in (1.) basic diagnostic procedures, (2.) monitoring, and (3.) pharmaceuticals. The calculation is based on a remuneration scheme in the statutory health insurance system. In treatment-naive noncirrhotic patients, the average cost is 41 766 (sic)/SVR for the treatment with SOF/LDV calculated (PTV/r/ OMV+ DSV: 53 129 (sic)/SVR). In treatment-naive cirrhotic patients, costs were 60 323 (sic)/SVR (SOF/LDV + RBV) and 80 604 (sic)/SVR (PTV/r/OMV+ DSV+ RBV). Treatment-experienced genotype 1 patients had average costs of 60 366 (sic)/SVR for SOF/LDV treatment as well as 53 134 (sic)/SVR for PTV/r/OMV+ DSV +/- RBV treatment (cirrhotic patients: 62 208 (sic)/SVR for SOF/LDV+ RBV; 80 824 (sic)/SVR for PTV/r/OMV + DSV+ RBV). The average treatment costs per SVR in treatment-naive genotype 1 patients are comparable to previous standard of care treatments and lower in treatment-experienced patients. In other genotypes, treatment costs and costs per cure are significantly higher compared to previous standard of care. However, long-term modelling studies show that new regimens are cost-effective.
1. Objective Chronic hepatitis C virus infections (HCV) cause a significant public health burden. Introduction of telaprevir (TVR) and boceprevir (BOC) has increased sustained virologic response rates (SVR) in genotype 1 patients but were accompanied by higher treatment costs and more side effects. Aim of the study was to assess outcomes and costs of treating HCV with TVR or BOC in routine care. 2. Material and Methods Data was obtained from a non-interventional study. This analysis relates on a subset of 1,786 patients for whom resource utilisation was documented. Sociodemografic and clinical parameters as well as resource utilisation were collected using a web-based data recording system. Costs were calculated using official remuneration schemes. 3. Results Mean age of patients was 49.2 years, 58.6% were male. In treatment-naive patients SVR-rates of 62.2% and 55.7% for TVR and BOC were observed (prior relapser: 68.5% for TVR and 63.5% for BOC; prior non-responder: 45.6% for TVR and 39.1% for BOC). Treatment costs are dominated by costs for pharmaceuticals and range between €39,081 and €53,491. We calculated average costs per SVR of €81,347 (TVR) and €70,163 (BOC) in treatment-naive patients (prior relapser: 78,089 €/SVR for TVR and 82,077 €/SVR for BOC; prior non-responder: 116,509 €/SVR for TVR and 110,156 €/SVR for BOC). Quality of life data showed a considerable decrease during treatment. 4. Conclusion Our study is one of few investigating both, outcomes and costs, of treating HCV in a real-life setting. Data can serve as a reference in the discussion of increasing costs in recently introduced agents.
BACKGROUND:Early discovery of liver fibrosis is becoming more popular because of enhanced incidence of hepatocellular carcinoma. Ultrasound-based liver elastography is a method used to approve suspected liver fibrosis or cirrhosis. We assessed the clinical usefulness of acoustic radiation force impulse shear wave elasticity imaging (ARFI-SWEI) as a preventive screening method to uncover fibrosis.METHODS:We screened 382 patients by native routine sonography for abnormal liver results and divided them into six groups: group 1: normal liver, groups 2-4: fatty liver grade I-III, group 5: liver cirrhosis, and group 6: inhomogenic liver tissue. Then ARFI-SWEI was performed and the results were compared with published shear wave velocity cut-off values that were predictive of each fibrosis stage (F0-4). A control group consisted of 20 healthy volunteers.RESULTS:The part of liver fibrosis ≥ F2 was in groups 1-4: 20-32%, group 5: 100%, and group 6: 91%. Main causes for fibrosis stage ≥ F2 were (non)-alcoholic steatohepatitis, chronic viral or autoimmune hepatitis and chronic heart failure.CONCLUSIONS:Screening of the liver tissue in b-mode ultrasound can underestimate possible liver fibrosis; by using ARFI-SWEI, liver fibrosis can be uncovered early. It is a suitable preventive method comparable to colonoscopy for colon cancer.
Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly.
HISTORY AND CLINICAL FINDINGS:An 85-years-old woman with percutaneous endoscopic gastrostomy (PEG) presented at our emergency unit with repeating abdominal pain and changes in the consistency of the stool. The PEG was placed during a treatment of an oropharynxcarcinoma in the past, was replaced repeatedly and is still in use.INVESTIGATIONS:The initial clinical results were unobtrusive; the ultrasound of the abdomen showed mild distended loops of the small intestine, the x-ray of the abdomen was unsuspicious with diagnosis of subileus by constipation. The esophagogastroduodenoscopy was also without pathological findings and showed correct position of the PEG and normal aspect of the gastric tissue. An additional computerized tomography (ct-scan) of the abdomen demonstrated a foreign body nearly 2.5 cm in diameter in the distal part of the small intestine, the terminal ileum, differentiated as PEG retaining plate, also seen retrospectively in the initial x-ray.TREATMENT AND COURSE:Because the endoscopic salvage failed, the foreign body had to be removed surgically. The retaining plate was the cause for subtotal occlusion and also for the perforation of the small intestine. It was found nearly 15 cm before ileo-terminal valve. After operation the patient recovered soon.CONCLUSION:The history gave no hints of accidentally broken PEG-tube; presumably the retaining plate was cut off while the PEG was changed and let go on natural way. The aim of gastroenterologists should be removing PEG under endoscopic control.
An 85-years-old woman with percutaneous endoscopic gastrostomy (PEG) presented at our emergency unit with repeating abdominal pain and changes in the consistency of the stool. The PEG was placed during a treatment of an oropharynxcarcinoma in the past, was replaced repeatedly and is still in use.The initial clinical results were unobtrusive; the ultrasound of the abdomen showed mild distended loops of the small intestine, the x-ray of the abdomen was unsuspicious with diagnosis of subileus by constipation. The esophagogastroduodenoscopy was also without pathological findings and showed correct position of the PEG and normal aspect of the gastric tissue. An additional computerized tomography (ct-scan) of the abdomen demonstrated a foreign body nearly 2.5 cm in diameter in the distal part of the small intestine, the terminal ileum, differentiated as PEG retaining plate, also seen retrospectively in the initial x-ray.Because the endoscopic salvage failed, the foreign body had to be removed surgically. The retaining plate was the cause for subtotal occlusion and also for the perforation of the small intestine. It was found nearly 15 cm before ileo-terminal valve. After operation the patient recovered soon.The history gave no hints of accidentally broken PEG-tube; presumably the retaining plate was cut off while the PEG was changed and let go on natural way. The aim of gastroenterologists should be removing PEG under endoscopic control.
