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https://www.readbyqxmd.com/read/28102906/filling-the-gap-between-clinical-trials-and-real-life-in-the-treatment-of-severe-hcv-recurrence-after-liver-transplantation
#1
Patrizia Burra, Alberto Zanetto
In this issue of Transplant International, Herzer et al. report the results obtained in a real-world European cohort of 87 patients with severe recurrent hepatitis C (HCV) after liver transplantation (LT), who were treated with a compassionate use of daclatasvir (DCV) plus registered sofosbuvir (SOF), with or without ribavirin (RBV). The vast majority of patients were HCV genotype 1, though the sample included a few with genotypes 3 and 4. It is noteworthy that 37/87 patients (42.5%) had cirrhosis (and 16/37 patients [43%] had Child-Pugh B/C decompensated cirrhosis)...
January 19, 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28098253/the-clinically-approved-antiviral-drug-sofosbuvir-inhibits-zika-virus-replication
#2
Carolina Q Sacramento, Gabrielle R de Melo, Caroline S de Freitas, Natasha Rocha, Lucas Villas Bôas Hoelz, Milene Miranda, Natalia Fintelman-Rodrigues, Andressa Marttorelli, André C Ferreira, Giselle Barbosa-Lima, Juliana L Abrantes, Yasmine Rangel Vieira, Mônica M Bastos, Eduardo de Mello Volotão, Estevão Portela Nunes, Diogo A Tschoeke, Luciana Leomil, Erick Correia Loiola, Pablo Trindade, Stevens K Rehen, Fernando A Bozza, Patrícia T Bozza, Nubia Boechat, Fabiano L Thompson, Ana M B de Filippis, Karin Brüning, Thiago Moreno L Souza
Zika virus (ZIKV) is a member of the Flaviviridae family, along with other agents of clinical significance such as dengue (DENV) and hepatitis C (HCV) viruses. Since ZIKV causes neurological disorders during fetal development and in adulthood, antiviral drugs are necessary. Sofosbuvir is clinically approved for use against HCV and targets the protein that is most conserved among the members of the Flaviviridae family, the viral RNA polymerase. Indeed, we found that sofosbuvir inhibits ZIKV RNA polymerase, targeting conserved amino acid residues...
January 18, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28097103/efficacy-and-safety-of-daclatasvir-in-hepatitis-c-an-overview
#3
REVIEW
Nesrine Gamal, Stefano Gitto, Pietro Andreone
Hepatitis C virus (HCV) infection is a growing public health concern, with 184 million people infected worldwide. During the past decade, interferon has been the backbone of HCV treatment, even though it remains far from ideal. The latest development of the new direct antivirals has drastically changed the treatment approach for chronic hepatitis C (CHC). Inhibitors of the HCV NS5A region have garnered remarkable interest among treating physicians, due to their high potency and favourable safety profile. In particular, treatment with daclatasvir (DCV) has yielded high rates of vriologic response in patients infected with genotype (Gt) 1 and Gt 3, when used in combination with other antivirals of a different class, such as sofosbuvir...
December 28, 2016: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/28092171/a-pangenotypic-single-tablet-regimen-of-sofosbuvir-velpatasvir-for-the-treatment-of-chronic-hepatitis-c-infection
#4
Ilan S Weisberg, Ira M Jacobson
Hepatitis C virus (HCV) infects nearly 170 million people worldwide and is a leading cause of progressive liver damage, cirrhosis, and hepatocellular carcinoma. Curative therapies have historically relied on interferon-based treatments and were limited by significant toxicity and poor response rates, particularly among patients with prior treatment failure and advanced hepatic fibrosis. The recent advent of direct acting antiviral (DAA) agents which target key steps in the HCV viral life cycle has transformed the landscape of HCV treatment by offering highly effective and well tolerated interferon-free treatments...
