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https://www.readbyqxmd.com/read/29028125/ledipasvir-and-tenofovir-drug-interaction-in-hiv-hcv-co-infected-patients-impact-on-tenofovir-ctrough-and-renal-safety
#1
Caroline Solas, Sylvie Bregigeon, Olivia Faucher-Zaegel, Sylvie Quaranta, Véronique Obry-Roguet, Catherine Tamalet, Bruno Lacarelle, Isabelle Poizot-Martin
We evaluate the impact of ledipasvir on both tenofovir plasma trough concentration (Ctrough ) and estimated glomerular renal function (eGFR) in HIV-HCV co-infected patients receiving a tenofovir(TDF)-based antiretroviral regimen and treated with ledipasvir/sofosbuvir. Twenty-six patients [81% male, median age: 51years; HCV genotype 1(75%)/4(15%)] were included. Tenofovir Ctrough (interquartile:IQR) increased from 78ng/mL (53-110) at baseline to 141ng/mL (72-176) at M1 (p=0.003). No significant difference on eGFR using both Cockroft-Gault and MDRD formula, respectively [median(IQR)] was observed between baseline [101...
October 13, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29020359/sofosbuvir-based-interferon-free-direct-acting-antiviral-regimens-for-heart-transplant-recipients-with-chronic-hepatitis-c-virus-infection
#2
Chen-Hua Liu, Yih-Sharng Chen, Sheoi-Shen Wang, Chun-Jen Liu, Tung-Hung Su, Hung-Chih Yang, Chun-Ming Hong, Pei-Jer Chen, Ding-Shinn Chen, Jia-Horng Kao
We assessed the effectiveness and safety of sofosbuvir (SOF) combined with ledipasvir (LDV) or daclatasvir (DCV) in 12 heart transplant recipients with chronic hepatitis C virus (HCV). The sustained virologic response (SVR12) rate was 100% [95% CI: 75.8%-100%]. All patients tolerated treatment well without interruption, death or serious adverse events.
September 4, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28984067/resistance-characterization-of-ledipasvir-and-velpatasvir-in-hepatitis-c-virus-genotype-4
#3
Gregory Camus, Bin Han, Tarik Asselah, David Hsieh, Hadas Dvory-Sobol, Julia Lu, Evguenia Svarovskaia, Ross Martin, Bandita Parhy, Michael Miller, Diana M Brainard, Kathryn Kersey, Armand Abergel, Hongmei Mo
HCV genotype 4 (GT4) has often been overlooked in drug development, even though it infects approximately 20 million people worldwide. Ledipasvir/sofosbuvir and sofosbuvir/velpatasvir were highly efficacious in GT4 HCV infected patients from GS-US-337-1119 and GS-US-342-1138. Here we characterize the resistance profile of ledipasvir (LDV) and velpatasvir (VEL) in patients with GT4 HCV infection. NS5A deep-sequencing was performed for 454 patients infected with HCV GT4 at baseline, including 44 patients enrolled in GS-US-337-1119 and 116 patients enrolled in GS-US-342-1138, and at relapse for patients with virologic failure...
October 6, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28984059/treatment-of-hepatitis-c-with-8-weeks-of-ledipasvir-sofosbuvir-highly-effective-in-a-predominantly-black-male-patient-population
#4
Lydia Tang, Andre Parker, Yolanda Flores, Mary Dellario, Christina Dickson, Anthony Amoroso, Shyam Kottilil, Eleanor Wilson
Reducing the duration of hepatitis C therapy may cut costs and improve adherence, but recent studies suggest that black men have lower cure rates than other patients when treatment durations are shortened. Here, we report high efficacy in a real world cohort of predominantly black male patients with hepatitis C. This article is protected by copyright. All rights reserved.
