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Jérôme Dumortier, François Bailly, Georges-Philippe Pageaux, Anaïs Vallet-Pichard, Sylvie Radenne, François Habersetzer, Marie-Claude Gagnieu, Jean-Didier Grangé, Anne Minello, Olivier Guillaud, Nassim Kamar, Laurent Alric, Vincent Leroy
BACKGROUND: Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, second-generation direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCV-infected patients with severe renal failure [including haemodialysis (HD) patients]...
October 19, 2016: Nephrology, Dialysis, Transplantation
Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
Kendall R Beck, Nicole Kim, Mandana Khalili
BACKGROUND: Vulnerable populations are disproportionately affected by hepatitis C virus (HCV) infection and experience high rates of health disparity. There are no data on real-world experience with highly efficacious direct-acting anti-HCV treatment in this population. AIMS: We aimed to evaluate the real-world experience with sofosbuvir-based regimens among a vulnerable HCV-infected population. METHODS: HCV treatment response was assessed among 204 patients who completed 12-24 weeks of sofosbuvir-based regimens (in combination with pegylated interferon and ribavirin, simeprevir, ledipasvir, or daclatasvir) at the San Francisco safety-net healthcare system liver specialty clinic between January 2014 and December 2015...
October 14, 2016: Digestive Diseases and Sciences
L Benítez-Gutiérrez, C de Mendoza, I Baños, A Duca, A Arias, A Treviño, S Requena, M J Citores, V Cuervas-Mons
New direct-acting antivirals (DAAs) have dramatically improved sustained virologic response (SVR) rates in patients treated for chronic hepatitis C. Although the safety of these agents has been very good in registration trials, unexpected side effects have been reported after much broader use of DAAs on marketing. We retrospectively examined all liver transplant recipients with chronic hepatitis C that received sofosbuvir-based regimens at our clinic. A total of 24 liver transplant recipients with recurrent chronic hepatitis C had received sofosbuvir up to April 2015...
September 2016: Transplantation Proceedings
Zobair M Younossi, Haesuk Park, Douglas Dieterich, Sammy Saab, Aijaz Ahmed, Stuart C Gordon
BACKGROUND: New direct-acting antiviral (DAA) therapy has dramatically increased cure rates for patients infected with hepatitis C virus (HCV), but has also substantially raised treatment costs. AIM: The aim of this analysis was to evaluate the therapeutic benefit and net costs (i.e. efficiency frontier) and the quality-adjusted cost of care associated with the evolution of treatment regimens for patients with HCV genotype 1 in the United States. DESIGN: A decision-analytic Markov model...
October 2016: Medicine (Baltimore)
M P Economides, P Mahale, A Kyvernitakis, F Turturo, H Kantarjian, A Naing, J Hosry, T L Shigle, A Kaseb, H A Torres
BACKGROUND: Antiviral therapy improves hepatic outcomes in hepatitis C virus (HCV)-infected cancer patients. However, such patients are not treated simultaneously with antivirals and chemotherapy, owing to overlapping toxicities with previous standard of care treatment of pegylated interferon and ribavirin. AIM: To examine the safety and clinically-significant drug-drug interactions observed in patients who received simultaneous treatment with direct-acting antivirals (DAAs) and chemotherapy...
October 11, 2016: Alimentary Pharmacology & Therapeutics
Rasha Eletreby, Wafaa Elakel, Mohamed Said, Mohamed Elkassas, Sameh Seif, Tamer Elbaz, Maissa El Raziky, Siham Abdel Rehim, Samy Zaky, Rabab Fouad, Hadeel Gamal, Mahmoud Abdo, Mohamed Korany, Ayman Yosry, Magdy El Serafy, Manal Hamdy El-Sayed, Yehia ElShazly, Imam Waked, Wahid Doss, Gamal Esmat
BACKGROUND & AIM: Major changes have emerged during the last few years in the therapy of chronic HCV. Several direct acting antiviral agents have been developed showing potent activity with higher rates of sustained virological response (SVR), even in difficult-to-treat patients. This study explores real life experience concerning efficacy, safety and possible predictors of response for the first cohort of Egyptian patients with chronic HCV genotype IV treated with Sofosbuvir / Simprevir combination therapy...
October 6, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
B Fevery, T Verbinnen, M Peeters, K Janssen, J Witek, W Jessner, S De Meyer, O Lenz
Simeprevir is a hepatitis C virus NS3/4A protease inhibitor. Hepatitis C virus baseline NS3/4A polymorphisms and emerging mutations were characterized in treatment-naїve and treatment-experienced genotype 4-infected patients treated with simeprevir+peginterferon/ribavirin in the RESTORE study. Population sequencing of the NS3/4A region was performed and in vitro simeprevir activity against site-directed mutants or chimeric replicons with patient-derived NS3 protease sequences was assessed in a transient replicon assay...
