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https://www.readbyqxmd.com/read/28815329/efficacy-and-safety-of-ledipasvir-sofosbuvir-with-ribavirin-in-chronic-hepatitis-c-patients-who-failed-daclatasvir-asunaprevir-therapy-pilot-study
#1
Yoshiiku Kawakami, Hidenori Ochi, Clair Nelson Hayes, Michio Imamura, Masataka Tsuge, Takashi Nakahara, Yoshio Katamura, Hiroshi Kohno, Hirotaka Kohno, Keiji Tsuji, Shintaro Takaki, Nami Mori, Yohji Honda, Keiko Arataki, Shoichi Takahashi, Shinsuke Kira, Toru Tamura, Kazunari Masuda, Toshio Nakamura, Masaya Kikkawa, Kazuaki Chayama
BACKGROUND: In Japan, daclatasvir (DCV) and asunaprevir (ASV) therapy was the first IFN-free treatment to be approved, and thousands of patients have since been successfully treated, with an SVR rate of around 90%. The converse, however, is that around 10% of patients fail to achieve viral eradication and must be retreated using a different approach. This study is to evaluate treatment efficacy of ledipasvir/sofosbuvir and ribavirin in patients who failed to respond to DCV and ASV therapy...
August 16, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28809742/treatment-of-chronic-hcv-infection-with-the-new-direct-acting-antivirals-daa-first-report-of-a-real-world-experience-in-southern-brazil
#2
Hugo Cheinquer, Hoel Sette-Jr, Fernando H Wolff, Alexandre de Araujo, Silvia Coelho-Borges, Silvia R P Soares, Mauricio F A Barros
INTRODUCTION AND AIM: There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil. MATERIALS AND METHODS: Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis...
August 8, 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28795982/treatment-of-patients-with-hepatitis-c-virus-infection-genotype-4-with-ledipasvir-sofosbuvir-in-the-liver-transplant-setting
#3
Faisal Abaalkhail, Hussein Elsiesy, Hany Elbeshbeshy, Mohamed Shawkat, Sarra Yousif, Waheed Ullah, Saleh Alabbad, Ahmed Al-Jedai, Aziza Ajlan, Dieter Broering, Sammy Saab, Mohammed Al Sebayel, Waleed Al-Hamoudi
BACKGROUND: Hepatitis C virus infection is a major cause of liver cirrhosis and hepatocellular carcinoma and the leading indication for liver transplantation. In the Middle East, genotype 4 HCV infection is the most common genotype. However, limited data exists on the treatment of genotype-4 in the liver transplant setting. We evaluated the safety and efficacy of ledipasvir-sofosbuvir (LDV/SOF) in treating HCV genotype-4 infected patients with cirrhosis or postliver transplantation. METHODS: This prospective, single-arm, observational study includes cohort of patients with cirrhosis before liver transplantation (Cohort A) and a cohort of postliver transplantation patients (Cohort B)...
August 9, 2017: Transplantation
https://www.readbyqxmd.com/read/28783604/a-new-innovative-spectrophotometric-method-for-the-simultaneous-determination-of-sofosbuvir-and-ledipasvir
#4
Fotouh R Mansour
A new innovative spectrophotometric method is developed to determine the concentration ratios in binary mixtures by determining the zero crossing point in the first derivative of the gross curve. This relationship can be applied if the part of the UV spectrum of substance Y, that intersects with the overlaid spectra of substance X is straight. By plotting the intersection wavelength against the concentration ratio (CxCy), a straight line was obtained with a co-efficient of determination equals 0.9999. As an application, simultaneous determination of sofosbuvir and ledipasvir in their binary mixtures was performed using two methods; a direct UV spectrophotometric method for determination of ledipasvir at 333nm, and the new "wavelength-intersection ratio" method for determination of sofosbuvir...
July 31, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/28783205/successful-treatment-of-chronic-hepatitis-c-with-ground-ledipasvir-sofosbuvir-in-a-patient-with-crohn-s-disease-and-short-bowel-syndrome
#5
Johann von Felden, Christoph Scheurich, Jin Yamamura, Diana M Brainard, Erik Mogalian, Ansgar W Lohse, Julian Schulze-Zur-Wiesch
We read the comprehensive review by Gitto et al. entitled 'NS5A inhibitors for the treatment of hepatitis C infection' (CHC) with great interest (1). Indeed, the development of direct acting antivirals (DAAs) now enables successful treatment of formerly difficult-to-treat patient populations (e.g. cirrhosis or chronic kidney disease). However, little is known about the use of DAAs in patients with short bowel syndrome, e.g. following inflammatory bowel disease (IBD), because these patients are yet excluded from clinical trials (2)...
