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L P Zanaga, N Miotto, L C Mendes, R S B Stucchi, A G Vigani
Hepatitis C virus (HCV) genotype 3 is responsible for 30.1% of chronic hepatitis C infection cases worldwide. In the era of direct-acting antivirals, these patients have become one of the most challenging to treat, due to fewer effective drug options, higher risk of developing cirrhosis and hepatocellular carcinoma and lower sustained virological response (SVR) rates. Currently there are 4 recommended drugs for the treatment of HCV genotype 3: pegylated interferon (PegIFN), sofosbuvir (SOF), daclatasvir (DCV) and ribavirin (RBV)...
October 24, 2016: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
Eva Schrezenmeier, Kayin Wu, Fabian Halleck, Lutz Liefeldt, Susanne Brakemeier, Friederike Bachmann, Susanne Kron, Klemens Budde, Michael Duerr
Recurrence of hepatitis C virus (HCV)-associated membranoproliferative glomerulonephritis (MPGN) in the kidney transplant may lead to continuous graft deterioration and the need for further renal replacement therapy. The novel direct acting antiviral agents (DAAs) allow a highly effective and interferon-free treatment option for chronic HCV infected patients. Data on the therapeutic safety and efficacy in HCV infected renal transplant patients are sparse, especially for patients with severe renal impairment...
October 25, 2016: American Journal of Transplantation
Jun Itakura, Masayuki Kurosaki, Chitomi Hasebe, Yukio Osaki, Kouji Joko, Hitoshi Yagisawa, Shinya Sakita, Hiroaki Okushin, Takashi Satou, Hiroyuki Hisai, Takehiko Abe, Keiji Tsuji, Takashi Tamada, Haruhiko Kobashi, Akeri Mitsuda, Yasushi Ide, Chikara Ogawa, Syotaro Tsuruta, Kouichi Takaguchi, Miyako Murakawa, Yasuhiro Asahina, Nobuyuki Enomoto, Namiki Izumi
BACKGROUNDS & AIMS: We aimed to clarify the characteristics of resistance-associated substitutions (RASs) after treatment failure with NS5A inhibitor, daclatasvir (DCV) in combination with NS3/4A inhibitor, asunaprevir (ASV), in patients with chronic hepatitis C virus genotype 1b infection. METHODS: This is a nationwide multicenter study conducted by the Japanese Red Cross Liver Study Group. The sera were obtained from 68 patients with virological failure after 24 weeks of DCV/ASV treatment...
2016: PloS One
Norihiko Morisawa, Yohei Koshima, Jun-Ichi Satoh, Yukio Maruyama, Satoru Kuriyama, Takashi Yokoo, Morimasa Amemiya
AIM: Combination therapy with Daclatasvir (DCV) plus Asunaprevir (ASV) has been proven effective in patients with chronic hepatitis C virus (HCV) infection. However, little is known as to the effect of this therapy in patients with reduced renal function. Focusing on CKD patients whose renal function has declined, the present trial addresses the efficacy and safety of this combination therapy in CKD patients with reduced estimated glomerular filtration rate (eGFR). MATERIALS AND METHODS: The study design is a single-center, retrospective longitudinal observational study enrolling 106 patients with (n = 29) or without (n = 77) CKD...
October 22, 2016: Clinical and Experimental Nephrology
Noboru Hirashima, Hiroaki Iwase, Masaaki Shimada, Nobumitsu Ryuge, Junji Imamura, Hiroki Ikeda, Yasuhito Tanaka, Nobuyuki Matsumoto, Chiaki Okuse, Fumio Itoh, Yoshiyuki Yokomaku, Tsunamasa Watanabe
Co-infection with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) often accelerates the course of HCV-associated liver disease. Daclatasvir (DCV) plus asunaprevir (ASV) have been shown to be highly effective for HCV-infected patients with genotype 1b. Three patients co-infected with HIV/HCV genotype 1b were enrolled in this study. Prior to initiation of HCV treatment, the variants associated with L31 and Y93 in the non-structural protein 5A (NS5A) region of the HCV genome were confirmed to be absent using a direct sequencing method...
October 20, 2016: Clinical Journal of Gastroenterology
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
Y Wang, P Liu
WHAT IS KNOWN AND THE OBJECTIVE: Sofosbuvir (SOF) and daclatasvir (DCV) have revolutionized the treatment of hepatitis C virus and now represent the preferred therapy for this disease. Limited data are available on the dermatological side effects resulting from co-administration of SOF and DCV. CASE DESCRIPTION: We report a case of an erythema multiforme drug eruption associated with erythrodermic psoriasis induced by SOF and DCV. After ceasing treatment, the skin condition significantly improved...
October 18, 2016: Journal of Clinical Pharmacy and Therapeutics
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
Satoru Hagiwara, Naoshi Nishida, Tomohiro Watanabe, Toshiharu Sakurai, Hiroshi Ida, Yasunori Minami, Masahiro Takita, Tomohiro Minami, Mina Iwanishi, Hirokazu Chishina, Kazuomi Ueshima, Yoriaki Komeda, Tadaaki Arizumi, Masatoshi Kudo
OBJECTIVE: Treatment for chronic hepatitis C has recently developed in a very rapid manner. In Japan, in September 2014, IFN-free asunaprevir (ASV) and daclatasvir (DCV) became available for combination therapy. We report the treatment outcomes achieved at our hospital using this combination therapy. METHODS: Sustained virological response (SVR) 24 could be evaluated in 120 of 125 patients with chronic liver disease type C who visited our hospital and were treated with ASV/DCV after September 2014, and these patients were analyzed...
