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https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#1
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28621007/effectiveness-of-a-fixed-combination-formula-of-ombitasvir-paritaprevir-ritonavir-for-hepatitis-c-virus-infection-in-patients-on-maintenance-haemodialysis
#2
Norihiko Morisawa, Yohei Koshima, Satoru Kuriyama, Momoko Matsuyama, Naomi Hayashi, Jun-Ichi Satoh, Morimasa Amemiya, Takashi Yokoo
A fixed-dose formula that combines Ombitasvir (OBV), Paritaprevir (PTV) and Ritonavir (RTV) has been launched into the field of anti-HCV therapy in Japan for patients infected with HCV genotypes 1 and 2 in 2015. However, little is yet known as to the efficacy and safety of this novel therapy in patients on maintenance haemodialysis (HD). The present report describes a preliminary experience in 10 patients (five males and five females) who underwent maintenance HD. All of them had HCV genotype 1b, without having the resistance-associated variants at Y93 or L31 in the nonstructural proteins 5A (NS5A) region...
July 2017: Nephrology
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/28590324/is-there-a-relationship-between-treatment-with-direct-antiviral-agents-for-hcv-infection-and-the-development-of-malignancies
#4
Tarek Saadi, Johad Khoury
BACKGROUND AND AIMS: Direct antiviral agents (DAAs) have become the treatment of choice for patients with chronic hepatitis C virus (HCV) infection. As these drugs are new, it is important to learn the adverse events of these drugs in the short and long terms. We report on 7 patients who developed malignancies during treatment with DAAs or a short time after finishing treatment. METHODS: We treated 133 patients with DAAs in our unit between January 2015 and June 2016, 100 (75%) of whom were treated with the combination of paritaprevir/ritonavir/ombitasvir with/without dasabuvir (PrOD)...
June 5, 2017: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/28579812/cost-per-care-of-the-first-year-of-direct-antiviral-agents-in-the-liguria-region-a-multicenter-analysis
#5
Giovanni Cenderello, Caterina Fanizza, Simona Marenco, Laura Ambra Nicolini, Stefania Artioli, Isabella Baldissarro, Chiara Dentone, Pasqualina De Leo, Antonio Di Biagio
AIMS: Despite the remarkable efficacy shown in clinical practice, concerns have been raised about the costs associated with direct antiviral agent (DAA) therapy. This article presents the real-life costs for DAA treatment sustained by the Italian National Health Service in the Liguria Region (Northern Italy). METHODS: A retrospective analysis of the cost per care sustained for DAA treatment, relating to the period from January 1 to December 31, 2015 in five centers in Liguria was performed...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28570836/the-influence-of-hepatitis-c-virus-therapy-on-the-dna-base-excision-repair-system-of-peripheral-blood-mononuclear-cells
#6
Piotr Czarny, Anna Merecz-Sadowska, Kinga Majchrzak, Maciej Jabłkowski, Janusz Szemraj, Tomasz Śliwiński, Bolesław Karwowski
Hepatitis C virus (HCV) can infect extrahepatic tissues, including lymphocytes, creating reservoir of the virus. Moreover, HCV proteins can interact with DNA damage response proteins of infected cells. In this article we investigated the influence of the virus infection and a new ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) anti-HCV therapy on the PBMCs (peripheral blood mononuclear cells, mainly lymphocytes) DNA base excision repair (BER) system. BER protein activity was analyzed in the nuclear and mitochondrial extracts (NE and ME) of PBMC isolated from patients before and after therapy, and from subjects without HCV, using modeled double-strand DNA, with 2'-deoxyuridine substitution as the DNA damage...
June 1, 2017: DNA and Cell Biology
https://www.readbyqxmd.com/read/28536999/randomized-phase-3-trial-of-ombitasvir-paritaprevir-ritonavir-and-ribavirin-for-hepatitis-c-virus-genotype-2-infected-japanese-patients
#7
Ken Sato, Kazuaki Chayama, Katia Alves, Hidenori Toyoda, Fumitaka Suzuki, Koji Kato, Lino Rodrigues, Xinyan Zhang, Carolyn Setze, Tami Pilot-Matias, Margaret Burroughs, Rebecca Redman, Hiromitsu Kumada
INTRODUCTION: In Japan, hepatitis C virus (HCV) genotype (GT) 2 accounts for approximately 32% of HCV infections. Limited treatment options exist in Japan for HCV GT2-infected patients. GIFT-II was a phase 3, randomized, open-label study evaluating the efficacy and safety of 16- and 12-week regimens of co-formulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus ribavirin (RBV) in Japanese adults with HCV GT2 infection. METHODS: Patients were randomized in a 1:1 ratio to once-daily, co-formulated OBV/PTV/r (25/150/100 mg) with weight-based RBV for 16 or 12 weeks...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28533924/interferon-free-treatments-in-patients-with-hepatitis-c-genotype-1-4-infections-in-a-real-world-setting
#8
Huascar Ramos, Pedro Linares, Ester Badia, Isabel Martín, Judith Gómez, Carolina Almohalla, Francisco Jorquera, Sara Calvo, Isidro García, Pilar Conde, Begoña Álvarez, Guillermo Karpman, Sara Lorenzo, Visitación Gozalo, Mónica Vásquez, Diana Joao, Marina de Benito, Lourdes Ruiz, Felipe Jiménez, Federico Sáez-Royuela, Asociación Castellano Y Leonesa de Hepatología ACyLHE
AIM: To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV). METHODS: We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively)...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28516201/budget-impact-and-cost-effectiveness-analyses-of-direct-acting-antivirals-for-chronic-hepatitis-c-virus-infection-in-hong-kong
#9
X Li, N S Chan, A W Tam, I F N Hung, E W Chan
The purpose of this investigation was to evaluate the budget impact and cost-effectiveness of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection in Hong Kong. A decision analytic model was developed to compare short-term costs and health outcomes of patients with chronic HCV genotype 1 infection in Hong Kong who were treated with an interferon (INF)-based treatment (dual therapy of pegylated interferon and ribavirin) or DAA-based treatments (sofosbuvir or ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir plus dasabuvir)...