October 6, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28977040/incidence-of-daa-failure-and-the-clinical-impact-of-retreatment-in-real-life-patients-treated-in-the-advanced-stage-of-liver-disease-interim-evaluations-from-the-piter-network
#5
Loreta A Kondili, Giovanni Battista Gaeta, Maurizia Rossana Brunetto, Alfredo Di Leo, Andrea Iannone, Teresa Antonia Santantonio, Adele Giammario, Giovanni Raimondo, Roberto Filomia, Carmine Coppola, Daniela Caterina Amoruso, Pierluigi Blanc, Barbara Del Pin, Liliana Chemello, Luisa Cavalletto, Filomena Morisco, Laura Donnarumma, Maria Grazia Rumi, Antonio Gasbarrini, Massimo Siciliano, Marco Massari, Romina Corsini, Barbara Coco, Salvatore Madonia, Marco Cannizzaro, Anna Linda Zignego, Monica Monti, Francesco Paolo Russo, Alberto Zanetto, Marcello Persico, Mario Masarone, Erica Villa, Veronica Bernabucci, Gloria Taliani, Elisa Biliotti, Luchino Chessa, Maria Cristina Pasetto, Pietro Andreone, Marzia Margotti, Giuseppina Brancaccio, Donatella Ieluzzi, Guglielmo Borgia, Emanuela Zappulo, Vincenza Calvaruso, Salvatore Petta, Loredana Falzano, Maria Giovanna Quaranta, Liliana Elena Weimer, Stefano Rosato, Stefano Vella, Edoardo Giovanni Giannini
BACKGROUND: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. AIM: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. METHODS: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers...
2017: PloS One
https://www.readbyqxmd.com/read/28972699/ledipasvir-and-sofosbuvir-for-untreated-hcv-genotype-1-infection-in-end-stage-renal-disease-patients-a-prospective-observational-study
#6
Mandarapu Surendra, Sree Bhushan Raju, Nimmagadda Sridhar, Bangillapati Vijay Kiran, Goli Rajesh, Golla Anvesh, Nallagasu Raju
INTRODUCTION: Hepatitis C virus (HCV) infection in end stage renal disease (ESRD) is associated with increased mortality. Recently, numerous directly acting antiviral agents have been approved for the management of HCV. Ledipasvir along with Sofosbuvir has been approved for management of genotype 1 infection in patients with eGFR ≥30 mL/min. However, there is paucity of data regarding its role in the management of patients on dialysis. MATERIAL AND METHODS: This is a single center prospective open label observational study to assess the safety and efficacy of Ledipasvir and Sofosbuvir in hemodialysis (HD) patients who were diagnosed with HCV genotype 1 infection...
October 3, 2017: Hemodialysis International
https://www.readbyqxmd.com/read/28971875/pharmacokinetic-interactions-between-simeprevir-and-ledipasvir-in-treatment-na%C3%A3-ve-hepatitis-c-virus-genotype-1-infected-patients-without-cirrhosis-treated-with-a-simeprevir-sofosbuvir-ledipasvir-regimen
#7
Stefan Bourgeois, Yves Horsmans, Frederik Nevens, Hans van Vlierberghe, Christophe Moreno, Maria Beumont, Leen Vijgen, Veerle van Eygen, Donghan Luo, Vera Hillewaert, Pieter Van Remoortere, Jolanda van de Logt, Sivi Ouwerkerk-Mahadevan
Interactions between simeprevir (hepatitis C virus [HCV] NS3/4A protease inhibitor) and ledipasvir (HCV NS5A replication complex inhibitor) were investigated in treatment-naïve HCV genotype 1-infected patients without cirrhosis, treated with simeprevir/sofosbuvir/ledipasvir in a two-panel, Phase 2, open-label study (NCT02421211). Patients had stable background treatment with sofosbuvir (400 mg once daily [QD]). In Panel 1 (N=20), the effect of ledipasvir (90 mg QD) on simeprevir (150 mg QD) was studied. Patients received simeprevir and sofosbuvir from Days 1--14; steady-state pharmacokinetics (PK) of simeprevir were assessed (Day 14)...
October 2, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28971607/lack-of-clinically-important-pk-interaction-between-coformulated-ledipasvir-sofosbuvir-and-rilpivirine-emtricitabine-tenofovir-alafenamide
#8
Joseph M Custodio, Susan K Chuck, Hoa Chu, Huyen Cao, Grace Ma, John Flaherty, John Ling, Brian P Kearney
The drug-drug interaction (DDI) potential between the fixed-dose combinations of ledipasvir/sofosbuvir 90/400 mg for hepatitis C virus and emtricitabine/rilpivirine/tenofovir alafenamide (TAF) 200/25/25 mg for HIV was evaluated in a randomized, open-label, single-center, multiple-dose, 3-way, 6-sequence, crossover Phase 1 study in 42 healthy subjects. Emtricitabine/rilpivirine/TAF had no relevant effect on the pharmacokinetic parameters of maximum concentration [Cmax ] and area under the concentration versus time curve over the dosing interval [AUCtau ] for ledipasvir, sofosbuvir, and the metabolites GS-566500 and GS-331007...
