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https://www.readbyqxmd.com/read/28225572/daclatasvir-and-asunaprevir-for-genotype-1b-chronic-hepatitis-c-patients-with-chronic-kidney-disease
#1
Chisa Kondo, Masanori Atsukawa, Akihito Tsubota, Noritomo Shimada, Hiroshi Abe, Toru Asano, Kai Yoshizawa, Tomomi Okubo, Yoshimichi Chuganji, Yoshio Aizawa, Etsuko Iio, Yasuhito Tanaka, Katsuhiko Iwakiri
AIM: To evaluate the efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C (CHC) patients with non-dialysis chronic kidney disease (CKD). METHODS: In a multicenter collaborative study, 249 patients received 60 mg of daclatasvir (NS5A inhibitor) once a day and 100 mg of asunaprevir (NS3/4A protease inhibitor) twice a day for 24 weeks between September 2014 and September 2015 and were subjected to this analysis...
February 22, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28224470/three-patients-treated-with-sofosbuvir-plus-ledipasvir-for-recurrent-hepatitis-c-after-liver-transplantation
#2
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...
February 21, 2017: Clinical Journal of Gastroenterology
https://www.readbyqxmd.com/read/28224352/hcv-management-in-resource-constrained-countries
#3
REVIEW
Seng Gee Lim
With the arrival of all-oral directly acting antiviral (DAA) therapy with high cure rates, the promise of hepatitis C virus (HCV) eradication is within closer reach. The availability of generic DAAs has improved access to countries with constrained resources. However, therapy is only one component of the HCV care continuum, which is the framework for HCV management from identifying patients to cure. The large number of undiagnosed HCV cases is the biggest concern, and strategies to address this are needed, as risk factor screening is suboptimal, detecting <20% of known cases...
February 21, 2017: Hepatology International
https://www.readbyqxmd.com/read/28210927/efficacy-and-safety-of-daclatasvir-plus-pegylated-interferon-alfa-2a-and-ribavirin-in-previously-untreated-hcv-subjects-coinfected-with-hiv-and-hcv-genotype-1-a-phase-iii-open-label-study
#4
Mark S Sulkowski, Walford J Fessel, Adriano Lazzarin, Juan Berenguer, Natalia Zakharova, Hugo Cheinquer, Pierre Côté, Douglas Dieterich, Adrian Gadano, Gail Matthews, Jean-Michel Molina, Christophe Moreno, Juan Antonio Pineda, Federico Pulido, Antonio Rivero, Jurgen Rockstroh, Dennis Hernandez, Fiona McPhee, Timothy Eley, Zhaohui Liu, Patricia Mendez, Eric Hughes, Stephanie Noviello, Peter Ackerman
BACKGROUND: Daclatasvir (DCV) is a potent, pangenotypic, hepatitis C virus (HCV) non-structural protein 5A inhibitor with low potential for drug interactions with antiretroviral therapy (ART). We evaluated the safety and efficacy of DCV plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in HIV-1/HCV genotype-1-coinfected patients. METHODS: AI444043 (NCT01471574), an open-label, Phase III, single-arm, response-guided treatment (RGT) study included 301 patients. They received DCV doses of 30, 60 or 90 mg once daily (depending on concomitant ART), plus weight-based RBV (<75 kg, 1000 mg/day; or ≥75 kg, 1200 mg/day), and once-weekly PegIFN 180 μg, for 24 weeks...
February 16, 2017: Hepatology International
https://www.readbyqxmd.com/read/28187879/validated-stability-indicating-hplc-dad-method-for-determination-of-the-recently-approved-hepatitis-c-antiviral-agent-daclatasvir
#5
M M Baker, D S El-Kafrawy, M S Mahrous, T S Belal
A comprehensive stability indicating HPLC with diode array detection method was developed for the determination of the recently approved antiviral drug daclatasvir dihydrochloride (DCV) which is used for the treatment of chronic Hepatitis C Virus (HCV) genotype 3 infection. Effective chromatographic separation was achieved using Waters C8 column (4.6×250mm, 5μm particle size) with isocratic elution of the mobile phase composed of mixed phosphate buffer pH 2.5 and acetonitrile in the ratio of 75:25 (by volume)...
