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Speranta Iacob, Razvan Cerban, Corina Pietrareanu, Carmen Ester, Razvan Iacob, Cristian Gheorghe, Irinel Popescu, Liana Gheorghe
BACKGROUND: Nowadays, interferon-free therapy using new direct-acting antivirals (DAA) has dramatically increased the cure rate across different HCV-infected patient populations, including groups traditionally viewed as difficult-to-treat (patients with co-infections, cirrhosis and liver transplant - LT recipients) with marked improvement in safety and tolerability. AIM: To present our experience with DAA therapy in LT recipients, as well as to compare pre- and post-treatment liver stiffness (LS) and noninvasive fibrosis scores...
June 2018: Journal of Gastrointestinal and Liver Diseases: JGLD
Yuji Teraoka, Takuro Uchida, Michio Imamura, Nobuhiko Hiraga, Mitsutaka Osawa, Hiromi Kan, Yuhei Saito, Masataka Tsuge, Hiromi Abe-Chayama, C Nelson Hayes, Grace Naswa Makokha, Hiroshi Aikata, Daiki Miki, Hidenori Ochi, Yuji Ishida, Chise Tateno, Kazuaki Chayama
Combined daclatasvir (DCV)/asunaprevir (ASV) plus beclabuvir (BCV) treatment shows a high virological response for genotype 1b chronic hepatitis C patients. However, its efficacy for patients for whom previous direct-acting antiviral (DAA) therapy failed is not known. We analysed the efficacy of DCV/ASV/BCV treatment for HCV-infected mice and chronic hepatitis patients. Human hepatocyte chimaeric mice were injected with serum samples obtained from either a DAA-naïve patient or a DCV/ASV treatment failure and were then treated with DCV/ASV alone or in combination with BCV for 4 weeks...
June 19, 2018: Journal of General Virology
Mathias Flume, Marc Bardou, Stefano Capri, Oriol Sola-Morales, David Cunningham, Lars-Ake Levin, Maarten J Postma, Nicolas Touchot
Background:  The launch of hepatitis C (HCV) drugs such as sofosbuvir or ledipasvir has fostered the question of affordability of novel high budget impact therapies even in countries with high domestic product. European countries have developed a variety of mechanisms to improve affordability of such therapies, including 'affordability thresholds', price volume agreements or caps on individual product sales, and special budgets for innovative drugs. While some of these mechanisms may help limit budget impact, there are still significant progresses to be made in the definition and implementation of approaches to ensure affordability, especially in health systems where the growth potential in drug spending and/or in the patient contribution to health insurance are limited...
2018: Journal of Market Access & Health Policy
Megan Sue Soliman, Youssef Yousry Soliman, Qamar Ahmad, Roopa Yarlagadda
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third highest cause of cancer mortality worldwide. Risk factors include chronic liver disease and cirrhosis of various causes including chronic hepatitis B and C. In cases of chronic hepatitis C virus (HCV), HCC usually does not manifest unless the liver has become cirrhotic. Fortunately, novel treatments for hepatitis C including ledipasvir/sofosbuvir can cure patients from their disease and as a result, may never develop cirrhosis and therefore, be at much lower risk of developing HCC...
2018: Journal of Community Hospital Internal Medicine Perspectives
Calvin Q Pan, Benjamin C Tiongson, Ke-Qin Hu, Steven-Huy B Han, Myron Tong, Danny Chu, James Park, Tai Ping Lee, Kalyan Ram Bhamidimarri, Xiaoli Ma, Pei Ying Xiao, Smruti R Mohanty, Dan Wang
BACKGROUND: Limited data exist with regard to treatment outcomes in Asian Americans with chronic hepatitis C (CHC). We evaluated sofosbuvir (SOF)-based regimens in a national cohort of Asian Americans. METHODS: Eligible Asian Americans patients with CHC who had posttreatment follow-up of 24 weeks for SOF -based therapies from December 2013 to June 2017 were enrolled from 11 sites across the United States. The primary endpoint was sustained virologic response (SVR) rates at posttreatment weeks 12 and 24...
June 16, 2018: Journal of Clinical Gastroenterology
Satoshi Miuma, Hisamitsu Miyaaki, Akihiko Soyama, Masaaki Hidaka, Mitsuhisa Takatsuki, Hidetaka Shibata, Naota Taura, Susumu Eguchi, Kazuhiko Nakao
AIM: Recently, elbasvir/grazoprevir combination therapy (EBR/GZR therapy) has been reported to have excellent antiviral effects for chronic genotype 1 hepatitis C virus (HCV) infection. However, it has not been recommended for patients with post-liver transplant (LT) HCV re-infections because of a lack of evidence for effectiveness and drug-drug interactions. METHODS: We report the usage of EBR/GZR in five post-LT HCV re-infected patients with the kinetics of renal function and tacrolimus (Tac) trough levels during and after therapy...
