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https://www.readbyqxmd.com/read/28440885/a-comparison-of-direct-sequencing-and-invader-assay-for-y93h-mutation-and-response-to-interferon-free-therapy-in-hepatitis-c-virus-genotype-1b
#1
Kazuhiko Hayashi, Masatoshi Ishigami, Yoji Ishizu, Teiji Kuzuya, Takashi Honda, Hiroki Kawashima, Tetsuya Ishikawa, Yoshihiko Tachi, Masashi Hattori, Yoshiaki Katano, Hidemi Goto, Yoshiki Hirooka
BACKGROUND AND AIM: Virologic failure of interferon (IFN)-free therapy has been associated with Y93H mutation in the NS5A region in hepatitis C virus (HCV) genotype 1b, and screening is recommended. A simple assay based on Q-Invader technology was developed for Y93H mutant screening to reduce cost and effort. The present study sought to compare two methods of detection of Y93H mutation and to evaluate the effect of Y93H mutation on response to IFN free therapy. METHODS: Y93H mutation was examined in 258 patients with HCV genotype 1b using both direct sequencing analysis and the PCR-Invader assay...
April 25, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28437385/before-or-after-transplantation-a-review-of-the-cost-effectiveness-of-treating-waitlisted-patients-with-hepatitis-c
#2
Elliot B Tapper, Nezam H Afdhal, Michael P Curry
All patients with chronic hepatitis C virus (HCV) infections can and should be treated. Though highly effective direct-acting antiviral therapies are costly, the price of a cure is a 1-time investment that is outweighed by future benefits. For clinicians caring for patients requiring liver transplant, the key question relates to the timing of treatment: before or after liver transplantation? On 1 hand, treating HCV often improves our patients' model for end-stage liver disease (MELD) score, decreasing costs, and potentially improving longevity by reducing our patients' risk of death and transplantation...
May 2017: Transplantation
https://www.readbyqxmd.com/read/28435690/the-complex-legal-and-ethical-issues-related-to-generic-medications-viral-hepatitis-a-case-study
#3
EDITORIAL
M Danta, N Ghinea
The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world...
April 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/28426313/substance-use-criteria-to-restrict-medicaid-coverage-of-hepatitis-c-treatment-cost-versus-ethics
#4
Joshua M Liao, Michael A Fischer
Medicaid programs provide health insurance coverage for many patients with hepatitis C, a public health problem for which effective but very expensive treatments are now available. Facing constrained budgets, most states adopted prior authorization criteria for sofosbuvir, the first of these agents. Using fee-for-service utilization data from 42 Medicaid programs in 2014, we found that strict behavioral criteria-those that limited coverage on the basis of drug or alcohol use and included specific abstinence or treatment requirements-were associated with significantly less spending on sofosbuvir...
April 20, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28425406/curing-chronic-hepatitis-c-a-cost-comparison-of-the-combination-simeprevir-plus-sofosbuvir-vs-protease-inhibitor-based-triple-therapy
#5
Jacob A Langness, David Tabano, Amanda Wieland, Sarah Tise, Lindsay Pratt, Lauren Ayres Harrington, Sonia Lin, Vahram Ghuschcyan, Kavita V Nair, Gregory T Everson
INTRODUCTION: Interferon-free, multi-direct acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection is highly effective and well tolerated, but costly. To gain perspective on the evolving economics of HCV therapy, we compared the cost per cure of a multi-DAA regimen with the prior standard of triple therapy. MATERIAL AND METHODS: Patients infected with HCV genotype 1 who were treated through the University of Colorado Hepatology Clinic between May 2011 and December 2014 comprised the study population...
May 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28424064/effectiveness-of-triple-therapy-with-direct-acting-antivirals-for-hepatitis-c-genotype-1-infection-application-of-propensity-score-matching-in-a-national-hcv-treatment-registry
#6
Emma Gray, David J Pasta, Suzanne Norris, Aisling O'Leary
BACKGROUND: Observational studies are used to measure the effectiveness of an intervention in non-experimental, real world scenarios at the population level and are recognised as an important component of the evidence pyramid. Such data can be accrued through prospective cohort studies and a patient registry is a proven method for this type of study. The national hepatitis C (HCV) registry was established in Ireland in 2012 with the aim of monitoring the clinical and economic outcomes from new, high cost regimens for the treatment of HCV infection...
