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https://www.readbyqxmd.com/read/28295849/efficacy-safety-and-pharmacokinetics-of-simeprevir-daclatasvir-and-ribavirin-in-patients-with-recurrent-hepatitis-c-virus-genotype-1b-infection-after-orthotopic-liver-transplantation-the-phase-ii-saturn-study
#1
Xavier Forns, Marina Berenguer, Kerstin Herzer, Martina Sterneck, Maria Francesca Donato, Pietro Andreone, Stefano Fagiuoli, Tomasz Cieciura, Magdalena Durlik, Jose Luis Calleja, Zoe Mariño, Umesh Shukla, Thierry Verbinnen, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Katrien Janssen, Ronald Kalmeijer, Wolfgang Jessner
BACKGROUND: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival. METHODS: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24 weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT). RESULTS: High rates of both on-treatment and sustained virologic response 12 weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naïve or had failed post-OLT treatment with peginterferon and RBV...
March 13, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28281085/efficacy-and-safety-of-sofosbuvir-based-regimens-in-chronic-hepatitis-c-patients-on-dialysis
#2
Narendra S Choudhary, Amit Kumar, Vijay Bodh, Shyam Bihari Bansal, Reetesh Sharma, Manish Jain, Sanjiv Saigal, Neeraj Saraf
INTRODUCTION: Patients with end-stage renal disease (ESRD) have poor treatment tolerance and outcome to interferon-based regimens. Sofosbuvir-based regimens have improved treatment success in chronic hepatitis C. There is limited data in ESRD patients as sofosbuvir is excreted by the kidney. Several small studies have shown good results. METHODS: Sixteen consecutive patients of ESRD (on dialysis) and chronic hepatitis C were treated with sofosbuvir-based regimens as they were prospective kidney transplantation recipients, at a tertiary care center in north India...
March 9, 2017: Indian Journal of Gastroenterology: Official Journal of the Indian Society of Gastroenterology
https://www.readbyqxmd.com/read/28270038/inf-free-sofosbuvir-based-treatment-of-post-transplant-hepatitis-c-relapse-a-swedish-real-life-experience
#3
Castedal Maria, Segenmark Michael, Cederberg Susanne, Skoglund Catarina, Weiland Ola
BACKGROUND: Relapse of hepatitis C virus (HCV) infection after liver transplantation has been universal, and the fibrosis progression faster than in non-transplanted patients. Interferon (IFN)-free treatment with direct antiviral agents (DAA) has improved the treatment outcome dramatically. We here report on the outcome of IFN-free treatment for HCV relapse after liver transplantation in a real life setting in Sweden. MATERIAL: In total, 93 patients with a mean age of 60 years (range 32-80) with HCV relapse after liver transplantation were given sofosbuvir-based treatment in combination with a protease inhibitor (simeprevir) or a NS5A inhibitor (daclatasvir or ledipasvir) with or without addition of ribavirin (RBV), or sofosbuvir and RBV only...
May 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28224470/three-patients-treated-with-sofosbuvir-plus-ledipasvir-for-recurrent-hepatitis-c-after-liver-transplantation
#4
Tomokazu Kawaoka, Michio Imamura, Kei Morio, Yuki Nakamura, Masataka Tsuge, Clair Nelson Hayes, Yoshiiku Kawakami, Hiroshi Aikata, Hidenori Ochi, Kouhei Ishiyama, Hideki Ohdan, Kazuaki Chayama
We previously reported results of interferon (IFN)-free daclatasvir and asunaprevir for the treatment of recurrent hepatitis C virus (HCV) genotype 1 infection after liver transplantation (LT). Here we report three patients who achieved viral response with no effect on the blood concentrations of immunosuppressive agents following sofosbuvir plus ledipasvir treatment. The first patient was a 68-year-old female with HCV-related liver cirrhosis who failed to respond to pegylated-IFN and ribavirin (PEG-IFN/RBV) after living donor LT...
