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https://www.readbyqxmd.com/read/29682307/bioequivalent-pharmacokinetics-for-generic-and-originator-hepatitis-c-direct-acting-antivirals
#1
EDITORIAL
Andrew Hill, Loai Tahat, Mohammed Khalil Mohammed, Rabab Fayez Tayyem, Giten Khwairakpam, Sanjay Nath, James Freeman, Ismahane Benbitour, Sherine Helmy
Mass production of low-cost, generic direct-acting antivirals (DAAs) will be required to achieve targets of eliminating hepatitis C (HCV) by 2030. The pharmaceutical companies Gilead and Bristol-Myers Squibb have granted voluntary licences (VLs) to generic companies to mass produce the DAAs sofosbuvir and daclatasvir at low cost. However, generic manufacturers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originator versions, to fulfil World Health Organization standards for prequalification...
April 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29681166/direct-acting-antivirals-to-prevent-vertical-transmission-of-viral-hepatitis-c-when-is-the-optimal-time-to-treat
#2
Leigh Cervino, Lauren M Hynicka
OBJECTIVE: To describe the most current evidence for the use of direct-acting antivirals (DAAs) to treat hepatitis C along the pregnancy-pediatric continuum in the United States. DATA SOURCES: The MEDLINE/PubMed databases were searched (January 1995 to February 2018) for articles in English using the terms: hepatitis C, vertical transmission, pregnancy, pediatrics, ribavirin, interferon, direct acting antivirals, daclatasvir, dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, simeprevir, sofosbuvir, and velpatasvir...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29679347/pre-emptive-treatment-of-hcv-after-living-donor-liver-transplantation-with-direct-acting-antiviral-agents
#3
Jinmin Jung, Jae Hyun Kwon, Gi-Won Song, Eun-Young Tak, Vavara A Kirchner, Sung-Gyu Lee
BACKGROUND: Hepatitis C virus (HCV) universally recurs after liver transplantation (LT). Although the introduction of direct-acting antiviral agents (DAAs) has revolutionized the treatment of HCV infection, no optimal treatment for HCV recurrence after LT has been developed. METHODS: This study retrospectively evaluated the efficacy of DAAs as a pre-emptive treatment for recurrent HCV infection after living donor liver transplantation (LDLT). From January 2010 to December 2016, 70 patients received pegylated interferon (PegIFN) and 35 patients were treated with DAA-based regimens to treat recurrent HCV after LDLT...
April 20, 2018: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
https://www.readbyqxmd.com/read/29676846/generic-sofosbuvir-based-direct-acting-antivirals-in-hepatitis-c-virus-infected-patients-with-chronic-kidney-disease
#4
Manoj Kumar Sharma, Suman Lata Nayak, Ekta Gupta, Ashish Kataria, Shiv K Sarin
BACKGROUND & AIMS: There is scant data on use of sofosbuvir containing directly acting anti-viral (DAA) regimens in chronic kidney disease (CKD) patients. Recently generic versions of DAAs have become available in low income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir, or daclatasvir in HCV infected patients with CKD including patients with advanced CKD (CKD stage 4 or 5 with an estimated glomerular filtration rate (GFR) <30 mL/min or those on dialysis)...
April 20, 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29663115/sofosbuvir-plus-daclatasvir-with-or-without-ribavirin-for-treatment-of-chronic-hcv-genotype-4-patients-real-life-experience
#5
G Shiha, R Soliman, M ElBasiony, A A Hassan, N N H Mikhail
INTRODUCTION: New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800-1000 mg) in treating chronic hepatitis C genotype 4 patients. METHODS: This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated...
April 16, 2018: Hepatology International
https://www.readbyqxmd.com/read/29661434/daclatasvir-and-sofosbuvir-with-or-without-ribavirin-in-liver-transplant-recipients-a-single-center-real-world-study
#6
M Mucenic, A Bandeira de Mello Brandao, C A Marroni, A Medeiros Fleck, M L Zanotelli, G Kiss, M H Meine, I Leipnitz, E Soares Schlindwein, J Martini, A M Costabeber, F K F Sacco, G P Cracco Cantisani
BACKGROUND: Treatment with direct-acting antiviral drugs in interferon-free regimens is currently recommended for viral hepatitis C recurrence after liver transplantation. There are limited data regarding its results in this population, and no optimal treatment scheme has yet been singled out. METHODS: We report our real-world results in liver transplant (LT) recipients. All patients were hepatitis C virus (HCV) monoinfected and completed a 12-week treatment course, followed 12 weeks later by HCV polymerase chain reaction testing with 12 IU/mL sensibility...