April 19, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28419665/lettuce-produced-hepatitis-c-virus-e1e2-heterodimer-triggers-immune-responses-in-mice-and-antibody-production-after-oral-vaccination
#7
Jihong Liu Clarke, Lisa Paruch, Mihaela-Olivia Dobrica, Iuliana Caras, Catalin Tucureanu, Adrian Onu, Sonya Ciulean, Crina Stavaru, Andre Eerde, Yanliang Wang, Hege Steen, Sissel Haugslien, Catalina Petrareanu, Catalin Lazar, Ioan Popescu, Ralph Bock, Jean Dubuisson, Norica Branza-Nichita
The hepatitis C virus (HCV) is a major etiologic agent for severe liver diseases (e.g., cirrhosis, fibrosis and hepatocellular carcinoma). Approximately 140 million people have chronic HCV infections and about 500,000 die yearly from HCV-related liver pathologies. To date, there is no licenced vaccine available to prevent HCV infection and production of an HCV vaccine remains a major challenge. Here we report the successful production of the HCV E1E2 heterodimer, an important vaccine candidate, in an edible crop (lettuce, Lactuca sativa) using Agrobacterium-mediated transient expression technology...
April 17, 2017: Plant Biotechnology Journal
https://www.readbyqxmd.com/read/28405170/hepatitis-c-virus-pharmacogenomics-in-latin-american-populations-implications-in-the-era-of-direct-acting-antivirals
#8
REVIEW
Julieta Trinks, Mariela Caputo, María L Hulaniuk, Daniel Corach, Diego Flichman
In recent years, great progress has been made in the field of new therapeutic options for hepatitis C virus (HCV) infection. The new direct-acting antiviral agents (DAAs) represent a great hope for millions of chronically infected individuals because their use may lead to excellent cure rates with fewer side effects. In Latin America, the high prevalence of HCV genotype 1 infection and the significant association of Native American ancestry with risk predictive single-nucleotide polymorphisms (SNPs) in IFNL4 and ITPA genes highlight the need to implement new treatment regimens in these populations...
2017: Pharmacogenomics and Personalized Medicine
https://www.readbyqxmd.com/read/28404015/management-of-hepatitis-c-virus-infection-in-the-asia-pacific-region-an-update
#9
REVIEW
Seng Gee Lim, Alessio Aghemo, Pei-Jer Chen, Yock Young Dan, Edward Gane, Rino Gani, Robert G Gish, Richard Guan, Ji Dong Jia, Kieron Lim, Teerha Piratvisuth, Samir Shah, Mitchell L Shiffman, Frank Tacke, Soek Siam Tan, Tawesak Tanwandee, Khin Maung Win, Cihan Yurdaydin
The Asia-Pacific region has disparate hepatitis C virus (HCV) epidemiology, with prevalence ranging from 0·1% to 4·7%, and a unique genotype distribution. Genotype 1b dominates in east Asia, whereas in south Asia and southeast Asia genotype 3 dominates, and in Indochina (Vietnam, Cambodia, and Laos), genotype 6 is most common. Often, availability of all-oral direct-acting antivirals (DAAs) is delayed because of differing regulatory requirements. Ideally, for genotype 1 infections, sofosbuvir plus ledipasvir, sofosbuvir plus daclatasvir, or ombitasvir, paritaprevir, and ritonavir plus dasabuvir are suitable...
January 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28403327/internal-control-for-real-time-polymerase-chain-reaction-based-on-ms2-bacteriophage-for-rna-viruses-diagnostics
#10
Miriam Ribas Zambenedetti, Daniela Parada Pavoni, Andreia Cristine Dallabona, Alejandro Correa Dominguez, Celina de Oliveira Poersch, Stenio Perdigão Fragoso, Marco Aurélio Krieger
BACKGROUND: Real-time reverse transcription polymerase chain reaction (RT-PCR) is routinely used to detect viral infections. In Brazil, it is mandatory the use of nucleic acid tests to detect hepatitis C virus (HCV), hepatitis B virus and human immunodeficiency virus in blood banks because of the immunological window. The use of an internal control (IC) is necessary to differentiate the true negative results from those consequent from a failure in some step of the nucleic acid test. OBJECTIVES: The aim of this study was the construction of virus-modified particles, based on MS2 bacteriophage, to be used as IC for the diagnosis of RNA viruses...