June 16, 2018: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Mete Akin, Osman Cagin Buldukoglu, Haydar Adanir, Inci Suleymanlar, Dinc Dincer, Bulent Yildirim
Objective: Successful treatment is possible with novel direct-acting oral antiviral agents in solid organ transplant patients with hepatitis C. In this study, the effectiveness and safety of sofosbuvir/ledipasvir ± ribavirin treatment in liver and/or renal transplant patients with chronic hepatitis C were evaluated. Materials and methods: A total of 23 liver and/or renal transplant patients who received sofosbuvir/ledipasvir ± ribavirin for chronic hepatitis C over 12 or 24 weeks were enrolled in the study...
2018: SAGE Open Medicine
Narendra S Choudhary, Sanjiv Saigal, Dheeraj Gautam, Neeraj Saraf, Amit Rastogi, Sanjay Goja, Prashant Bhangui, Arvinder S Soin
Introduction: Results of Sofosbuvir based regimens for hepatitis C (HCV) recurrence after liver transplantation are available from well-designed clinical trials. Most of the data is from deceased donor liver transplant (DDLT) setting, and data on "real world" experience for HCV recurrence after living donor liver transplantation (LDLT) is limited. Material and methods: Consecutive 78 patients who completed Sofosbuvir based HCV treatment after liver transplantation were included...
June 2018: Journal of Clinical and Experimental Hepatology
Yoshihito Uchida, Shugo Nakamura, Jun-Ichi Kouyama, Kayoko Naiki, Daisuke Motoya, Kayoko Sugawara, Mie Inao, Yukinori Imai, Nobuaki Nakayama, Tomoaki Tomiya, Charlotte Hedskog, Diana Brainard, Hongmei Mo, Satoshi Mochida
To evaluate the effects of HCV NS5B amino acid substitutions on treatment outcome in Ledipasvir (LDV)/Sofosbuvir (SOF) for Japanese patients with genotype 1b HCV infection, NS5B sequences were examined in i) seven patients experiencing virologic failure after LDV/SOF in real-world practice, ii) 109 SOF-naïve patients, iii) 165 patients enrolled in Phase-3 LDV/SOF trial. A218S and C316N were detected in all patients with viral relapse; the percentages of these substitutions in SOF-naïve patients were 64.2% and 55...
June 11, 2018: Scientific Reports
G Li Cavoli, O Schillaci, C Zagarrigo, F Servillo, T V Li Cavoli, M Palmeri, U Rotolo
No abstract text is available yet for this article.
March 2018: Indian Journal of Nephrology
Isabel Campos-Varela, Eliana Z Agudelo, Norah A Terrault
BACKGROUND: Clearance of hepatitis C virus (HCV) under antiviral therapy, including direct acting antivirals (DAAs), has been associated with higher risk of rejection. Whether patients who are not on immunosuppression (IS) during DAA therapy are at higher risk of rejection is unknown. METHODS: Four transplant recipients who were off IS and treated with DAA therapy were identified. For each identified patient, one control on stable IS was included. RESULTS: All patients were genotype 1 infection and treated for 12 weeks with sofosbuvir/ledipasvir/ribavirin...
May 31, 2018: Clinical Transplantation
Claudia Westermann, Dana Wendeler, Albert Nienhaus
Background: Hepatitis C Virus (HCV) infections are blood-borne, generally chronic and are associated with increased morbidity and mortality. The aim of this study is to describe the results of therapies with direct-acting antiviral agents (DAAs) in healthcare personnel. Methods: Secondary data analysis using data from the Statutory Accident Insurance of the Health and Welfare Service. The study surveyed DAA therapies administered to insured parties (healthcare personnel with an HCV infection recognised as an occupational disease) in Germany between 01/01/2014 and 30/11/2016...
2018: Journal of Occupational Medicine and Toxicology
Amira F El-Yazbi, Glen R Loppnow
Hepatocellular carcinoma is one of the most common malignant tumors in the world. Chronic hepatitis B and C infections are the most common etiologies of hepatocellular carcinoma worldwide. In this study, we explore the potential DNA damaging effect of some FDA-approved antiviral drugs which may be able to serve as anticancer agents for hepatocellular carcinoma, in order to better elucidate their mode of action. Five antiviral drugs were selected; ribavirin, sofosbuvir, tenofovir disoproxil fumerate, daclatasvir and ledipasvir...