October 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28968574/spectroflurimetric-estimation-of-the-new-antiviral-agent-ledipasvir-in-presence-of-sofosbuvir
#9
Fathy M Salama, Khalid A Attia, Ahmed A Abouserie, Ahmed El-Olemy, Ebrahim Abolmagd
A spectroflurimetric method has been developed and validated for the selective quantitative determination of ledipasvir in presence of sofosbuvir. In this method the native fluorescence of ledipasvir in ethanol at 405nm was measured after excitation at 340nm. The proposed method was validated according to ICH guidelines and show high sensitivity, accuracy and precision. Furthermore this method was successfully applied to the analysis of ledipasvir in pharmaceutical dosage form without interference from sofosbuvir and other additives and the results were statistically compared to a reported method and found no significant difference...
August 10, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/28964443/cost-utility-of-elbasvir-grazoprevir-in-patients-with-chronic-hepatitis-c-genotype-1-infection
#10
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/28957984/health-related-quality-of-life-in-adolescent-patients-with-hepatitis-c-genotype-1-treated-with-sofosbuvir-and-ledipasvir
#11
Zobair M Younossi, Maria Stepanova, William Balistreri, Kathleen Schwarz, Karen F Murray, Philip Rosenthal, Sanjay Bansal, Sharon Hunt
OBJECTIVE: To assess the impact of treatment with ledipasvir/sofosbuvir (LDV/SOF) on the health-related quality of life (HRQL) of pediatric patients with chronic hepatitis C virus (HCV) infection. METHODS: Adolescents (12-17 years) with HCV were treated with LDV/SOF (90 mg/400 mg daily) for 12 weeks. HRQL was assessed using the PedsQLv4.0-SF15 completed by the children and caregivers before, during, and after treatment. RESULTS: We included 100 adolescents with HCV genotype 1 infection [14...
September 27, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28925327/treatment-of-chronic-hepatitis-c-virus-infection-with-crushed-ledipasvir-sofosbuvir-administered-via-a-percutaneous-endoscopic-gastrostomy-tube
#12
Lauren Jindracek, Jennifer Stark
INTRODUCTION: Ledipasvir/sofosbuvir (Harvoni®) is a fixed-dose tablet indicated for the treatment of chronic hepatitis C virus (HCV) infection. There are currently no data available on the safety and efficacy of crushed ledipasvir/sofosbuvir tablets. CASE SUMMARY: This report describes the first documented case of successful treatment of chronic HCV infection in a patient crushing ledipasvir/sofosbuvir for administration via a percutaneous endoscopic gastrostomy (PEG) tube...
January 1, 2017: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28923637/ledipasvir%C3%A2-sofosbuvir-for-liver-transplant-recipients-with-recurrent-hepatitis-c-a-systematic-review-and-meta-analysis
#13
H-T Liao, P Tan, J-W Huang, K-F Yuan
INTRODUCTION: Studies focusing on the efficacy and safety of ledipasvir (LDV) + sofosbuvir (SOF) therapy in liver transplant (LT) recipients with hepatitis C virus (HCV) recurrence are still limited. Therefore, the aim of our work was to perform a systematic review and meta-analysis to evaluate outcome data of LDV + SOF therapy in LT recipients. METHODS: Multiple databases were systematically searched for eligible studies. We included studies reporting sustained virological response 12 weeks after treatment (SVR12) and treatment-related adverse events (AEs) in LT recipients treated with LDV + SOF ± ribavirin (RBV) for HCV recurrence...
October 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28903508/effect-of-paritaprevir-ritonavir-ombitasvir-dasabuvir-and-ledipasvir-sofosbuvir-regimens-on-survival-compared-with-untreated-hepatitis-c-virus-infected-persons-results-from-erchives
#14
Adeel Ajwad Butt, Peng Yan, Tracey G Simon, Abdul-Badi Abou-Samra
Background: Interferon-based regimens are associated with a substantial survival benefit for persons infected with hepatitis C virus (HCV). Survival data with direct-acting antiviral agents are not available. We conducted this study to quantify the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) regimens upon mortality. Methods: In the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), a well-established national cohort of HCV-infected Veterans, we identified HCV-infected persons initiated on PrOD or LDV/SOF, excluding those with human immunodeficiency virus, hepatitis B surface antigen positivity, hepatocellular carcinoma, or missing HCV RNA or FIB-4 scores...
