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https://read.qxmd.com/read/30778716/safety-and-efficacy-of-glecaprevir-and-pibrentasvir-in-japanese-hemodialysis-patients-with-genotype-2-hepatitis-c-virus-infection
#1
Goki Suda, Chitomi Hasebe, Masami Abe, Masayuki Kurosaki, Jun Itakura, Namiki Izumi, Yoshihito Uchida, Satoshi Mochida, Hiroaki Haga, Yoshiyuki Ueno, Kazumichi Abe, Atsushi Takahashi, Hiromasa Ohira, Yoko Tsukuda, Ken Furuya, Masaru Baba, Yoshiya Yamamoto, Tomoe Kobayashi, Jun Inoue, Katsumi Terasita, Masatsugu Ohara, Naoki Kawagishi, Takaaki Izumi, Masato Nakai, Takuya Sho, Mitsuteru Natsuizaka, Kenichi Morikawa, Koji Ogawa, Naoya Sakamoto
BACKGROUND: Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection...
February 18, 2019: Journal of Gastroenterology
https://read.qxmd.com/read/30775622/efficacy-and-safety-of-ombitasvir-paritaprevir-ritonavir-in-patients-with-hepatitis-c-virus-genotype-1-or-4-infection-and-advanced-kidney-disease
#2
Eric Lawitz, Edward Gane, Eric Cohen, John Vierling, Kosh Agarwal, Tarek Hassanein, Parvez S Mantry, Paul J Pockros, Michael Bennett, Nyingi Kemmer, Giuseppe Morelli, Jiuhong Zha, Deli Wang, Nancy S Shulman, Daniel E Cohen, K Rajender Reddy
Introduction: Hepatitis C virus (HCV) infection is common in patients with end-stage renal disease. We investigated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) ± dasabuvir (DSV) ± ribavirin (RBV) in 2 phase 3, open-label, multicenter studies in patients with stage 4 or 5 chronic kidney disease (CKD). Methods: RUBY-I, Cohort 2 enrolled treatment-naïve or -experienced patients with HCV genotype (GT) 1a or 1b infection, with or without cirrhosis...
February 2019: KI Reports
https://read.qxmd.com/read/30768838/transplanting-hepatitis-c-virus-infected-hearts-into-uninfected-recipients-a-single-arm-trial
#3
Rhondalyn C McLean, Peter P Reese, Michael Acker, Pavan Atluri, Christian Bermudez, Lee Goldberg, Peter L Abt, Emily A Blumberg, Vivianna M Van Deerlin, K Rajender Reddy, Roy D Bloom, Richard Hasz, Lawrence Suplee, Anna Sicilia, Ashley Woodards, Muhammad Nauman Zahid, Katharine J Bar, Paige Porrett, Matthew Levine, Nicole Hornsby, Caren Gentile, Jennifer Smith, David S Goldberg
The advent of direct-acting antiviral therapy for hepatitis C virus (HCV) has generated tremendous interest in transplanting organs from HCV-infected donors. We conducted a single-arm trial of orthotopic heart transplantation (OHT) from HCV-infected donors into uninfected recipients, followed by elbasvir/grazoprevir treatment after recipient HCV was first detected (NCT03146741; sponsor: Merck). We enrolled OHT candidates aged 40-65 years; LVAD support and liver disease were exclusions. We accepted hearts from HCV-genotype 1 donors...
February 15, 2019: American Journal of Transplantation
https://read.qxmd.com/read/30765933/results-of-sofosbuvir-plus-ribavirin-in-patients-with-hepatitis-c-related-decompensated-cirrhosis
#4
Naveen Tmu, Ashish Kumar, Praveen Sharma, Vikas Singla, Naresh Bansal, Anil Arora
Background: Sofosbuvir (SOF), a direct acting antiviral, has revolutionized the treatment of chronic Hepatitis C Virus (HCV) infection. However, data is scarce about efficacy of SOF plus Ribavarin (RBV) in Indian patients with decompensated cirrhosis. We evaluated the efficacy of SOF plus RBV in decompensated cirrhosis, and compared the outcome with compensated cirrhosis and non-cirrhotics. Patients and methods: Consecutive decompensated cirrhotic patients of chronic HCV with detectable HCV RNA were treated with 24-week course of SOF (400 mg) plus weight based RBV...
