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daclatasvir transplant

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
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
Sylvie Prud'homme, Frederik Nevens, Ingele Casteels
We report a patient with a bilateral optic anterior ischemic neuropathy as an extrahepatic complication of a chronic hepatitis C (HCV) infection. The patient presented with a bilateral visual acuity loss and bilateral optic disc oedema. The optic neuropathy was associated with a sudden increase in the viral HCV load after a recent liver transplantation. The stop of the calcineurin inhibitor had no effect on the course of the optic neuropathy. Visual improvement and normalization of HCV viraemia occurred after treatment with sofosbuvir and daclatasvir, which are direct acting antivirals...
2016: GMS Ophthalmol Cases
Tania M Welzel, Jörg Petersen, Kerstin Herzer, Peter Ferenci, Michael Gschwantler, Heiner Wedemeyer, Thomas Berg, Ulrich Spengler, Ola Weiland, Marc van der Valk, Jürgen Rockstroh, Markus Peck-Radosavljevic, Yue Zhao, Maria Jesus Jimenez-Exposito, Stefan Zeuzem
OBJECTIVE: We assessed the effectiveness and safety of daclatasvir (DCV) plus sofosbuvir (SOF), with or without ribavirin (RBV), in a large real-world cohort, including patients with advanced liver disease. DESIGN: Adults with chronic HCV infection at high risk of decompensation or death within 12 months and with no available treatment options were treated in a European compassionate use programme. The recommended regimen was DCV 60 mg plus SOF 400 mg for 24 weeks; RBV addition or shorter duration was allowed at physicians' discretion...
September 7, 2016: Gut
Leon Louis Seifert, Hauke Heinzow, Iyad Kabar, Stefan Christensen, Anna Hüsing, Hartmut H-J Schmidt
BACKGROUND Direct-acting antivirals (DAAs) represent a new hallmark in antiviral therapy of hepatitis C virus (HCV). DAAs have been shown to be safe and effective after liver transplantation (LT), but there is little information about their use in peritransplant settings. Former intravenous drug users represent an increasing group seeking HCV treatment. This case report demonstrates the successful peritransplant antiviral treatment of a former intravenous drug user who had been treated in a methadone maintenance program...
2016: American Journal of Case Reports
Gillian M Keating
The hepatitis C virus (HCV) NS5A replication complex inhibitor daclatasvir (Daklinza(®)) is indicated for use in combination with sofosbuvir, with or without ribavirin, in a pangenotypic all-oral regimen. In patients with chronic HCV genotype 1 or 3 infection without cirrhosis, a 12-week regimen of daclatasvir plus sofosbuvir achieved high sustained virological response rates 12 weeks' post-treatment (SVR12), regardless of prior treatment experience, according to the results of the AI444040 and ALLY-3 trials...
September 2016: Drugs
Keisuke Arai, Kaori Kuramitsu, Takumi Fukumoto, Masahiro Kido, Atsushi Takebe, Motofumi Tanaka, Hisoka Kinoshita, Tetsuo Ajiki, Hirochika Toyama, Sadaki Asari, Tadahiro Goto, Yonson Ku
There are few descriptions of severe thrombocytopenia during the early postoperative period after liver transplantation, and these have not been fully documented in the literature. Here, we report a case of drug-induced thrombocytopenia requiring transfusion of blood products after living donor liver transplantation. We determined that this was not caused by the interferon-free anti-viral therapy but by tacrolimus A 61-year-old woman with hepatitis C-related cirrhosis and hepatorenal syndrome underwent living donor liver transplantation using a left lobe graft from her son...
2016: Kobe Journal of Medical Sciences
Spilios Manolakopoulos, George Zacharakis, Miltiadis Zissis, Vassilis Giannakopoulos
Daclatasvir (Daklinza™), a new oral direct-acting antiviral, is an inhibitor of hepatitis C virus NS5A protein and has recently been approved in the United States, Europe and Japan in chronic hepatitis C. It shows potent pangenotypic activity and moderately high genetic barrier to resistance improving the sustained virological response (SVR) rates. In COMMAND phase 2 trials, daclatasvir demonstrated high SVR rates in HCV genotype 1-4 chronically infected patients treated with peginterferon-a (pegIFNα) plus ribavirin (RBV)...
July 2016: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
Marta Hreńczuk, Renata Sowińska, Olga Tronina, Piotr Małkowski, Magdalena Durlik, Marek Pacholczyk, Maciej Kosieradzki
BACKGROUND Recurrent HCV infection following liver transplantation is a common problem, and usually has a more aggressive course than primary infection. The aim of the paper was to present nursing problems in the care of a 22-year-old female patient after liver transplantation (Ltx) with a rapid recurrence of HCV infection shortly after Ltx. CASE REPORT Ltx was performed 22 July 2012 due to chronic cirrhosis secondary to HCV infection with viremia (HCV PCR 3.5×107 IU/mL). Graft function worsened 14 days following transplantation...