September 15, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28884930/retreatment-with-sofosbuvir-ledipasvir-with-or-without-lead-in-interferon-%C3%AE-injections-in-patients-infected-with-genotype-1b-hcv-after-unsuccessful-daclatasvir-asunaprevir-therapy
#15
Hayato Uemura, Yoshihito Uchida, Jun-Ichi Kouyama, Kayoko Naiki, Shinpei Yamaba, Akira Fuchigami, Yoichi Saito, Keisuke Shiokawa, Yohei Fujii, Hiroshi Uchiya, Manabu Nakazawa, Satsuki Ando, Masamitsu Nakao, Daisuke Motoya, Kayoko Sugawara, Mie Inao, Yukinori Imai, Nobuaki Nakayama, Tomoaki Tomiya, Satoshi Mochida
AIMS: To improve the therapeutic efficacy of sofosbuvir/ledipasvir for the retreatment of patients after daclatasvir/asunaprevir, a customized therapy with or without lead-in interferon-β injections was performed according to the types of resistance-associated substitutions (RASs) in the NS5A region of genotype 1b HCV. METHODS: Thirty-three patients failing prior daclatasvir/asunaprevir received sofosbuvir/ledipasvir for 12 weeks. Patients with HCV carrying unfavorable NS5A-RASs and/or those with previous simeprevir administration were given lead-in interferon-β injections twice a day for 2 weeks; sequential changes in the NS5A-RASs during the injection period were evaluated using deep sequencing...
September 8, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28884440/disappearance-of-multiple-hyperechoic-liver-nodules-in-sporadic-porphyria-cutanea-tarda-after-treatment-with-ledipasvir-sofosbuvir-for-hepatitis-c
#16
Kazuhide Takata, Satoshi Shakado, Keiko Sakamoto, Hiromi Fukuda, Ryo Yamauchi, Sho Fukuda, Hideo Kunimoto, Kaoru Umeda, Takashi Tanaka, Keiji Yokoyama, Daisuke Morihara, Yasuaki Takeyama, Makoto Irie, Shotaro Sakisaka
Ultrasonography in a 60-year-old man with chronic hepatitis C (CHC) demonstrated multiple hyperechoic nodules. Radiological investigations did not reveal any signs of malignancy. However, magnetic resonance chemical shift imaging showed multiple focal fatty changes in the liver. Urinary levels of uroporphyrin and coproporphyrin were elevated, and we made a diagnosis of porphyria cutanea tarda. Direct-acting antivirals, ledipasvir/sofosbuvir, were initiated for CHC, which led to sustained viral response, resolution of the liver nodules, and normalization of urinary porphyrin...
September 7, 2017: Clinical Journal of Gastroenterology
https://www.readbyqxmd.com/read/28874040/direct-acting-antiviral-agents-in-korean-patients-with-chronic-hepatitis-c-and-hemophilia-who-are-treatment-na%C3%A3-ve-or-treatment-experienced
#17
Hyun Woong Lee, Ki Young Yoo, Joung Won Won, Hyung Joon Kim
Background/Aims: Chronic hepatitis C (CHC) is a major comorbidity in patients with hemophilia. Methods: Patients (n=30) were enrolled between September 2015 and April 2016. Twenty-six patients were genotype 1 (1b, n=21; 1a, n=5) and four patients were genotype 2a/2b. Among 21 patients with genotype 1b, Y93H resistance-associated variants (RAVs) were detected in three patients (14.3%). We evaluated sustained virologic response (SVRs) at 12 weeks, as well as relapse and safety...
