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Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C) - Addendum to Commission A17-35 1 Translation of addendum A18-05 Sofosbuvir/Velpatasvir/Voxilaprevir (Chronische Hepatitis C) – Addendum zum Auftrag A17-35 (Version 1.0; Status: 25 January 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 25 January 2018 1.0 Commission: A18-05 Version (...) : Status: IQWiG Reports – Commission No. A18-05 Sofosbuvir/velpatasvir/ voxilaprevir (chronic hepatitis C) – Addendum to Commission A17-35 1 Addendum A18-05 Version 1.0 Sofosbuvir/velpatasvir/voxilaprevir – Addendum to Commission A17-35 25 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C) – Addendum to Commission A17-35
Treatment of Adolescents With Chronic Hepatitis C Virus Infection: New Regimen on the Block Editorial to Leung et al. "Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4".
Hepatic Encephalopathy in Patients in Lviv (Ukraine) Hepatic encephalopathy (HE) research has long been impeded by the vague definition of this disabling complication of liver failure. This article provides an overview of the etiology and impact of HE on neuromuscular functions as well as its role in the development of infections and anemia.This was a descriptive study conducted in 36 patients with HE. Close monitoring of these patients was done by checking on several parameters.The etiological (...) distribution: alcohol (67%), hepatitis C virus (HCV; 17%), HCV and alcohol (8%), hepatitis B virus (HBV; 3%), HBV and alcohol (3%), HBV and HCV (6%), and cryptogenic (3%). The laboratory results indicated an elevation of De Ritis level in 69% of cases and in 92% of total bilirubin values. The Halstead-Reitan (H-R) test score with regards to gender indicated that more than half of the patients had a score of 2, while only few cases received the scores 3 and 4. The frequency of H-R score with regards
VAXELIS, hexavalent vaccine against diphtheria, tetanus, poliomyelitis, pertussis, Haemophilus influenzae type b infections, hepatitis B Haute Autorité de Santé - VAXELIS, vaccin hexavalent contre diphtérie, tétanos, poliomyélite, coqueluche, infections à Haemophilus influenzae type b, hépatite B Développer la qualité dans le champ sanitaire, social et médico-social Recherche Évaluation & Recommandation La HAS Accréditation & Certification Outils, Guides & Méthodes Agenda Avis sur les
Evaluating Womenâ€™s Preferences for Hepatitis C Treatment During Pregnancy There is a rising prevalence of hepatitis C (HCV) among women of child-bearing age nationally, which prompted a recommendation by national guidelines to screen all women for HCV during pregnancy. Women with HCV during pregnancy are at risk of perinatal transmission of HCV. Directly acting antiviral (DAA) therapy during pregnancy can potentially reduce the risk of perinatal transmission as well as cure women while
Hepatic Nuclear Receptor Expression Associates with Features of Histology in Pediatric Nonalcoholic Fatty Liver Disease Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in children and adults. This study examined the relationship between hepatic nuclear receptor (NR) expression and histologic features of NAFLD. Drugs targeting a variety of NRs for nonalcoholic steatohepatitis (NASH) are in clinical trials. Liver messenger RNA was isolated from 40
Randomized, Doubleâ€Blind, Placeboâ€Controlled, Single Ascending Dose Trial of Synthetic Preimplantation Factor in Autoimmune Hepatitis Preimplantation factor (PIF) is an evolutionary conserved peptide secreted by viable embryos which promotes maternal tolerance without immune suppression. Synthetic PIF (sPIF) replicates native peptide activity. The aim of this study was to conduct the first-in-human trial of the safety, tolerability, and pharmacokinetics of sPIF in patients with autoimmune (...) hepatitis (AIH). We performed a randomized, double-blind, placebo-controlled, prospective phase I clinical trial. Patients were adults with documented AIH with compensated chronic liver disease. Diagnosis of AIH was confirmed by either a pretreatment International Criteria for the Diagnosis of AIH score of 15 or more, or a posttreatment score of 17 or more. Patients were divided into three dosing cohorts (0.1, 0.5, or 1.0 mg/kg) of 6 patients in each group. Three patients in each group had normal liver
Autoimmune Hepatitis During Ledipasvir/Sofosbuvir Treatment of Hepatitis C: A Case Report We report the case of a woman with chronic hepatitis C and idiopathic thrombocytopenic purpura (ITP) who developed autoimmune hepatitis (AIH) during antiviral therapy with ledipasvir (LDV)/sofosbuvir (SOF). The onset of acute hepatitis rose two weeks after starting treatment with LDV/SOF when HCV-RNA tested negative, suggesting a link between rapid HCV clearance and de novo autoimmune diseases. Conclusion (...) : This case report proposes new immunologic scenarios in patients with hepatitis C virus (HCV) with laboratory or clinical signs of autoimmunity during direct-acting antiviral (DAA) therapy.
