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https://www.readbyqxmd.com/read/27917405/efficacy-and-safety-of-3-week-response-guided-triple-direct-acting-antiviral-therapy-for-chronic-hepatitis-c-infection-a-phase-2-open-label-proof-of-concept-study
#1
George Lau, Yves Benhamou, Guofeng Chen, Jin Li, Qing Shao, Dong Ji, Fan Li, Bing Li, Jialiang Liu, Jinlin Hou, Jian Sun, Cheng Wang, Jing Chen, Vanessa Wu, April Wong, Chris L P Wong, Stella T Y Tsang, Yudong Wang, Leda Bassit, Sijia Tao, Yong Jiang, Hui-Mien Hsiao, Ruian Ke, Alan S Perelson, Raymond F Schinazi
BACKGROUND: To shorten the course of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, we examined the antiviral efficacy and safety of 3 weeks of response-guided therapy with an NS3 protease inhibitor and dual NS5A inhibitor-NS5B nucleotide analogue. METHODS: In this open-label, phase 2a, single centre study, Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir, daclatasvir, and asunaprevir) until six patients in each group (1:1:1) achieved an ultrarapid virological response (plasma HCV RNA <500 IU/mL by day 2, measured by COBAS TaqMan HCV test, version 2...
October 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27917261/anti-hepatitis-c-virus-drugs-and-kidney
#2
REVIEW
Paul Carrier, Marie Essig, Marilyne Debette-Gratien, Denis Sautereau, Annick Rousseau, Pierre Marquet, Jérémie Jacques, Véronique Loustaud-Ratti
Hepatitis C virus (HCV) mainly targets the liver but can also induce extrahepatic manifestations. The kidney may be impacted via an immune mediated mechanism or a cytopathic effect. HCV patients are clearly at a greater risk of chronic kidney disease (CKD) than uninfected patients are, and the presence of CKD increases mortality. Interferon-based therapies and ribavirin are difficult to manage and are poorly effective in end-stage renal disease and hemodialysis. These patients should be given priority treatment with new direct anti-viral agents (DAAs) while avoiding peginterferon and ribavirin...
November 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/27917084/sofosbuvir-and-simeprevir-combination-therapy-for-hcv-genotype-1-infection-results-of-a-single-center-va-experience
#3
Seth N Sclair, Maria Del Pilar Hernandez, Evan Vance, Dani Gilinski, Helen Youtseff, Maribel Toro, Marie Antoine, Lennox J Jeffers, Adam Peyton
Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection...
August 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27914803/effectiveness-of-direct-acting-antivirals-in-hepatitis-c-virus-infection-in-haemodialysis-patients
#4
Soraya Abad, Almudena Vega, Diego Rincón, Eduardo Hernández, Evangelina Mérida, Nicolás Macías, Raquel Muñoz, Mónica Milla, Jose Luño, Juan Manuel López-Gómez
Hepatitis C virus (HCV) infection is highly prevalent among patients on haemodialysis and leads to a poorer prognosis compared to patients who do not have said infection. Treatment with interferon and ribavirin is poorly tolerated and there are limited data on the experience with new direct-acting antivirals (DAAs). The aim of this study is to retrospectively analyse the current prevalence of HCV infection and efficacy and safety results with different DAA regimens in the haemodialysis population of 2hospital areas...
November 30, 2016: Nefrología: Publicación Oficial de la Sociedad Española Nefrologia
https://www.readbyqxmd.com/read/27913920/ns5a-resistance-associated-variants-undermine-the-effectiveness-of-ledipasvir-and-sofosbuvir-for-cirrhotic-patients-infected-with-hcv-genotype-1b
#5
Eiichi Ogawa, Norihiro Furusyo, Hideyuki Nomura, Kazufumi Dohmen, Nobuhiko Higashi, Kazuhiro Takahashi, Akira Kawano, Koichi Azuma, Takeaki Satoh, Makoto Nakamuta, Toshimasa Koyanagi, Masaki Kato, Shinji Shimoda, Eiji Kajiwara, Jun Hayashi
BACKGROUND: Little real-world cohort data has been reported for Asians who have received interferon-free regimens with sofosbuvir (SOF) for chronic hepatitis C virus (HCV) infection. We evaluated the effectiveness and safety in clinical practice of ledipasvir (LDV) plus SOF for Japanese patients infected with HCV genotype 1. METHODS: This large, multicenter, real-world cohort study consisted of 772 patients treatment-naive or -experienced, with or without compensated cirrhosis, who were treated with LDV (90 mg)/SOF (400 mg) for a fixed 12-week duration...
