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https://www.readbyqxmd.com/read/29454794/hcv-genotype-6a-escape-from-and-resistance-to-velpatasvir-pibrentasvir-and-sofosbuvir-in-robust-infectious-cell-culture-models
#1
Long V Pham, Santseharay Ramirez, Judith M Gottwein, Ulrik Fahnøe, Yi-Ping Li, Jannie Pedersen, Jens Bukh
BACKGROUND & AIMS: Chronic liver diseases caused by hepatitis C virus (HCV) genotype 6 are prevalent in Asia, and millions of people require treatment with direct-acting antiviral regimens, such as NS5A inhibitor velpatasvir combined with the NS5B polymerase inhibitor sofosbuvir. We developed infectious cell culture models of HCV genotype 6a infection to study the effects of these inhibitors and the development of resistance. METHODS: The consensus sequences of prototype strains HK2 (MG717925) and HK6a (MG717928), originating from serum of patients with chronic HCV infection, were determined by Sanger sequencing of genomes amplified by reverse transcription-PCR...
February 15, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29453451/prevalence-and-impact-of-baseline-resistance-associated-substitutions-on-the-efficacy-of-ledipasvir-sofosbuvir-or-simeprevir-sofosbuvir-against-gt1-hcv-infection
#2
Gary P Wang, Norah Terrault, Jacqueline D Reeves, Lin Liu, Eric Li, Lisa Zhao, Joseph K Lim, Giuseppe Morelli, Alexander Kuo, Josh Levitsky, Kenneth E Sherman, Lynn M Frazier, Ananthakrishnan Ramani, Joy Peter, Lucy Akuskevich, Michael W Fried, David R Nelson
Baseline resistance-associated substitutions (RASs) have variable impacts in clinical trials but their prevalence and impact in real-world patients remains unclear. We performed baseline resistance testing using a commercial assay (10% cutoff) for 486 patients treated with LDV/SOF or SMV/SOF, with or without ribavirin, in the multi-center, observational HCV-TARGET cohort. Linkage of RASs was evaluated in selected samples using a novel quantitative single variant sequencing assay. Our results showed that the prevalence of NS3, NS5A, NS5B RASs was 45%, 13%, and 8%, respectively, and 10% of patients harbored RASs in 2 or more drug classes...
February 16, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29452294/vitamin-d-pathway-genetic-variants-are-able-to-influence-sofosbuvir-and-its-main-metabolite-pharmacokinetics-in-hcv-mono-infected-patients
#3
Jessica Cusato, Amedeo De Nicolò, Lucio Boglione, Fabio Favata, Alessandra Ariaudo, Simone Mornese Pinna, Chiara Carcieri, Federica Guido, Valeria Avataneo, Giuseppe Cariti, Giovanni Di Perri, Antonio D'Avolio
Vitamin D levels and genetic variants were associated with drug outcome/toxicity and concentrations. The plasma exposure of GS-331007, the main sofosbuvir metabolite, has been related to SVR. We evaluated the impact of polymorphisms in genes (CYP27B1, CYP24A1, VDBP and VDR) related to vitamin D pathway on sofosbuvir and GS-331007 plasma levels in HCV mono-infected patients at one month of treatment. Polymorphisms were investigated through real-time PCR; drug plasma quantification was performed through a UHPLC-MS/MS method...
February 13, 2018: Infection, Genetics and Evolution
https://www.readbyqxmd.com/read/29451090/study-of-changes-in-lipid-profile-and-insulin-resistance-in-egyptian-patients-with-chronic-hepatitis-c-genotype-4-in-the-era-of-daas
#4
Ghada El Sagheer, Elwy Soliman, Asmaa Ahmad, Lamiaa Hamdy
Chronic hepatitis C virus (HCV) infection is associated with altered metabolism, including dyslipidemia and insulin resistance. These contribute to disease progression and influences the response to therapy. To investigate the relationships of new direct-acting antiviral drugs, simeprevir/sofosbuvir, with lipid profile and insulin resistance (IR). Eighty chronic hepatitis C genotype 4 patients were included; they were divided into four groups according to the severity of fibrosis as detected by fibroscan. Forty healthy persons volunteered as a control group...