April 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29660665/investigation-of-anti-hepatitis-c-virus-sofosbuvir-and-daclatasvir-in-pure-form-human-plasma-and-human-urine-using-micellar-monolithic-hplc-uv-method-and-application-to-pharmacokinetic-study
#7
Dalia W Zidan, Wafaa S Hassan, Manal S Elmasry, Abdalla A Shalaby
Simultaneous determination of sofosbuvir (SOF), and daclatasvir (DAC) in their dosage forms, human urine and human plasma using simple and rapid micellar high performance liquid chromatographic method coupled with UV detection (HPLC-UV) had been developed and validated. These drugs are described as co-administered for treatment of Hepatitis C virus (HCV). HCV is the cause of Hepatitis C and some cancers such as liver cancer (hepatocellular carcinoma) and lymphomas in humans. Separation and quantitation were carried out on anonyx™ C8 monolithic (100 × 4...
April 7, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29628768/outcomes-and-predictors-of-treatment-response-with-sofosbuvir-plus-daclatasvir-with-or-without-ribavirin-in-egyptian-patients-with-genotype-4-hepatitis-c-virus-infection
#8
Ossama A Ahmed, Mohamed A Elsebaey, Mohamed Hassan A Fouad, Heba Elashry, Ahmed I Elshafie, Ahmed A Elhadidy, Noha E Esheba, Mohammed H Elnaggar, Shaimaa Soliman, Sherief Abd-Elsalam
Background and aims: Treatment of hepatitis C virus (HCV) changed dramatically with the introduction of oral direct-acting antiviral drugs due to their high antiviral potency and safety profile. Sofosbuvir plus daclatasvir combination therapy was extensively investigated in HCV genotypes 1, 2, and 3, while published data regarding its real-life application in the treatment of genotype 4 is lacking. Therefore, we conducted this study to assess the outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection...
2018: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29619415/daclatasvir-and-sofosbuvir-treatment-of-decompensated-liver-disease-or-post-liver-transplant-hepatitis-c-virus-recurrence-in-patients-with-advanced-liver-disease-cirrhosis-in-a-real-world-cohort
#9
Paul Kwo, Michael W Fried, K Rajender Reddy, Consuelo Soldevila-Pico, Saro Khemichian, Jama Darling, Phillippe J Zamor, Andrew A Napoli, Beatrice Anduze-Faris, Robert S Brown
We report the findings of an early access program providing treatment for chronic hepatitis C virus infection (any genotype) with daclatasvir and sofosbuvir with/without ribavirin to patients with Child-Pugh class C cirrhosis or prior liver transplant recipients with recurrent hepatitis C virus infection and advanced fibrosis/cirrhosis. Patients had <12-month life expectancies per the local investigator. Patients received daclatasvir 60 mg and sofosbuvir 400 mg once daily, with/without ribavirin, for 24 weeks...
April 2018: Hepatology Communications
https://www.readbyqxmd.com/read/29599611/daclatasvir-plus-asunaprevir-in-treatment-na%C3%A3-ve-patients-with-hepatitis-c-virus-genotype-1b-infection
#10
Lai Wei, Fu-Sheng Wang, Ming-Xiang Zhang, Ji-Dong Jia, Alexey A Yakovlev, Wen Xie, Eduard Burnevich, Jun-Qi Niu, Yong Jin Jung, Xiang-Jun Jiang, Min Xu, Xin-Yue Chen, Qing Xie, Jun Li, Jin-Lin Hou, Hong Tang, Xiao-Guang Dou, Yash Gandhi, Wen-Hua Hu, Fiona McPhee, Stephanie Noviello, Michelle Treitel, Ling Mo, Jun Deng
AIM: To assess daclatasvir plus asunaprevir (DUAL) in treatment-naïve patients from mainland China, Russia and South Korea with hepatitis C virus (HCV) genotype 1b infection. METHODS: Patients were randomly assigned (3:1) to receive 24 wk of treatment with DUAL (daclatasvir 60 mg once daily and asunaprevir 100 mg twice daily) beginning on day 1 of the treatment period (immediate treatment arm) or following 12 wk of matching placebo (placebo-deferred treatment arm)...