August 7, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28765697/eight-week-ledipasvir-sofosbuvir-in-non-cirrhotic-treatment-na%C3%A3-ve-hepatitis-c-genotype-1-patients-with-hepatitis-c-virus-rna-6-million-single-center-real-world-effectiveness-and-safety
#6
Nyan L Latt, Beshoy T Yanny, Derenik Gharibian, Rita Gevorkyan, Amandeep K Sahota
AIM: To evaluate sustained viral response (SVR) of 8-wk ledipasvir/sofosbuvir therapy among non-cirrhotic, genotype-1 hepatitis C virus (HCV) patients with RNA < 6 million IU/mL. METHODS: We performed a retrospective cohort study to examine SVR rates, predictors of treatment failure and safety analysis of 8-wk ledipasvir/sofosbuvir (LDV/SOF) therapy among non-cirrhotic, genotype 1 HCV patients with viral load < 6 million IU/mL. Primary outcome was an achievement of SVR at 12 wk after treatment...
July 14, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28762681/-novel-antiviral-agents-for-the-treatment-of-hcv-among-renal-transplant-recipients
#7
REVIEW
Fabrizio Fabrizi, Francesca M Donato, Piergiorgio Messa
The frequency of hepatitis C virus infection remains high in renal transplant recipients and plays a detrimental role on survival in this population. According to the latest evidence, the adjusted relative risk of mortality and graft loss for anti-HCV seropositive versus anti-HCV negative renal transplant recipients was 1.85 with a 95% confidence interval (CI) of 1.49 ; 2.31 (P < 0.0001) and 1.76 (95% CI, 1.46 ; 2.11) (P < 0.0001), respectively. Interferon-based regimens have been recommended for the treatment of hepatitis C after renal transplantation only in selected circumstances because of an increased risk of acute rejection due to the immuno-stimulatory properties of interferon...
August 1, 2017: Giornale Italiano di Nefrologia: Organo Ufficiale Della Società Italiana di Nefrologia
https://www.readbyqxmd.com/read/28724837/chemical-analysis-of-counterfeit-hepatitis-c-drug-found-in-japan
#8
Nahoko Uchiyama, Hiroyuki Kamakura, Sayaka Masada, Takashi Tsujimoto, Junko Hosoe, Hiroko Tokumoto, Takuro Maruyama, Yukihiro Goda, Takashi Hakamatsuka
<bibitem lang="en">  In January 2017, counterfeits of the hepatitis C drug 'HARVONI(®) Combination Tablets' (HARVONI(®)) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI(®) (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR...
July 19, 2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28714143/efficacy-and-safety-of-new-direct-antiviral-agents-in-hcv-infected-patients-with-diffuse-large-b-cell-non-hodgkin-lymphoma
#9
Marcello Persico, Andrea Aglitti, Rosa Caruso, Amalia De Renzo, Carmine Selleri, Catello Califano, Ludovico Abenavoli, Alessandro Federico, Mario Masarone
INTRODUCTION: The association of HCV with Non-Hodgkin Lymphoma (NHL) has been demonstrated all over the world. The new interferon-free, direct antiviral agents (DAA), showed high efficacy and safety, and preliminary data seem to confirm their activity on low-grade NHL. The question arises as whether or not -and how- to treat the HCV positive patients suffering from diffuse large B cell lymphomas(DLBCL). Aim of this observational study was to evaluate whether the DAAs antiviral treatment of DLBCL/HCV-infected patients in concomitance with chemotherapy is a safe and effective option...
July 17, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28710853/real-world-effectiveness-of-sofosbuvir-based-treatment-regimens-for-chronic-hepatitis-c-genotype-3-infection-results-from-the-multicenter-german-hepatitis-c-cohort-gecco-03
#10
Malte H Wehmeyer, Patrick Ingiliz, Stefan Christensen, Dietrich Hueppe, Thomas Lutz, Karl Georg Simon, Knud Schewe, Christoph Boesecke, Axel Baumgarten, Heiner Busch, Juergen Rockstroh, Guenther Schmutz, Torben Kimhofer, Florian Berger, Stefan Mauss, Julian Schulze Zur Wiesch
There are limited data regarding the real world effectiveness of direct acting antivirals (DAA) for the therapy of chronic genotype 3 hepatitis C virus (HCV) infection. All HCV genotype 3 infected patients from the German hepatitis C cohort (GECCO), which is a prospective database of nine German hepatitis C treatment centers, were included in the study. 342 chronically infected HCV genotype 3 patients were analyzed (253 males [74.0%], mean age 47.3 years, 127 cirrhotic patients [37.1%] mostly with Child A cirrhosis, 113 treatment experienced patients [37...