December 2, 2016: Journal of Gastroenterology
https://www.readbyqxmd.com/read/27910116/the-cost-effectiveness-of-testing-for-ns5a-resistance-associated-polymorphisms-at-baseline-in-genotype-1a-infected-treatment-na%C3%A3-ve-and-treatment-experienced-subjects-treated-with-all-oral-elbasvir-grazoprevir-regimens-in-the-united-states
#6
E H Elbasha, M N Robertson, C Nwankwo
BACKGROUND: The presence of baseline NS5A resistance-associated variants (RAVs) impacted treatment response in HCV genotype 1a (GT1a)-infected patients treated with elbasvir/grazoprevir (EBR/GZR) for 12 weeks, but not patients treated with EBR/GZR and ribavirin (RBV) for 16 weeks. AIM: We assessed the cost-effectiveness of baseline testing for NS5A RAVs in EBR/GZR-treated patients compared without testing and with current treatments for GT1a patients. METHODS: We simulated the course of treatment with EBR/GZR, ledipasvir/sofosbuvir (LDV/SOF) and ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) with or without RBV and natural history of disease of GT1a patients...
December 1, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27906834/successful-continuation-of-hcv-treatment-following-liver-transplantation
#7
Carlos Fernández Carrillo, Gonzalo Crespo, Juan de la Revilla, Lluís Castells, Maria Buti, José Luis Montero, Emilio Fábrega, Inmaculada Fernández, Cristina Serrano-Millán, Victoria Hernández, José Luis Calleja, María-Carlota Londoño
BACKGROUND: Guidelines recommend that patients with hepatitis C virus (HCV)-related liver disease be treated for HCV before liver transplant (LT) to eliminate the virus prior to surgery. However, the unpredictability of donor organ availability may limit treatment duration. Interruption of HCV treatment with resumption post-LT is one potential solution which has not been investigated widely. METHODS: Patients from 5 clinical centres included in the large, national, noninterventional Hepa-C registry who started treatment with direct-acting antiviral agents (DAAs) while awaiting LT were identified retrospectively and followed up prospectively...
December 1, 2016: Transplantation
https://www.readbyqxmd.com/read/27902933/the-fda-approved-drug-sofosbuvir-inhibits-zika-virus-infection
#8
Kristen M Bullard-Feibelman, Jennifer Govero, Zhe Zhu, Vanessa Salazar, Milena Veselinovic, Michael S Diamond, Brian J Geiss
The rapidly expanding Zika virus (ZIKV) epidemic has affected thousands of individuals with severe cases causing Guillain-Barré syndrome, congenital malformations, and microcephaly. Currently, there is no available vaccine or therapy to prevent or treat ZIKV infection. We evaluated whether sofosbuvir, an FDA-approved nucleotide polymerase inhibitor for the distantly related hepatitis C virus, could have antiviral activity against ZIKV infection. Cell culture studies established that sofosbuvir efficiently inhibits replication and infection of several ZIKV strains in multiple human tumor cell lines and isolated human fetal-derived neuronal stem cells...
November 27, 2016: Antiviral Research
https://www.readbyqxmd.com/read/27896858/efficacy-and-safety-of-simeprevir-and-sofosbuvir-with-and-without-ribavirin-in-subjects-with-recurrent-genotype-1-hepatitis-c-post-orthotopic-liver-transplant-the-randomized-galaxy-study
#9
Jacqueline G O'Leary, Robert J Fontana, Kimberly Brown, James R Burton, Roberto Firpi-Morell, Andrew Muir, Christopher O'Brien, Mordechai Rabinovitz, K Rajender Reddy, Robert Ryan, Adam Shprecher, Shirley Villadiego, Avinash Prabhakar, Robert S Brown
This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 post-orthotopic liver transplant evaluated once-daily simeprevir 150mg+sofosbuvir 400mg, with and without ribavirin 1,000mg. Primary endpoint was proportion of subjects with Week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by geno/subtype and Q80K): Arm 1, simeprevir+sofosbuvir+ribavirin, 12 weeks; Arm 2, simeprevir+sofosbuvir, 12 weeks; Arm 3, simeprevir+sofosbuvir, 24 weeks; 13 additional subjects (2 with cirrhosis, 11 without cirrhosis) entered Arm 3...
