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https://www.readbyqxmd.com/read/29053909/impact-of-ledipasvir-sofosbuvir-on-the-work-productivity-of-genotype-1-chronic-hepatitis-c-patients-in-asia
#1
Zobair M Younossi, Henry Lik Yuen Chan, Yock Young Dan, Mei Hsuan Lee, Young-Suk Lim, Eliza Kruger, Seng Chuen Tan
Chronic, untreated hepatitis C virus (HCV) infection is associated with a poor clinical prognosis and a detrimental impact on patients' lives, including on work productivity. To estimate the value of productivity losses due to genotype 1 (GT1) HCV infection in Hong Kong, Singapore, South Korea and Taiwan and to estimate the potential productivity gains associated with treating patients with ledipasvir/sofosbuvir (LDV/SOF) therapy,an economic model was developed with a time horizon of one year. HCV patients entered the model at 12 weeks post-treatment, having achieved or not achieved sustained virological response (SVR)...
October 20, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29050674/the-outcomes-of-glucose-abnormalities-in-chronic-hepatitis-c-patients-receiving-interferon-free-direct-antiviral-agents
#2
Jee-Fu Huang, Chung-Feng Huang, Ming-Lun Yeh, Chia-Yen Dai, Meng-Hsuan Hsieh, Jeng-Fu Yang, Ching-I Huang, Yi-Hung Lin, Po-Cheng Liang, Zu-Yau Lin, Shinn-Chern Chen, Ming-Lung Yu, Wan-Long Chuang
Direct-acting antiviral agents (DAAs) have been widely used for chronic hepatitis C (CHC) treatment recently. The characteristics of glucose abnormalities after DAAs therapy however, remain elusive. We aimed to elucidate the mutual impact between treatment response and parameters of glucose abnormalities after DAAs therapy in CHC patients. CHC patients who received DAAs therapy were recruited. The primary outcome measurements were their insulin resistance (IR) and beta-cell function assessed by the homeostasis model assessment (HOMA) method before treatment and at end-of-follow-up (EOF)...
November 2017: Kaohsiung Journal of Medical Sciences
https://www.readbyqxmd.com/read/29048558/modeling-neuro-immune-interactions-during-zika-virus-infection
#3
Pinar Mesci, Angela Macia, Christopher N LaRock, Leon Tejwani, Isabella R Fernandes, Nicole A Suarez, Paolo M de A Zanotto, Patricia C B Beltrão-Braga, Victor Nizet, Alysson R Muotri
Although Zika virus (ZIKV) infection is often asymptomatic, in some cases it can lead to birth defects in newborns or serious neurologic complications in adults. However, little is known about the interplay between immune and neural cells that could contribute to the ZIKV pathology. To understand the mechanisms at play during infection and the antiviral immune response, we focused on neural precursor cells (NPC)-microglia interactions. Our data indicate that human microglia infected with the current circulating Brazilian ZIKV induces a similar pro-inflammatory response found in ZIKV-infected human tissues...
October 17, 2017: Human Molecular Genetics
https://www.readbyqxmd.com/read/29045448/interferon-free-therapy-with-direct-acting-antivirals-for-hcv-hiv-1-co-infected-japanese-patients-with-inherited-bleeding-disorders
#4
Haruka Uemura, Kunihisa Tsukada, Daisuke Mizushima, Takahiro Aoki, Koji Watanabe, Ei Kinai, Katsuji Teruya, Hiroyuki Gatanaga, Yoshimi Kikuchi, Masaya Sugiyama, Masashi Mizokami, Shinichi Oka
INTRODUCTION: Almost 30 years ago, about 30% of Japanese hemophiliacs became infected with HIV-1 and hepatitis C virus (HCV) after receiving contaminated blood products. While several studies have reported the high efficacy and safety of direct acting antivirals (DAA) in HIV-1 co-infected patients, such data are limited in hemophiliacs. METHODS: We conducted a single-center, open-label study involving 27 Japanese patients (median age; 45 years) with inherited bleeding disorders who were co-infected with HCV/HIV-1...