July 15, 2017: Journal of Medical Virology
https://www.readbyqxmd.com/read/28704381/sofosbuvir-based-treatment-of-chronic-hepatitis-c-genotype-3-infections-a-scandinavian-real-life-study
#11
Olav Dalgard, Ola Weiland, Geir Noraberg, Lars Karlsen, Lars Heggelund, Martti Färkkilâ, Ulla Balslev, Erika Belard, Anne Øvrehus, Mette Skalshøi Kjær, Henrik Krarup, Birgit Thorup Røge, Sofie Hallager, Lone G Madsen, Alex Lund Laursen, Martin Lagging, Nina Weis
BACKGROUND AND AIMS: Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat. We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia. METHODS: Consecutive patients with chronic HCV genotype 3 infection were enrolled at 16 treatment centers in Denmark, Sweden, Norway and Finland. Patients who had received a SOF containing regimen were included...
2017: PloS One
https://www.readbyqxmd.com/read/28703905/successful-treatment-of-chronic-hepatitis-c-infection-with-directly-acting-antivirals-in-renal-transplant-recipients
#12
Sunil Taneja, Ajay Duseja, Arka De, Vivek Kumar, Raja Ramachandran, Ashish Sharma, Radha K Dhiman, Krishan L Gupta, Yogesh Chawla
AIMS: The data regarding the treatment of chronic hepatitis C (CHC) in renal transplant recipients is lacking from the Asia-Pacific region. Aim of the present study was to assess the safety and efficacy of directly acting antivirals (DAAs) in the treatment of CHC infection in renal transplant recipients. METHODS: A total of 47 CHC infected renal transplant recipients were enrolled in this real life observational cohort analysis between March 2015 and September 2016...
July 13, 2017: Nephrology
https://www.readbyqxmd.com/read/28691377/effectiveness-of-8-or-12-weeks-of-ledipasvir-and-sofosbuvir-in-real-world-treatment-na%C3%A3-ve-genotype-1-hepatitis-c-infected-patients
#13
M P Curry, E B Tapper, B Bacon, D Dieterich, S L Flamm, L Guest, K V Kowdley, Y Lee, S Milligan, N Tsai, Z Younossi, N H Afdhal
BACKGROUND: Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCV patients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA <6 million IU/mL can be treated for 8 weeks. This guidance stemmed from a post hoc analysis of the ION 3 clinical trial, which demonstrated similar SVR for patients treated with ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks...
July 10, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28690490/a-hepatitis-c-virus-associated-cirrhotic-patient-developing-interstitial-pneumonia-during-the-course-of-antiviral-therapy-with-ombitasvir-paritaprevir-ritonavir
#14
Kazuo Tarao, Kouzo Yamada
Oral direct-acting antivirals (DAAs) are the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the first agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. More recently, ombitasvir/paritaprevir/ritonavir is also recommended as a potent therapy for HCV genotype 1b. Among the adverse events associated with these oral DAAs, interstitial pneumonia is one of the most severe ones. Regarding treatment with daclatasvir plus asunaprevir or sofosbuvir plus ledipasvir, a few cases have already been reported in a postmarketing surveillance...
May 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/28680834/direct-acting-anti-hepatitis-c-virus-drugs-clinical-pharmacology-and-future-direction
#15
Ayman Geddawy, Yasmine F Ibrahim, Nabil M Elbahie, Mohammad A Ibrahim
Chronic hepatitis C virus (HCV) infection is a leading cause of chronic liver disease. The introduction of direct acting antiviral agents (DAAs) for its treatment represents a major advance in terms of sustained virologic response (SVR) rates and adverse effect profiles. Mechanistically, DAAs inhibit specific HCV non-structural proteins (NS) that are vital for its replication. Boceprevir, telaprevir, simeprevir, asunaprevir, grazoprevir and paritaprevir are NS3/4A inhibitors. Ombitasvir, ledipasvir, daclatasvir, elbasvir and velpatasvir are NS5A inhibitors...
March 2017: Journal of Translational Internal Medicine
https://www.readbyqxmd.com/read/28677020/treatment-discontinuation-adherence-and-real-world-effectiveness-among-patients-treated-with-ledipasvir-sofosbuvir-in-the-united-states
#16
Amy Puenpatom, Michael Hull, Jeffrey McPheeters, Kay Schwebke
INTRODUCTION: Ledipasvir/sofosbuvir (LDV/SOF) for hepatitis C virus (HCV) treatment provides an oral interferon-free treatment regimen with high rates of sustained virologic response (SVR). This study assessed treatment discontinuation, factors associated with treatment completion, and real-world effectiveness. METHODS: Patients with HCV treated with LDV/SOF between October 2014 and June 2015 and enrolled in a large US health plan were identified. Expected treatment duration was calculated based on IDSA/AASLD treatment guidelines and US labels using data for genotype, initial treatment regimen, baseline cirrhosis, and prior treatments...
