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https://www.readbyqxmd.com/read/29446138/editorial-sofosbuvir-plus-daclatasvir-for-the-treatment-of-hepatitis-c-can-one-size-fit-all
#1
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
#2
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/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
#3
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
#4
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
#5
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/29427481/treatment-of-hepatitis-c-results-in-real-life
#6
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/29425396/resistance-analysis-of-genotype-3-hcv-indicates-subtypes-inherently-resistant-to-ns5a-inhibitors
#7
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/29417464/cost-effectiveness-of-daclatasvir-plus-asunaprevir-therapy-for-chinese-patients-with-chronic-hepatitis-c-virus-genotype-1b
#8
Yuchen Liu, Zhenhua Wang, Ruoyan Gai Tobe, Houwen Lin, Bin Wu
BACKGROUND AND OBJECTIVES: Daclatasvir plus asunaprevir has shown superior efficacy and safety for treating hepatitis C virus genotype 1b infection in comparison with pegylated interferon and ribavirin. The objective of this analysis is to investigate the cost effectiveness of daclatasvir plus asunaprevir compared with interferon-α-based therapies from the perspective of the Chinese healthcare system. METHODS: A Markov model was established to measure economic and health outcomes of daclatasvir plus asunaprevir compared with general interferon-α plus ribavirin and pegylated interferon plus ribavirin for hepatitis C virus genotype 1b infection...
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
#9
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
https://www.readbyqxmd.com/read/29409309/daclatasvir-plus-asunaprevir-for-the-treatment-of-patients-with-hepatitis-c-virus-genotype-1b-infection-real-world-efficacy-changes-in-liver-stiffness-and-fibrosis-markers-and-safety
#10
Hye Won Lee, Se Rim Oh, Dong Yun Kim, Yechan Jeong, Seungtaek Kim, Beom Kyung Kim, Seung Up Kim, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Jun Yong Park
Background/Aims: The treatment with daclatasvir plus asunaprevir (DCV+ASV) is associated with potent antiviral effects in patients with genotype 1b hepatitis C virus (HCV) infection. We investigated the real-world efficacy, changes in liver stiffness and noninvasive fibrosis markers, and the safety of DCV+ASV treatment in Korean patients. Methods: In total, 363 patients with chronic hepatitis C were treated with DCV+ASV between August 2015 and January 2017. Finally, we analyzed the data of 270 patients who were monitored for at least 12 weeks after the end of treatment...
February 8, 2018: Gut and Liver
https://www.readbyqxmd.com/read/29399282/efficacy-of-direct-acting-antiviral-treatment-for-chronic-hepatitis-c-a-single-hospital-experience
#11
Rena Kaneko, Natsuko Nakazaki, Risa Omori, Yuichiro Yano, Masazumi Ogawa, Yuzuru Sato
AIM: To evaluate the efficacy of direct-acting antivirals (DAAs) in Kanto Rosai Hospital. METHODS: All patients with hepatitis C virus (HCV) who underwent DAA prescription were enrolled in this study. The present study was a single center retrospective analysis using patients infected with HCV genotype 1 or 2. Resistance analysis was performed by using direct sequencing and cycleave PCR in genotype 1 patients treated with interferon (IFN)-free DAA. The primary endpoint was sustained virologic response at 12 wk after therapy (SVR12)...
January 27, 2018: World Journal of Hepatology
https://www.readbyqxmd.com/read/29399105/health-related-quality-of-life-on-the-clinical-course-of-patients-with-chronic-hepatitis-c-receiving-daclatasvir-asunaprevir-therapy-a-prospective-observational-study-comparing-younger-70-and-elderly-%C3%A2-70-patients
#12
Kazuki Ohashi, Toru Ishikawa, Mitsuyuki Suzuki, Hiroko Abe, Fujiko Koyama, Tomomi Nakano, Aya Ueki, Hirohito Noguchi, Erina Hasegawa, Shiori Hirosawa, Miki Kobayashi, Hiroshi Hirosawa, Kaede Sato, Takako Fukazawa, Yuka Maruyama, Toshiaki Yoshida
Interferon-free direct acting antiviral agent regimens for chronic hepatitis C (CHC) have been developed. These regimens have shown a high rate of sustained virologic response (SVR), and a reduction in side effects during treatment is also anticipated. However, the impact of the regimens on health-related quality of life (HRQOL) and side effects during treatment is not fully understood. The purpose of the present study was to evaluate HRQOL in the clinical course of patients with CHC receiving daclatasvir/asunaprevir (DCV/ASV) therapy using the Short Form-36 (SF-36) method...