2017: PloS One
https://www.readbyqxmd.com/read/29040986/comparison-of-sofosbuvir-plus-ribavirin-treatment-with-pegylated-interferon-plus-ribavirin-treatment-for-chronic-hepatitis-c-genotype-2
#5
Kayo Seo, Soo Ki Kim, Soo Ryang Kim, Aya Ohtani, Mana Kobayashi, Airi Kato, Eri Morimoto, Yuka Saijo, Ke Ih Kim, Susumu Imoto, Chi Wan Kim, Yoshihiko Yano, Masatoshi Kudo, Yoshitake Hayashi
BACKGROUND: Sofosbuvir plus ribavirin (RBV) therapy showed higher sustained virological response at 12 weeks after treatment (SVR12) than pegylated interferon (peg-IFN) plus RBV; however, liver function, fibrosis, and hepatocellular carcinoma markers have not been assessed so far. SUMMARY: Patients (n = 21) receiving Sofosbuvir plus RBV and those (n = 24) receiving peg-IFN plus RBV were enrolled in this study. Changes in alanine aminotransferase (ALT) and α-fetoprotein (AFP) levels, platelet (PLT) counts, FIB-4, and aspartate aminotransferase-to-platelet ratio index (APRI) in both groups were assessed in patients achieving SVR12...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/29035002/short-term-risk-of-hepatocellular-carcinoma-after-hepatitis-c-virus-eradication-following-direct-acting-anti-viral-treatment
#6
E Ogawa, N Furusyo, H Nomura, K Dohmen, N Higashi, K Takahashi, A Kawano, K Azuma, T Satoh, M Nakamuta, T Koyanagi, M Kato, S Shimoda, E Kajiwara, J Hayashi
BACKGROUND: With the development of direct-acting anti-virals (DAAs), almost all patients with chronic hepatitis C virus (HCV) infection can achieve sustained viral response (SVR). AIM: To evaluate the short-term risk of HCC among patients with SVR by DAAs, including those with cirrhosis or previous HCC. METHODS: This large-scale, multicentre cohort study included 1,675 consecutive patients who achieved SVR by treatment with interferon-free sofosbuvir-based regimens, divided into groups with (n = 152) or without previous HCC (n = 1,523)...
October 16, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29028125/ledipasvir-and-tenofovir-drug-interaction-in-hiv-hcv-co-infected-patients-impact-on-tenofovir-ctrough-and-renal-safety
#7
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/29020583/glecaprevir-and-pibrentasvir-in-patients-with-hcv-and-severe-renal-impairment
#8
MULTICENTER STUDY
Edward Gane, Eric Lawitz, David Pugatch, Georgios Papatheodoridis, Norbert Bräu, Ashley Brown, Stanislas Pol, Vincent Leroy, Marcello Persico, Christophe Moreno, Massimo Colombo, Eric M Yoshida, David R Nelson, Christine Collins, Yang Lei, Matthew Kosloski, Federico J Mensa
BACKGROUND: Chronic hepatitis C virus (HCV) infection is more prevalent among patients who have chronic kidney disease than among those who do not have the disease. Patients with chronic kidney disease who also have HCV infection are at higher risk for progression to end-stage renal disease than those who have chronic kidney disease without HCV infection. Patients with both HCV infection and advanced chronic kidney disease have limited treatment options. METHODS: We conducted a multicenter, open-label, phase 3 trial to evaluate the efficacy and safety of treatment with the combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults who had HCV genotype 1, 2, 3, 4, 5, or 6 infection and also had compensated liver disease (with or without cirrhosis) with severe renal impairment, dependence on dialysis, or both...