September 15, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28860456/the-paradox-of-highly-effective-sofosbuvir-based-combination-therapy-despite-slow-viral-decline-can-we-still-rely-on-viral-kinetics
#18
Thi Huyen Tram Nguyen, Jérémie Guedj, Susan L Uprichard, Anita Kohli, Shyam Kottilil, Alan S Perelson
High sustained virologic response (SVR) rates have been observed after 6 weeks of anti-HCV treatment using sofosbuvir, ledipasvir and a non-nucleoside polymerase-inhibitor (GS-9669) or a protease-inhibitor (GS-9451) and after 12 weeks with sofosbuvir + ledipasvir. Here we analyze the viral kinetics observed during these treatments to decipher the origin of the rapid cure and to evaluate the possibility of further reducing treatment duration. We found that viral kinetics were surprisingly slow in all treatment groups and could not reproduce the high SVR rates observed...
August 31, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28856278/efficacy-of-hcv-treatment-in-poland-at-the-turn-of-the-interferon-era-the-epiter-study
#19
Robert Flisiak, Joanna Pogorzelska, Hanna Berak, Andrzej Horban, Iwona Orłowska, Krzysztof Simon, Ewelina Tuchendler, Grzegorz Madej, Anna Piekarska, Maciej Jabłkowski, Zbigniew Deroń, Włodzimierz Mazur, Marcin Kaczmarczyk, Ewa Janczewska, Arkadiusz Pisula, Jacek Smykał, Krzysztof Nowak, Marek Matukiewicz, Waldemar Halota, Joanna Wernik, Katarzyna Sikorska, Iwona Mozer-Lisewska, Błażej Rozpłochowski, Aleksander Garlicki, Krzysztof Tomasiewicz, Joanna Krzowska-Firych, Barbara Baka-Ćwierz, Wiesław Kryczka, Dorota Zarębska-Michaluk, Iwona Olszok, Anna Boroń-Kaczmarska, Barbara Sobala-Szczygieł, Bronisława Szlauer, Bogumiła Korcz-Ondrzejek, Jerzy Sieklucki, Robert Pleśniak, Agata Ruszała, Barbara Postawa-Kłosińska, Jolanta Citko, Anna Lachowicz-Wawrzyniak, Joanna Musialik, Edyta Jezierska, Witold Dobracki, Beata Dobracka, Jan Hałubiec, Rafał Krygier, Anna Strokowska, Wojciech Chomczyk, Krystyna Witczak-Malinowska
THE AIM OF THE STUDY: Was to analyze the efficacy achieved with regimens available for chronic hepatitis C (CHC) in Poland between 2013 and 2016. MATERIAL AND METHODS: Data were collected from 29 centers and included 6786 patients with available sustained virologic response (SVR) data between 1 January 2013 and 31 March 2016. RESULTS: The sustained virologic response rate for genotypes (G) 1a, 1b, 2, 3 and 4 was 62%, 56%, 92%, 67% and 56% respectively; 71% patients (n = 4832) were treated with pegylated interferon α (Peg-IFNα) and ribavirin (RBV), with SVR rates of 58%, 49%, 92%, 67% and 55% respectively...
December 2016: Clin Exp Hepatol
https://www.readbyqxmd.com/read/28846559/sofosbuvir-based-regimens-in-hiv-hcv-coinfected-patients-after-liver-transplantation-results-from-the-anrs-co23-cupilt-study
#20
Teresa Maria Antonini, Audrey Coilly, Emilie Rossignol, Claire Fougerou-Leurent, Jérôme Dumortier, Vincent Leroy, Aurélie Veislinger, Sylvie Radenne, Danielle Botta-Fridlund, François Durand, Pauline Houssel-Debry, Nassim Kamar, Valérie Canva, Philippe Perré, Victor De Ledinghen, Alexandra Rohel, Alpha Diallo, Anne-Marie Taburet, Didier Samuel, Georges-Philippe Pageaux, Jean-Charles Duclos-Vallée
BACKGROUND: A recurrence of hepatitis C virus after liver transplantation affects survival in HIV/HCV coinfected patients. This study assessed the efficacy and safety of sofosbuvir-based regimens in HIV/HCV coinfected patients following liver transplantation. METHODS: 29 HIV/HCV coinfected transplanted patients receiving tacrolimus, cyclosporine or everolimus-based immunosuppressive therapy were enrolled in the CUPILT cohort. Their antiviral treatment combined sofosbuvir, daclatasvir with or without ribavirin (n=10/n=6), or sofosbuvir, ledipasvir with or without ribavirin (n=2/n=11)...
August 24, 2017: Transplantation
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