January 2018: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/29396744/economic-evaluation-of-direct-acting-antivirals-for-hepatitis-c-in-norway
#13
Torbjørn Wisløff, Richard White, Olav Dalgard, Ellen J Amundsen, Hinta Meijerink, Astrid Louise Løvlie, Hilde Kløvstad
PURPOSE: New direct-acting antiviral (DAA) drugs have revolutionized the treatment of hepatitis C in recent years. OBJECTIVE: Our objective was to analyse the cost effectiveness of combinations of different DAAs compared with ribavirin and peginterferon-α-2a, taking into account rebates from tender negotiations. METHODS: We used a compartmental model specifically developed for Norway to simulate hepatitis C and complications with and without different DAAs...
February 2, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/29377464/efficacy-of-generic-oral-directly-acting-agents-in-patients-with-hepatitis-c-virus-infection
#14
Swatantra Gupta, Gyanranjan Rout, Arpan H Patel, Mousumi Mahanta, Nancy Kalra, Pabitra Sahu, Rahul Sethia, Ashish Agarwal, Gyan Ranjan, Saurabh Kedia, Subrat Kumar Acharya, Baibaswata Nayak, Shalimar
Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented...
January 28, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29377274/all-oral-daa-therapy-against-hcv-in-hiv-hcv-coinfected-subjects-in-real-world-practice-madrid-core-findings
#15
Juan Berenguer, Ángela Gil-Martin, Inmaculada Jarrin, Ana Moreno, Lourdes Dominguez, Marisa Montes, Teresa Aldámiz-Echevarría, María J Téllez, Ignacio Santos, Laura Benitez, José Sanz, Pablo Ryan, Gabriel Gaspar, Beatriz Alvarez, Juan E Losa, Rafael Torres-Perea, Carlos Barros, Juan V San Martin, Sari Arponen, María Teresa de Guzmán, Raquel Monsalvo, Ana Vegas, María T Garcia-Benayas, Regino Serrano, Luis Gotuzzo, María Antonia Menendez, Luis M Belda, Eduardo Malmierca, María J Calvo, Encarnación Cruz-Martos, Juan J González-García
We evaluated treatment outcomes in a prospective registry of HIV/HCV-coinfected patients treated with interferon-free direct-acting antiviral agent (DAA)-based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response (SVR) at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% were non-cirrhotic (Non-C), 33.9% had compensated cirrhosis (Co-C), and 6...
January 29, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29376623/interferon-free-treatments-in-patients-with-hepatitis-c-genotype-3-infection-in-a-tertiary-hospital
#16
J C Del Rio-Valencia, R Asensi-Diez, R Madera-Pajin, L Yunquera-Romero, I Muñoz-Castillo
OBJECTIVE: Hepatitis C virus genotype 3 represents a unique entity within HCV treatment and multiple studies have documented that HCV genotype 3 infection is associated with more rapid disease progression than other genotypes, resulting in increased risk of cirrhosis, hepatocellular carcinoma, and all-cause mortality. In the current study, we further evaluated the real-world effectiveness of 12 weeks of ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV) and sofosbuvir + daclatasvir (SOF + DCV) for treatment-naive or treatment-experienced patients infected with HCV genotype 3, with or without cirrhosis...