March 28, 2018: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/29599610/successful-combination-of-direct-antiviral-agents-in-liver-transplanted-patients-with-recurrent-hepatitis-c-virus
#11
Christian Rupp, Theresa Hippchen, Manuel Neuberger, Peter Sauer, Jan Pfeiffenberger, Wolfgang Stremmel, Daniel Nils Gotthardt, Arianeb Mehrabi, Karl-Heinz Weiss
AIM: To analyze the safety and efficiency of direct-acting antiviral (DAA) regimens in liver-transplanted patients with hepatitis C virus (HCV) reinfection. METHODS: Between January 2014 and December 2016, 39 patients with HCV reinfection after liver transplantation were treated at our tertiary referral center with sofosbuvir (SOF)-based regimens, including various combinations with interferon (IFN), daclatasvir (DAC), simeprivir (SIM) and/or ledipasvir (LDV). Thirteen patients were treated with SOF + IFN ± RBV...
March 28, 2018: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/29589331/population-pharmacokinetic-analysis-of-asunaprevir-in-subjects-with-hepatitis-c-virus-infection
#12
Li Zhu, Hanbin Li, Phyllis Chan, Timothy Eley, Yash Gandhi, Marc Bifano, Mayu Osawa, Takayo Ueno, Eric Hughes, Malaz AbuTarif, Richard Bertz, Tushar Garimella
INTRODUCTION: Asunaprevir (ASV) is a potent, pangenotypic, twice-daily hepatitis C virus (HCV) NS3 inhibitor indicated for the treatment of chronic HCV infection. METHODS: A population pharmacokinetic (PPK) model was developed using pooled ASV concentration data from 1239 HCV-infected subjects who received ASV either as part of the DUAL regimen with daclatasvir or as part of the QUAD regimen with daclatasvir and peg-interferon/ribavirin. RESULTS: A two-compartment model with first-order elimination from the central compartment, an induction effect on clearance, and an absorption model consisted of zero-order release followed by first-order absorption adequately described ASV PK after oral administration...
March 27, 2018: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/29582685/-real-life-experience-with-direct-acting-antiviral-agents-for-hepatitis-c-virus-in-end-stage-renal-disease
#13
Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi
BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' group of patients with end-stage renal disease. METHODS: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29579872/therapy-with-direct-acting-antiviral-agents-for-hepatitis-c-in-liver-transplant-recipients
#14
F Nogueras López, A López Garrido, E J Ortega Suazo, F Vadillo Calles, F Valverde López, M D Espinosa Aguilar
BACKGROUND: Recurrent infection with the hepatitis C virus (HCV) after liver transplantation (LT) is associated with decreased graft and patient survival. Direct-acting antiviral (DAA) therapies have changed the landscape of HCV due to their excellent safety profile and cure rates. Our aim was to evaluate the efficacy and tolerability of antiviral therapy in recurrent HCV after LT with DAA therapy. METHODS: Our retrospective analysis included 46 LT recipients with HCV recurrence...
March 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29570560/dual-sofosbuvir-daclatasvir-therapy-in-adolescent-patients-with-chronic-hepatitis-c-infection
#15
Mostafa Yakoot, Mortada H El-Shabrawi, Manal M AbdElgawad, Aml A Mahfouz, Sherine Helmy, Alaa M Abdo, Hisham R El-Khayat
OBJECTIVES: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by The European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus infection (HCV) in adults for all genotypes; however it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection. METHODS: We conducted a prospective, uncontrolled, open-label multicenter study...
March 22, 2018: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29551607/anti-e1e2-antibodies-status-prior-therapy-favors-direct-acting-antiviral-treatment-efficacy
#16
Victor Virlogeux, Pascale Berthillon, Isabelle Bordes, Sylvie Larrat, Stéphanie Crouy, Caroline Scholtès, Pierre Pradat, Marianne Maynard, Fabien Zoulim, Vincent Leroy, Isabelle Chemin, Christian Trépo, Marie-Anne Petit
INTRODUCTION: Presence of anti-E1E2 antibodies was previously associated with spontaneous cure of hepatitis C virus (HCV) and predictive before treatment of a sustained virological response (SVR) to bi- or tri-therapy in naïve or experienced patients, regardless of HCV genotype. We investigated the impact of anti-E1E2 seroprevalence at baseline on treatment response in patients receiving direct-acting antiviral (DAA) therapy. MATERIAL AND METHODS: We screened anti-E1E2 antibodies by ELISA in serum samples collected at treatment initiation for two groups of patients: 59 with SVR at the end of DAA treatment and 44 relapsers after DAA treatment...