April 6, 2017: Memórias do Instituto Oswaldo Cruz
https://www.readbyqxmd.com/read/28401125/drug-therapies-for-chronic-hepatitis-c-infection-a-cost-effectiveness-analysis
#11
William W L Wong, Karen M Lee, Sumeet Singh, George Wells, Jordan J Feld, Murray Krahn
BACKGROUND: Before 2011, pegylated interferon plus ribavirin was the standard therapy for chronic hepatitis C. Interferon-free direct-acting antiviral agents were then approved. Although these treatments appear to be more effective, they are substantially more expensive. In anticipation of the need for information regarding the comparative cost-effectiveness of new regimens in a recent therapeutic review, we conducted the analysis to inform listing decision in Canada. METHODS: A state-transition model was developed in the form of a cost-utility analysis...
January 2017: CMAJ Open
https://www.readbyqxmd.com/read/28398978/clinical-effectiveness-cost-effectiveness-and-acceptability-of-community-based-management-of-chronic-hepatitis-c-a-mixed-methods-systematic-review-protocol
#12
Davoud Pourmarzi, Lisa Hall, Tony Rahman, David Lim, Gerard FitzGerald
The current mixed methods review aims to develop an aggregated synthesis of quantitative, qualitative and economic systematic evidence on chronic hepatitis C virus (HCV) infection management intervention delivered in community settings so as to gain an increased understanding of the clinical effectiveness, cost-effectiveness and acceptability of community-based chronic HCV management. This review will contribute to the development of a community-based chronic HCV intervention and inform clinical practice and policy discussion...
April 2017: JBI Database of Systematic Reviews and Implementation Reports
https://www.readbyqxmd.com/read/28389707/the-race-of-10-synthetic-rnai-based-drugs-to-the-pharmaceutical-market
#13
REVIEW
Ricardo Titze-de-Almeida, Catherine David, Simoneide Souza Titze-de-Almeida
Ten years after Fire and Melo's Nobel Prize for discovery of gene silencing by double-stranded RNA, a remarkable progress was achieved in RNA interference (RNAi). Changes in the chemical structure of synthetic oligonucleotides make them more stable and specific, and new delivery strategies became progressively available. The attention of pharmaceutical industry rapidly turned to RNAi, as an opportunity to explore new drug targets. This review addresses nine small-interfering RNAs (siRNAs) and one unique microRNA (miRNA) inhibitor, which entered the phase 2-3 clinical trials...
April 7, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28389143/identification-of-treatment-experienced-hepatitis-c-patients-with-poor-cost-effectiveness-of-pegylated-interferon-plus-ribavirin-from-a-real-world-cohort
#14
Ta-Wei Liu, Pei-Chien Tsai, Ching-I Huang, Yi-Shan Tsai, Shu-Chi Wang, Yu-Min Ko, Ching-Chih Lin, Kuan-Yu Chen, Po-Cheng Liang, Yi-Hung Lin, Ming-Yen Hsieh, Nai-Jen Hou, Chung-Feng Huang, Ming-Lun Yeh, Zu-Yau Lin, Shinn-Cherng Chen, Chia-Yen Dai, Wan-Long Chuang, Jee-Fu Huang, Ming-Lung Yu
BACKGROUND/PURPOSE: Pegylated interferon (PegIFN) plus ribavirin (RBV) combination therapy has been the standard of care since 2002. Although a better viral response has been achieved among chronic hepatitis C (CHC) patients in Taiwan, approximately 25% of hepatitis C virus (HCV) genotype 1 (G1) patients and 15% of G2 patients failed to achieve a sustained virological response (SVR) at the first therapy. The actual cost-effectiveness of the retreatment remains elusive. The present study conducted a real-world cost-effectiveness analysis of a large cohort among different pre-specified subgroups of treatment-experienced CHC patients...
April 4, 2017: Journal of the Formosan Medical Association, Taiwan Yi Zhi
https://www.readbyqxmd.com/read/28386819/disease-burden-early-discontinuation-and-healthcare-costs-in-hepatitis-c-patients-with-and-without-chronic-kidney-disease-treated-with-interferon-free-direct-acting-antiviral-regimens
#15
Amy Puenpatom, Michael Hull, Jeffrey McPheeters, Kay Schwebke
BACKGROUND: Hepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited. OBJECTIVE: This study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Comorbidities, early discontinuation rates, and healthcare costs were compared between patients with and without CKD...
