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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
Henrique Pott Junior, Guilherme Bricks, Giuliano Grandi, Jorge Figueiredo Senise, Adauto Castelo Filho
OBJECTIVES: This study aimed to investigate the efficacy and safety of sofosbuvir plus daclatasvir (SOF+DCV) or simeprevir (SOF+SMV) in a randomized, open-label, non-inferiority trial of patients infected with hepatitis c virus (HCV) genotype 1, who were previously unresponsive to pegylated interferon and ribavirin or were treatment-naïve. METHODS: Patients were randomly assigned to receive SOF (400 mg once daily) plus DCV (60 mg once daily) or SMV (150 mg once daily) for 12 weeks...
June 12, 2018: Clinical Microbiology and Infection
Fumitaka Suzuki, Naoya Hatanaka, Etsuya Bando, Koji Nakamura, Akira Komoto
BACKGROUND: Safety and effectiveness of daclatasvir (DCV)/asunaprevir (ASV) dual therapy were demonstrated in Japanese patients with chronic hepatitis C (CHC) genotype (GT) 1b in phase III studies. This postmarketing surveillance (PMS) was conducted to assess the safety and effectiveness of DCV/ASV in Japanese patients with GT-1 CHC treated in routine clinical practice. METHODS: This PMS was conducted between September 2014 and February 2017 at 261 centers in Japan...
May 2018: Hepatology International
Sara Lo Menzo, Enrico Biagi, Mariachiara Di Nuzzo, Anastasio Grilli, Carlo Contini
Directly-acting antivirals (DAA) have changed the chronic hepatitis C virus (HCV) infection therapeutic scenario allowing virus eradication in more than 95% of patients, independently from the genotype, with 12 to 24-week treatment regimens. We describe a 51-year-old Pakistani man with a chronic HCV-genotype 3 (GT3a) infection with moderate liver fibrosis, who achieved sustained virological response (SVR) 24 after a tripled dose of Daclatasvir (DCV) taken erroneously associated to Sofosbuvir (SOF). The patient had a concomitant intestinal TB infection whose treatment had been delayed in order to firstly eradicate HCV to reduce the liver toxicity of anti-mycobacterial drugs...
July 2018: Annals of Hepatology
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
Ankur Gupta, Puneet Arora, Priyanka Jain
Background: Hepatitis C infection is known to increase the morbidity in patients with end stage renal disease (ESRD). Interferon based treatment is poorly tolerated and has limited cure rates in these patients. In limited available data, sofosbuvir based regimens have been shown to have favorable outcomes in these patients. Methods: We treated 7 patients with ESRD on hemodialysis, 6 with chronic hepatitis C and one with acute hepatitis C. Two of them were cirrhotic of which one was decompensated...
June 2018: Journal of Clinical and Experimental Hepatology
A Thiam, B Conway
Hepatitis C is killing 350,000 persons per year worldwide, 60% of the cases being patients with genotype 1 (GT-1). The fixed-dose tablet combination of daclatasvir (30 mg)/asunaprevir (200 mg)/beclabuvir (75 mg), DCV-TRIO, is one of the latest drugs in the pipeline of interferon-free direct-acting antiviral hepatitis C virus (HCV) therapies. DCV-TRIO increases the genetic barrier to resistance by acting at the same time against three hepatitis C key viral proteins. Results from the UNITY 1, 2, 3 and 4 phase III clinical trials showed that DCV-TRIO exhibited high sustained virologic responses at 12 weeks (between 92% and 100% for HCV GT-1 treatment-naive patients)...
April 2018: Drugs of Today
Noha N Atia, Salwa R El-Shaboury, Samia M El-Gizawy, Mohammad Nabil Abo-Zeid
Sofosbuvir (SOF) and daclatasvir (DCS) are novel, recently developed direct acting antiviral agents characterized by potent anti-hepatitis C virus action. A fast and efficient HPLC-UV method was developed, validated and applied for simultaneous determination of SOF and DCS in pharmaceutical formulations and biological fluids based on coupling liquid-liquid extraction with ultrasound and dual wavelength detection at λmax ; 260 and 313 nm for SOF and DCS, respectively. This approach provided simple, sensitive, specific and cost-effective determination of the SOF-DCS mixture with good recoveries of the analytes from plasma...
May 22, 2018: Journal of Pharmaceutical and Biomedical Analysis
Wen Chen, Thomas Ward, Mai Ping Tan, Jing Yan, Peter Feng Wang, Gail D Wygant, Jason Gordon
AIM: To evaluate the cost-effectiveness of the novel all-oral direct-acting antiviral regimen daclatasvir + asunaprevir (DUAL), versus interferon-based regimens for the treatment of chronic hepatitis C virus genotype 1b infection. METHODS: Inputs for a lifetime Markov model were sourced from clinical trials and published literature. Outputs include disease management costs, life expectancy, quality-adjusted life-years and cost-effectiveness. Sensitivity analyses assessed the drivers of cost-effectiveness and sustained virologic response thresholds at which DUAL is cost-saving...
June 4, 2018: Journal of Comparative Effectiveness Research
Seyed M Alavian, Heidar Sharafi
No abstract text is available yet for this article.