April 2017: Clinical Journal of Gastroenterology
https://www.readbyqxmd.com/read/28177199/daclatasvir-plus-sofosbuvir-with-or-without-ribavirin-for-hepatitis-c-virus-genotype-3-in-a-french-early-access-programme
#5
Christophe Hézode, Pascal Lebray, Victor De Ledinghen, Fabien Zoulim, Vincent Di Martino, Nathalie Boyer, Dominique Larrey, Danielle Botta-Fridlund, Christine Silvain, Hélène Fontaine, Louis D'Alteroche, Vincent Leroy, Marc Bourliere, Isabelle Hubert-Fouchard, Dominique Guyader, Isabelle Rosa, Eric Nguyen-Khac, Larysa Fedchuk, Raoudha Akremi, Yacia Bennai, Anne Filipovics, Yue Zhao, Jean-Pierre Bronowicki
BACKGROUND AND AIMS: Optimally effective treatment for hepatitis C virus (HCV) genotype 3 (GT3) is urgently needed, particularly in advanced liver disease. Daclatasvir (DCV) plus sofosbuvir (SOF) was efficacious in phase 3 studies. Real-world data for DCV+SOF in advanced GT3 infection are presented from the French Temporary Authorisation for Use programme, which allowed patients in need without other treatment options access to DCV ahead of its market authorization. METHODS: Patients with F3/F4 fibrosis and/or extrahepatic HCV manifestations, post-liver-transplant HCV recurrence, and/or indication for liver/kidney transplant, were treated with DCV+SOF (60+400 mg daily) for a recommended duration of 24 weeks...
February 8, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28102906/filling-the-gap-between-clinical-trials-and-real-life-in-the-treatment-of-severe-hcv-recurrence-after-liver-transplantation
#6
Patrizia Burra, Alberto Zanetto
In this issue of Transplant International, Herzer et al. report the results obtained in a real-world European cohort of 87 patients with severe recurrent hepatitis C (HCV) after liver transplantation (LT), who were treated with a compassionate use of daclatasvir (DCV) plus registered sofosbuvir (SOF), with or without ribavirin (RBV). The vast majority of patients were HCV genotype 1, though the sample included a few with genotypes 3 and 4. It is noteworthy that 37/87 patients (42.5%) had cirrhosis (and 16/37 patients [43%] had Child-Pugh B/C decompensated cirrhosis)...
January 19, 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28070200/the-risk-of-hepatocellular-carcinoma-after-directly-acting-antivirals-for-hepatitis-c-virus-treatment-in-liver-transplanted-patients-is-it-real
#7
Alessio Strazzulla, Rosa Maria Rita Iemmolo, Ennio Carbone, Maria Concetta Postorino, Maria Mazzitelli, Mario De Santis, Fabrizio Di Benedetto, Costanza Maria Cristiani, Chiara Costa, Vincenzo Pisani, Carlo Torti
INTRODUCTION: Since directly acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) were introduced, conflicting data emerged about the risk of hepatocellular carcinoma (HCC) after interferon (IFN)-free treatments. We present a case of recurrent, extra-hepatic HCC in a liver-transplanted patient soon after successful treatment with DAAs, along with a short review of literature. CASE PRESENTATION: In 2010, a 53-year old man, affected by chronic HCV (genotype 1) infection and decompensated cirrhosis, underwent liver resection for HCC and subsequently received orthotopic liver transplantation...
November 2016: Hepatitis Monthly
https://www.readbyqxmd.com/read/28061762/the-effectiveness-of-daclatasvir-based-therapy-in-european-patients-with-chronic-hepatitis-c-and-advanced-liver-disease
#8
Jim Young, Nina Weis, Harald Hofer, William Irving, Ola Weiland, Emiliano Giostra, Juan Manuel Pascasio, Lluis Castells, Martin Prieto, Roelien Postema, Cinira Lefevre, David Evans, Heiner C Bucher, Jose Luis Calleja
BACKGROUND: There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. The Named Patient Program in Europe included patients with advanced chronic hepatitis C, a life expectancy of less than 12 months and no other treatment options. METHODS: A retrospective multi-country cohort of patients with chronic hepatitis C who received daclatasvir as part of the Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland and the United Kingdom...
January 7, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28051797/%C3%A2-sofosbuvir-and-daclatasvir-in-mono-and-hiv-coinfected-patients-with-recurrent-hepatitis-c-after-liver-transplant
#9
Lluís Castells, Jordi Llaneras, Isabel Campos-Varela, Itxarone Bilbao, Manel Crespo, Oscar Len, Francisco Rodríguez-Frías, Ramon Charco, Teresa Salcedo, Juan Ignacio Esteban, Rafael Esteban-Mur
 Background and aims. Pegylated interferon (Peg-INF) and ribavirin (RBV) based therapy is suboptimal and poorly tolerated. We evaluated the safety, tolerability and efficacy of a 24-week course of sofosbuvir plus daclatasvir without ribavirin for the treatment of hepatitis C virus (HCV) recurrence after liver transplantation (LT) in both HCV-monoinfected and human immunodeficiency virus (HIV)-HCV coinfected patients. MATERIAL AND METHODS: We retrospectively evaluated 22 consecutive adult LT recipients (16 monoinfected and 6 coinfected with HIV) who received a 24-week course of sofosbuvir plus daclatasvir treatment under an international compassionate access program...