November 29, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/27896822/simeprevir-in-combination-with-sofosbuvir-in-treatment-na%C3%A3-ve-and-experienced-patients-with-hepatitis-c-virus-genotype-4-infection-a-phase-iii-open-label-single-arm-study-pluto
#10
M Buti, J L Calleja, S Lens, M Diago, E Ortega, J Crespo, R Planas, M Romero-Gómez, F G Rodríguez, J M Pascasio, B Fevery, D Kurland, C Corbett, R Kalmeijer, W Jessner
BACKGROUND: Hepatitis C virus (HCV) infection is a leading cause of liver cirrhosis and subsequent hepatocellular carcinoma. HCV genotype 4 is found widely in the Middle East, Egypt and Africa, and has also spread into Europe. There are limited data available regarding the use of direct-acting antiviral agents in HCV genotype 4-infected patients with cirrhosis. AIM: The Phase III, open-label, single-arm PLUTO study evaluated the efficacy and safety of 12 weeks of simeprevir (HCV NS3/4A protease inhibitor) plus sofosbuvir (HCV nucleotide-analogue NS5B polymerase inhibitor) in treatment-naïve and (peg)interferon ± ribavirin-experienced HCV genotype 4-infected patients, with or without compensated cirrhosis...
November 29, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27895394/concise-review-interferon-free-treatment-of-hepatitis-c-virus-associated-cirrhosis-and-liver-graft-infection
#11
REVIEW
Nina Weiler, Stefan Zeuzem, Martin-Walter Welker
Chronic hepatitis C is a major reason for development of cirrhosis and hepatocellular carcinoma and a leading cause for liver transplantation. The development of direct-acting antiviral agents lead to (pegylated) interferon-alfa free antiviral therapy regimens with a remarkable increase in sustained virologic response (SVR) rates and opened therapeutic options for patients with advanced cirrhosis and liver graft recipients. This concise review gives an overview about most current prospective trials and cohort analyses for treatment of patients with liver cirrhosis and liver graft recipients...
November 7, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/27882839/real-world-drug-costs-of-treating-hepatitis-c-genotypes-1-4-with-direct-acting-antivirals-initiating-treatment-at-fibrosis-0-2-and-3-4
#12
Timothy A Bach, Kathy Zaiken
BACKGROUND: Direct-acting antivirals (DAA) for the treatment of hepatitis C virus (HCV) have drastically improved outcomes but are also very costly. For this reason, priority for treatment is often given to patients with a higher fibrosis score at baseline by payers and providers rather than treating all eligible patients. Simulation studies have suggested that waiting to treat patients until fibrosis 3-4 may be more costly and result in worse outcomes; however, real-world implications are unknown...
December 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27882706/high-frequency-of-potential-interactions-between-direct-acting-antivirals-and-concomitant-therapy-in-hiv-hepatitis-c-virus-coinfected-patients-in-clinical-practice
#13
J Macías, P Monge, M Mancebo, N Merchante, K Neukam, L M Real, J A Pineda
OBJECTIVES: The aim of the study was to analyse the frequency and degree of potential drug-drug interactions (DDIs) between direct-acting antivirals (DAAs) and concomitant medication used by HIV/hepatitis C virus (HCV)-coinfected patients, including antiretroviral therapy (ART) and other drugs. METHODS: All patients with HIV infection and viraemic HCV genotype 1, 3 or 4 coinfection attending a tertiary care centre in Spain (November 2014 to November 2015) were included in the study...
November 24, 2016: HIV Medicine
https://www.readbyqxmd.com/read/27878906/simeprevir-daclatasvir-and-sofosbuvir-for-hepatitis-c-virus-infected-patients-with-decompensated-liver-disease
#14
E Lawitz, F Poordad, J A Gutierrez, T N Kakuda, G Picchio, G Beets, A Vandevoorde, P Van Remoortere, B Jacquemyn, D Luo, S Ouwerkerk-Mahadevan, L Vijgen, V Van Eygen, M Beumont
Approximately three million individuals in the United States are chronically infected with hepatitis C virus (HCV). Chronic HCV infection may lead to the development of compensated as well as decompensated liver cirrhosis. The Phase II IMPACT study was conducted in HCV genotype 1- or 4-infected cirrhotic patients with portal hypertension or decompensated liver disease and assessed for the first time the combination of the three direct-acting antivirals simeprevir, daclatasvir and sofosbuvir. Treatment-naïve or treatment-experienced adults with Child-Pugh (CP) score <7 (CP A) and evidence of portal hypertension, or CP score 7-9 (CP B), received 12 weeks of simeprevir 150 mg, daclatasvir 60 mg and sofosbuvir 400 mg, once daily...