May 17, 2017: European Journal of Clinical Microbiology & Infectious Diseases
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/28497758/ombitasvir-paritaprevir-and-ritonavir-with-or-without-dasabuvir-plus-ribavirin-for-patients-with-hepatitis-c-virus-genotype-1-or-4-infection-with-cirrhosis-abacus-a-prospective-observational-study
#11
Salvatore Petta, Marco Marzioni, Pierluigi Russo, Alessio Aghemo, Alfredo Alberti, Antonio Ascione, Andrea Antinori, Raffaele Bruno, Savino Bruno, Antonio Chirianni, Giovanni Battista Gaeta, Edoardo G Giannini, Manuela Merli, Vincenzo Messina, Simona Montilla, Carlo Federico Perno, Massimo Puoti, Giovanni Raimondo, Maria Rendina, Francesca Ceccherini Silberstein, Erica Villa, Anna Linda Zignego, Luca Pani, Antonio Craxì
BACKGROUND: We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. METHODS: In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015...
June 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28483778/mechanisms-and-predictions-of-drug-drug-interactions-of-the-hepatitis-c-virus-three-direct-acting-antiviral-regimen-paritaprevir-ritonavir-ombitasvir-and-dasabuvir
#12
Mohamad Shebley, Jinrong Liu, Olga Kavetskaia, Jens Sydor, Sonia M de Morais, Volker Fischer, Marjoleen J M A Nijsen, Daniel A J Bow
To assess drug-drug interaction (DDI) potential for the three direct-acting antiviral (3D) regimen of ombitasvir, dasabuvir, and paritaprevir, in vitro studies profiled drug-metabolizing enzyme and transporter interactions. Using mechanistic static and dynamic models, DDI potential was predicted for CYP3A, CYP2C8, UDP-glucuronosyltransferase (UGT) 1A1, organic anion-transporting polypeptide (OATP) 1B1/1B3, breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp). Perpetrator static model DDI predictions for metabolizing enzymes were within 2-fold of the clinical observations, but additional physiologically based pharmacokinetic modeling was necessary to achieve the same for drug transporters...
July 2017: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/28480743/hepatitis-c-virus-resistance-testing-in-genotype-1-the-changing-role-in-clinical-utility
#13
Suzanne Molino, Michelle T Martin
OBJECTIVE: To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment. DATA SOURCES: Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.gov using the pipeline medication names. STUDY SELECTION AND DATA EXTRACTION: Authors identified reports of current and pipeline genotype 1 retreatment regimens...
May 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28480525/real-world-effectiveness-of-ombitasvir-paritaprevir-ritonavir-%C3%A2-dasabuvir-%C3%A2-ribavirin-in-patients-with-hcv-genotype-1-or-4-infection-a-meta-analysis
#14
Heiner Wedemeyer, Antonio Craxí, Eli Zuckerman, Douglas Dieterich, Robert Flisiak, Stuart K Roberts, Andreas Pangerl, Zhenzhen Zhang, Marisol Martinez, Yanjun Bao, José-Luis Calleja
The direct-acting antiviral regimen of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) ± dasabuvir (DSV) ± ribavirin (RBV) demonstrated high rates of sustained viral response at post-treatment week 12 (SVR12) in clinical trials for treatment of hepatitis C virus (HCV) genotypes (GT) 1 and 4. To confirm the effectiveness of this regimen in the real world, we conducted meta-analyses of published literature on 30 April 2016. Freeman-Tukey transformation determined the SVR rate within GTs 1a, 1b, and 4, as well as specific SVR rates by cirrhosis or prior treatment experience status...
