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https://www.readbyqxmd.com/read/28990339/the-antiviral-effects-of-rsv-fusion-inhibitor-mdt-637-on-clinical-isolates-versus-its-achievable-concentrations-in-the-human-respiratory-tract-and-comparison-to-ribavirin
#1
Young-In Kim, Rajat Pareek, Ryan Murphy, Lisa Harrison, Eric Farrell, Robert Cook, John DeVincenzo
BACKGROUND: RSV viral load and disease severity associate, and the timing of viral load and disease run in parallel. An antiviral must be broadly effective against the natural spectrum of RSV genotypes and must attain concentrations capable of inhibiting viral replication within the human respiratory tract. OBJECTIVES: We evaluated a novel RSV fusion inhibitor, MDT-637, and compared it with ribavirin for therapeutic effect in vitro to identify relative therapeutic doses achievable in humans...
October 9, 2017: Influenza and Other Respiratory Viruses
https://www.readbyqxmd.com/read/28986139/restrictions-for-reimbursement-of-interferon-free-direct-acting-antiviral-drugs-for-hcv-infection-in-europe
#2
Alison D Marshall, Evan B Cunningham, Stine Nielsen, Alessio Aghemo, Hannu Alho, Markus Backmund, Philip Bruggmann, Olav Dalgard, Carole Seguin-Devaux, Robert Flisiak, Graham R Foster, Liana Gheorghe, David Goldberg, Ioannis Goulis, Matthew Hickman, Patrick Hoffmann, Ligita Jancorienė, Peter Jarcuska, Martin Kåberg, Leondios G Kostrikis, Mihály Makara, Matti Maimets, Rui Tato Marinho, Mojca Matičič, Suzanne Norris, Sigurður Ólafsson, Anne Øvrehus, Jean-Michel Pawlotsky, James Pocock, Geert Robaeys, Carlos Roncero, Marieta Simonova, Jan Sperl, Michele Tait, Ieva Tolmane, Stefan Tomaselli, Marc van der Valk, Adriana Vince, Gregory J Dore, Jeffrey V Lazarus, Jason Grebely
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions...
October 3, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28964443/cost-utility-of-elbasvir-grazoprevir-in-patients-with-chronic-hepatitis-c-genotype-1-infection
#3
COMPARATIVE STUDY
Shelby Corman, Elamin H Elbasha, Steven N Michalopoulos, Chizoba Nwankwo
OBJECTIVE: To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection. METHODS: A Markov cohort state-transition model was constructed to evaluate the cost-utility of EBR/GZR ± RBV over a lifetime time horizon from the payer perspective...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28963790/phase-i-study-of-induction-chemotherapy-with-afatinib-ribavirin-and-weekly-carboplatin-and-paclitaxel-for-stage-iva-ivb-human-papillomavirus-associated-oropharyngeal-squamous-cell-cancer
#4
Lara A Dunn, Matthew G Fury, Eric J Sherman, Alan A Ho, Nora Katabi, Sofia S Haque, David G Pfister
BACKGROUND: The human papillomavirus (HPV) E6 oncoprotein enhances the oncogenic potential of ErbB proteins in HPV-related malignancies. This phase I study evaluates the addition of afatinib, an ErbB family inhibitor, and ribavirin to paclitaxel and carboplatin induction chemotherapy in HPV-associated, locally advanced oropharyngeal squamous cell carcinoma (SCC). METHODS: This dose escalation study included 2 doses of oral afatinib: 30 and 40 mg daily. Ribavirin dosing was weight based...
September 30, 2017: Head & Neck
https://www.readbyqxmd.com/read/28961921/optimal-cure-rate-by-personalized-hcv-regimens-in-real-life-a-proof-of-concept-study
#5
Valeria Cento, Marianna Aragri, Elisabetta Teti, Ennio Polilli, Ada Bertoli, Luca Foroghi, Silvia Barbaliscia, Velia Chiara Di Maio, Alessandro Pieri, Valeria Pace Palitti, Loredana Sarmati, Giustino Parruti, Massimo Andreoni, Carlo Federico Perno, Francesca Ceccherini-Silberstein
Background: Pretreatment evaluation of HCV-infected patients is a complex interplay between multiple clinical and viral parameters, leading to a tailored approach that may bring real-life sustained virological response (SVR) rates close to 98%-99%. Objectives: As proof-of-concept, we evaluated the efficacy of all-oral direct-acting antiviral (DAA) regimens in patients whose personalization included pre-therapy evaluation of natural resistance-associated substitutions (RASs), in addition to international guideline recommendations...