January 16, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28088870/fatal-relapse-of-myelodysplastic-syndrome-in-a-patient-with-hiv-hepatitis-c-coinfection-treated-with-simeprevir-sofosbuvir
#5
Efemena Michael Diejomaoh, Joseph Clayton Gathe, Carl Craig Mayberry, John Benjamin Clemmons, Bernie Miguel, Alan Glombicki, Benjamin Daquioag
Registrational studies and observational cohorts clearly suggest sustained virologic response (SVR) rates in HIV-/hepatitis C-coinfected patients are similar to monoinfected patients when utilizing interferon-free regimens, and this can be accomplished with agents that are well tolerated with minimal adverse events. These randomized trials that led to the approval of several of our new direct-acting antiviral agents, however, specifically excluded patients who had significant comorbidities and none to our knowledge accepted patients with a history of cancer...
January 1, 2017: Journal of the International Association of Providers of AIDS Care
https://www.readbyqxmd.com/read/28081594/management-of-direct-antiviral-agent-failures
#6
REVIEW
María Buti, Rafael Esteban
The current standard of care for patients with chronic hepatitis C virus (HCV) infection is a combination of direct-acting antiviral agents (DAAs). Most HCV patients treated with these drugs achieve viral elimination, but 1% to 15% fail to attain this objective. Treatment failures are usually related to relapse, and less often to on-treatment viral breakthrough. HCV drug resistant associated substitutions are detected in most patients who do not eliminate the virus. The risk of developing these variants depends on host- and virus-related factors, the properties of the drugs used, and the treatment strategies applied...
December 2016: Clinical and Molecular Hepatology
https://www.readbyqxmd.com/read/28079269/ledipasvir-plus-sofosbuvir-as-salvage-therapy-for-hcv-genotype-1-failures-to-prior-ns5a-inhibitors-regimens
#7
Norio Akuta, Hitomi Sezaki, Fumitaka Suzuki, Shunichiro Fujiyama, Yusuke Kawamura, Tetsuya Hosaka, Masahiro Kobayashi, Mariko Kobayashi, Satoshi Saitoh, Yoshiyuki Suzuki, Yasuji Arase, Kenji Ikeda, Hiromitsu Kumada
There is little information on retreatment efficacy and predictors of the combination of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir) for patients who fail to respond to NS5A inhibitors. NS5A resistance variants are known to persist for long periods after such treatment. Here, we evaluated 54 patients with chronic HCV genotype 1b infection, free of decompensated cirrhosis and hepatocellular carcinoma, for sustained virological response after 12 weeks (SVR12) of once-daily treatment with 90 mg ledipasvir and 400 mg sofosbuvir...
January 12, 2017: Journal of Medical Virology
https://www.readbyqxmd.com/read/28078644/eight-or-12-week-treatment-of-hepatitis-c-with-ledipasvir-sofosbuvir-real-world-experience-in-a-large-integrated-health-system
#8
Jennifer B Lai, Maxwell A Witt, Mary Patricia Pauly, Joanna Ready, Michael Allerton, Suk Seo, David J Witt
BACKGROUND: Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system...
January 11, 2017: Drugs
https://www.readbyqxmd.com/read/28070899/sofosbuvir-based-treatment-regimens-real-life-results-of-14-409-chronic-hcv-genotype-4-patients-in-egypt
#9
A Elsharkawy, R Fouad, W El Akel, M El Raziky, M Hassany, G Shiha, M Said, I Motawea, T El Demerdash, S Seif, A Gaballah, Y El Shazly, M A M Makhlouf, I Waked, A O Abdelaziz, A Yosry, M El Serafy, M Thursz, W Doss, G Esmat
BACKGROUND: Chronic hepatitis C virus infection is one of the most important health problems in Egypt. The Ministry of Health's National Treatment Programme introduced sofosbuvir-based therapy in October 2014. AIM: To assess the clinical effectiveness and predictors of response to SOF-based treatment regimens, either dual therapy, with SOF/ribavirin (RBV) for 6 months or triple therapy with SOF/peg-IFN-alfa-2a/RBV for 3 months, in a cohort of patients treated in National Treatment Programme affiliated centres in Egypt...