December 2018: Libyan Journal of Medicine
https://www.readbyqxmd.com/read/29450210/sofosbuvir-based-direct-acting-antiviral-therapies-for-hcv-in-people-receiving-opioid-substitution-therapy-an-analysis-of-phase-3-studies
#5
Jason Grebely, Jordan J Feld, David Wyles, Mark Sulkowski, Liyun Ni, Joe Llewellyn, Heshaam M Mir, Nika Sajed, Luisa M Stamm, Robert H Hyland, John McNally, Diana M Brainard, Ira Jacobson, Stefan Zeuzem, Marc Bourlière, Graham Foster, Nezam Afdhal, Gregory J Dore
Background: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6)...
February 2018: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/29446138/editorial-sofosbuvir-plus-daclatasvir-for-the-treatment-of-hepatitis-c-can-one-size-fit-all
#6
EDITORIAL
J Sun, X Liang, R Fan, J Hou
No abstract text is available yet for this article.
March 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29443655/is-interferon-based-treatment-of-viral-hepatitis-c-genotype-3-infection-still-of-value-in-the-era-of-direct-acting-antivirals
#7
Dorota Zarębska-Michaluk, Robert Flisiak, Jerzy Jaroszewicz, Ewa Janczewska, Agnieszka Czauż-Andrzejuk, Hanna Berak, Andrzej Horban, Agnieszka Staniaszek, Andrzej Gietka, Magdalena Tudrujek, Krzysztof Tomasiewicz, Dorota Dybowska, Waldemar Halota, Anna Piekarska, Marek Sitko, Aleksander Garlicki, Iwona Orłowska, Krzysztof Simon, Teresa Belica-Wdowik, Barbara Baka-Ćwierz, Włodzimierz Mazur, Jolanta Białkowska, Łukasz Socha, Marta Wawrzynowicz-Syczewska, Łukasz Laurans, Zbigniew Deroń, Beata Lorenc, Beata Dobracka, Olga Tronina, Małgorzata Pawłowska
The aim of the study is to analyze treatments available for patients infected with genotype (G) 3 hepatitis C virus (HCV) in Poland at the beginning of the interferon (IFN)-free era and evaluate the efficacy and safety of different therapeutic options administered in a real-world setting. We analyzed data of 198 patients who started antiviral therapy after July 1, 2015, and completed it before December 31, 2016; 57.6% of them had liver cirrhosis and 46% were treatment experienced. Fifty percent of patients were assigned to sofosbuvir (SOF)+pegylated IFN alfa (PegIFNa)+ribavirin (RBV), 9% to PegIFNa+RBV, 36% received SOF+RBV, and 5% SOF+daclatasvir (DCV)±RBV...
February 2018: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/29442067/retreatment-with-sofosbuvir-velpatasvir-in-cirrhotic-patients-with-genotype-4-who-failed-a-previous-interferon-free-regimen-a-case-series
#8
Lucio Boglione, Simone Mornese Pinna, Tommaso Lupia, Giuseppe Cariti, Giovanni Di Perri
BACKGROUND: The novel available interferon (IFN)-free regimens significantly improved the sustained virological response (SVR) in patients with chronic hepatitis C (CHC), without important side-effects and with shorter duration of treatment. In a subset of patients, however, the treatment failure (TF) was due to the presence of resistance-associated substitutions (RAS) that lead to virological breakthrough (BT) or relapse. We analyzed in this case-series the role of RAS on the TF in cirrhotic patients with GT4, treated with a previous IFN-free regimen, and retreated with the combination of sofosbuvir (SOF)/velpatasvir (VEL) for 12 or 24 weeks, without ribavirin (RBV)...
February 14, 2018: Antiviral Therapy
https://www.readbyqxmd.com/read/29439971/sofosbuvir-and-ribavirin-liver-pharmacokinetics-in-patients-infected-with-hepatitis-c-virus
#9
Darius Babusis, Michael P Curry, Brian Kirby, Yeojin Park, Eisuke Murakami, Ting Wang, Anita Mathias, Nezam Afdhal, John G McHutchison, Adrian S Ray
Sofosbuvir and ribavirin exert their anti-hepatitis C virus (HCV) activity following metabolic activation in the liver. However, intrahepatic concentrations of the pharmacologically active nucleotide metabolites in humans are poorly characterized due to the inaccessibility of tissue and technical challenges with measuring nucleotide levels. A clinical study assessing the efficacy of sofosbuvir and ribavirin administered prior to liver transplant to prevent HCV reoccurrence provided a unique opportunity to quantify nucleotide concentrations in human liver...