2016: Annals of Transplantation: Quarterly of the Polish Transplantation Society
Jérôme Dumortier, Vincent Leroy, Christophe Duvoux, Victor de Ledinghen, Claire Francoz, Pauline Houssel-Debry, Sylvie Radenne, Louis d'Alteroche, Claire Fougerou-Leurent, Valérie Canva, Vincent di Martino, Filomena Conti, Nassim Kamar, Christophe Moreno, Pascal Lebray, Albert Tran, Camille Besch, Alpha Diallo, Alexandra Rohel, Emilie Rossignol, Armand Abergel, Danielle Botta-Fridlund, Audrey Coilly, Didier Samuel, Jean-Charles Duclos-Vallée, Georges-Philippe Pageaux
Recurrence of hepatitis C virus (HCV) after liver transplantation (LT) can rapidly lead to liver graft cirrhosis and, therefore, graft failure and retransplantation or death. The aim of the present study was to assess efficacy and tolerance of sofosbuvir (SOF)-based regimens for the treatment of HCV recurrence in patients with severe fibrosis after LT. The Compassionate Use of Protease Inhibitors in Viral C Liver Transplantation (CULPIT) study is a prospective multicenter cohort including patients with HCV recurrence following LT treated with second generation direct antivirals...
October 2016: Liver Transplantation
Dinesh Jothimani, Sanjay Govil, Mohamed Rela
Recurrent HCV infection (rHCV) of the liver allograft following transplantation is universal and is associated with poor graft and patient survival in comparison with other indications. Treatment of rHCV infection in the previous era with pegylated interferon and ribavirin was associated with low sustained virological response (SVR) due to poor tolerability, adverse events and graft rejection. Recently, directly acting antiviral drugs (DAA) have been approved for the treatment of hepatitis C infection and a number of clinical trials have been conducted across various centers in the management of rHCV infection of the graft...
September 2016: Hepatology International
Audrey Coilly, Claire Fougerou-Leurent, Victor de Ledinghen, Pauline Houssel-Debry, Christophe Duvoux, Vincent Di Martino, Sylvie Radenne, Nassim Kamar, Louis D'Alteroche, Vincent Leroy, Valérie Canva, Pascal Lebray, Christophe Moreno, Jérôme Dumortier, Christine Silvain, Camille Besch, Philippe Perre, Danielle Botta-Fridlund, Rodolphe Anty, Claire Francoz, Armando Abergel, Maryline Debette-Gratien, Filomena Conti, François Habersetzer, Alexandra Rohel, Emilie Rossignol, Hélène Danjou, Anne-Marie Roque-Afonso, Didier Samuel, Jean-Charles Duclos-Vallée, Georges-Philippe Pageaux
BACKGROUND & AIMS: HCV recurrence remains a major issue in the liver transplant field, as it has a negative impact on both graft and patient survival. The purpose of this study was to investigate the efficacy and safety of treating HCV recurrence with sofosbuvir (SOF) and daclatasvir (DCV) combination therapy. METHODS: From October 2013 to March 2015, 559 liver recipients were enrolled in the prospective multicentre France REcherche Nord&Sud Sida-hiv Hépatites (ANRS) Compassionate use of Protease Inhibitors in viral C Liver Transplantation cohort...
October 2016: Journal of Hepatology
Hussein El-Fishawy, Gamal Saadi, May Hassaballa, Mohamed Hussein, Wahid Doss, Gaafar Ragab, Rashad Barsoum
Egypt, the single country with highest incidence of HCV infection in the world, has embarked on a government-sponsored mass treatment program using several combinations of DAAs. Recognizing the importance of extrahepatic manifestations, independently of the hepatic, a subcommittee was assigned to develop national guidelines for respective prioritizing indications and protocols. It evaluated the benefit of treating patients with different extrahepatic manifestations, and reviewed relevant clinical trials and guidelines concerning DAA combinations available in Egypt...
May 2016: Journal of Advanced Research
Sandra Beinhardt, Ramona Al Zoairy, Peter Ferenci, Karin Kozbial, Clarissa Freissmuth, Rafael Stern, Albert Friedrich Stättermayer, Rudolf Stauber, Michael Strasser, Heinz Zoller, Bruno Watschinger, Alice Schmidt, Michael Trauner, Harald Hofer, Andreas Maieron
DAA-based regimens for chronic hepatitis C infection encourage treatment of "difficult-to-treat" cohorts. This study investigated efficacy and safety of DAA-based regimens in HCV patients on dialysis or postkidney or liver/kidney transplantation. Twenty-five patients treated with DAA combinations were evaluated: 10 were on dialysis (eight: hemodialysis, two: peritoneal dialysis), eight were kidney transplant recipients, and seven were liver/kidney transplant recipients. Except for one patient treated with daclatasvir ([DCV]/60 mg/QD)/simeprevir ([SMV]/150 mg/QD), the others received sofosbuvir-based regimens ([SOF];400 mg/QD) combined with SMV:eight, DCV:13 or either ledipasvir ([LDV]90 mg/QD), ribavirin ([RBV];weight based) or pegylated interferon/RBV...
