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Daclatasvir

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https://www.readbyqxmd.com/read/28645021/development-a-validated-highly-sensitive-lc-ms-ms-method-for-simultaneous-quantification-of-ledipasvir-sofosbuvir-and-its-major-metabolite-gs-331007-in-human-plasma-application-to-a-human-pharmacokinetic-study
#1
Ola M Abdallah, Ahmed M Abdel-Megied, Amira S Gouda
A highly sensitive and rapid LC-MS/MS method was developed, fully optimized and validated for the simultaneous determination of Ledipasvir (LED) and Sofosbuvir (SOF) in the presence of its major metabolite GS-331007 in human plasma using Daclatasvir as internal standard (IS). The extraction of analytes and IS from plasma was performed using liquid-liquid extraction with ethyl acetate. The chromatographic separation of these prepared samples was achieved on Xterra MS C8 column (4.6×50mm,5μm) using gradient elution with a mobile phase of ammonium formate buffer (pH 3...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28626376/successful-treatment-for-chronic-hepatitis-c-autoimmune-hepatitis-overlap-syndrome-due-to-daclatasvir-and-asunaprevir
#2
Ayumi Sugiura, Shuichi Wada, Hiromitsu Mori, Takefumi Kimura, Yoshiaki Matsuda, Naoki Tanaka, Eiji Tanaka, Kendo Kiyosawa
Persistent hepatitis C virus (HCV) infection may induce autoimmune diseases and chronic hepatitis C is sometimes accompanied by autoimmune hepatitis (AIH). However, we are worried about the treatment for chronic hepatitis C-AIH overlap syndrome because interferon-based antiviral therapies may enhance autoimmunity and immunosuppressive corticosteroid administration may promote viral replication. Here, we report a patient having chronic hepatitis C-AIH overlap syndrome treated with the direct-acting antivirals (DAA), daclatasvir and asunaprevir...
May 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/28618285/belgian-experience-with-direct-acting-antivirals-in-people-who-inject-drugs
#3
Rob Bielen, Christophe Moreno, Hans Van Vlierberghe, Stefan Bourgeois, Jean-Pierre Mulkay, Thomas Vanwolleghem, Wim Verlinden, Christian Brixko, Jochen Decaestecker, Chantal De Galocsy, Filip Janssens, Mike Cool, Lode Van Overbeke, Christophe Van Steenkiste, François D'heygere, Wilfried Cools, Frederik Nevens, Geert Robaeys
BACKGROUND AND AIM: Hepatitis C viral infection (HCV) has become a curable disease due to the development of direct acting antivirals (DAA). The WHO has set a target to eliminate HCV completely. Therefore, people who inject drugs (PWID) also need to be treated. In this study, we compared the real-life uptake and outcome of DAA treatment for HCV in PWID and non-PWID. METHODS: We performed a nation-wide, retrospective cohort study in 15 hospitals. All patients who were treated with simeprevir-sofosbuvir, daclatasvir-sofosbuvir, or ombitasvir/paritaprevir ritonavir-dasabuvir between December 2013 and November 2015 were included...
May 30, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28608619/efficacy-and-safety-of-daclatasvir-based-antiviral-therapy-in-hcv-recurrence-after-liver-transplantation-role-of-cirrhosis-and-genotype-3-a-multi-centre-cohort-study
#4
Magdalena Salcedo, Martín Prieto, Lluís Castells, Juan Manuel Pascasio, Jose Luis Montero Alvarez, Inmaculada Fernández, Gloria Sánchez-Antolín, Luisa González-Diéguez, Miguel García-Gonzalez, Alejandra Otero, Sara Lorente, Maria Dolores Espinosa, Milagros Testillano, Antonio González, Jose Castellote, Fernando Casafont, Maria-Carlota Londoño, Jose Antonio Pons, Esther Molina Pérez, Valentín Cuervas-Mons, Sonia Pascual, Jose Ignacio Herrero, Isidoro Narváez, Carmen Vinaixa, Jordi Llaneras, Jose Manuel Sousa, Rafael Bañares
BACKGROUND & AIMS: Direct-acting antiviral agents (DAA) combining daclatasvir (DCV) have reported good outcomes in the recurrence of hepatitis C virus (HCV) infection after liver transplant (LT). However, its effect on the severe recurrence and the risk of death remains controversial. We evaluated the efficacy, predictors of survival, and safety of DAC-based regimens in a large real-world cohort. METHODS: A total of 331 patients received DCV-based therapy. Duration of therapy and ribavirin use were at the investigator's discretion...