February 12, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29435907/sustained-virological-response-in-special-populations-with-chronic-hepatitis-c-using-interferon-free-treatments-a-systematic-review-and-meta-analysis-of-observational-cohort-studies
#10
REVIEW
Vinicius Lins Ferreira, Letícia Paula Leonart, Fernanda Stumpf Tonin, Helena Hiemisch Lobo Borba, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C...
February 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29435197/successful-retreatment-with-sofosbuvir-plus-ledipasvir-for-cirrhotic-patients-with-hepatitis-c-virus-genotype-1b-who-discontinued-the-prior-treatment-with-asunaprevir-plus-daclatasvir-a-case-series-and-review-of-the-literature
#11
Yuki Haga, Tatsuo Kanda, Shin Yasui, Masato Nakamura, Yoshihiko Ooka, Koji Takahashi, Shuang Wu, Shingo Nakamoto, Makoto Arai, Tetsuhiro Chiba, Hitoshi Maruyama, Osamu Yokosuka, Nobuo Takada, Mitsuhiko Moriyama, Fumio Imazeki, Naoya Kato
Background: Interferon-free treatment results in higher sustained virologic response (SVR) rates, with no serious adverse events in hepatitis C virus (HCV)-infected patients. However, in some patients with treatment-failure in HCV NS5A inhibitor-including interferon-free regimens, the treatment-emergent HCV NS5A resistance-associated variants (RAVs), which are resistant to interferon-free retreatment including HCV NS5A inhibitors, are observed. In HCV-infected Japanese patients with daclatasvir and asunaprevir treatment failure, retreatment with sofosbuvir and ledipasvir could lead to only ∼70% SVR rates...
January 12, 2018: Oncotarget
https://www.readbyqxmd.com/read/29430226/a-hepatitis-c-virus-associated-chronic-hepatitis-patient-developing-various-adverse-events-including-severe-gingivitis-gingival-bleeding-and-inflammation-of-genital-vulva-during-the-course-of-antiviral-therapy-with-elbasvir-grazoprevir
#12
Kazuo Tarao, Akira Sato
Oral direct-acting antivirals comprise the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the primary agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. Ombitasvir/paritaprevir/ritonavir was also recommended as a therapy for HCV genotype 1b. More recently, elbasvir (NS5A inhibitor)/grazoprevir (NS3/4A protease inhibitor) was also recommended as a potent therapy for HCV genotype 1b infection. This agent achieved an SVR12 as high as 96...
September 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29430221/successful-treatment-of-oral-lichen-planus-with-direct-acting-antiviral-agents-after-liver-transplantation-for-hepatitis-c-virus-associated-hepatocellular-carcinoma
#13
Yumiko Nagao, Kazunori Nakasone, Tatsuji Maeshiro, Nao Nishida, Kanae Kimura, Yuji Kawahigashi, Yasuhito Tanaka, Michio Sata
Hepatitis C virus (HCV) infection is frequently associated with various extrahepatic manifestations, such as autoimmune features and immune complex deposit diseases. Oral lichen planus (OLP) is one such extrahepatic manifestation of HCV infection. Recently, direct-acting antivirals (DAA) have proved to be highly effective and safe for the eradication of HCV. Herein, we report a case of OLP accompanied by HCV-related hepatocellular carcinoma (HCC) that disappeared after liver transplantation and achievement of sustained virological response following interferon (IFN)-free treatment with ledipasvir (LDV) and sofosbuvir (SOF)...
September 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29429413/a-case-of-a-patient-infected-with-a-hepatitis-c-virus-genotype-3a-multidrug-resistant-variant-in-pakistan
#14
Asad Zia, Muhammad Ali, Hafsa Aziz, Muhammad Zia, Zabta Khan Shinwari, Abida Raza
BACKGROUND: Approximately 10 million people in Pakistan are infected with the hepatitis C virus (HCV). Most patients develop chronic hepatitis, with rare cases of spontaneous clearance. However, little is known about multidrug resistant viral variants in Pakistan. FINDINGS: This case study describes a 47-year-old male diagnosed with chronic HCV genotype 3a infection in 2003. After an initial diagnosis of viral infection, the patient remained treatment naïve for 5 years...