September 18, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28958678/oseltamivir-amantadine-and-ribavirin-combination-antiviral-therapy-versus-oseltamivir-monotherapy-for-the-treatment-of-influenza-a-multicentre-double-blind-randomised-phase-2-trial
#6
John H Beigel, Yajing Bao, Joy Beeler, Weerawat Manosuthi, Alex Slandzicki, Sadia M Dar, John Panuto, Richard L Beasley, Santiago Perez-Patrigeon, Gompol Suwanpimolkul, Marcelo H Losso, Natalie McClure, Dawn R Bozzolo, Christopher Myers, H Preston Holley, Justin Hoopes, H Clifford Lane, Michael D Hughes, Richard T Davey
BACKGROUND: Influenza continues to have a substantial socioeconomic and health impact despite a long established vaccination programme and approved antivirals. Preclinical data suggest that combining antivirals might be more effective than administering oseltamivir alone in the treatment of influenza. METHODS: We did a randomised, double-blind, multicentre phase 2 trial of a combination of oseltamivir, amantadine, and ribavirin versus oseltamivir monotherapy with matching placebo for the treatment of influenza in 50 sites, consisting of academic medical centre clinics, emergency rooms, and private physician offices in the USA, Thailand, Mexico, Argentina, and Australia...
September 22, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28947525/successful-treatment-of-chronic-hepatitis-c-virus-infection-in-a-patient-receiving-daily-peritoneal-dialysis
#7
Jennifer E Stark, Jennifer Cole
PURPOSE: Successful use of a 4-drug oral fixed-dose combination therapy to treat chronic hepatitis C in a patient receiving peritoneal dialysis (PD) is reported. SUMMARY: New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited. A 73-year-old black man with chronic HCV genotype 1a infection and stage 5 chronic renal disease requiring daily automated PD was referred for HCV treatment prior to renal transplantation...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28947524/elbasvir-grazoprevir-a-new-direct-acting-antiviral-combination-for-hepatitis-c
#8
REVIEW
Lamis R Karaoui, Hanine Mansour, Elias B Chahine
PURPOSE: The chemistry, pharmacology, pharmacodynamics, pharmacokinetics, efficacy, safety, dosage, administration, and role of elbasvir-grazoprevir in the treatment of hepatitis C virus (HCV) infection are reviewed. SUMMARY: Elbasvir-grazoprevir was recently approved by the Food and Drug Administration for the treatment of chronic HCV genotype 1 or 4 infections with or without ribavirin in patients with or without compensated cirrhosis. Elbasvir exhibits antiviral activity against HCV genotypes 1a, 1b, 2a, 3a, and 4a...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28927676/a-pilot-study-to-expand-treatment-of-chronic-hepatitis-c-in-resource-limited-settings
#9
REVIEW
Poonam Mathur, Emily Comstock, Edward McSweegan, Natalia Mercer, Nongthombam Suraj Kumar, Shyamasundaran Kottilil
The past five years have seen a revolution in the treatment of chronic hepatitis C, as short duration oral regimens of direct-acting antiviral drugs (DAAs), with nearly 100% cure rates for all genotypes, have replaced longer courses of ribavirin and injected interferon. Although initially very expensive, these DAAs are now becoming available in generic equivalents in countries with large numbers of chronically infected people, such as India. However, a number of obstacles may hinder the delivery of these drugs in resource-limited settings, including lack of access to diagnostic testing and the restriction of treatment to a small number of medical specialists...