Problemstellung: Die Acoustic Radiation Force Impluse (ARFI) Methode wird zur Beurteilung der Lebersteifigkeit genutzt. Sie erweist sich als zuverlässig zur nicht-invasiven Einschätzung des hepatischen Fibrosegrades. Die Therapie der CHC basiert auf einer Kombination von pegyliertem Interferon (PG) und Ribavirin (R); seit 2 Jahren werden für den Genotyp (GT) 1 ergänzend Proteaseinhibitoren und neuerdings weitere direkt antivirale Medikamente (DAA) mit einer sustained viral response (SVR) von ca. 90% angewandt. Wir prüften mittels der AFRI Methode den Einfluss der CHC Behandlung auf die Lebersteifigkeit in Abhängigkeit vom Therapieverlauf und -erfolg. Patienten und Methode: In die Kohortenstudie wurden über einen Zeitraum von 15 Monaten 83 Patienten mit CHC (GT 1 – 4) eingeschlossen und in 2 Gruppen aufgeteilt: Gruppe 1 (n = 29) erhielt eine Standardtherapie (PG, R +/- PI) und Gruppe 2 (n = 54) blieb unbehandelt. Jeder Patient erhielt zur Woche 0, 8 und am Therapieende ein Nativsonogramm der Leber mit ARFI Messung und Ermittlung der medianen Scherwellengeschwindigkeit (SWV); die Ergebnisse wurden mit dem Verlauf der Viruslast (VL) und der GPT – Werte korreliert. Ergebnisse: Im Zuge der Behandlung verbesserten sich in der Gruppe 1 die SWV-Werte ab Woche 8 um 0,02 – 0,5 m/s, verbunden mit einem Abfall bzw. Normalisierung der GPT-Werte und der CHC-Viruslast. In 40% d. F. kam es zur Verringerung des Fibrosegrades. Schlussfolgerungen: Die Studie belegt die positiven Auswirkungen der CHC Therapie auf den Fibrosegrad der Leber, objektiviert durch eine Verringerung der SWV-Werte, korrelierend zum Verlauf der GPT-Werte und der VL. Zu diskutieren ist, ob inflammatorische Einflüsse im Rahmen der CHC zu initial falsch hohen SWV-Werten führen.
Background Viral hepatitis is major a public health problem affecting millions of people worldwide. Estimates assume 400 000–500 000 people chronically infected with hepatitis C virus (HCV) in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess the costs for treating patients with chronic HCV in Germany. Methods We conducted a retrospective multicenter observational study. The design was approved by an ethics committee, and patients were asked for their informed consent. Patients were grouped in four different health states. Healthcare utilization data were extracted from doctor files of six medical centers in Germany. Results Data of 315 patients with chronic HCV were analyzed. The mean age was 49.4 years, 57.5% were male and 67.9% had a genotype 1 infection. The most common routes of transmission were injection drug use (39.0%) and infection through blood products (15.9%). The average total cost was €19 147 including ambulatory care and diagnostics (€1686), pharmaceuticals (€14 875), inpatient care (€1293), and sick leave (€1293). For patients in stable health states (mild and moderate HCV, compensated cirrhosis), costs did not differ significantly and were mainly influenced by antiviral treatment. For patients with decompensated cirrhosis, inpatient care accounted for the largest part of the costs. Conclusion Treatment of HCV patients involves high costs, mainly associated with the length of antiviral therapy. Viral eradication can prevent severe disease stages, which are associated with high costs. It is necessary to follow current guidelines and monitor patients closely to avoid unnecessary costs.
The costs of a guideline-based treatment in chronic hepatitis C infected people are unknown. The goal of HCV therapy is to achieve a sustained viral response and thereby to reduce morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma. This study analyses the costs of a guideline-based treatment based on the German guideline on the management of HCV infection. In addition, costs of newly introduced protease inhibitors were calculated. Costs for baseline diagnostics, monitoring and medical treatment were calculated according to the stage of the disease, the HCV genotype and viral response. Costs for baseline diagnostics account for (sic) 302.75 and monitoring accounts for (sic) 596 to (sic) 1173. Dual therapy with pegylated interferon and ribavirin results in average costs of (sic) 7709 to (sic) 34 692. Total costs of a guideline-based treatment range between (sic) 8,608 and (sic) 36 167 depending on HCV genotype and length of therapy. With the introduction of protease inhibitors for HCV genotype 1 patients, costs of pharmaceuticals have increased further. Triple-therapy with telaprevir accounts for (sic) 43 280 respectively (sic) 54 844. Costs for Boceprevir treatment range from (sic) 34 143 to (sic) 60 990. Due to increasing costs, health-economic evaluations gain significant relevance and should be considered when implementing new treatment strategies.