June 13, 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28594332/pooled-analysis-of-hcv-genotype-1-resistance-associated-substitutions-in-ns5a-ns3-and-ns5b-pre-and-post-treatment-with-12-weeks-of-daclatasvir-asunaprevir-and-beclabuvir
#5
Fiona McPhee, Dennis Hernandez, Nannan Zhou, Joseph Ueland, Fei Yu, Vincent Vellucci, Xin Huang, Xuning Wang, Hiroki Ishikawa, Yoshiyasu Karino, Hiromitsu Kumada
BACKGROUND: Daclatasvir (DCV; non-structural [NS]5A inhibitor) plus asunaprevir (ASV; NS3 inhibitor) plus beclabuvir (BCV; non-nucleoside NS5B inhibitor) is an approved regimen for hepatitis C virus (HCV) genotype (GT)-1 treatment in Japan. A comprehensive analysis of pre-treatment and treatment-emergent HCV resistance to this regimen ± ribavirin (RBV) was performed. METHODS: Data were pooled from five phase 2/3 studies of DCV+ASV+BCV±RBV given for 12 weeks to GT-1a- or GT-1b-infected patients...
June 8, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28583525/effective-treatment-with-daclatasvir-and-asunaprevir-in-kidney-transplant-patients-infected-with-hepatitis-c-virus-a-report-of-two-cases
#6
K Koshino, H Ushigome, K Masuda, T Matsuyama, S Harada, T Nakamura, S Nobori, T Iida, N Yoshimura
BACKGROUND: Hepatitis C virus (HCV) infection is known to affect long-term patient and graft survivals after kidney transplantation (KT). Recently, combination therapy with the use of 2 oral direct-acting antivirals, daclatasvir (DCV) and asunaprevir (ASV) reportedly showed a high rate of HCV eradication. We report the safety and efficacy of DCV and ASV therapy in 2 KT patients. METHODS: The safety and viral responses were investigated in a prospective study of KT patients infected with HCV genotype 1...
June 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28579587/direct-acting-antiviral-agents-improved-nephrotic-syndrome-associated-with-refractory-pleural-effusion-and-ascites-caused-by-hepatitis-c-virus-related-nephropathy-a-case-report
#7
Masatoshi Yamato, Kuniaki Arai, Hajime Takatori, Tetsuro Shimakami, Taro Yamashita, Yoshio Sakai, Tatsuya Yamashita, Eishiro Mizukoshi, Masao Honda, Shuichi Kaneko
A 74-year-old man with hepatitis C virus (HCV)-related cirrhosis was admitted because of dyspnea. Laboratory investigations revealed severe proteinuria (4.0g/day), low serum albumin level, and cryoglobulinemia. Computed tomography showed massive pleural effusion and ascites. Because these effusions were leaky and the hepatic reserve was relatively intact, we thought these were mainly caused by nephrotic syndrome. Renal biopsy revealed membranoproliferative glomerulonephritis with mesangial proliferation and excessive matrix deposition...
2017: Nihon Shokakibyo Gakkai Zasshi, the Japanese Journal of Gastro-enterology
https://www.readbyqxmd.com/read/28560477/daclatasvir-and-asunaprevir-in-hemodialysis-patients-with-hepatitis-c-virus-infection-a-nationwide-retrospective-study-in-japan
#8
Goki Suda, Norihiro Furusyo, Hidenori Toyoda, Yoshiiku Kawakami, Hiroki Ikeda, Michihiro Suzuki, Keiko Arataki, Nami Mori, Keiji Tsuji, Yoshio Katamura, Koichi Takaguchi, Toru Ishikawa, Kunihiko Tsuji, Noritomo Shimada, Atsushi Hiraoka, Sho Yamsaki, Masato Nakai, Takuya Sho, Kenichi Morikawa, Koji Ogawa, Mineo Kudo, Atsushi Nagasaka, Ken Furuya, Yoshiya Yamamoto, Kanji Kato, Yoshiyuki Ueno, Etsuko Iio, Yasuhito Tanaka, Masayuki Kurosaki, Takashi Kumada, Kazuaki Chayama, Naoya Sakamoto
BACKGROUND: Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV)...