February 7, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28182611/use-of-daclatasvir-in-hcv-hiv-coinfected-patients-in-a-real-life-setting
#6
Stefano Bonora, Massimo Puoti
The burden of HIV and HCV coinfection is estimated to affect 5-7 million people worldwide, with approximately 15-30% of people with HIV coinfected with HCV. The first oral direct-acting antivirals have shown to improve the response in patients with HIV/HCV coinfection, and more recently, other direct-acting antivirals that target various stages of the HCV life cycle have been developed, among them daclatasvir. The objective of this article is to examine recent clinical studies investigating the efficacy and safety of daclatasvir in comparison with other antiretroviral drugs, focusing on its efficacy in the coinfected HIV patient and real-life data...
January 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28178397/the-efficacy-and-safety-of-dual-oral-therapy-with-daclatasvir-and-asunaprevir-for-genotype-1b-in-japanese-real-life-settings
#7
Hitomi Sezaki, Fumitaka Suzuki, Tetsuya Hosaka, Norio Akuta, Shunichiro Fujiyama, Yusuke Kawamura, Masahiro Kobayashi, Yoshiyuki Suzuki, Satoshi Saitoh, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, Hiromitsu Kumada
BACKGROUND & AIMS: It is important to investigate the treatment outcomes in patients excluded from clinical trials (CTR). The aims of this study were to evaluate the efficacy and safety of a 24-week daclatasvir (DCV) and asunaprevir (ASV) therapy for patients with chronic hepatitis C virus (HCV)-1b infection. METHODS: 651 HCV-1b patients started dual oral therapy with DCV and ASV for 24 weeks in Toranomon Hospital, Tokyo. Among them, 276 patients met phase III-CTR inclusion criteria...
February 8, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
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
#8
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/28174263/quantifying-antiviral-activity-optimizes-drug-combinations-against-hepatitis-c-virus-infection
#9
Yoshiki Koizumi, Hirofumi Ohashi, Syo Nakajima, Yasuhito Tanaka, Takaji Wakita, Alan S Perelson, Shingo Iwami, Koichi Watashi
With the introduction of direct-acting antivirals (DAAs), treatment against hepatitis C virus (HCV) has significantly improved. To manage and control this worldwide infectious disease better, the "best" multidrug treatment is demanded based on scientific evidence. However, there is no method available that systematically quantifies and compares the antiviral efficacy and drug-resistance profiles of drug combinations. Based on experimental anti-HCV profiles in a cell culture system, we quantified the instantaneous inhibitory potential (IIP), which is the logarithm of the reduction in viral replication events, for both single drugs and multiple-drug combinations...
February 7, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28157683/erratum-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin-achieved-high-sustained-virological-response-rates-in-patients-with-hcv-infection-and-advanced-liver-disease-in-a-real-world-cohort
#10
https://www.readbyqxmd.com/read/28137633/week-4-response-predicts-sustained-virologic-response-to-all-oral-direct-acting-antiviral-based-therapy-in-cirrhotic-patients-with-hepatitis-c-virus-genotype-3-infection
#11
Juan A Pineda, Luis E Morano-Amado, Rafael Granados, Juan Macías, Francisco Téllez, Miguel García-Deltoro, María J Ríos, Antonio Collado, Marcial Delgado-Fernández, Marta Suárez-Santamaría, Miriam Serrano, Celia Miralles-Álvarez, Karin Neukam
OBJECTIVE: The aim of this study was to determine the predictive capacity of response at treatment week (TW) 4 for the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) to treatment against hepatitis C virus (HCV) genotype (GT) 3-infection with all-oral direct-acting antiviral (DAA)-based regimens. PATIENTS AND METHODS: From a prospective multicohort study, HCV GT3-infected patients who completed a course of currently recommended DAA-based therapy at 33 Spanish hospitals and who had reached SVR12 evaluation timepoint were selected...