May 8, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28457003/efficacy-and-safety-of-ombitasvir-paritaprevir-ritonavir-in-dialysis-patients-with-genotype-1b-chronic-hepatitis-c
#15
Masanori Atsukawa, Akihito Tsubota, Yohei Koushima, Tadashi Ikegami, Kouji Watanabe, Noritomo Shimada, Shinichi Sato, Keizo Kato, Hiroshi Abe, Tomomi Okubo, Taeang Arai, Norio Itokawa, Chisa Kondo, Shigeru Mikami, Toru Asano, Yoshimichi Chuganji, Yasushi Matsuzaki, Katsuhiko Iwakiri
AIM: From a pharmacokinetic viewpoint, ombitasvir/paritaprevir/ritonavir, one of the standards of care for genotype 1b chronic hepatitis C in Japan, could be possible in patients with impaired renal function. The aim of this study was to assess the efficacy and safety that have not yet been addressed in patients undergoing dialysis. METHODS: A retrospective, multicenter study evaluated the outcome of 12-week ombitasvir (NS5A inhibitor)/paritaprevir (NS3/4A protease inhibitor)/ritonavir combination therapy for dialysis patients...
April 29, 2017: Hepatology Research: the Official Journal of the Japan Society of 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
#16
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/28422376/spontaneous-remission-of-hepatitis-b-virus-reactivation-during-direct-acting-antiviral-agent-based-therapy-for-chronic-hepatitis-c
#17
Ken Sato, Takeshi Kobayashi, Yuichi Yamazaki, Satoshi Takakusagi, Norio Horiguchi, Satoru Kakizaki, Motoyasu Kusano, Masanobu Yamada
The administration of direct-acting antiviral agents (DAAs) to treat hepatitis C virus (HCV) infection has been reported to cause hepatitis B virus (HBV) reactivation. However, the actual conditions of HBV reactivation and the ideal timing of medical intervention have not been fully evaluated. We report the cases of two female patients dually infected with HBV and HCV. Both patients were inactive HBV carriers. Although the serum HCV RNA levels promptly decreased after the initiation of DAA-based therapy, the serum HBV DNA levels gradually increased during DAA-based therapy, with the peak serum HBV DNA levels observed at 16 weeks after the initiation of DAA-based therapy in both cases...
April 19, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28422043/real-world-efficacy-and-safety-of-ritonavir-boosted-paritaprevir-ombitasvir-dasabuvir-%C3%A2-ribavirin-for-hepatitis-c-genotype-1-final-results-of-the-rev1tal-study
#18
John Lubel, Simone Strasser, Katherine A Stuart, Gregory Dore, Alexander Thompson, Stephen Pianko, Steven Bollipo, Joanne L Mitchell, Vincenzo Fragomeli, Tracey Jones, Sarah Chivers, Paul Gow, David Iser, Miriam Levy, Edmund Tse, Alessia Gazzola, Wendy Cheng, Saroj Nazareth, Sam Galhenage, Amanda Wade, Martin Weltman, Alan Wigg, Gerry MacQuillan, Joe Sasadeusz, Jacob George, Amany Zekry, Stuart K Roberts
BACKGROUND: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pre-treatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. METHODS: 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included...
April 19, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28416221/ombitasvir-paritaprevir-and-ritonavir-plus-dasabuvir-for-8-weeks-in-previously-untreated-patients-with-hepatitis-c-virus-genotype-1b-infection-without-cirrhosis-garnet-a-single-arm-open-label-phase-3b-trial
#19
Tania M Welzel, Tarik Asselah, Emily O Dumas, Stefan Zeuzem, David Shaw, Rawi Hazzan, Xavier Forns, Tami Pilot-Matias, Wenjing Lu, Daniel E Cohen, Jordan J Feld
BACKGROUND: Clinical studies have shown high rates of sustained virological response (hepatitis C virus [HCV] RNA <15 IU/mL) at post-treatment week 12 (SVR12) in patients with genotype 1b infection with and without cirrhosis who received coformulated ombitasvir, paritaprevir, and ritonavir, plus dasabuvir, without ribavirin, for 12 weeks. In this study, we aimed to assess 8-week treatment with ombitasvir, paritaprevir, and ritonavir, plus dasabuvir, without ribavirin in patients infected with HCV genotype 1b without cirrhosis...
April 13, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28412381/optimal-efficacy-of-interferon-free-hcv-retreatment-after-protease-inhibitors-failure-in-real-life
#20
Valeria Cento, Silvia Barbaliscia, Ilaria Lenci, Tina Ruggiero, Carlo Federico Magni, Stefania Paolucci, Sergio Babudieri, Massimo Siciliano, Caterina Pasquazzi, Alessia Ciancio, Carlo Federico Perno, Francesca Ceccherini-Silberstein
OBJECTIVES: First-generation protease-inhibitors (PIs) had suboptimal efficacy in GT-1 patients with advanced liver disease, and those who failed may need urgent retreatment. Our objective was to analyze the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. METHODS: In this multi-center observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included...
April 12, 2017: Clinical Microbiology and Infection
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