July 4, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28663671/efficacy-and-safety-of-sofosbuvir-based-direct-acting-antivirals-for-hepatitis-c-in-septuagenarians-and-octogenarians
#17
Heather S Snyder, Bilal Ali, Humberto C Gonzalez, Satheesh Nair, Sanjaya K Satapathy
BACKGROUND/AIMS: Treatment of chronic hepatitis C (HCV) with newer direct acting antiviral (DAA) agents has been highly effective. Unfortunately, patients over 70 years old are underrepresented in studies. Given current recommendations to screen patients born between 1945 and 1965 for HCV, it is essential to determine the efficacy and safety of DAAs within the elderly population. This study aims to evaluate clinical outcomes of patients aged 70 years or older treated for HCV with DAAs at a single tertiary care center...
June 2017: Journal of Clinical and Experimental Hepatology
https://www.readbyqxmd.com/read/28660640/randomised-clinical-trial-sofosbuvir-and-ledipasvir-in-patients-with-transfusion-dependent-thalassaemia-and-hcv-genotype-1-or-4-infection
#18
A Mangia, R Sarli, R Gamberini, A Piga, G Cenderello, V Piazzolla, R Santoro, V Caruso, A Quarta, R Ganga, M Copetti, G Forni
BACKGROUND: Patients with thalassaemia major depend on blood transfusions. In Italy, up to 80% of thalassaemia patients bear HCV antibodies due to HCV contaminated transfusions before 1990. Thalassaemia patients with HCV infection have high risk of developing HCC. Treatment based on Pegylated-IFN (Peg-IFN) and Ribavirin (RBV) was limited by relevant side effects. AIM: To evaluate the impact of Sofosbuvir/Ledipasvir (SOF/LDV) fixed dose combination for 12 weeks without RBV, in patients with thalassaemia major and HCV Genotype 1 or 4 (GT1/4)...
June 29, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28660147/effectiveness-of-ledipasvir-sofosbuvir-with-without-ribavarin-in-liver-transplant-recipients-with-hepatitis-c
#19
Sammy Saab, Justin Rheem, Melissa A Jimenez, Tiffany M Fong, Michelle H Mai, Caterina A Kachadoorian, Negin L Esmailzadeh, Sherona N Bau, Susan Kang, Samantha D Ramirez, Jonathan Grotts, Gina Choi, Francisco A Durazo, Mohammed M El-Kabany, Steven-Huy B Han, Ronald W Busuttil
Background and Aims: Recurrent infection of hepatitis C virus (HCV) in liver transplant (LT) recipients is universal and associated with significant morbidity and mortality. Methods: We retrospectively evaluated the safety and efficacy of ledipasvir/sofosbuvir with and without ribavirin in LT recipients with recurrent genotype 1 hepatitis C. Results: Eighty-five LT recipients were treated for recurrent HCV with ledipasvir/sofosbuvirwith and without ribavirin for 12 or 24 weeks. The mean (± standard deviation [SD]) time from LT to treatment initiation was 68 (±71) months...
June 28, 2017: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/28657143/emergence-of-drug-resistance-associated-variants-and-changes-in-serum-lipid-profiles-in-sofosbuvir-plus-ledipasvir-treated-chronic-hepatitis-c-patients
#20
Hiromi Kan, Michio Imamura, Yoshiiku Kawakami, Kana Daijo, Yuji Teraoka, Fumi Honda, Yuki Nakamura, Kei Morio, Tomoki Kobayashi, Takashi Nakahara, Yuko Nagaoki, Tomokazu Kawaoka, Masataka Tsuge, Hiroshi Aikata, Clair Nelson Hayes, Daiki Miki, Hidenori Ochi, Yoji Honda, Nami Mori, Shintaro Takaki, Keiji Tsuji, Kazuaki Chayama
Combination of sofosbuvir plus ledipasvir therapy has been expected to enhance sustained virological response (SVR) rates in hepatitis C virus (HCV) genotype 1 chronic infected patients. We analyzed the emergence of drug resistance-associated variants (RAVs) in treatment failure and changes in lipid profiles in sofosbuvir/ledipasvir-treated patients. A total of 176 patients with chronic HCV genotype 1 infection without decompensated liver cirrhosis were treated with sofosbuvir/ledipasvir for 12 weeks. NS5A and NS5B RAVs were determined by either Invader assay or direct sequencing...
June 28, 2017: Journal of Medical Virology
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