January 27, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/28135777/simeprevir-and-daclatasvir-for-12-or-24-weeks-in-treatment-na%C3%A3-ve-patients-with-hcv-genotype-1b-and-advanced-liver-disease
#12
Christophe Hézode, Piero L Almasio, Stefan Bourgeois, Peter Buggisch, Ashley Brown, Moises Diago, Yves Horsmans, Lawrence Serfaty, Ferenc Szalay, Giovanni B Gaeta, Ramon Planas, Michael Schlag, Isabelle Lonjon-Domanec, Edmund Omoruyi, Ralph DeMasi, Stefan Zeuzem
We investigated the efficacy and safety of simeprevir (SMV) plus daclatasvir (DCV) in treatment-naïve patients with chronic, genotype (GT) 1b hepatitis C virus (HCV) infection and advanced liver disease, excluding patients with pre-defined NS5A resistance-associated substitutions (RAS) METHODS: This phase II, open-label, single-arm, multicentre study included patients aged ≥18 years with advanced fibrosis or compensated cirrhosis (METAVIR F3/4). Patients with NS5A-Y93H or L31M/V RAS at screening were excluded...
January 30, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28134353/baseline-quasispecies-selection-and-novel-mutations-contribute-to-emerging-resistance-associated-substitutions-in-hepatitis-c-virus-after-direct-acting-antiviral-treatment
#13
Yugo Kai, Hayato Hikita, Naoki Morishita, Kazuhiro Murai, Tasuku Nakabori, Sadaharu Iio, Hideki Hagiwara, Yasuharu Imai, Shinji Tamura, Syusaku Tsutsui, Masafumi Naito, Meiko Nishiuchi, Yasuteru Kondo, Takanobu Kato, Hiroshi Suemizu, Ryoko Yamada, Tsugiko Oze, Takayuki Yakushijin, Naoki Hiramatsu, Ryotaro Sakamori, Tomohide Tatsumi, Tetsuo Takehara
Resistance-associated substitutions (RASs) in hepatitis C virus (HCV) appear upon failure of treatment with direct-acting antivirals (DAAs). However, their origin has not been clarified in detail. Among 11 HCV genotype 1b patients who experienced virologic failure with asunaprevir (ASV)/daclatasvir (DCV), 10 had major NS5A L31M/V-Y93H variants after treatment. L31M/V-Y93H variants were detected as a minor clone before therapy in 6 patients and were the most closely related to the post-treatment variants by phylogenetic tree analysis in 4 patients...
January 30, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28124463/hepatitis-c-treatment-from-response-guided-to-resource-guided-therapy-in-the-transition-era-from-ifn-containing-to-ifn-free-regimens
#14
REVIEW
Ming-Lung Yu
Peginterferon/ribavirin has been the standard-of-care for chronic hepatitis C virus (HCV) infections: 48-week for genotype 1 or 4 (HCV-1/4) and 24-week for HCV-2/3. Response-guided therapy recommended shorter 24-week and 16-week regimens for HCV-1 with lower baseline viral loads (LVL, <400,000-800,000 IU/ml) and rapid virological response (RVR, undetectable HCV RNA at week 4) and HCV-2/3 with RVR, respectively; and extending to 72 and 48 weeks for HCV-1 slower responders and HCV-2 non-RVR patients, respectively, to improve the efficacy...
January 26, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28118381/clinical-significance-of-two-real-time-pcr-assays-for-chronic-hepatitis-c-patients-receiving-protease-inhibitor-based-therapy
#15
Takako Inoue, Su Su Hmwe, Noritomo Shimada, Keizo Kato, Tatsuya Ide, Takuji Torimura, Takashi Kumada, Hidenori Toyoda, Akihito Tsubota, Koichi Takaguchi, Takaji Wakita, Yasuhito Tanaka
The aim of this study was to determine the efficacy of two hepatitis C virus (HCV) real-time PCR assays, the COBAS AmpliPrep/COBAS TaqMan HCV test (CAP/CTM) and the Abbott RealTime HCV test (ART), for predicting the clinical outcomes of patients infected with HCV who received telaprevir (TVR)-based triple therapy or daclatasvir/asunaprevir (DCV/ASV) dual therapy. The rapid virological response rates in patients receiving TVR-based triple therapy were 92% (23/25) and 40% (10/25) for CAP/CTM and ART, respectively...
2017: PloS One
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
#16
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
#17
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
#18
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
#19
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
#20
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
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