May 30, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28509128/a-case-of-rapid-amelioration-of-hepatitis-c-virus-associated-cryoglobulinemic-membranoproliferative-glomerulonephritis-treated-by-interferon-free-directly-acting-antivirals-for-hcv-in-the-absence-of-immunosuppressant
#9
Fumiaki Obata, Taichi Murakami, Junko Miyagi, Sayo Ueda, Taizo Inagaki, Masanori Minato, Hiroyuki Ono, Kenji Nishimura, Eriko Shibata, Masanori Tamaki, Sakiya Yoshimoto, Fumi Kishi, Seiji Kishi, Motokazu Matsuura, Kojiro Nagai, Hideharu Abe, Toshio Doi
Mixed cryoglobulinemic syndrome, which is a systemic vasculitis characterized by the immune complex deposition in small- and medium-sized arteries and most often due to chronic hepatitis C virus (HCV) infection, sometimes clinically manifests as refractory glomerulonephritis or nephritic syndrome. Patients with mixed cryoglobulinemic nephropathy who have a rapidly progressive glomerulonephritis should receive immunosuppressive therapy. After disease stabilization, patients should receive concurrent therapy for the underlying HCV infection...
May 2017: CEN Case Reports
https://www.readbyqxmd.com/read/28504842/safety-and-efficacy-of-current-daa-regimens-in-kidney-and-liver-transplant-recipients-with-hepatitis-c-results-from-the-hcv-target-study
#10
Varun Saxena, Vandana Khungar, Elizabeth C Verna, Josh Levitsky, Robert S Brown, Mohamed A Hassan, Mark S Sulkowski, Jacqueline G O'Leary, Farrukh Koraishy, Joseph S Galati, Alexander A Kuo, Monika Vainorius, Lucy Akushevich, David R Nelson, Michael W Fried, Norah Terrault, K Rajender Reddy
BACKGROUND: Data outside of clinical trials with direct acting antiviral (DAA) regimens with or without ribavirin as treatment of chronic HCV in solid organ transplant recipients is limited. METHODS: Liver transplant (LT), kidney transplant (KT) and dual liver kidney (DLK) transplant recipients from the HCV-TARGET database, a multicenter, longitudinal clinical care treatment cohort, treated with DAA regimens between January 1 2014 and February 15, 2016 were included to assess safety and efficacy...
May 15, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28497432/resistance-mechanisms-in-hepatitis-c-virus-implications-for-direct-acting-antiviral-use
#11
Sabrina Bagaglio, Caterina Uberti-Foppa, Giulia Morsica
Multiple direct-acting antiviral (DAA)-based regimens are currently approved that provide one or more interferon-free treatment options for hepatitis C virus (HCV) genotypes (G) 1-6. The choice of a DAA regimen, duration of therapy, and use of ribavirin depends on multiple viral and host factors, including HCV genotype, the detection of resistance-associated amino acid (aa) substitutions (RASs), prior treatment experience, and presence of cirrhosis. In regard to viral factors that may guide the treatment choice, the most important is the infecting genotype because a number of DAAs are genotype-designed...