October 3, 2016: Journal of Viral Hepatitis
Stefan Mauss, Florian Berger, Malte H Wehmeyer, Patrick Ingiliz, Dietrich Hueppe, Thomas Lutz, Karl G Simon, Knud Schewe, Juergen K Rockstroh, Axel Baumgarten, Stefan Christensen
HCV has complex interactions with human lipid metabolism leading to down regulation of cholesterol levels. Interferon therapy has been shown to decrease cholesterol even further. With the availability of second generation direct acting antiviral agents (DAA) the effect of suppressing and eliminating HCV on lipid metabolism warrants reevaluation. 
Methods: Prospective German multicenter cohort on HCV- and HIV/HCV-infected patients treated with direct antiviral agents (GECCO). Lipids were assessed at baseline, during and after therapy...
September 29, 2016: Antiviral Therapy
Tatsuya Ide, Yuichiro Eguchi, Masaru Harada, Kunihide Ishii, Masaru Morita, Yasuyo Morita, Gen Sugiyama, Hirofumi Fukushima, Yoichi Yano, Kazunori Noguchi, Hiroki Nakamura, Junjiro Hisatomi, Hiroto Kumemura, Miki Shirachi, Shinji Iwane, Michiaki Okada, Yuichi Honma, Teruko Arinaga-Hino, Ichiro Miyajima, Kei Ogata, Reiichiro Kuwahara, Keisuke Amano, Toshihiro Kawaguchi, Ryoko Kuromatsu, Takuji Torimura
BACKGROUND: The aim of this study was to evaluate the efficacy of daclatasvir plus asunaprevir therapy in patients infected with hepatitis C virus and determine its relevance to resistant variants. METHODS: A total of 629 consecutive patients infected with hepatitis C virus genotype 1 were assessed. Daclatasvir (60 mg/day) plus asunaprevir (200 mg/day) was given for 24 weeks. The virological responses and resistance-associated substitutions of hepatitis C virus mutants were examined by the direct sequence and cycleave methods were evaluated...
2016: PloS One
S W Johnson, M M Davis, L M Stever, D H Priest
WHAT IS KNOWN AND OBJECTIVE: Significant progression in the treatment of chronic hepatitis C virus has been made with the introduction of direct-acting antivirals (DAAs). However, limited data are available for the retreatment of individuals who have failed multiple prior DAAs. CASE DESCRIPTION: We report a single case of an individual who was unsuccessfully treated with five prior hepatitis C virus treatment regimens including simeprevir plus sofosbuvir who was successfully cured after treatment with ledipasvir/sofosbuvir...
September 27, 2016: Journal of Clinical Pharmacy and Therapeutics
Pavel Lavitas, Mark Tesell, Tasmina Hydery, Bonnie C Greenwood, Mylissa Price, Kimberly Lenz, Paul Jeffrey
BACKGROUND: Breakthrough direct-acting antivirals set a new standard in the management of hepatitis C virus (HCV) with regard to cure rates and improved tolerability; however, the health care system is challenged by the cost of these medications. OBJECTIVE: To describe the effect of a comprehensive HCV medication management program on optimized regimen use, prior authorization (PA) modifications, and medication cost avoidance in a state Medicaid program. METHODS: This program consists of a 2-tiered prescriber outreach: (1) regimen outreach to promote optimized regimen selection and (2) refill outreach to support medication adherence...
October 2016: Journal of Managed Care & Specialty Pharmacy
Timothy P Gauthier, Eva Moreira, Chantal Chan, Alexandria Cabrera, Maribel Toro, Mara Z Carrasquillo, Mark Corentin, Elizabeth M Sherman
OBJECTIVES: To describe an innovative hepatitis C virus (HCV) care program and treatment outcomes resulting from pharmacist services. SETTING: Adult ambulatory care HCV clinic within the Miami Veteran Affairs Healthcare System. PRACTICE DESCRIPTION: Pharmacists with limited prescriptive authority are integrated into a medical hepatology care team. PRACTICE INNOVATION: Pharmacists screen patients with HCV infection for treatment eligibility, counsel patients upon treatment initiation, assess ongoing treatment success and toxicity through patient appointments, telephone calls, and the ordering of pertinent laboratory data, and provide oversight of all patients on HCV therapies...
September 22, 2016: Journal of the American Pharmacists Association: JAPhA
Astrid M Newsum, Cynthia K Y Ho, Faydra I Lieveld, Thijs J W Van De Laar, Sylvie M Koekkoek, Sjoerd P Rebers, Jan T M Van Der Meer, Anne M J Wensing, Greet J Boland, Joop E Arends, Karel J Van Erpecum, Maria Prins, Richard Molenkamp, Janke Schinkel
OBJECTIVES: The Q80K polymorphism is a naturally occurring resistance-associated variant (RAV) in the hepatitis C virus (HCV) NS3 region and is likely transmissible between hosts. This study describes the Q80K origin and prevalence among HCV risk groups in the Netherlands and examines whether Q80K is linked to specific transmission networks. DESIGN AND METHODS: Stored blood samples from HCV genotype 1a infected patients were used for PCR and sequencing to reconstruct the NS3 maximum likelihood phylogeny...