January 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28039098/efficacy-and-tolerability-of-interferon-free-antiviral-therapy-in-kidney-transplant-recipients-with-chronic-hepatitis-c
#10
Inmaculada Fernández, Raquel Muñoz-Gómez, Juan M Pascasio, Carme Baliellas, Natalia Polanco, Nuria Esforzado, Ana Arias, Martín Prieto, Lluis Castells, Valentín Cuervas-Mons, Olga Hernández, Javier Crespo, José L Calleja, Xavier Forns, María-Carlota Londoño
BACKGROUND & AIMS: The development of direct-acting antiviral agents (DAAs) is a major step forward in the treatment of hepatitis C (HCV). The aims of the study were to evaluate the efficacy and tolerability of DAAs in kidney transplant (KT) recipients. METHODS: Hepa-C is a Spanish registry of patients treated with DAAs in which clinical, virological and analytical data were prospectively included. We report on the data from 103 KT recipients who received DAAs. RESULTS: The most commonly used DAAs combinations were sofosbuvir/ledipasvir (n=59, 57%) and sofosbuvir+daclatasvir (n=18, 17%)...
December 28, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/28024124/developing-therapies-to-treat-hepatitis-c-infection-in-post-liver-transplant-recipients
#11
REVIEW
Thomas R McCarty, Joseph K Lim
Currently, hepatitis C virus (HCV) infection remains the most common indication for liver transplant in the United States (US) with almost universal HCV recurrence in the post-liver transplant setting. Previous interferon (IFN)-related efficacy and tolerability concerns about worsening liver function have limited treatment options for many patients with HCV-associated decompensated liver disease and post-liver transplant recipients. However, the last decade has seen a seen a radical shift in the management of HCV with multiple direct-acting antiviral (DAA) treatments that provide more effective, all-oral, IFN-free alternatives...
February 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28012215/real-world-experience-with-daclatasvir-plus-sofosbuvir-%C3%A2-ribavirin-for-post-liver-transplant-hcv-recurrence-and-severe-liver-disease
#12
Kerstin Herzer, Tania M Welzel, Ulrich Spengler, Holger Hinrichsen, Hartwig Klinker, Thomas Berg, Peter Ferenci, Markus Peck-Radosavljevic, Akin Inderson, Yue Zhao, Maria Jesus Jimenez-Exposito, Stefan Zeuzem
Optimizing therapy of post-transplant HCV recurrence remains important, especially in advanced liver disease. We evaluated daclatasvir (DCV) plus sofosbuvir (SOF), with or without ribavirin (RBV), in patients with post-liver transplant recurrence in a real-world European cohort at high risk of decompensation or death within 12 months. Recommended treatment was DCV 60mg plus SOF 400mg once-daily for 24 weeks; RBV use/shorter treatment duration was at physicians' discretion. Patients (N=87) were 70% male, 93% white, and mostly infected with HCV genotypes 1b (48%), 1a (32%), or 3 (9%); 37 (43%) had cirrhosis (16 decompensated), five had fibrosing cholestatic hepatitis...
December 24, 2016: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28002876/outcomes-of-treatment-with-daclatasvir-and-asunaprevir-for-recurrent-hepatitis-c-after-liver-transplantation
#13
Masaki Honda, Yasuhiko Sugawara, Takehisa Watanabe, Masakuni Tateyama, Motohiko Tanaka, Koushi Uchida, Seiichi Kawabata, Daiki Yoshii, Kouhei Miura, Kaori Isono, Shintaro Hayashida, Yuki Ohya, Hidekazu Yamamoto, Yutaka Sasaki, Yukihiro Inomata
AIM: The development of direct - acting oral agents has dramatically changed the treatment strategy of hepatitis C virus (HCV) infection. Here we aimed to reveal the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) for recurrent HCV genotype 1 infection after liver transplantation (LT). METHODS: A retrospective study was conducted on 9 patients [5 men; 4 had failed peg-interferon/ribavirin, 2 had failed simeprevir/peg-interferon/ribavirin, 1 had the resistance-associated variant (RAV) Y93H in the NS5A region, 1 underwent maintenance dialysis ] who underwent a 24 -week DCV/ASV treatment regimen for recurrent HCV genotype 1 infection...