January 2019: Journal of Clinical and Experimental Hepatology
https://read.qxmd.com/read/30758299/patients-with-hcv-genotype-1-who-have-failed-a-direct-acting-antiviral-regimen-virological-characteristics-and-efficacy-of-retreatment
#5
Mariantonietta Pisaturo, Mario Starace, Carmine Minichini, Stefania De Pascalis, Margherita Macera, Laura Occhiello, Vincenzo Messina, Vincenzo Sangiovanni, Ernesto Claar, Davide Precone, Gianfranca Stornaiuolo, Maria Stanzione, Ivan Gentile, Giuseppina Brancaccio, Salvatore Martini, Addolorata Masiello, Angelo Salomone Megna, Carmine Coppola, Alessandro Federico, Evangelista Sagnelli, Marcello Persico, Alfonso Galeota Lanza, Aldo Marrone, Giovanni Battista Gaeta, Nicola Coppola
BACKGROUND: This real-world clinical-setting study characterized the virological patterns in genotype-1 patients failing IFN-free regimens and evaluated the efficacy of re-treatment. METHODS: Seventy-three consecutive patients failing IFN-free regimens were enrolled (17 genotype 1a and 56 1b). At failure Sanger sequencing of NS3, NS5A and NS5B regions was performed by home-made protocols. RESULTS: In patients having failed an NS3 inhibitor, the prevalence of NS3-RASs was higher in the 10 with genotype 1a than in the 24 with genotype 1b (80% vs...
February 13, 2019: Antiviral Therapy
https://read.qxmd.com/read/30718256/impact-of-pre-existing-hepatitis-c-virus-genotype-6-ns3-ns5a-and-ns5b-polymorphisms-on-their-in-vitro-susceptibility-to-inhibition-by-direct-acting-antiviral-agents
#6
Fiona McPhee, Joseph Ueland, Vincent Vellucci, Scott Bowden, William Sievert, Nannan Zhou
HCV genotype (GT)-6 is found predominantly in East and Southeast Asia. Clinical studies have focused on patients infected with HCV GT-6a where high response rates to direct-acting antivirals (DAAs) have been achieved. However, GT-6 is highly diverse with 29 reported subtypes. We explored the diversity of GT-6 polymorphisms at residues associated with DAA resistance, their impact on DAA in vitro potency when evaluated in a GT-6a consensus replicon and their association with specific GT-6 subtypes. GT-6 sequences from 25 patient-derived samples and 105 sequences from the US HCV database were compared and substitutions at resistance-associated residue positions were phenotyped against different DAAs...
February 4, 2019: Antimicrobial Agents and Chemotherapy
https://read.qxmd.com/read/30717681/a-prospective-study-of-daclatasvir-and-sofosbuvir-in-chronic-hcv-infected-kidney-transplant-recipients
#7
Michael Duerr, Eva V Schrezenmeier, Lukas J Lehner, Léon Bergfeld, Petra Glander, Stephan R Marticorena Garcia, Christian E Althoff, Ingolf Sack, Susanne Brakemeier, Kai-Uwe Eckardt, Klemens Budde, Fabian Halleck
BACKGROUND: Only a few prospective trials exist regarding the use of novel direct-acting antiviral agents (DAAs) in kidney transplant recipients (KTR) with chronic hepatitis C virus (HCV) infection. METHODS: This prospective single-center trial evaluated treatment with daclatasvir (DCV) and sofosbuvir (SOF) over 12 weeks in 16 adult chronic HCV infected KTR and eGFR > 30 ml/min/1.73m2 . Primary endpoint was sustained virological response 12 weeks after end of therapy (SVR12)...
February 4, 2019: BMC Nephrology
https://read.qxmd.com/read/30687952/systematic-review-epidemiology-and-response-to-direct-acting-antiviral-therapy-in-genotype-6-chronic-hepatic-c-virus-hcv
#8
REVIEW
Panita Mettikanont, Chalermrat Bunchorntavakul, K Rajender Reddy
BACKGROUND: Hepatitis C virus (HCV) genotype 6 (GT6) is predominantly encountered in Southeast Asia and data on GT6 response to direct-acting antiviral (DAA) therapy are relatively limited. AIM: To review the epidemiology and virologic outcome of DAA regimens in HCV GT6 patients. METHODS: Electronic literature search of PubMed, EMBASE, and The Cochrane Library databases were conducted. RESULTS: Hepatitis C virus genotype 6 is the most genetically diverse, has a prevalence of 19...
