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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
#1
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/28102583/successful-splenorenal-shunt-occlusion-with-balloon-occluded-retrograde-transvenous-obliteration-yielded-improvement-of-residual-liver-function-enabled-administration-of-direct-acting-antivirals-and-achieved-sustained-virologic-response-to-hepatitis-c-virus
#2
Hironori Ochi, Michiko Aono, Shunji Takechi, Toshie Mashiba, Tomoyuki Yokota, Kouji Joko
We report the use of balloon-occluded retrograde transvenous obliteration (BRTO) for portosystemic shunt in one patient, resulting in marked improvements in residual liver function and enabling safe hepatitis C virus (HCV) elimination with direct-acting antiviral agents. A woman undergoing outpatient treatment at our institution for HCV-related cirrhosis with a history of hepatocellular carcinoma (HCC) treatment developed hepatic encephalopathy (HE; Child-Pugh score 8) at age 65 years. Improvement was obtained with conservative treatment; however, contrast-enhanced computed tomography revealed a splenorenal shunt with decreased portal vein blood flow...
January 19, 2017: Journal of Digestive Diseases
https://www.readbyqxmd.com/read/28097103/efficacy-and-safety-of-daclatasvir-in-hepatitis-c-an-overview
#3
REVIEW
Nesrine Gamal, Stefano Gitto, Pietro Andreone
Hepatitis C virus (HCV) infection is a growing public health concern, with 184 million people infected worldwide. During the past decade, interferon has been the backbone of HCV treatment, even though it remains far from ideal. The latest development of the new direct antivirals has drastically changed the treatment approach for chronic hepatitis C (CHC). Inhibitors of the HCV NS5A region have garnered remarkable interest among treating physicians, due to their high potency and favourable safety profile. In particular, treatment with daclatasvir (DCV) has yielded high rates of vriologic response in patients infected with genotype (Gt) 1 and Gt 3, when used in combination with other antivirals of a different class, such as sofosbuvir...
December 28, 2016: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/28090038/combination-therapy-with-ombitasvir-paritaprevir-ritonavir-for-dialysis-patients-infected-with-hepatitis-c-virus-a-prospective-multi-institutional-study
#4
Ken Sato, Kenichi Hosonuma, Yuichi Yamazaki, Takeshi Kobayashi, Satoshi Takakusagi, Norio Horiguchi, Satoru Kakizaki, Motoyasu Kusano, Hiroshi Ohnishi, Hiroaki Okamoto, Masanobu Yamada
Hepatitis C virus (HCV) infection is common in dialysis patients worldwide and nosocomial HCV spread within dialysis facilities continues to develop. Combination therapy with daclatasvir and asunaprevir (DCV/ASV) that has proven efficacy for dialysis patients infected with genotype 1b HCV (HCV/1b) has several concerns in Japan. The recently available combination therapy with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) is not contraindicated in patients with chronic renal failure and has more safety profile and shorter treatment period than that with DCV/ASV...
2017: Tohoku Journal of Experimental Medicine
https://www.readbyqxmd.com/read/28078469/new-resistance-associated-substitutions-and-failure-of-dual-oral-therapy-with-daclatasvir-and-asunaprevir
#5
Seiichi Mawatari, Kohei Oda, Kazuaki Tabu, Sho Ijuin, Kotaro Kumagai, Yukiko Inada, Hirofumi Uto, Yasunari Hiramine, Takeshi Kure, Kunio Fujisaki, Masafumi Hashiguchi, Takeshi Hori, Akihiko Oshige, Dai Imanaka, Akiko Saishoji, Oki Taniyama, Haruka Sakae, Tsutomu Tamai, Akihiro Moriuchi, Akio Ido
BACKGROUND: Daclatasvir (DCV) and asunaprevir (ASV) combination therapy has been primarily used in patients without NS5A L31 or Y93 resistance-associated substitutions (RASs) before treatment. We examined the characteristics of patients without these baseline RASs who did not achieve hepatitis C virus eradication with DCV and ASV combination therapy and identified new baseline NS5A RASs that are closely associated with failure of combination therapy. METHODS: Three hundred thirty-five patients with hepatitis C virus genotype 1 infection with no NS5A L31, NS5A Y93, and NS3 D168 RASs before DCV and ASV combination therapy and no history of protease inhibitor therapy were enrolled...