Estimates assume that 400,000 to 500,000 people are chronically infected with Hepatitis C in Germany. About 27% of end-stage liver cirrhosis and 25% of hepatocellular carcinoma are associated with HCV. The economic relevance of hepatitis C results from high costs for antiviral treatment as well as accompanying and secondary diseases. The aim of the study was to gain information on epidemiological characteristics, treatment outcomes and costs. Underlying data were collected in a non-interventional trial between 2008 and 2011. Inclusion criteria were a confirmed HCV diagnosis and need for antiviral treatment. Besides sociodemographic and clinical parameters, HCV related resource utilization was gathered for a subgroup of patients. Data presented are mean values. Data on 7,637 patients receiving antiviral treatment with peginterferon-α-2a and ribavirin were collected. This analysis relates on 3,708 patients without HIV coinfection and/or drug substitution treatment. Mean age was 43.7 years, 60.3% were male. Most patients had a genotype-1 (61.3%) or genotype-3 infection (28.5%). The majority of patients was treatment-naïve (86.5%), 7.3% were relapser and 5.6% non-responder. Main sources of infection were injection drug use (34.8%) and blood products (14.2%). Mean duration of infection was 13.6 years. In average 48.9% of treatment-naïve GT-1(4-6) and 63.0% of GT-2/3 patients achieved SVR. For prior relapse patients and non-responder SVR-rates were: GT-1(4-6): 35.4%; GT-2/3: 58.5 and GT-1(4-6): 23.3% GT-2/3: 37.9%, respectively. Costs for antiviral treatment amount for €20,889 in GT-1(4-6) patients and €13,610 in GT-2/3 patients. Costs for the management of adverse events or HCV-related diseases sum up for €11.70. Ambulatory care, diagnostics procedures and hospital care amount for a small proportion of total costs. This study provides an overview on epidemiologic characteristics, treatment outcomes and treating costs in routine care. Treatment of HCV is costly and mainly affected by length of antiviral therapy.
Background Viral hepatitis is major a public health problem affecting millions of people worldwide. Estimates assume 400 000-500 000 people chronically infected with hepatitis C virus (HCV) in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess the costs for treating patients with chronic HCV in Germany.Methods We conducted a retrospective multicenter observational study. The design was approved by an ethics committee, and patients were asked for their informed consent. Patients were grouped in four different health states. Healthcare utilization data were extracted from doctor files of six medical centers in Germany.Results Data of 315 patients with chronic HCV were analyzed. The mean age was 49.4 years, 57.5% were male and 67.9% had a genotype 1 infection. The most common routes of transmission were injection drug use (39.0%) and infection through blood products (15.9%). The average total cost was (sic)19 147 including ambulatory care and diagnostics ((sic)1686), pharmaceuticals ((sic)14 875), inpatient care ((sic)1293), and sick leave ((sic)1293). For patients in stable health states (mild and moderate HCV, compensated cirrhosis), costs did not differ significantly and were mainly influenced by antiviral treatment. For patients with decompensated cirrhosis, inpatient care accounted for the largest part of the costs.Conclusion Treatment of HCV patients involves high costs, mainly associated with the length of antiviral therapy. Viral eradication can prevent severe disease stages, which are associated with high costs. It is necessary to follow current guidelines and monitor patients closely to avoid unnecessary costs. (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.
Hintergrund: 27% der Zirrhose-Fälle, 25% der HCCs und ein Großteil der Lebertransplantationen sind auf HCV-Infektionen zurückzuführen. Eine ökonomische Relevanz ergibt sich wegen hoher Therapiekosten, Kosten zur Behandlung von Folgeerkrankungen und Produktivitätsverlusten durch Arbeits- und Erwerbsunfähigkeit. Die Kosten einer leitliniengerechten Therapie inkl. Diagnostik und Monitoring liegen je nach Therapiedauer zwischen 8.706 € und 36.266 €. Ziel der Analyse war daher die Gewinnung von epidemiologischen Daten, Behandlungsergebnissen und Kosten in der Versorgungspraxis.