January 9, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28070175/a-special-meeting-review-edition-advances-in-the-treatment-of-hepatitis-c-virus-infection-from-the-2016-easl-meeting-the-annual-meeting-of-the-european-association-for-the-study-of-the-liver-%C3%A2-april-13-17-2016-%C3%A2-barcelona-spainspecial-reporting-on-%C3%A2-six-weeks
#10
https://www.readbyqxmd.com/read/28069884/purification-of-zika-virus-rna-dependent-rna-polymerase-and-its-use-to-identify-small-molecule-zika-inhibitors
#11
Hong-Tao Xu, Said A Hassounah, Susan P Colby-Germinario, Maureen Oliveira, Clare Fogarty, Yudong Quan, Yingshan Han, Olga Golubkov, Ilinca Ibanescu, Bluma Brenner, Brent R Stranix, Mark A Wainberg
BACKGROUND: The viral RNA-dependent RNA polymerase (RdRp) enzymes of the Flaviviridae family are essential for viral replication and are logically important targets for development of antiviral therapeutic agents. Zika virus (ZIKV) is a rapidly re-emerging human pathogen for which no vaccine or antiviral agent is currently available. METHODS: To facilitate development of ZIKV RdRp inhibitors, we have established an RdRp assay using purified recombinant ZIKV NS5 polymerase...
January 8, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28063334/towards-interference-free-hplc-sers-for-the-trace-analysis-of-drug-metabolites-in-biological-fluids
#12
Waleed A Hassanain, Emad L Izake, Arumugam Sivanesan, Godwin A Ayoko
Sofosbuvir metabolite, 2'-deoxy-2'-fluoro-2'-C-methyluridine (PSI-6206) was studied for the first time by surface enhanced Raman spectroscopy (SERS) using the paper-based SERS substrate. The quantification limit of PSI-6206 by SERS was found to be 13ngL(-1) (R(2) value=0.959, RSD=5.23%). For the structural and quantitative analysis of PSI-6206 in blood plasma, an interference-free HPLC-SERS method was developed and compared to HPLC-DAD and HPLC-MS methods. The SERS quantification of the drug by the paper substrate was 4 orders of magnitude more sensitive than that by the diode array detector...
December 23, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28061762/the-effectiveness-of-daclatasvir-based-therapy-in-european-patients-with-chronic-hepatitis-c-and-advanced-liver-disease
#13
Jim Young, Nina Weis, Harald Hofer, William Irving, Ola Weiland, Emiliano Giostra, Juan Manuel Pascasio, Lluis Castells, Martin Prieto, Roelien Postema, Cinira Lefevre, David Evans, Heiner C Bucher, Jose Luis Calleja
BACKGROUND: There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. The Named Patient Program in Europe included patients with advanced chronic hepatitis C, a life expectancy of less than 12 months and no other treatment options. METHODS: A retrospective multi-country cohort of patients with chronic hepatitis C who received daclatasvir as part of the Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland and the United Kingdom...
January 7, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28060446/successful-treatment-of-donor-derived-hepatitis-c-viral-infection-in-three-transplant-recipients-from-a-donor-at-increased-risk-for-bloodborne-pathogens
#14
Ashesh P Shah, Andrew Cameron, Pooja Singh, Adam M Frank, Jonathan M Fenkel
We report here the successful treatment of hepatitis C virus (HCV) transmitted from a nucleic acid testing (NAT)-negative donor to 3 HCV-negative recipients - 2 renal transplants and 1 liver. Both renal recipients underwent standard deceased-donor renal transplantation with immediate graft function. The liver recipient underwent standard orthotopic liver transplantation and recovered uneventfully. The donor was a 39-year-old woman with a terminal serum creatinine of 0.7 mg/dL. She was high risk for bloodborne pathogens, based upon a history of sexual contact with an HCV-infected male partner...