May 12, 2017: Drugs
https://www.readbyqxmd.com/read/28475232/safety-and-efficacy-of-sofosbuvir-based-daa-regimens-for-hepatitis-c-virus-genotypes-1-4-and-6-in-myanmar-real-world-experience
#12
Naomi Khaing Than Hlaing, Robert A Mitrani, Soe Thu Aung, Wai Wai Phyo, Marina Serper, A Mi Mi Kyaw, Aung Hlaing Bwa, Khin Maung Win, K Rajender Reddy
This open-label, clinical experience investigated the safety and efficacy of direct-acting antiviral (DAA) Hepatitis C Virus (HCV) therapy in Myanmar. 344 patients completed treatment between June 2015 and May 2016. Patients with HCV genotypes 1 - 4 and 6 received one of four treatments: (1) Peg-interferon (PEG-IFN) + Sofosbuvir (SOF) + Ribavirin (RBV) for 12 weeks, (2) SOF + RBV for 24 weeks, (3) Ledipasvir (LDV) + SOF for 12 weeks, or (4) Daclatasvir (DCV) + SOF + RBV for 12 or 24 weeks. Genotype 3 was most common (n = 133, 38...
May 5, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28474741/metformin-and-daclatasvir-absence-of-a-pharmacokinetic-pharmacodynamic-drug-interaction-in-healthy-volunteers
#13
Elise J Smolders, Angela Colbers, Clara T M M de Kanter, Kirsten Velthoven-Graafland, Leonie T Wolberink, Noor van Ewijk-Beneken Kolmer, Joost P H Drenth, Rob E Aarnoutse, Cees J Tack, David M Burger
AIM: The aim of the present study was to evaluate the effect of the proposed organic cation transporter (OCT) inhibitor daclatasvir on the pharmacokinetics and pharmacodynamics of the OCT substrate metformin. METHODS: This was an open-label, two-period, randomized, crossover trial in 20 healthy subjects. Treatment A consisted of metformin and treatment B consisted of metformin + daclatasvir. Pharmacokinetic curves were recorded at steady-state. Geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were calculated for metformin area under the concentration-time curve from 0 h to 12 h (AUC0-12 ), maximum plasma concentration (Cmax ) and final plasma concentration (Clast )...
May 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28469810/efficacy-and-safety-of-dual-therapy-with-daclatasvir-and-asunaprevir-in-elderly-patients
#14
Kazuo Tarao, Katsuaki Tanaka, Akito Nozaki, Akira Sato, Toshiya Ishii, Hirokazu Komatsu, Takaaki Ikeda, Tatsuji Komatsu, Shozo Matsushima, Kenji Oshige
AIM: To survey the efficacy and safety of dual therapy with daclatasvir and asunaprevir in the elderly hepatitis C virus (HCV) patients multicentricity. METHODS: Interferon-ineligible/intolerant patients and non-responders to previous pegylated-interferon/ribavirin therapy with chronic HCV genotype 1b infection were enrolled. Child B, C cirrhotic patients were excluded. Patients received oral direct acting antiviral treatment consisting of 60 mg daclatasvir once daily plus 200 mg asunaprevir twice daily for 24 wk...
April 18, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28467359/long-term-follow-up-of-resistance-associated-substitutions-in-hepatitis-c-virus-in-patients-in-which-direct-acting-antiviral-based-therapy-failed
#15
Kanako Yoshida, Hoang Hai, Akihiro Tamori, Yuga Teranishi, Ritsuzo Kozuka, Hiroyuki Motoyama, Etsushi Kawamura, Atsushi Hagihara, Sawako Uchida-Kobayashi, Hiroyasu Morikawa, Masaru Enomoto, Yoshiki Murakami, Norifumi Kawada
We evaluated the transition of dominant resistance-associated substitutions (RASs) in hepatitis C virus during long-term follow-up after the failure of DAAs (direct acting antivirals)-based therapy. RASs in non-structure (NS)3/4A, NS5A, NS5B, and deletions in NS5A from 20 patients who failed simeprevir/pegylated-interferon/ribavirin (SMV/PEG-IFN/RBV) and 25 patients who failed daclatasvir/asunaprevir (DCV/ASV) treatment were examined by direct sequencing. With respect to SMV/PEG-IFN/RBV treatment, RAS was detected at D168 in NS3/4A but not detected in NS5A and NS5B at treatment failure in 16 of 20 patients...