May 17, 2018: Journal of Pharmaceutical and Biomedical Analysis
Q F Zhang, D Z Zhang
Chronic hepatitis C (CHC) has a prevalence rate of 0.43% in China and approximately 10 million chronically infected people are in urgent need of treatment. Since the beginning of 2013, pan-genotypic sofosbuvir (SOF) with its potent antiviral activity, minimal drug resistance, less drug-drug interactions and good safety has created a new era in HCV treatment. Its combination with ribavirin, in single tablet regimen with either ledipasvir or velpatasvir has been widely used in about 1.6 million patients worldwide...
March 20, 2018: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
Amber R Tierney, William Huepfel, Aasma P Shaukat, John R Lake, Mark Boldt, Qi Wang, Mohamed A Hassan
Hepatitis C treatment has rapidly evolved with the arrival of direct-acting antiviral therapy. Sustained virologic response (SVR) rates in clinical trials are high but it is unknown how this translates to the immigrant community. Data from December 2013 to September 2015 was collected from a Midwest academic and community practice with a large immigrant population. There were 802 patients with an overall SVR rate of 88%. Ledipasvir/sofosbuvir was associated with favorable response among genotype 1 and 4 patients compared to other regimens (p < 0...
May 25, 2018: Journal of Immigrant and Minority Health
A A Butt, Y Ren, A Puenpatom, J M Arduino, R Kumar, A-B Abou-Samra
BACKGROUND: Chronic kidney disease (CKD) was a relative contraindication to hepatitis C virus (HCV) treatment in the interferon/ribavirin era. AIM: To determine the efficacy, tolerability and safety of sofosbuvir/ledipasvir (SOF/LDV) and paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens in persons with CKD. METHODS: We identified persons initiated on a SOF/LDV or PrOD regimen from October 30, 2014 to April 30, 2016. We excluded those with missing HCV genotype or eGFR values...
May 24, 2018: Alimentary Pharmacology & Therapeutics
Sourabh Sharma, Debabrata Mukherjee, Ranjith K Nair, Bhaskar Datt, Ananth Rao
Background: Since the introduction of direct antiviral agents (DAAs), morbidity of HCV has considerably decreased but still no guidelines have been formulated in renal transplant recipients (RTRs). We studied efficacy and tolerability of direct antiviral agents in RTRs. Methods: This prospective observational study was conducted at Army Hospital Research & Referral, Delhi, from June 2016 to May 2017. Forty-five HCV infected RTRs with stable graft function were included...
2018: Journal of Transplantation
Lena A Mikolas, Kimberly Jacques, Mostaqul Huq, Charles Krasner, Scott E Mambourg
OBJECTIVES: To evaluate outcomes of a clinical pharmacist specialist (CPS)-managed hepatitis C virus (HCV) treatment clinic (HCVTC) in treating HCV-infected veterans with direct-acting antivirals (DAAs). METHODS: We established a CPS-managed HCVTC under a collaborative practice agreement with our infectious disease physician (IDP). A total of 132 veterans were treated between November 1, 2014, and November 30, 2015. The CPS engaged in pretreatment screening, drug selection, patient education, medication counseling, drug therapy monitoring, drug utilization review, addressing issues on drug adherence, and routine and posttreatment follow-up of patients to assess sustained virologic response (SVR) after 12 weeks of treatment...
January 1, 2018: Journal of Pharmacy Practice
Ramadan Ali, Adel A Marzouk, Reda A Abdelhameid, Mahmoud A Omar
A rapid and specific spectrofluorimetric method with higher sensitivity was developed for determination of ledipasvir (LDS) in tablets and human plasma. The proposed method relies on hydrogen bonding formations between the hydroxyl groups of polyoxyethylene 50 stearate and LDS, causing significant enhancement of its native fluorescence. The fluorescence intensity was measured at 430 nm after excitation at 340 nm. The fluorescence-concentration plot was rectilinear over the range 1-400 ng mL-1 with detection and quantification limits of 0...
May 16, 2018: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
Marianne Martinello, Behzad Hajarizadeh, Jason Grebely, Gregory J Dore, Gail V Matthews
The management of acute HCV infection has not been standardized following the availability of direct-acting antiviral agents (DAAs) for chronic HCV infection, and substantial uncertainty exists regarding the optimal treatment regimen and duration. Despite the lack of direct evidence, the 2016 American Association for the Study of Liver Diseases (AASLD)-Infectious Diseases Society of America (IDSA) guidelines supported "the same regimens for acute HCV as recommended for chronic HCV infection … owing to high efficacy and safety", whereas the 2016 European Association for the Study of the Liver (EASL) guidelines recommended sofosbuvir-ledipasvir, sofosbuvir-velpatasvir or sofosbuvir plus daclatasvir for 8 weeks in acute HCV infection, with a longer duration of 12 weeks recommended for those infected with HIV and/or baseline HCV RNA levels >1,000,000 IU/ml...
May 17, 2018: Nature Reviews. Gastroenterology & Hepatology
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