January 27, 2019: Alimentary Pharmacology & Therapeutics
https://read.qxmd.com/read/30684016/combinations-of-two-drugs-among-ns3-4a-inhibitors-ns5b-inhibitors-and-non-selective-antiviral-agents-are-effective-for-hepatitis-c-virus-with-ns5a-p32-deletion-in-humanized-liver-mice
#9
Akira Doi, Hayato Hikita, Yugo Kai, Yuki Tahata, Yoshinobu Saito, Tasuku Nakabori, Ryoko Yamada, Takahiro Kodama, Ryotaro Sakamori, Asako Murayama, Sayuri Nitta, Yasuhiro Asahina, Hiroshi Suemizu, Tomohide Tatsumi, Takanobu Kato, Tetsuo Takehara
BACKGROUND: The emergence of a deletion mutant at hepatitis C virus (HCV) NS5A-P32 (P32del) has recently been reported in a subset of chronic hepatitis C patients who experience virologic failure after direct-acting antiviral drug (DAA) treatment. This mutation confers extremely high resistance to NS5A inhibitors. No effective treatment has been established for cases with this mutation. METHODS: We used a JFH1-based recombinant virus with NS5A from a genotype 1b strain to introduce a P32del mutation...
January 25, 2019: Journal of Gastroenterology
https://read.qxmd.com/read/30669818/discussion-on-critical-points-for-a-tailored-therapy-to-cure-hepatitis-c-virus-infection
#10
Nadia Marascio, Angela Quirino, Giorgio Settimo Barreca, Luisa Galati, Chiara Costa, Vincenzo Pisani, Maria Mazzitelli, Giovanni Matera, Maria Carla Liberto, Alfredo Focà, Carlo Torti
Hepatitis C virus (HCV) infects around 71 million people worldwide and in 2018 it is still a major health problem. Since 2011, anti-HCV therapy with availability of direct-acting antiviral drugs has revolutionized the clinical response and paved the way to eradication strategies. However, despite the high rate of sustained virological response, treatment failure may occur in a limited percentage of patients, possibly due to resistance-associated substitutions (RASs), either emergent or pre-existent even in minority viral populations...
January 23, 2019: Clinical and Molecular Hepatology
https://read.qxmd.com/read/30669786/-a-real-world-study-of-paritaprevir-ritonavir-ombitasvir-combined-with-dasabuvir-in-the-treatment-of-genotype-1b-chronic-hepatitis-c
#11
J P Liu, Y Q Cheng, J M Zhang, H M Jin, H B Ning, K Li, M Y Ma, Y N Wu, Z Peng, H Yin, C P Liu, J Shang
Objective: To recognize the efficacy and safety of paritaprevir/ritonavir-ombitasvir combined with dasabuvir (OBV/PTV/RTV+DSV) in the treatment of genotype 1b chronic hepatitis C. Methods: Patients with genotype 1b chronic hepatitis C who were admitted to the People's Hospital of Henan Province, Huashan Hospital of Shanghai and the Fifth Medical Center of the General Hospital of the People's Liberation Army of China between November 2017 to August 2018 were enlisted. All patients received OBV/PTV/RTV+DSV antiviral therapy...
December 20, 2018: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://read.qxmd.com/read/30667592/exposure-response-analysis-for-efficacy-of-daclatasvir-asunaprevir-and-beclabuvir-combinations-in-hcv-infected-patients
#12
T Ueno, M Osawa, T Shiozaki, M Green, T Garimella
The combination regimen of daclatasvir, asunaprevir, and beclabuvir (3DAA regimen) was developed as a fixed-dose combination for the treatment of hepatitis C virus (HCV) infection in Japan. The objectives of this analysis were to characterize the relationship between drug exposure and sustained virologic response at posttreatment week 12 (SVR12) in HCV-infected subjects and to evaluate the impact of demographic covariates and clinical factors on the exposure-response (E-R) relationship. The E-R efficacy analysis was performed with data from phase 2 and phase 3 studies in HCV-infected subjects treated with the 3DAA regimen...