December 21, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27932113/hepatitis-c-treatment-with-direct-acting-antivirals-in-kidney-transplant-preliminary-results-from-a-multicenter-study
#14
M A Gentil, C González-Corvillo, M Perelló, S Zarraga, C Jiménez-Martín, L R Lauzurica, A Alonso, A Franco, D Hernández-Marrero, A Sánchez-Fructuoso
Hepatitis C (HC) is a very relevant negative prognosis factor for graft and transplant recipient survival. New direct-acting antivirals (DAAs) allow us to solve this problem in an effective way. It is crucial to understand their real impact in our daily practice. We analyzed treatment results with DAA, free of interferon, in kidney transplant recipients (KTRs) from 15 Spanish hospitals (Grupo Español de Actualización en Trasplante), regarding effectiveness, tolerance, and impact on immunosuppression, renal function-proteinuria, and diabetes...
November 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27932111/hepatitis-c-virus-in-kidney-transplant-recipients-a-problem-on-the-path-to-eradication
#15
A Suarez Benjumea, C Gonzalez-Corvillo, J M Sousa, G Bernal Blanco, M Suñer Poblet, M A Perez Valdivia, F M Gonzalez Roncero, P Acevedo, M A Gentil Govantez
BACKGROUND: Hepatitis C virus (HCV) still has significant prevalence in kidney transplant (KT) recipients and is related to poor recipient and graft survival. New direct-acting antivirals (DAA) are leading to a radical change in the problem. METHODS: We studied HCV prevalence at the time of transplantation and in follow-up patients, the way cases are handled, and the results of DAA. RESULTS: A total of 2,001 KT had been performed in our center since 1978...
November 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27906834/successful-continuation-of-hcv-treatment-following-liver-transplantation
#16
Carlos Fernández Carrillo, Gonzalo Crespo, Juan de la Revilla, Lluís Castells, Maria Buti, José Luis Montero, Emilio Fábrega, Inmaculada Fernández, Cristina Serrano-Millán, Victoria Hernández, José Luis Calleja, María-Carlota Londoño
BACKGROUND: Guidelines recommend that patients with hepatitis C virus (HCV)-related liver disease be treated for HCV before liver transplant (LT) to eliminate the virus prior to surgery. However, the unpredictability of donor organ availability may limit treatment duration. Interruption of HCV treatment with resumption post-LT is one potential solution which has not been investigated widely. METHODS: Patients from 5 clinical centres included in the large, national, noninterventional Hepa-C registry who started treatment with direct-acting antiviral agents (DAAs) while awaiting LT were identified retrospectively and followed up prospectively...
December 1, 2016: Transplantation
https://www.readbyqxmd.com/read/27875005/asunaprevir-daclatasvir-and-sofosbuvir-ledipasvir-for-recurrent-hepatitis-c-following-living-donor-liver-transplantation
#17
Kiyohiko Omichi, Nobuhisa Akamatsu, Kazuhiro Mori, Junichi Togashi, Junichi Arita, Junichi Kaneko, Kiyoshi Hasegawa, Yoshihiro Sakamoto, Norihiro Kokudo
AIM: This study aimed to clarify the efficacy and safety of interferon-free therapy using asunaprevir and daclatasvir, or sofosbuvir and ledipasvir for post living donor liver transplantation (LDLT) recipients with hepatitis C virus (HCV). METHODS: A retrospective cohort study of LDLT recipients with HCV genotype 1b treated with asunaprevir (100 mg twice daily) and daclatasvir (60 mg once daily), or sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was carried out...
November 22, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27825643/-sofosbuvir-and-daclatasvir-combination-therapy-in-hemodialysis-patient-with-liver-transplantation
#18
Mourad Hachicha, Danielle Botta-Fridlund
We report a case of sustained remission of a liver transplant patient infected with hepatitis C virus (HCV) genotype 1 undergoing hemodialysis treatment. Oral treatment regimen of the HCV infection consists of a combination of sofosbuvir 400 mg after each hemodialysis session and daclatasvir 60 mg daily, for a period of 3 months. Laboratory testing indicate that the combination regimen was well-tolerated with no sign of drug-drug interaction. Confirmation of these clinical observations in large clinical studies may help improve morbidity and decrease mortality outcome in patients infected with HCV and undergoing hemodialysis treatment...
December 2016: Néphrologie & Thérapeutique
https://www.readbyqxmd.com/read/27778453/successful-recovery-of-acute-renal-transplant-failure-in-recurrent-hepatitis-c-virus-associated-membranoproliferative-glomerulonephritis
#19
E Schrezenmeier, K Wu, F Halleck, L Liefeldt, S Brakemeier, F Bachmann, S Kron, K Budde, M 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...
March 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/27742338/drug-induced-lung-injury-in-a-liver-transplant-patient-treated-with-sofosbuvir
#20
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
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