September 18, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28877086/short-article-retreatment-of-chronic-hepatitis-c-virus-infection-after-unsuccessful-therapy-with-all-oral-direct-acting-antiviral-regimens-a-real-life-experience
#10
Laura Milazzo, Carlo Magni, Fosca Niero, Monica Schiavini, Alessia Lai, Valeria Cento, Francesca Binda, Spinello Antinori, Salvatore Sollima
OBJECTIVE: Few real-life data are available on the retreatment of patients who failed direct-acting antiviral (DAA)-regimens. We reported the outcome of retreatment with approved DAA regimens in a real-life cohort of patients who previously failed an all-oral DAAs combination and we analyzed the association with resistance substitutions (RASs) performed at the time of virological failure. AIM AND METHODS: Next-generation sequencing of the NS3, NS5A, and NS5B regions was performed by Illumina deep sequencing...
November 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28867970/occurrence-and-recurrence-of-hepatocellular-carcinoma-after-successful-direct-acting-antiviral-therapy-for-patients-with-chronic-hepatitis-c-virus-infection
#11
Sirisha Grandhe, Catherine T Frenette
Chronic hepatitis C virus (HCV) infection has generally been associated with a slightly increased risk of developing hepatocellular carcinoma (HCC). For the past several decades, most patients with chronic HCV cirrhosis have been treated with pegylated interferon and ribavirin therapies, which were known to achieve sustained virologic response (SVR) but also carried their own side effects and toxicities. The recent implementation of direct-acting antiviral (DAA) treatments revealed an increased efficacy in difficult-to-treat populations and higher adherence rates given the all-oral nature of the regimens...
July 2017: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28865152/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-japanese-patients-with-chronic-genotype-2-hepatitis-c-virus-infection
#12
Hidenori Toyoda, Kazuaki Chayama, Fumitaka Suzuki, Ken Sato, Tomofumi Atarashi, Tsunamasa Watanabe, Masanori Atsukawa, Atsushi Naganuma, Kazuo Notsumata, Yukio Osaki, Makoto Nakamuta, Koichi Takaguchi, Satoru Saito, Koji Kato, David Pugatch, Margaret Burroughs, Rebecca Redman, Katia Alves, Tami J Pilot-Matias, Rajneet K Oberoi, Bo Fu, Hiromitsu Kumada
Glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P), a coformulated once-daily, all oral, ribavirin (RBV)-free, direct-acting anti-viral (DAA) regimen was evaluated for safety and efficacy in Hepatitis C Virus GT2-infected Japanese patients, including those with compensated cirrhosis. CERTAIN-2 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120mg) once daily (QD) in treatment-naïve and interferon (IFN) ± RBV treatment-experienced non-cirrhotic Japanese patients with GT2 infection...
September 2, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28860025/hepatitis-e-virus-induced-primary-cutaneous-cd30-t-cell-lymphoproliferative-disorder
#13
Vincent Mallet, Julie Bruneau, Julien Zuber, Cécile Alanio, Stéphanie Leclerc-Mercier, Anne-Marie Roque-Afonso, Anke R M Kraft, Lucile Couronné, Dominique Roulot, Heiner Wedemeyer, Matthew L Albert, Patrick Hillon, Liliane Laroche, Stanislas Pol, Olivier Hermine
BACKGROUND AND AIM: Several types of unexplained extra-hepatic manifestations, including haematological disorders, have been reported in the context of hepatitis E virus (HEV) infection. However, the underlying mechanism(s) of these manifestations are unknown. We provide evidence that HEV has an extra-hepatic endothelial tropism that can engage cutaneous T cells towards clonality. PATIENT AND METHODS: A patient with a CD30(+) cutaneous T cell lymphoproliferative disorder (T-LPD) and biopsy-proven chronic HEV infection received 3 rounds of oral ribavirin treatment administered either without or with interferon and eventually achieved a sustained virological response (SVR)...
August 28, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28833855/efficacy-of-vitamin-d-supplementation-in-combination-with-conventional-antiviral-therapy-in-patients-with-chronic-hepatitis-c-infection-a-meta-analysis-of-randomised-controlled-trials
#14
H-B Kim, S-K Myung, Y-J Lee, B-J Park
BACKGROUND: Although a contributory role of vitamin D levels for the development of chronic hepatitis C has been suggested, the efficacy of vitamin D supplementation in combination with conventional antiviral therapy consisting of pegylated interferon-α (Peg-IFN-α) injection and oral ribavirin (RBV) remains unclear. We investigated its efficacy in the treatment of chronic hepatitis C via a meta-analysis of randomised controlled trials. METHODS: We searched PubMed, EMBASE, the Cochrane Library, ClinicalTrials...