July 2018: European Journal of Gastroenterology & Hepatology
Isak Sundberg, Anders Lannergård, Mia Ramklint, Janet L Cunningham
BACKGROUND: Treatment of Hepatitis C virus (HCV) infection has evolved from interferon (IFN)-based treatments to direct-acting antivirals (DAAs). Patients with HCV have an elevated psychiatric morbidity (including substance abuse) and patients with such comorbidity have often been excluded from treatment with IFN. To date, little is known about psychiatric adverse effects of DAA-based regimens. We therefore aimed to study the psychiatric side effects of new IFN-free treatment for HCV (including depressive symptoms and sleep) in real world patients also including those with a history of psychiatric diagnosis, substance abuse or drug dependence...
May 29, 2018: BMC Psychiatry
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
Ashish Dogra, Shipra Bhatt, Asmita Magotra, Anjna Sharma, Pankul Kotwal, Abhishek Gour, Priya Wazir, Gurdarshan Singh, Utpal Nandi
Curcumin, a natural diarylheptanoid, is extensively used as a food additive or dietary supplement on the regular basis. It is known to have potential to encumber the drug transporters and hepatic drug metabolizing enzymes that lead to pharmacokinetic interactions with drug or food. Daclatasvir is a new orally acting drug for the treatment of chronic Hepatitis C Virus infections. This is a substrate of P-glycoprotein and CYP3A4 that are involved in the major pharmacokinetic interaction. Hence, the studies' aim is to assess for any possible pharmacokinetic interactions...
May 28, 2018: Phytotherapy Research: PTR
J Lu, H J Zhou, Q Xie
All-oral, pan-genotypic combination of direct-acting antiviral agents is currently clinically prescribed trends in the management of chronic hepatitis C virus infection. The combination of daclatasvir and sofosbuvir has proven strong antiviral activity across all common genotypes in clinical trials and real world studies. Furthermore, it can be safely used in patients with advanced liver disease, HCV/HIV co-infection, or HCV recurrence after liver transplantation, more patients will gain clinical benefits. We aim to summarize the clinical progress about this combination...
February 20, 2018: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
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
Jae Young Oh, Byung Seok Kim, Chang Hyeong Lee, Jeong Eun Song, Heon Ju Lee, Jung Gil Park, Jae Seok Hwang, Woo Jin Chung, Byoung Kuk Jang, Young Oh Kweon, Won Young Tak, Soo Young Park, Se Young Jang, Jeong Ill Suh, Sang Gyu Kwak
Background/Aims: Previous studies have reported a high rate of sustained virologic response (SVR) and a low rate of serious adverse events with the use of daclatasvir (DCV) and asunaprevir (ASV) combination therapy. We evaluated the efficacy and safety of DCV and ASV combination therapy for patients with chronic hepatitis C virus (HCV) genotype 1b infection in real world. Methods: We enrolled 278 patients (184 treatment-naïve patients) from five hospitals in Daegu and Gyeongsangbuk-do...
May 25, 2018: Korean Journal of Internal Medicine
Jessica Cusato, Amedeo De Nicolò, Lucio Boglione, Fabio Favata, Alessandra Ariaudo, Simone Mornese Pinna, Chiara Carcieri, Federica Guido, Giuseppe Cariti, Giovanni Di Perri, Antonio D'Avolio
AIM: Vitamin D (VD) influences genetic expression through its receptor (VDR). VD pathway gene polymorphisms seem to influence antiviral drug pharmacokinetics and therapeutic outcome/toxicity. We investigated the association between daclatasvir (DCV) plasma concentrations and genetic variants (SNPs) associated with the VD pathway. PATIENTS & METHODS: Chronic hepatitis C patients treated with DCV from 2014 to 2016 were included. Genotypes were assessed through real-time PCR and plasma concentrations through liquid chromatography...
June 1, 2018: Pharmacogenomics
Wafaa S Hassan, Manal S Elmasry, Heba M Elsayed, Dalia W Zidan
In accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, six novel, simple and precise sequential spectrophotometric methods were developed and validated for the simultaneous analysis of Ribavirin (RIB), Sofosbuvir (SOF), and Daclatasvir (DAC) in their mixture without prior separation steps. 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...
May 18, 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
Luis Antonio Uribe-Noguez, Alicia Ocaña-Mondragón, José Antonio Mata-Marín, Allison Cázares-Cortázar, Rosa María Ribas-Aparicio, María Elena Gómez-Torres, Jesus Gaytán-Martínez, María de la Luz Martínez-Rodríguez
Hepatitis C virus (HCV) infection is a global health problem. HCV has been classified into seven genotypes and >67 subtypes. Genotyping is necessary to enable selection of appropriate treatments. The commercial molecular techniques currently used do not identify some HCV subtypes, mixed infections and recombinant forms. In this study, the core-E1 and NS5B regions were sequenced and phylogenetically analysed to identify infections by HCV recombinant genotype 1b-2b in two patients who had initially been diagnosed with HCV genotype 2 infection by reverse hybridization with a Versant HCV Genotype 2...
May 15, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
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