October 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29020359/sofosbuvir-based-interferon-free-direct-acting-antiviral-regimens-for-heart-transplant-recipients-with-chronic-hepatitis-c-virus-infection
#9
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/28992878/peginterferon-alfa-2a-for-the-treatment-of-chronic-hepatitis-c-in-the-era-of-direct-acting-antivirals
#10
REVIEW
Yan Huang, Ming-Hui Li, Min Hou, Yao Xie
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population...
October 15, 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28984067/resistance-characterization-of-ledipasvir-and-velpatasvir-in-hepatitis-c-virus-genotype-4
#11
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
#12
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/28983675/efficacy-and-safety-of-sofosbuvir-plus-ribavirin-for-treatment-of-cirrhotic-patients-with-genotype-4-hepatitis-c-virus-in-real-life-clinical-practice
#13
Sherief Abd-Elsalam, Mohamed Sharaf-Eldin, Shaimaa Soliman, Asem Elfert, Rehab Badawi, Youssef K Ahmad
Egypt has the highest hepatitis C virus (HCV) prevalence in the world. Sofosbuvir is a new highly effective drug for treatment of HCV infection. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to fourfold reduced duration of therapy. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin in Egyptian patients with liver cirrhosis due to chronic HCV infection. We studied 2400 cirrhotic Egyptian patients with chronic HCV infection who were treated with dual therapy with sofosbuvir and ribavirin for 24 weeks...
October 5, 2017: Archives of Virology
https://www.readbyqxmd.com/read/28981513/real-life-results-of-sofosbuvir-based-therapy-in-chronic-hepatitis-c-na%C3%A3-ve-and-experienced-patients-in-egypt
#14
Ahmed Nagaty, Ekram W Abd El-Wahab
BACKGROUND: More than ten million Egyptians are infected with HCV. Every one of them is going to infect about three to four persons every year. Treating those patients is a matter of national security. A dramatic improvement in hepatitis C virus (HCV) infection treatment was achieved in the last five years. A new era of direct-acting antivirals is now dawning in Egypt. OBJECTIVE(S): We share in this report our clinical experience in treating chronic HCV Egyptian patients with Sofosbuvir based regimens to evaluate its safety and efficacy on real life practical ground...
2017: PloS One
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
#15
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
#16
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
#17
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
#18
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/28970702/generic-direct-acting-antivirals-in-treatment-of-chronic-hepatitis-c-infection-in-patients-of-thalassemia-major
#19
Aabha Nagral, Smita Sawant, Nishtha Nagral, Pathik Parikh, Priya Malde, Rashid Merchant
BACKGROUND: There is no published data of treating hepatitis C in thalassemia major patients with any sofosbuvir based direct acting antivirals (DAAs). This study was performed to determine the efficacy and safety of these regimes using generic drugs in the thalassemia major population. METHODS: In this observational study, 902 patients of thalassemia major from five transfusion centres in Mumbai were screened for HCV antibody. Of the 120 positive patients, HCV RNA was detected in 50%...
September 2017: Journal of Clinical and Experimental Hepatology
https://www.readbyqxmd.com/read/28970701/sofosbuvir-and-ribavirin-for-24-weeks-is-an-effective-treatment-option-for-recurrent-hepatitis-c-infection-after-living-donor-liver-transplantation
#20
Anil C Anand, Shaleen K Agarwal, Hitendra K Garg, Sudeep Khanna, Subhash Gupta
BACKGROUND: Recurrent hepatitis C virus (HCV) has been a serious problem after liver transplantation (LT). We report our experience of 24-week therapy with sofosbuvir (SOF) and ribavirin (RBV) in post-LT recurrent HCV in living donor liver transplantation (LDLT) setting in South Asia. METHODS: Data from all patients treated for post-transplantation HCV recurrence in a single center were analyzed. Treatment regimen was 24 weeks of SOF 400 mg daily and RBV (starting at 800 mg daily, increased as tolerated)...
September 2017: Journal of Clinical and Experimental Hepatology
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