August 18, 2017: Journal of Human Nutrition and Dietetics: the Official Journal of the British Dietetic Association
https://www.readbyqxmd.com/read/28818546/glecaprevir-plus-pibrentasvir-for-chronic-hepatitis-c-virus-genotype-1-2-4-5-or-6-infection-in-adults-with-compensated-cirrhosis-expedition-1-a-single-arm-open-label-multicentre-phase-3-trial
#15
MULTICENTER STUDY
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
BACKGROUND: The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. METHODS: We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA...
October 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28804248/effect-of-chronic-hepatitis-c-virus-treatment-by-combination-therapy-on-cardiovascular-system
#16
Reda Biomy, Mohamed Abdelshafy, Ahmed Abdelmonem, Hesham Abu-Elenin, George Ghaly
BACKGROUND: The prevalence of hepatitis C virus (HCV) in Egypt is quite high, and the combined oral direct-acting antiviral agents (DAAs) may have impressive results. OBJECTIVE: To assess the cardiovascular effects of DAAs in patients with HCV. METHODS: A total of 170 patients with HCV were divided into 2 groups: first group (100 patients) received triple combination therapy (pegylated interferon alfa, sofosbuvir, and ribavirin, whereas the second group (70 patients) received dual combination therapy (sofosbuvir and simeprevir)...
2017: Clinical Medicine Insights. Cardiology
https://www.readbyqxmd.com/read/28777714/serious-adverse-events-with-sofosbuvir-combined-with-interferon-and-ribavirin-real-life-egyptian-experience
#17
Tamer Elbaz, Magdy Elserafy, Wafaa Elakel, Mohammad A Mohey, Mahmoud Abdo, Mohamed Hassany, Mai Mehrez, Mahmoud Abouelkhair, Ayman Yosry, Ashraf Omar, Imam Waked, Manal Hamdy Elsayed, Zakaria Mahran, Yahia Elshazly, Noman Elgarem, Aly Gaballa, Wahid Doss, Gamal Esmat
Viral hepatitis is a serious problem worldwide that was under-recognized till recently. The prevalence of chronic hepatitis C virus (HCV) is estimated to be 180 million people worldwide. Treatment of chronic HCV using combined pegylated interferon and ribavirin (PEG/RIBA) has long been the standard of care with modest response. In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment...
August 2017: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/28708211/direct-acting-antivirals-for-hepatitis-c-virus-in-patients-on-maintenance-dialysis
#18
Fabrizio Fabrizi, Francesca M Donato, Piergiorgio Messa
The frequency of hepatitis C virus (HCV) infection remains high in patients with chronic kidney disease (CKD) and plays a detrimental role in mortality in this population. According to the latest survey, the adjusted hazard ratio for HCV-positive versus HCV-negative patients on long-term dialysis was 1.12 (95% CI, 1.05 to 1.20) and 1.10 (95% CI, 0.98 to 1.22) for all-cause and cardiovascular mortality, respectively. An impairment on quality of life has also been documented in HCV-infected patients undergoing regular dialysis...
July 8, 2017: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/28688129/grazoprevir-ruzasvir-and-uprifosbuvir-for-hcv-after-ns5a-treatment-failure
#19
David Wyles, Heiner Wedemeyer, Ziv Ben-Ari, Edward J Gane, Jesper Bach Hansen, Ira M Jacobson, Alex L Laursen, Annie Luetkemeyer, Ronald Nahass, Stephen Pianko, Stefan Zeuzem, Patricia Jumes, Hsueh-Cheng Huang, Joan Butterton, Michael Robertson, Janice Wahl, Eliav Barr, Hee-Koung Joeng, Elizabeth Martin, Lawrence Serfaty
People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks...
July 7, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#20
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r±DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r±ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r+DSV±RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 21, 2017: Journal of Hepatology
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