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Haozhi Fan, Peng Huang, Ting Tian, Jingjing Wu, Xueshan Xia, Yue Feng, Jie Wang, Rongbin Yu, Yun Zhang, Ming Yue
BACKGROUND AND AIM: Sofosbuvir is a hepatitis C virus (HCV) NS5B polymerase inhibitor. The objective of this study was to explore the efficacy and safety of sofosbuvir for HCV genotype (GT) 2 and 3 infected patients. METHOD: We searched randomized controlled trials (RCTs) which analyzed the efficacy and safety of sofosbuvir-containing regimens for HCV GT 2/3 infected patients and collected data. The endpoints were sustained virological response 12- and 24-weeks after the cessation of therapy (SVR12 and SVR24), the adverse events (AEs) and the severe adverse events (SAEs)...
June 2018: Journal of Gastrointestinal and Liver Diseases: JGLD
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
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
Dorota Zarębska-Michaluk, Piotr M Stępień, Katarzyna Paluch, Paweł Pabjan
A 52-year-old woman with chronic hepatitis C virus genotype 3 infection developed clinically symptomatic mixed cryoglobulinemia. She started pegylated interferon and ribavirin therapy and in week 12 became negative for HCV RNA with resolution of clinical signs of cryoglobulinemia. The dual treatment was discontinued due to interferon-related bilateral retinopathy. After therapy cessation, relapse of HCV RNA and recurrence of symptomatic cryoglobulinemia were observed. While waiting for the antiviral retreatment option she developed glomerulonephritis with renal impairment...
June 2018: Clinical and Experimental 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
Ada Bertoli, Maria Chiara Sorbo, Marianna Aragri, Ilaria Lenci, Elisabetta Teti, Ennio Polilli, Velia Chiara Di Maio, Laura Gianserra, Elisa Biliotti, Chiara Masetti, Carlo F Magni, Sergio Babudieri, Laura A Nicolini, Martina Milana, Pierluigi Cacciatore, Loredana Sarmati, Adriano Pellicelli, Stefania Paolucci, Antonio Craxì, Filomena Morisco, Valeria Pace Palitti, Massimo Siciliano, Nicola Coppola, Nerio Iapadre, Massimo Puoti, Giuliano Rizzardini, Gloria Taliani, Caterina Pasquazzi, Massimo Andreoni, Giustino Parruti, Mario Angelico, Carlo Federico Perno, Valeria Cento, Francesca Ceccherini-Silberstein
Natural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7...
June 12, 2018: Scientific Reports
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
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
Kosh Agarwal, Lluís Castells, Beat Müllhaupt, William M C Rosenberg, Brian McNabb, Sarah Arterburn, Gregory Camus, John McNally, Luisa M Stamm, Diana M Brainard, G Mani Subramanian, Zoe Mariño, Jean-François Dufour, Xavier Forns
BACKGROUND & AIMS: Sofosbuvir, an NS5B inhibitor, combined with velpatasvir, an NS5A inhibitor (SOF/VEL), produces high sustained virologic response rates 12 weeks after treatment (SVR12) in patients with genotype 1-6 HCV infection, and has no anticipated clinically relevant drug-drug interactions with immunosuppressants. This study evaluated the safety and efficacy of SOF/VEL in adults with recurrent chronic genotype 1-4 HCV infection after liver transplant. METHODS: Patients received SOF/VEL 400/100 mg daily for 12 weeks...
June 7, 2018: Journal of Hepatology
B B Summers
Hepatitis C virus (HCV) is a significant public health burden worldwide, owing in large part to ineffective and poorly tolerated treatments. The antivirals have evolved over time to become more effective and better tolerated with cure rates increasing from an average of 50% to a complete virologic response. This article summarizes the latest Food and Drug Administration (FDA)-approved addition to combination treatment for patients with HCV, voxilaprevir plus sofosbuvir/velpatasvir.
April 2018: Drugs of Today
Young Min Kim, Seok Bae Kim, Il Han Song, Sae Hwan Lee, Hong Soo Kim, Tae Hee Lee, Young Woo Kang, Seok Hyun Kim, Byung Seok Lee, Hee Bok Chae, Myeong Jun Song, Ji Woong Jang, Soon Yeong Ko, Jae Dong Lee
Background/Aims: Sofosbuvir plus ribavirin is a standard treatment for patients infected with chronic hepatitis C virus (HCV) genotype 2 in Korea. The purpose of this study was to examine the efficacy and safety of this treatment in Korean patients with chronic HCV genotype 2 infection. Methods: We retrospectively analyzed clinical data of patients treated with sofosbuvir plus ribavirin for chronic HCV genotype 2 from May 2016 to December 2017 at eight hospitals located in the Daejeon-Chungcheong area...
June 4, 2018: Clinical and Molecular Hepatology
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
Amit Goel, Qiushi Chen, Jagpreet Chhatwal, Rakesh Aggarwal
BACKGROUND: Treatment of HCV infection with low-cost generic direct-acting antivirals (DAAs) available in India and other developing countries needs determination of HCV genotype ('genotype-dependent' regimens). Generic velpatasvir, a DAA that obviates the need for genotype determination ('pan-genotypic' regimen) recently became available but is costlier. AIM: To evaluate the cost-effectiveness of genotype-dependent versus pan-genotypic DAA treatments in India. METHODS: A previously-validated microsimulation model, adapted to Indian population, was used to compare the costs and long-term outcomes of three scenarios: no treatment, and treatment with genotype-dependent and pan-genotypic regimens...
June 4, 2018: Journal of Gastroenterology and Hepatology
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