January 11, 2017: Journal of Gastroenterology
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
#6
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/28066880/population-pharmacokinetic-analysis-of-daclatasvir-in-subjects-with-chronic-hepatitis-c-virus-infection
#7
Phyllis Chan, Hanbin Li, Li Zhu, Marc Bifano, Timothy Eley, Mayu Osawa, Takayo Ueno, Eric Hughes, Richard Bertz, Tushar Garimella, Malaz AbuTarif
BACKGROUND AND OBJECTIVE: Daclatasvir is a potent, pangenotypic once-daily hepatitis C virus (HCV) NS5A inhibitor that is approved for the treatment of chronic HCV infection. The objective of this analysis was to characterize the pharmacokinetics of daclatasvir in subjects with chronic HCV infection. METHODS: A population pharmacokinetic (PPK) model was developed to evaluate effects of covariates on daclatasvir pharmacokinetics in subjects with chronic HCV infection (n = 2149 from 11 studies)...
January 9, 2017: Clinical Pharmacokinetics
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/28052633/hepatitis-c-efficacy-and-safety-in-real-life
#9
REVIEW
Robert Flisiak, Joanna Pogorzelska, Marta Flisiak-Jackiewicz
Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis...
January 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28051797/%C3%A2-sofosbuvir-and-daclatasvir-in-mono-and-hiv-coinfected-patients-with-recurrent-hepatitis-c-after-liver-transplant
#10
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/28051795/%C3%A2-daclatasvir-plus-asunaprevir-dual-therapy-for-chronic-hcv-genotype-1b-infection-results-of-turkish-early-access-program
#11
Seyfettin Köklü, Iftihar Köksal, Ulus Salih Akarca, Ayhan Balkan, Rahmet Güner, Aylin Demirezen, Memduh Sahin, Sila Akhan, Reşat Ozaras, Ramazan Idilman
:  Background. Daclatasvir and asunaprevir dual therapy is approved for the treatment of HCV genotype 1b infection in several countries. AIM: To evaluate the efficacy and safety of daclatasvir and asunaprevir dual therapy in Turkish patients. MATERIAL AND METHODS: Sixty-one patients with HCV genotype 1b were enrolled in the Turkish early access program. Most of the patients were in difficult-to-treat category. Patients were visited at each 4 week throughout the follow-up period...
January 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28049871/identification-of-genotype-2-hcv-in-serotype-1-hepatitis-c-patients-unresponsive-to-daclatasvir-plus-asunaprevir-treatment
#12
Jun Inoue, Atsushi Kanno, Yuta Wakui, Masahito Miura, Tomoo Kobayashi, Tatsuki Morosawa, Takayuki Kogure, Eiji Kakazu, Masashi Ninomiya, Yasuyuki Fujisaka, Teruyuki Umetsu, Satoshi Takai, Takuya Nakamura, Tooru Shimosegawa
It is important to determine the genotypes or serotypes of hepatitis C virus (HCV) in patients before treatment with direct-acting antiviral agents (DAAs), because the effects of DAAs differ among genotypes. In Japan, two tests for HCV typing are available clinically, but only serotyping, not genotyping, is approved by the public health insurance. Although most serotype-1 Japanese patients are infected with genotype 1b HCV, it is known that a small proportion of patients show different results from two typing methods...
2017: Tohoku Journal of Experimental Medicine
https://www.readbyqxmd.com/read/28040549/increased-peripheral-cd4-regulatory-t-cells-persist-after-successful-direct-acting-antiviral-treatment-of-chronic-hepatitis-c
#13
Bettina Langhans, Hans Dieter Nischalke, Benjamin Krämer, Annekristin Hausen, Leona Dold, Peer van Heteren, Robert Hüneburg, Jacob Nattermann, Christian P Strassburg, Ulrich Spengler
INTRODUCTION: CD4(+) regulatory T cells (Tregs) expand during chronic hepatitis C virus (HCV) infection, inhibit antiviral immunity and promote fibrosis. Directly acting antivirals (DAA) have revolutionized HCV therapy. However, it is unclear if Tregs are normalized after DAA-induced HCV elimination. METHODS: We analyzed Tregs before (=baseline), at end of therapy (EOT), 12 and 24 weeks (SVR12, SVR24) and long-term (51±14 weeks) after EOT in 26 genotype-1-infected patients successfully treated with sofosbuvir (SOF) plus IFN/ribavirin (n=12) and IFN-free DAA regimens (SOF plus daclatasvir or simeprevir; n=14)...