September 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
I Campos-Varela, A Moreno, A Morbey, G Guaraldi, H Hasson, K R Bhamidimarri, L Castells, P Grewal, I Baños, P Bellot, D M Brainard, J G McHutchison, N A Terrault
BACKGROUND: For liver transplant recipients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection, recurrence after LT is associated with a higher risk of graft loss than for HCV mono-infected patients. Prior HCV treatment options were limited by side effects and drug-drug interactions. AIM: To evaluate treatment outcomes with sofosbuvir (SOF)-based therapy among HIV/HCV coinfected liver transplant recipients. METHODS: Access to SOF and ribavirin (RBV) prior to regulatory approval was attained via an international compassionate access program for transplant recipients with a life expectancy of 1 year or less in the absence of HCV treatment...
June 2016: Alimentary Pharmacology & Therapeutics
J Llaneras, L Castells, B Santos, M Crespo, T Puig, J I Esteban, R Esteban
We present a human immunodeficiency virus-infected patient with severe decompensated hepatitis C virus-related cirrhosis awaiting liver transplantation (LT) who received a 24-week course of interferon/ribavirin-free antiviral treatment with sofosbuvir and daclatasvir on a compassionate basis. Rapid viral suppression was associated with progressive improvement of his liver function tests. The patient achieved a sustained virological response and concomitant clinical improvement, which prompted removal from the LT list 12 weeks after the end of treatment...
June 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Paul Y Kwo
PURPOSE OF REVIEW: Historically, postliver transplant patients with chronic hepatitis C have had worse outcomes than nonhepatitis C-related causes because of accelerated fibrosis posttransplantation and the lack of effective well tolerated therapies for hepatitis C, and posttransplant hepatitis C patients have been considered a special population. Since 2013, we have entered the era of all oral direct acting antiviral agents for hepatitis C with sustained response rates that are consistently above 90% in nontransplant patients...
May 2016: Current Opinion in Gastroenterology
C Bunchorntavakul, K Rajender Reddy
The management of hepatitis C virus (HCV) infection in patients with decompensated cirrhosis has evolved dramatically over the past few years mainly due to the availability of all-oral antiviral regimens. The currently approved all-oral direct-acting antivirals (DAA) containing sofosbuvir, ledipasvir, daclatasvir and ribavirin, in various combinations, have shown to be safe and effective in patients with decompensated cirrhosis with sustained virological response (SVR) rates nearly comparable to those with well-compensated liver disease...
June 2016: Journal of Viral Hepatitis
Robert J Fontana, Robert S Brown, Ana Moreno-Zamora, Martin Prieto, Shobha Joshi, Maria-Carlota Londoño, Kerstin Herzer, Kristina R Chacko, Rudolf E Stauber, Viola Knop, Syed-Mohammed Jafri, Lluís Castells, Peter Ferenci, Carlo Torti, Christine M Durand, Laura Loiacono, Raffaella Lionetti, Ranjeeta Bahirwani, Ola Weiland, Abdullah Mubarak, Ahmed M ElSharkawy, Bernhard Stadler, Marzia Montalbano, Christoph Berg, Adriano M Pellicelli, Stephan Stenmark, Francis Vekeman, Raluca Ionescu-Ittu, Bruno Emond, K Rajender Reddy
Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy when combined with sofosbuvir (SOF) or simeprevir (SMV) with or without ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection. Herein, we report efficacy and safety data for DCV-based all-oral antiviral therapy in liver transplantation (LT) recipients with severe recurrent HCV. DCV at 60 mg/day was administered for up to 24 weeks as part of a compassionate use protocol. The study included 97 LT recipients with a mean age of 59...
April 2016: Liver Transplantation
N Kamar, O Marion, L Rostaing, O Cointault, D Ribes, L Lavayssière, L Esposito, A Del Bello, S Métivier, K Barange, J Izopet, L Alric
There is no approved therapy for hepatitis C virus (HCV) infection after kidney transplantation, and no data regarding the use of new-generation direct antiviral agents (DAAs) have been published so far. The aims of this pilot study were to assess the efficacy and safety of an interferon-free sofosbuvir-based regimen to treat chronic HCV infection in kidney transplant recipients. Twenty-five kidney transplant recipients with chronic HCV infection were given, for 12 (n = 19) or 24 weeks (n = 6), sofosbuvir plus ribavirin (n = 3); sofosbuvir plus daclatasvir (n = 4); sofosbuvir plus simeprevir, with (n = 1) or without ribavirin (n = 6); sofosbuvir plus ledipasvir, with (n = 1) or without ribavirin (n = 9); and sofosbuvir plus pegylated-interferon plus ribavirin (n = 1)...
May 2016: American Journal of Transplantation
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