March 15, 2018: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/29549787/identification-of-nucleotides-in-the-5-utr-and-amino-acids-substitutions-that-are-essential-for-the-infectivity-of-5-utr-ns5a-recombinant-of-hepatitis-c-virus-genotype-1b-strain-con1
#17
Jinqian Li, Shengjun Feng, Xi Liu, Mingzhe Guo, Mingxiao Chen, Yiyi Chen, Liang Rong, Jinyu Xia, Yuanping Zhou, Jin Zhong, Yi-Ping Li
Genotype 1b strain Con1 represents an important reference in the study of hepatitis C virus (HCV). Here, we aimed to develop an advanced infectious Con1 recombinant. We found that previously identified mutations A1226G/F1464L/A1672S/Q1773H permitted culture adaption of Con1 Core-NS5A (C-5A) recombinant containing 5'UTR and NS5B-3'UTR from JFH1 (genotype 2a), thus acquired additional mutations L725H/F886L/D2415G. C-5A containing all seven mutations (C-5A_7m) replicated efficiently in Huh7.5 and Huh7.5.1 cells and had an increased infectivity in SEC14L2-expressing Huh7...
March 14, 2018: Virology
https://www.readbyqxmd.com/read/29526955/improvement-of-proteinuria-due-to-combination-therapy-with-daclatasvir-and-asunaprevir-in-hepatitis-c-virus-associated-renal-disease-without-cryoglobulinemia-a-case-report
#18
Satoshi Takakusagi, Ken Sato, Yuhei Suzuki, Yuichi Yamazaki, Takashi Kosone, Satoru Kakizaki, Motoyasu Kusano, Hitoshi Takagi
We herein report a unique case of hepatitis C virus (HCV)-associated renal disease without cryoglobulinemia that showed proteinuria, hypoproteinemia, ascites, and edema. Due to combination therapy with daclatasvir and asunaprevir, the patient achieved sustained virological response at week 24 of the therapy. Furthermore, the therapy caused marked amelioration of her proteinuria, ascites, edema, and hypoalbuminemia, and finally improved her estimated glomerular filtration rate. There were no adverse events, and the combination therapy was well-tolerated...
March 9, 2018: Internal Medicine
https://www.readbyqxmd.com/read/29526929/chronic-hepatitis-c-treatment-with-daclatasvir-plus-asunaprevir-does-not-lead-to-a-decreased-quality-of-life
#19
Megumi Kawakubo, Yuichiro Eguchi, Michiaki Okada, Shinji Iwane, Satoshi Oeda, Taiga Otsuka, Syunya Nakashita, Norimasa Araki, Akemi Koga
Objective The aim of this study was to determine if direct-acting antiviral (DAA) treatment with daclatasvir (DCV) plus asunaprevir (ASV) for 24 weeks influenced the health-related quality of life (HRQOL) at 12 and 24 weeks after treatment initiation (end of treatment [EOT]). Methods This was a prospective, longitudinal study comparing the HRQOL of patients receiving DAA treatment at 12 weeks after treatment initiation and EOT with the HRQOL at baseline. We used a Japanese-validated version of the 8-item Short Form Health Survey (SF-8) to assess the HRQOL of patients...
March 9, 2018: Internal Medicine
https://www.readbyqxmd.com/read/29511552/optimization-of-direct-anti-viral-agent-treatment-schedule-focus-on-hcv-genotype-3
#20
Filomena Morisco, Rocco Granata, Silvia Camera, Antonio Ippolito, Michele Milella, Fabio Conti, Chiara Masetti, Antonella Smedile, Paolo Tundo, Teresa Santantonio, Maria Rosa Valvano, Antonio Termite, Pietro Gatti, Vincenzo Messina, Angelo Iacobellis, Marta Librandi, Nicola Caporaso, Angelo Andriulli
Background and aim: Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option. Methods: Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs...
March 2018: United European Gastroenterology Journal
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