January 22, 2019: Clinical Pharmacology in Drug Development
https://read.qxmd.com/read/30666967/real-life-results-of-treatment-with-ombitasvir-paritaprevir-dasabuvir-and-ritonavir-combination-in-patients-with-chronic-renal-failure-infected-with-hcv-in-turkey
#13
Serkan Yaraş, Enver Üçbilek, Osman Özdoğan, Fehmi Ateş, Engin Altıntaş, Orhan Sezgin
BACKGROUND/AIMS: As the most common liver disease in hemodialysis patients, chronic hepatitis C (CHC) can cause cirrhosis and hepatocellular carcinoma, even increase in renal-related mortality. In Turkey, the frequency of anti-hepatitis C virus (HCV) antibodies in hemodialysis patients ranged from 31.4% to 51%. Until recently, the mainstay of the CHC treatment for these patients was pegylated interferon with potential toxicities and low sustained virological response. The 3D regimen, a combination of four drugs (ombitasvir, paritaprevir, dasabuvir, and ritonavir), has recently been used for patients with chronic kidney disease infected with genotype 1a and 1b HCV...
January 22, 2019: Turkish Journal of Gastroenterology: the Official Journal of Turkish Society of Gastroenterology
https://read.qxmd.com/read/30666120/amiodarone-and-risk-of-liver-cirrhosis-a-nationwide-population-based-study
#14
Ching-Hui Huang, Ya-Yun Lai, Yu-Jui Kuo, Su-Ching Yang, Yu-Jun Chang, Kuo-Kuan Chang, Wen-Kang Chen
Background: Liver cirrhosis is an uncommon but not rare side effect of amiodarone-induced hepatotoxicity. Patients with hepatitis B virus and hepatitis C virus infections are at a high risk for developing liver cirrhosis. However, the relationship between this treatment and risk of liver cirrhosis in high-risk chronic hepatitis B and chronic hepatitis C patients is unknown. Patients and methods: The present study identified amiodarone users (N=8,081) from the Taiwan National Health Insurance Research Database from 1997 through 2013...
2019: Therapeutics and Clinical Risk Management
https://read.qxmd.com/read/30660617/treatment-of-acute-hepatitis-c-genotypes-1-and-4-with-8-weeks-of-grazoprevir-plus-elbasvir-dahhs2-an-open-label-multicentre-single-arm-phase-3b-trial
#15
Anne Boerekamps, Anja De Weggheleire, Guido E van den Berk, Fanny N Lauw, Mark A A Claassen, Dirk Posthouwer, Wouter F Bierman, Sebastiaan J Hullegie, Stephanie Popping, David A C M van de Vijver, Anthonius S M Dofferhoff, Gert Jan Kootstra, Eliane M Leyten, Jan den Hollander, Marjo E van Kasteren, Robert Soetekouw, Heidi S M Ammerlaan, Janke Schinkel, Eric Florence, Joop E Arends, Bart J A Rijnders
BACKGROUND: Direct-acting antivirals effectively treat chronic hepatitis C virus (HCV) infection but there is a paucity of data on their efficacy for acute HCV, when immediate treatment could prevent onward transmission. We assessed the efficacy of grazoprevir plus elbasvir treatment in acute HCV infection and investigated whether treatment can be shortened during the acute phase of HCV infection. METHODS: The Dutch Acute HCV in HIV study number 2 (DAHHS2) study was a single-arm, open-label, multicentre, phase 3b trial...
January 16, 2019: Lancet. Gastroenterology & Hepatology
https://read.qxmd.com/read/30641483/treating-hcv-infection-it-doesn-t-get-much-better-than-this
#16
Susanna Naggie
Direct-acting antiviral (DAA) regimens now allow treatment of previously untreated or treated (including prior DAA failures) patients with chronic hepatitis C virus (HCV) infection with 8 or 12 week regimens, largely without the use of ribavirin. Newer next-generation pan-genotypic regimens with activity against resistance-associated substitutions include glecaprevir/pibrentasvir (GLE/PIB), a combination of a nonstructural protein (NS)3 protease inhibitor and an NS5A inhibitor, and sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX), a combination of an NS5B polymerase inhibitor, NS5A inhibitor, and NS3 protease inhibitor...