April 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28380022/estimating-cost-effectiveness-associated-with-all-oral-regimen-for-chronic-hepatitis-c-in-china
#16
Hai Chen, Lijun Chen
BACKGROUND: All-oral regimens are associated with higher effectiveness and shorter treatment duration for chronic hepatitis C. Given its superior effect and enormous patients in China, clinicians or patients may be compelled to consider delaying treatment for all-oral regimen. OBJECTIVE: To estimate cost-effectiveness of delaying treatment for all-oral regimen in the subsequent years under different assumptions about their price and efficacy compared with standard of care in China...
2017: PloS One
https://www.readbyqxmd.com/read/28374641/why-highly-effective-drugs-are-not-enough-the-need-for-an-affordable-solution-to-eliminating-hcv
#17
C Nelson Hayes, Kazuaki Chayama
Because of the rapid pace of development of new direct-acting antiviral (DAA) drugs, chronic hepatitis C virus (HCV) infection is now increasingly considered curable. However, the emphasis on DAA therapies disregards key issues related to cost, availability, and antiviral resistance. Areas covered: This perspective provides an overview of current HCV therapies and the development of DAAs, followed by a discussion of the limitations of DAA therapy. A literature search was used to select relevant studies, and a web search for relevant news articles and press releases was conducted...
April 4, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28361300/treatment-of-chronic-hepatitis-c-genotype-3-with-sofosbuvir-based-therpy-a-real-life-study
#18
Sandeep Singh Sidhu, Nirmaljeet Singh Malhi, Omesh Goyal, Rupinder Singh, Usha Dutta, Rajiv Grover, J S Sidhu, Vijay Nanda, Harmeet Saluja, Ajesh Bansal, Gursewak Singh, Alok Sehgal, Harsh Kishore, Simran Sidhu
BACKGROUND AND AIMS: Recently, Sofosbuvir was launched in India at affordable cost. We conducted a real-life study to determine the efficacy and safety of Sofosbuvir plus Ribavirin, with and without peginterferon-alfa 2a, in patients with chronic hepatitis C (CHC) genotype 3, the commonest genotype in South Asia. METHODS: This study included data of CHC patients from 11 sites in northern India between March 2015 and December 2015 (n = 1203). Patients with CHC genotype 3 (n = 931), who were treated with either Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×24 weeks (n = 432) (dual therapy), or Peginterferon-α2a 180 mcg weekly, Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×12 weeks (n = 499) (triple therapy) were included for analysis...
March 31, 2017: Hepatology International
https://www.readbyqxmd.com/read/28357031/concordance-of-non-invasive-mechanical-and-serum-tests-for-liver-fibrosis-evaluation-in-chronic-hepatitis-c
#19
Denise C Paranaguá-Vezozzo, Adriana Andrade, Daniel F C Mazo, Vinicius Nunes, Ana L Guedes, Taisa G Ragazzo, Renata Moutinho, Lucas S Nacif, Suzane K Ono, Venâncio A F Alves, Flair J Carrilho
AIM: To determine the sensitivity and specificity of liver stiffness measurement (LSM) and serum markers (SM) for liver fibrosis evaluation in chronic hepatitis C. METHODS: Between 2012 and 2014, 81 consecutive hepatitis C virus (HCV) patients had METAVIR score from liver biopsy compared with concurrent results from LSM [transient elastography (TE) [FibroScan(®)/ARFI technology (Virtual Touch(®))] and SM [FIB-4/aspartate aminotransferase-to-platelet ratio index (APRI)]...
March 18, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28342989/patient-engagement-and-study-design-of-prop-up-a-multi-site-patient-centered-prospective-observational-study-of-patients-undergoing-hepatitis-c-treatment
#20
Donna M Evon, Carol E Golin, Paul Stewart, Michael W Fried, Shani Alston, Bryce Reeve, Anna S Lok, Richard K Sterling, Joseph K Lim, Nancy Reau, Souvik Sarkar, David R Nelson, K R Reddy, Adrian M Di Bisceglie
BACKGROUND: New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. METHODS: PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5)...
March 22, 2017: Contemporary Clinical Trials
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