September 20, 2016: AIDS
Hiromi Kan, Michio Imamura, Takuro Uchida, Nobuhiko Hiraga, C Nelson Hayes, Masataka Tsuge, Hiromi Abe, Hiroshi Aikata, Grace Naswa Makokha, Sajeda Chowdhury, Daiki Miki, Hidenori Ochi, Yuji Ishida, Chise Tateno, Kazuaki Chayama
BACKGROUND:  Although treatment-emergent NS3/4A protease inhibitor (PI)-resistant variants typically decrease in frequency after cessation of PI therapy in chronic hepatitis C patients, susceptibility to PIs in patients who have previously failed to respond to PI therapy has not been addressed. METHODS:  Genotype 1 chronic hepatitis C patients were treated either with simeprevir plus interferon or with daclatasvir plus asunaprevir. Frequencies of drug-resistant mutations in treatment failure were analyzed by deep sequencing...
September 20, 2016: Journal of Infectious Diseases
N Raschzok, E Schott, A Reutzel-Selke, I Damrah, S Gül-Klein, B Strücker, I M Sauer, J Pratschke, D Eurich, M Stockmann
BACKGROUND: The new directly acting antivirals (DAAs) enable all-oral interferon-free treatment of chronic hepatitis C virus (HCV) infection. We here investigated the effect of DAAs on the enzymatic liver function of liver transplant recipients with recurrent hepatitis C. METHODS: Twenty-one patients with elevated liver enzymes or advanced fibrosis/compensated cirrhosis due to recurrent HCV were treated with sofosbuvir either in combination with simeprevir, or in combination with ribavirin or daclatasvir with or without ribavirin for 12 weeks...
September 15, 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Reona Morio, Michio Imamura, Yoshiiku Kawakami, Kei Morio, Tomoki Kobayashi, Satoe Yokoyama, Yuki Kimura, Yuko Nagaoki, Tomokazu Kawaoka, Masataka Tsuge, Akira Hiramatsu, C Nelson Hayes, Hiroshi Aikata, Shoichi Takahashi, Daiki Miki, Hidenori Ochi, Nami Mori, Shintaro Takaki, Keiji Tsuji, Kazuaki Chayama
BACKGROUND: Daclatasvir and asunaprevir combination therapy has shown a high virological response for chronic genotype 1 hepatitis C virus (HCV)-infected patients. However, the safety and efficacy of the therapy for older patients are unknown. METHODS: One hundred seventy patients younger than 75 years and 139 patients aged 75 years or older with genotype 1 HCV infection were treated for 24 weeks with daclatasvir plus asunaprevir. Pretreatment drug-resistance-associated variants at NS5A-L31 and NS5A-Y93 were determined by the Invader assay...
September 8, 2016: Journal of Gastroenterology
Vicente Gimeno-Ballester, Miguel Ángel Simón, Cristina Trigo, Javier Mar, Ramón San Miguel
INTRODUCTION: Sofosbuvir (SOF) with simeprevir (SIM) combination was the first interferon-free regimen that reached optimal results in terms of sustained viral response (SVR). AREAS COVERED: A systematic review of the scientific literature concerning the effects that the SOF/SIM combination had on hepatitis C genotype 1 patients yielded 771 references. After the revision process, four clinical trials and 15 observational studies met the inclusion criteria; in total, these studies involved 5,766 patients...
September 21, 2016: Expert Review of Gastroenterology & Hepatology
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MED WATCH program (800-FDA-1088). If you have reported an interesting, preventable ADR to MED WATCH, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: Your report will be published anonymously unless otherwise requested...
November 2015: Hospital Pharmacy
Nadia Marascio, Grazia Pavia, Alessio Strazzulla, Tim Dierckx, Lize Cuypers, Bram Vrancken, Giorgio Settimo Barreca, Teresa Mirante, Donatella Malanga, Duarte Mendes Oliveira, Anne-Mieke Vandamme, Carlo Torti, Maria Carla Liberto, Alfredo Focà, The Sinergie-Umg Study Group
Naturally occurring resistance-associated substitutions (RASs) can negatively impact the response to direct-acting antivirals (DAAs) agents-based therapies for hepatitis C virus (HCV) infection. Herein, we set out to characterize the RASs in the HCV1b genome from serum samples of DAA-naïve patients in the context of the SINERGIE (South Italian Network for Rational Guidelines and International Epidemiology, 2014) project. We deep-sequenced the NS3/4A protease region of the viral population using the Ion Torrent Personal Genome Machine, and patient-specific majority rule consensus sequence summaries were constructed with a combination of freely available next generation sequencing data analysis software...
2016: International Journal of Molecular Sciences
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