CEACAM1 Is Associated With the Suppression of Natural Killer Cell Function in Patients With Chronic Hepatitis C Natural killer cells (NK cells) play an essential role in the immunological mechanism underlying chronic hepatitis C (CHC). Impairment of NK cell function facilitates persistent infection with hepatitis C virus (HCV) and hepatocellular carcinogenesis. However, the mechanism by which NK cell activity is suppressed in CHC is not completely understood. In this study, we focused (...) on carcinoembryonic antigen-related cell-adhesion molecule 1 (CEACAM1). CEACAM1 is thought to suppress NK cell function. We examined the effect of CEACAM1 on NK cell function in CHC. We investigated the function of CEACAM1 in vitro using Huh7.5.1 cells and the HCV-Japanese fulminant hepatitis (JFH)-1 strain. We analyzed serum CEACAM1 level, NK cell function, and CEACAM1 messenger RNA (mRNA) level in human liver samples. Levels of CEACAM1 on the cell surface, CEACAM1 mRNA levels, and soluble CEACAM1 levels
Liver Disease Monitoring Practices After Hepatitis C Cure in the Underserved Population Recent hepatitis C virus (HCV) guidelines recommend disease monitoring and hepatocellular carcinoma (HCC) screening in patients with advanced fibrosis after a sustained virologic response (SVR) with direct-acting antiviral (DAA) therapy. However, data on practice patterns in this setting is lacking. We aimed to characterize disease monitoring and HCC screening practices post-SVR in an underserved HCV
Acute Kidney Injury in Patients Undergoing Chronic Hepatitis C Virus Treatment With Ledipasvir/Sofosbuvir Ledipasvir-sofosbuvir, a once-a-day, oral combination pill, was approved in 2014 for the treatment of chronic hepatitis C infection. Initial trials did not comment on nephrotoxicity; however, recent data suggest a risk of acute kidney injury (AKI) with the use of the medication. We assessed the rates of AKI in patients undergoing ledipasvir-sofosbuvir in a large, urban tertiary care center
Serum HBV RNA is a Potential Predictor of Hepatitis B Surface Antigen Reversion 30288471 2018 11 14 2471-254X 2 10 2018 Oct Hepatology communications Hepatol Commun Serum HBV RNA is a Potential Predictor of Hepatitis B Surface Antigen Reversion. 1168-1171 10.1002/hep4.1249 Wang Jie J State Key Laboratory of Natural and Biomimetic Drugs, Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences Peking University Health Science Center Beijing China. Chen Xiangmei
Serum Interleukinâ€8, Osteopontin, and Monocyte Chemoattractant Protein 1 Are Associated With Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease The severity of hepatic fibrosis is the primary predictor of liver-related morbidity and mortality in patients with nonalcoholic fatty liver disease (NAFLD). Unfortunately, noninvasive serum biomarkers for NAFLD-associated fibrosis are limited. We analyzed baseline serum samples for 24 cytokines of 97 patients with biopsy-proven NAFLD (...) . These patients were prospectively enrolled in a clinical study (ClinicalTrials.gov NCT00794716) to identify cytokines associated with liver fibrosis in patients with nonalcoholic steatohepatitis. Patients were stratified according to severity of hepatic fibrosis (mild, stage 0-1, n = 37; moderate, stage 2, n = 40; and advanced, stage 3-4, n = 20) while controlling for age, race, sex, body mass index, and diabetes mellitus. Interleukin-8 (IL-8), osteopontin (OPN), and monocyte chemoattractant protein 1 (MCP1