November 23, 2016: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/27875005/asunaprevir-daclatasvir-and-sofosbuvir-ledipasuvir-for-recurrent-hepatitis-c-following-living-donor-liver-transplantation
#15
Kiyohiko Omichi, Nobuhisa Akamatsu, Kazuhiro Mori, Junichi Togashi, Junichi Arita, Junichi Kaneko, Kiyoshi Hasegawa, Yoshihiro Sakamoto, Norihiro Kokudo
AIM: This study aimed to clarify the efficacy and safety of interferon-free therapy using asunaprevir and daclatasvir, or sofosbuvir and ledipasuvir for post living donor liver transplantation (LDLT) recipients with hepatitis C virus (HCV). METHODS: A retrospective cohort study of LDLT recipients with HCV genotype 1b treated with asunaprevir (100 mg twice daily) and daclatasvir (60 mg once daily), or sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was conducted...
November 22, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27872837/antineutrophil-cytoplasmic-antibodies-crescentic-allograft-glomerulonephritis-after-sofosbuvir-therapy
#16
Shilpa Gadde, Belinda Lee, Laura Kidd, Rubin Zhang
Antineutrophil cytoplasmic antibodies (ANCA) are well known to be associated with several types of vasculitis, including pauci-immune crescentic glomerulonephritis, a form of rapid progressive glomerular nephritis (RPGN). ANCA vasculitis has also been reported after administration of propylthiouracil, hydralazine, cocaine (adulterated with levimasole), allopurinol, penicillamine and few other drugs. All previously reported cases of drug-associated ANCA glomerulonephritis were in native kidneys. Sofosbuvir is a new and effective drug for hepatitis C virus infection...
November 6, 2016: World Journal of Nephrology
https://www.readbyqxmd.com/read/27872683/safe-and-effective-sofosbuvir-based-therapy-in-patients-with-mental-health-disease-on-hepatitis-c-virus-treatment
#17
Lydia Shuk Yee Tang, Jack Masur, Zayani Sims, Amy Nelson, Anu Osinusi, Anita Kohli, Sarah Kattakuzhy, Michael Polis, Shyam Kottilil
AIM: To study impact of baseline mental health disease on hepatitis C virus (HCV) treatment; and Beck's Depression Inventory (BDI) changes with sofosbuvir- and interferon-based therapy. METHODS: This is a retrospective cohort study of participants from 5 studies enrolled from single center trials conducted at the Clinical Research Center of the National Institutes of Health, Bethesda, MD, United States. All participants were adults with chronic HCV genotype 1 infection and naïve to HCV therapy...
November 8, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/27869323/comparative-treatment-effectiveness-of-direct-acting-antiviral-regimens-for-hepatitis-c-data-from-the-veterans-administration
#18
D S Fox, J J McGinnis, I Tonnu-Mihara, J S McCombs
BACKGROUND AND AIMS: Data addressing real world effectiveness of direct acting antiviral agents in hepatitis C infected patients are now emerging. This study compared the sustained virologic response rates achieved 12 weeks post-treatment in patients treated with three such agents by the Veterans Health Administration. METHODS: A retrospective cohort study was conducted using patients who terminated treatment by July 1, 2015. Data were retrieved from the Veterans Health Administration electronic medical records system...
November 21, 2016: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27868140/psoriasis-as-a-manifestation-of-an-immune-reconstitution-in-two-patients-with-hepatitis-c-treated-with-ledipasvir-sofosbuvir
#19
Franz Heppt, Michael Sticherling
is missing (Short communication).
November 21, 2016: Acta Dermato-venereologica
https://www.readbyqxmd.com/read/27867976/sofosbuvir-and-velpatasvir-a-stellar-option-for-patients-with-decompensated-hepatitis-c-virus-hcv-cirrhosis
#20
EDITORIAL
Joel V Chua, Shyam Kottilil
No abstract text is available yet for this article.
October 2016: Annals of Translational Medicine
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