January 2019: Topics in Antiviral Medicine
https://read.qxmd.com/read/30636361/treatment-with-direct-acting-antivirals-for-hcv-decreases-but-does-not-eliminate-the-risk-of-hepatocellular-carcinoma
#17
Federico Piñero, Manuel Mendizabal, Ezequiel Ridruejo, Fernando Herz Wolff, Beatriz Ameigeiras, Margarita Anders, María Isabel Schinoni, Virginia Reggiardo, Ana Palazzo, María Videla, Cristina Alonso, Luisa Santos, Adriana Varón, Sebastián Figueroa, Cecilia Vistarini, Raúl Adrover, Nora Fernández, Daniela Perez, Federico Tanno, Nelia Hernández, Marcela Sixto, Silvia Borzi, Andres Bruno, Daniel Cocozzella, Alejandro Soza, Valeria Descalzi, Claudio Estepo, Alina Zerega, Alexandre de Araujo, Hugo Cheinquer, Marcelo Silva
BACKGROUND & AIMS: Data from Europe and North America have been published regarding the risk of developing hepatocellular carcinoma (HCC) after treatment with direct antiviral agents (DAA). We proposed to evaluate cumulative incidence and associated risk factors for de novo HCC. METHODS: This was a prospective multicenter cohort study from Latin America including 1,400 F1-F4 treated patients with DAAs (F3-F4 n=1017). Cox proportional regression models (hazard ratios, HR and 95% CI) were used to evaluate independent associated variables with HCC...
January 13, 2019: Liver International: Official Journal of the International Association for the Study of the Liver
https://read.qxmd.com/read/30619941/real-world-safety-and-efficacy-of-sofosbuvir-and-ledipasvir-for-elderly-patients
#18
Hideyuki Tamai, Naoki Shingaki, Yoshiyuki Ida, Ryo Shimizu, Shuya Maeshima, Junpei Okamura, Akira Kawashima, Taisei Nakao, Takeshi Hara, Hiroyoshi Matsutani, Izumi Nishikawa, Katsuhiko Higashi
Background and Aim: In September 2015, sofosbuvir and ledipasvir were approved for clinical use in Japan for patients infected with genotype 1 hepatitis C virus. We conducted a postmarketing prospective cohort study to elucidate the safety and efficacy of this therapy in a real-world setting. Methods: We treated 509 patients using standard doses of sofosbuvir and ledipasvir for 12 weeks. As sustained virological response (SVR) in 2 patients could not be evaluated, 507 patients were finally analyzed...
December 2018: JGH open: an open access journal of gastroenterology and hepatology
https://read.qxmd.com/read/30612104/resistant-type-ii-cryoglobulinaemic-vasculitis-successfully-treated-with-bortezomib-in-a-patient-with-sle
#19
Katherine Dutton, Sinisa Savic, Roger Owen, Edward Vital
We report an interesting case of hepatitis C virus-negative type II cryoglobulinaemic vasculitis (CV) in a patient with a background history of systemic lupus erythematosus. The type II CV became less responsive to traditional treatments over time and culminated in an intensive care unit admission with critical multiorgan failure. A detailed flow cytometric evaluation of the bone marrow proved to be helpful in treatment. It demonstrated that bortezomib was a viable alternative treatment option for the type II CV...
January 4, 2019: BMJ Case Reports
https://read.qxmd.com/read/30605721/hcv-therapy-no-one-to-let-behind
#20
REVIEW
Marc Bourlière, Olivia Pietri
The advent of oral direct-acting antiviral agents (DAAs) has dramatically improved hepatitis C treatment landscape in the last four years, providing cure rates over 95% with shorter duration of treatment and a very good safety profile. This allowed giving access to treatment in nearly all Hepatitis C virus (HCV) infected patients. The launch of two pangenotypic fixed dose combinations (FDC) in 2017 made a new step forward in hepatitis C treatment by slightly increasing efficacy and more importantly allowing to treat patients without HCV genotyping and in some cases without fibrosis assessment...
December 31, 2018: International Journal of Antimicrobial Agents
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