December 28, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/28039098/efficacy-and-tolerability-of-interferon-free-antiviral-therapy-in-kidney-transplant-recipients-with-chronic-hepatitis-c
#14
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 AND AIMS: The development of direct-acting antivirals (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. RESULTS: We report on the data from 103 KT recipients who received DAAs...
December 27, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/28034492/addition-of-ribavirin-to-daclatasvir-plus-asunaprevir-for-chronic-hepatitis-c-1b-patients-with-baseline-ns5a-resistance-associated-variants-improved-response
#15
Chun-Ming Hong, Chun-Jen Liu, Shiou-Hwei Yeh, Pei-Jer Chen
BACKGROUND/PURPOSE: Daclatasvir is a nonstructural protein 5A inhibitor with potent activity against hepatitis C virus genotypes 1-6 in vitro, and asunaprevir is a nonstructural protein 3 protease inhibitor with activity against genotypes 1, 4, 5, and 6. Despite a 90% sustained virologic response (SVR) rate, the SVR rate in patients with baseline NS5A-L31/Y93H polymorphisms decreased to around 40%. Therefore, an alternative regimen under the consideration of cost-effectiveness would be important...
December 26, 2016: Journal of the Formosan Medical Association, Taiwan Yi Zhi
https://www.readbyqxmd.com/read/28025084/a-profiling-study-of-a-newly-developed-hcvcc-strain-pr63cc-s-sensitivity-to-direct-acting-antivirals
#16
Wanyin Tao, Tianyu Gan, Jie Lu, Jin Zhong
The development of direct-acting antivirals (DAAs) has significantly improved hepatitis C virus (HCV) treatment. However, drug resistance remains a potential concern in the real-world DAA-based therapies. We previously developed a novel full-length genotype 2a HCVcc clone PR63cc directly from clinical isolates. Here in this study, we compared the sensitivity of PR63cc and JFH1 to 12 different DAAs most of which are either already in clinical use or in the late clinical development phase. For NS5B inhibitors, PR63cc and JFH1 displayed comparable sensitivity to nucleoside/nucleotide analogues sofosbuvir and 2'-C-methyladenosine, while PR63cc was 4-fold more sensitive than JFH1 to nesbuvir, a non-nucleoside inhibitor...
December 23, 2016: Antiviral Research
https://www.readbyqxmd.com/read/28024124/developing-therapies-to-treat-hepatitis-c-infection-in-post-liver-transplant-recipients
#17
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...
December 26, 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28013118/real-world-data-of-daclatasvir-and-asunaprevir-combination-therapy-for-hcv-genotype-1b-infection-in-patients-with-renal-dysfunction
#18
Masatoshi Ishigami, Kazuhiko Hayashi, Takashi Honda, Teiji Kuzuya, Yoji Ishizu, Tetsuya Ishikawa, Isao Nakano, Fumihiro Urano, Takashi Kumada, Kentaro Yoshioka, Hidemi Goto, Yoshiki Hirooka
No abstract text is available yet for this article.
December 21, 2016: Clinical Gastroenterology and Hepatology
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
#19
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/28008868/effect-of-minor-populations-of-ns5a-and-ns5b-resistance-associated-variants-on-hcv-genotype-3-response-to-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin
#20
Fiona McPhee, Dennis Hernandez, Nannan Zhou
BACKGROUND: Treatment of hepatitis C virus (HCV) genotype 3 (GT3) is a medical priority. All-oral treatment of HCV GT3 with daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is recommended by several treatment guidelines. The impact of HCV minority populations at amino acid positions in NS5A and NS5B associated with drug resistance on response to DCV+SOF±RBV was assessed in SOF-naive and SOF-experienced HCV patients. METHODS: The presence of baseline NS5A or NS5B polymorphisms was assessed in 227 and 167 HCV-GT3-infected patients, respectively, from four clinical studies of DCV+SOF±RBV...
December 23, 2016: Antiviral Therapy
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