January 6, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28060441/successful-treatment-of-donor-derived-hepatitis-c-infection-in-a-lung-transplant-recipient
#15
Nicole Theodoropoulos, Bryan A Whitson, Stanley I Martin, Stephanie Pouch, Amy Pope-Harman
Data are limited regarding the use of direct-acting antivirals for treatment of hepatitis C infection post lung transplant, especially in a donor-derived infection. We present a case of a lung transplant recipient with donor-derived hepatitis C that was successfully treated with a 12-week regimen of simeprevir and sofosbuvir. This case reiterates the importance of screening recipients of increased-risk donor organs for disease transmission and the value of early therapy. This article is protected by copyright...
January 6, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28052633/hepatitis-c-efficacy-and-safety-in-real-life
#16
REVIEW
Robert Flisiak, Joanna Pogorzelska, Marta Flisiak-Jackiewicz
Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis...
January 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28051797/%C3%A2-sofosbuvir-and-daclatasvir-in-mono-and-hiv-coinfected-patients-with-recurrent-hepatitis-c-after-liver-transplant
#17
Lluís Castells, Jordi Llaneras, Isabel Campos-Varela, Itxarone Bilbao, Manel Crespo, Oscar Len, Francisco Rodríguez-Frías, Ramon Charco, Teresa Salcedo, Juan Ignacio Esteban, Rafael Esteban-Mur
:  Background and aims. Pegylated interferon (Peg-INF) and ribavirin (RBV) based therapy is suboptimal and poorly tolerated. We evaluated the safety, tolerability and efficacy of a 24-week course of sofosbuvir plus daclatasvir without ribavirin for the treatment of hepatitis C virus (HCV) recurrence after liver transplantation (LT) in both HCV-monoinfected and human immunodeficiency virus (HIV)-HCV coinfected patients. MATERIAL AND METHODS: We retrospectively evaluated 22 consecutive adult LT recipients (16 monoinfected and 6 coinfected with HIV) who received a 24-week course of sofosbuvir plus daclatasvir treatment under an international compassionate access program...
January 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28050236/hepatitis-c-eradication-with-sofosbuvir-leads-to-significant-metabolic-changes
#18
Amilcar L Morales, Zachary Junga, Manish B Singla, Maria Sjogren, Dawn Torres
AIM: To assess the effect of sofosbuvir (SOF) based regimens on glycemic and lipid control. METHODS: This is a retrospective analysis of hepatitis C virus (HCV)-infected patients treated and cured with a SOF regimen [SOF/ribavirin/interferon, SOF/simeprevir, or SOF/ledipasvir (LDV) ± ribavirin] from January 2014 to March 2015. Patients with hemoglobin A1C (HbA1C) and lipid panels within six months before and six months after therapy were identified and included in our study...
December 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/28046099/cost-effectiveness-of-treating-hepatitis-c-with-sofosbuvir-ledipasvir-in-germany
#19
Jona T Stahmeyer, Siegbert Rossol, Sebastian Liersch, Ines Guerra, Christian Krauth
BACKGROUND: Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines...
2017: PloS One
https://www.readbyqxmd.com/read/28041959/substrate-selectivity-of-dengue-and-zika-virus-ns5-polymerase-towards-2-modified-nucleotide-analogues
#20
Supanee Potisopon, François Ferron, Véronique Fattorini, Barbara Selisko, Bruno Canard
In targeting the essential viral RNA-dependent RNA-polymerase (RdRp), nucleotide analogues play a major role in antiviral therapies. In the Flaviviridae family, the hepatitis C virus (HCV) can be eradicated from chronically infected patients using a combination of drugs which generally include the 2'-modified uridine analogue Sofosbuvir, delivered as nucleotide prodrug. Dengue and Zika viruses are emerging flaviviruses whose RdRp is closely related to that of HCV, yet no nucleoside drug has been clinically approved for these acute infections...
December 29, 2016: Antiviral Research
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