January 29, 2018: Revista Española de Quimioterapia: Publicación Oficial de la Sociedad Española de Quimioterapia
https://www.readbyqxmd.com/read/29365309/glecaprevir-pibrentasvir-for-8-or-12-weeks-in-hcv-genotype-1-or-3-infection
#17
RANDOMIZED CONTROLLED TRIAL
Stefan Zeuzem, Graham R Foster, Stanley Wang, Armen Asatryan, Edward Gane, Jordan J Feld, Tarik Asselah, Marc Bourlière, Peter J Ruane, Heiner Wedemeyer, Stanislas Pol, Robert Flisiak, Fred Poordad, Wan-Long Chuang, Catherine A Stedman, Steven Flamm, Paul Kwo, Gregory J Dore, Gladys Sepulveda-Arzola, Stuart K Roberts, Ruth Soto-Malave, Kelly Kaita, Massimo Puoti, John Vierling, Edward Tam, Hugo E Vargas, Rafi Bruck, Francisco Fuster, Seung-Woon Paik, Franco Felizarta, Jens Kort, Bo Fu, Ran Liu, Teresa I Ng, Tami Pilot-Matias, Chih-Wei Lin, Roger Trinh, Federico J Mensa
BACKGROUND: Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection. METHODS: We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks...
January 25, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29356573/spur-of-the-moment-modification-in-national-treatment-policies-leads-to-a-surprising-hcv-viral-suppression-in-all-treated-patients-real-life-egyptian-experience
#18
Mohamed El Kassas, Dalia Omran, Kadry Elsaeed, Mohamed Alboraie, Wafaa Elakel, Adel El Tahan, Yasmeen Abd El Latif, Mohamed Mahmoud Nabeel, Mohamed Korany, Sameera Ezzat, Magdy El-Serafy, Yehia ElShazly, Wahid Doss, Gamal Esmat
The aim of this study was to retrospectively analyze the outcome of an unscheduled change in national Egyptian policies for the treatment of hepatitis C virus (HCV), which was transpired as a result of a reduction in interferon supplies, and to manage patients who already started interferon-based therapy. After completing a priming 4-weeks course of sofosbuvir/pegylated interferon/ribavirin (SOF/PEG IFN/RBV), a 12-weeks course of sofosbuvir/daclatasvir (SOF/DCV) combination was initiated. We evaluated the sustained virologic response at 12 weeks posttreatment (SVR12) for 2 groups of patients; Group 1, which included patients who had the previous regimen with IFN priming, and group 2, which included the first consecutive group of patients who received SOF/DCV for 12 weeks from the start without IFN priming...
January 22, 2018: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/29353349/daclatasvir-a-review-of-preclinical-and-clinical-pharmacokinetics
#19
REVIEW
Yash Gandhi, Timothy Eley, Aberra Fura, Wenying Li, Richard J Bertz, Tushar Garimella
Daclatasvir is a first-in-class, highly selective, hepatitis C virus, non-structural protein 5a polymerase replication complex inhibitor with picomolar potency and broad genotypic coverage in vitro. Daclatasvir undergoes rapid absorption, with a time to reach maximum plasma concentration of 1-2 h and an elimination half-life of ~ 10 to 14 h observed in single-ascending dose studies. Steady state was achieved by day 4 in multiple-ascending dose studies. Daclatasvir can be administered without regard to food or pH modifiers...
January 20, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29350402/effectiveness-and-safety-of-original-and-generic-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c-a-real-world-study
#20
Sebastián Marciano, Leila Haddad, María Virginia Reggiardo, Mirta Peralta, Cecilia Vistarini, Mónica Marino, Valeria Inés Descalzi, Claudia D'Amico, Sebastián Figueroa Escuti, Luis Alejandro Gaite, Roberto Pérez Ravier, Cristina Longo, Silvia Mabel Borzi, Omar Andrés Galdame, Fernando Bessone, Hugo Alberto Fainboim, Silvia Frías, Mariano Cartier, Adrián Carlos Gadano
We report the first real-world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir-based regimens in patients with chronic hepatitis C in Latin America. The main endpoints were assessment of sustained virological response and serious adverse events rates. A total of 321 patients with chronic hepatitis C treated with the following regimens were included: sofosbuvir plus daclatasvir for 12 (n = 34) or 24 (n = 135) weeks, sofosbuvir plus daclatasvir plus ribavirin for 12 (n = 84) or 24 (n = 56) weeks, or sofosbuvir plus ribavirin for 12 (n = 8) or 24 (n = 2) weeks...
January 19, 2018: Journal of Medical Virology
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