Morphometry Confirms Fibrosis Regression From Sustained Virologic Response to Directâ€Acting Antivirals for Hepatitis C Sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy for chronic hepatitis C results in significant decreases in liver stiffness measured by transient elastography (TE). The aim of this study was to clarify if TE can guide post-SVR management in patients with advanced fibrosis or cirrhosis prior to treatment as current guidelines are unclear (...) on the role of TE after SVR. In total, 84 patients with hepatitis C virus and advanced fibrosis or cirrhosis and from a single center underwent DAA treatment and achieved SVR. Overall, 62% had improved liver stiffness that was consistent with regression of at least one stage of fibrosis. In the cirrhosis group, 48% showed fibrosis regression by at least two stages by TE (<9.5 kPa). In the F3 fibrosis group, 39% regressed by at least two stages (<7 kPa). The median time from SVR to regression by TE was 1
Hepatitis C Virus Clearance by Direct-acting Antiviral Results in Rapid Resolution of Hepatocytic Injury as Indicated by Both Alanine Aminotransferase and Aspartate Aminotransferase Normalization Background and Aims: Hepatitis C virus (HCV) infection results in hepatocytic injury with elevation of both alanine aminotransferase (ALT) and aspartate aminotransferase (AST). It remains to be determined if direct-acting antiviral treatment can terminate hepatocytic injury following virologic response
Transmission of Hepatitis B and D Viruses in an African Rural Community According to the World Health Organization (WHO), an estimated 257 million people worldwide are chronically infected with hepatitis B virus (HBV), with approximately 15 million of them being coinfected with hepatitis D virus (HDV). To investigate the prevalence and transmission of HBV and HDV within the general population of a rural village in Cameroon, we analyzed serum samples from most (401/448) of the villagers. HBV
Hepatocellular carcinoma in children: hepatic resection and liver transplantation Hepatocellular carcinoma (HCC) is a rare malignancy in children and at the time of diagnosis up to 80% of pediatric HCC are unresectable due to large and multiple lesions. The majority of pediatric HCC occurs on a background of normal liver, and consequently the absence of concomitant chronic liver disease generally allows tolerating pre- and post-operative chemotherapy. Based on the large experiences of adult HCC (...) of the pediatric HCC therapeutic strategy is the radical tumor resection, weather by hepatic resection or liver transplantation, nevertheless the best surgical approaches as well as the optimal neoadjuvant and adjuvant treatment are still under debate. Different strategies have been explored to convert unresectable HCC into resectable tumors by extending criteria for surgical treatment and/or associating multi-modal treatments, such as systemic and local-regional therapy, but universal recommendation needs
Suboptimal Level of Boneâ€Forming Cells in Advanced Cirrhosis are Associated with Hepatic Osteodystrophy Bone loss is common in advanced cirrhosis, although the precise mechanisms underlying bone loss in cirrhosis are unknown. We studied the profile and functionality of bone-forming cells and bone-building proteins in bone marrow (BM) of individuals with cirrhosis (n = 61) and individuals without cirrhosis as normal controls (n = 50). We also performed dual energy X-ray absorptiometry
Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection Previous studies have demonstrated stapler hepatectomy and use of various energy devices to be safe alternatives to the clamp-crushing technique in elective hepatic resection. In this randomized trial, the effectiveness and safety of stapler hepatectomy were compared with those of parenchymal transection with the LigaSure™ vessel sealing system.Patients scheduled for elective liver
Preventing Hepatitis B Reactivation During Antiâ€CD20 Antibody Treatment in the Veterans Health Administration Hepatitis B virus (HBV) reactivation may occur with high risk immunosuppression, such as anti-cluster of differentiation (CD)20 antibodies (Abs). Appropriate HBV prophylaxis during anti-CD20 Ab therapy averts hepatitis, chemotherapy disruption, and death. Serologic evidence of prior HBV exposure is present in one in nine veterans in the Veterans Health Administration (VHA). In 2014