2016: Digestive Diseases
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
Maribel Rodriguez-Torres, Eric Lawitz, Bienvenido Yangco, Lennox Jeffers, Steven-Huy Han, Paul J Thuluvath, Vinod Rustgi, Stephen Harrison, Reem Ghalib, John M Vierling, Velimir Luketic, Philippe J Zamor, Natarajan Ravendhran, Timothy R Morgan, Brian Pearlman, Christopher O'Brien, Hicham Khallafi, Nikolaos Pyrsopoulos, George Kong, Fiona McPhee, Philip D Yin, Eric Hughes, Michelle Treitel
:  Background. Patient race and ethnicity have historically impacted HCV treatment response. This phase 3 study evaluated daclatasvir with peginterferon-alfa-2a/ribavirin (pegIFN alfa-2a/RBV) in treatment-naive black/African American (AA), Latino, and white non-Latino patients with chronic HCV genotype 1 infection. MATERIAL AND METHODS: In this single-arm, open-label study, 246 patients received daclatasvir plus pegIFN alfa-2a and weight-based RBV. Patients with an extended rapid virologic response (eRVR; undetectable HCV-RNA at treatment weeks 4 and 12) received 24 weeks of treatment; those without eRVR received an additional 24 weeks of treatment with pegIFN alfa-2a/RBV...
November 2016: Annals of Hepatology
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
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
Satoru Hashimoto, Hiroshi Yatsuhashi, Seigo Abiru, Kazumi Yamasaki, Atsumasa Komori, Shinya Nagaoka, Akira Saeki, Shinjiro Uchida, Shigemune Bekki, Yuki Kugiyama, Kazuyoshi Nagata, Minoru Nakamura, Kiyoshi Migita, Kazuhiko Nakao
BACKGROUND & AIM: We performed lipid analyses at the early period of therapy in patients with chronic hepatitis C who underwent interferon (IFN)-free direct-acting antiviral (DAA) treatment, and we attempted to identify the factors that contributed to a rapid increase in the patients' serum low-density lipoprotein cholesterol (LDL-C) concentration. METHODS: We retrospectively analyzed the cases of 100 consecutive patients with HCV infection treated at the National Hospital Organization Nagasaki Medical Center: 24 patients underwent daclatasvir (DCV) and asunaprevir (ASV) combination therapy (DCV/ASV) for 24 weeks, and the other 76 patients underwent ledipasvir and sofosbuvir combination therapy (LDV/SOF) for 12 weeks...
2016: PloS One
Tushar Garimella, Xiaoli You, Reena Wang, Shu-Pang Huang, Hamza Kandoussi, Marc Bifano, Richard Bertz, Timothy Eley
: The treatment of hepatitis C virus (HCV) infection has been revolutionized in recent years by the development of direct-acting antiviral regimens that do not contain peginterferon (pegIFN) and/or ribavirin (RBV). While direct-acting antiviral-based regimens have been shown to be greatly superior to pegIFN/RBV-based regimens in terms of efficacy and safety, they have a greater susceptibility to drug-drug interactions (DDIs). Daclatasvir (DCV)-the benchmark pangenotypic nonstructural protein 5A inhibitor-has been shown to be efficacious and generally well tolerated in partnership with other HCV direct-acting antivirals, including sofosbuvir, asunaprevir (ASV), and ASV plus beclabuvir...
September 23, 2016: Advances in Therapy
Qin Peng, Kang Li, Ming Rong Cao, Cai Qun Bie, Hui Jun Tang, Shao Hui Tang
Daclatasvir, a HCV NS5A inhibitor, is a new direct-acting antiviral drug for chronic hepatitis C (CHC). This study aimed to evaluate the efficacy and safety of daclatasvir combined with peginterferon-α (pegIFN-α) and ribavirin (RBV) for the treatment of CHC. The databases of PUBMED, EMBASE, COCHRANE, WANFANG, and CNKI were retrieved to identify eligible studies. Pooled risk ratio (RR) and 95 % confidence interval (CI) were calculated using random or fixed models. A total of six RCTs including 1100 adult patients with CHC met the inclusion criteria and the patients were infected with HCV genotype 1-4, with the genotype 1 infection accounting for 73...
2016: SpringerPlus
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
Min Gao, Donald R O'Boyle, Susan Roberts
The development of anti-HCV drugs is one of the most successful stories of antiviral therapy. In fact, for the first time in human history we have the potential to eradicate a chronic viral infection using only orally administered direct antiviral agents (DAAs). HCV NS5A replication complex inhibitors, exemplified by Daclatasvir (DCV, BMS-790052, Daklinza®), are a new class of DAA. The astonishing in vitro potency of DCV (pM to low nM range) translated to remarkable efficacy in clinical trials, and 2nd generation NS5A inhibitors have become essential components of HCV combination therapies...
October 2016: Current Opinion in Pharmacology
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