May 3, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28442915/efficacy-and-safety-outcomes-of-sofosbuvir-based-treatment-regimens-for-hepatitis-c-virus-infected-patients-with-or-without-cirrhosis-from-phase-iii-clinical-trials
#16
REVIEW
Young-Mo Yang, Eun Joo Choi
BACKGROUND: With the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens. METHODS: A literature search of clinical studies published in PubMed and posted on ClinicalTrials...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28440885/a-comparison-of-direct-sequencing-and-invader-assay-for-y93h-mutation-and-response-to-interferon-free-therapy-in-hepatitis-c-virus-genotype-1b
#17
Kazuhiko Hayashi, Masatoshi Ishigami, Yoji Ishizu, Teiji Kuzuya, Takashi Honda, Hiroki Kawashima, Tetsuya Ishikawa, Yoshihiko Tachi, Masashi Hattori, Yoshiaki Katano, Hidemi Goto, Yoshiki Hirooka
BACKGROUND AND AIM: Virologic failure of interferon (IFN)-free therapy has been associated with Y93H mutation in the NS5A region in hepatitis C virus (HCV) genotype 1b, and screening is recommended. A simple assay based on Q-Invader technology was developed for Y93H mutant screening to reduce cost and effort. The present study sought to compare two methods of detection of Y93H mutation and to evaluate the effect of Y93H mutation on response to IFN free therapy. METHODS: Y93H mutation was examined in 258 patients with HCV genotype 1b using both direct sequencing analysis and the PCR-Invader assay...
April 25, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28439915/treatment-of-chronic-hepatitis-c-with-direct-acting-antivirals-in-patients-with-%C3%AE-thalassaemia-major-and-advanced-liver-disease
#18
Emmanouil Sinakos, Dimitrios Kountouras, John Koskinas, Kalliopi Zachou, Stylianos Karatapanis, Christos Triantos, Themistoklis Vassiliadis, Ioannis Goulis, Alexandra Kourakli, Efthymia Vlachaki, Barbara Toli, Maria Tampaki, Pinelopi Arvaniti, Georgios Tsiaoussis, Aristea Bellou, Antonis Kattamis, Konstantinos Maragkos, Foteini Petropoulou, George N Dalekos, Evangelos Akriviadis, George V Papatheodoridis
Interferon-based regimens for chronic hepatitis C (CHC) were often deferred in patients with β-thalasaemia major (β-TM) due to poor efficacy and tolerance. Current guidelines recommend direct-acting antivirals (DAAs) for these patients. The aim of this study was to assess the safety and efficacy of DAAs in patients with β-TM and advanced liver disease due to CHC. Patients were recruited from eight liver units in Greece. The stage of liver disease was assessed using transient elastography and/or liver histology...
April 25, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28428715/impact-of-interferon-free-antivirus-therapy-on-lipid-profiles-in-patients-with-chronic-hepatitis-c-genotype-1b
#19
Daisuke Endo, Kenichi Satoh, Noritomo Shimada, Atsushi Hokari, Yoshio Aizawa
AIM: To investigate the influence of interferon-free antivirus therapy on lipid profiles in chronic hepatitis C virus genotype 1b (HCV1b) infection. METHODS: Interferon-free antiviral agents were used to treat 276 patients with chronic HCV1b infection, and changes in serum lipids of those who achieved sustained virologic response (SVR) were examined. The treatment regimen included 24 wk of daclatasvir plus asunaprevir (DCV + ASV) or 12 wk of sofosbuvir plus ledipasvir (SOF + LDV)...
April 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28421422/hepatitis-c-virus-genotype-3-update-on-current-and-emergent-therapeutic-interventions
#20
REVIEW
Steven W Johnson, Dorothea K Thompson, Brianne Raccor
PURPOSE OF REVIEW: Direct-acting antiviral agents (DAAs) have markedly improved the prognosis of hepatitis C virus (HCV)-genotype 3 (GT3), a highly prevalent infection worldwide. However, in patients with hepatic fibrosis, cirrhosis, or hepatocellular carcinoma (HCC), GT3 infection presents a treatment challenge compared with other genotypes. The dependence of the HCV life cycle on host lipid metabolism suggests the possible utility of targeting host cellular factors for combination anti-HCV therapy...
June 2017: Current Infectious Disease Reports
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