February 11, 2018: Infectious Diseases of Poverty
https://www.readbyqxmd.com/read/29427485/treatment-of-hepatitis-c-the-use-of-the-new-pangenotypic-direct-acting-antivirals-in-special-populations
#15
REVIEW
Stanislas Pol, Lucia Parlati
BACKGROUND & AIMS: The recommended combination of pangenotypic direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) associates the co-formulation of 2 or 3 second-generation DAAs. In the so-called "special populations" defined as patients with chronic kidney disease (CKD), HCV/HIV co-infection, HCV/HBV co-infection and an unsuccessful previous DAA regimen, these combinations have a high antiviral potency (sustained virologic response (SVR) > 95%), fair tolerance and a reduced pill burden...
February 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29427481/treatment-of-hepatitis-c-results-in-real-life
#16
REVIEW
Christophe Hézode
Direct-acting antivirals (DAAs) have transformed traditional treatment options for hepatitis C virus (HCV) infection. DAA combinations have been shown to be highly effective in reducing the burden of chronic HCV infection in clinical trials and have been recommended by the European Association for the Study of the Liver (EASL) treatment guidelines. This review examines the results of second-generation DAA combinations in real-life clinical practice in patients with genotypes 1-3 and in those co-infected with HIV (real-world data in genotypes 4-6 are rare)...
February 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29425404/ns5a-p32-deletion-after-failure-of-ledipasvir-sofosbuvir-in-hepatitis-c-virus-genotype-1b-infection
#17
Akira Doi, Hayato Hikita, Ryotaro Sakamori, Yuki Tahata, Yugo Kai, Ryoko Yamada, Takayuki Yakushijin, Eiji Mita, Kazuyoshi Ohkawa, Yasuharu Imai, Kunimaro Furuta, Takahiro Kodama, Tomohide Tatsumi, Tetsuo Takehara
No abstract text is available yet for this article.
February 9, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29425396/resistance-analysis-of-genotype-3-hcv-indicates-subtypes-inherently-resistant-to-ns5a-inhibitors
#18
David Smith, Andrea Magri, David Bonsall, Camilla Lc Ip, Amy Trebes, Anthony Brown, Palo Piazza, Rory Bowden, Dung Nguyen, M Azim Ansari, Peter Simmonds, Eleanor Barnes
BACKGROUND AND AIMS: HCV genotype-3 (gt3) is highly prevalent globally, with non-gt3a subtypes common in Southeast Asia. Resistance-associated substitutions (RASs) have been shown to play a role in treatment failure. However, the role of RASs in gt3 is not well understood. We report the prevalence of RASs in a cohort of directly acting antivirals (DAA) treatment-naïve gt3 infected patients, including those with rarer subtypes and evaluate the effect of these RAS on DAAs in-vitro. METHODS: Baseline samples from 496 gt3 patients enrolled in the BOSON clinical trial were analysed by next-generation sequencing after probe-based enrichment for HCV...
February 9, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29417463/drug-interchangeability-of-generic-and-brand-products-of-fixed-dose-combination-tablets-of-sofosbuvir-and-ledipasvir-400-90%C3%A2-mg-employment-of-reference-scaled-average-bioequivalence-study-on-healthy-egyptian-volunteers
#19
Ehab Rasmy Bendas, Mamdouh R Rezk, Kamal A Badr
BACKGROUND AND OBJECTIVES: The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers. METHODS: The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks...
February 7, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29414007/ultrasensitive-spectrofluorimetric-method-for-rapid-determination-of-daclatasvir-and-ledipasvir-in-human-plasma-and-pharmaceutical-formulations
#20
Mohammad Nabil Abo-Zeid, Noha N Atia, Samia M El-Gizawy, Salwa R El-Shaboury
Direct-acting antivirals (DAAs) represent a revolution in the treatment of chronic hepatitis C which have emerged at an extremely rapid pace over the past few years. DAAs act directly on the hepatitis C virus at various points in the viral life cycle to inhibit viral production. Among these novel DAAs, are daclatasvir (DCS) and ledipasvir (LDS). Herein, a novel, fast, simple, ultrasensitive and cost-effective spectrofluorimetric method was designed for determination of DCS and LDS in miscellaneous matrices...
January 31, 2018: Journal of Pharmaceutical and Biomedical Analysis
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