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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
#1
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
#2
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 reported 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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/28408931/drug-induced-pneumonitis-secondary-to-treatment-with-paritaprevir-ritonavir-ombitasvir-and-dasabuvir-viekira-pak%C3%A2-for-chronic-hepatitis-c-case-report-of-an-unexpected-life-threatening-adverse-reaction
#6
Shih Yea Sylvia Wu, Bridget Faire, Edward Gane
VIEKIRA PAK (ritonavir-boosted paritaprevir/ombitasvir and dasabuvir) is an approved treatment for compensated patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. This oral regimen has minimal adverse effects and is well tolerated. Cure rates are 97% in patients infected with HCV GT 1a and 99% in those with HCV GT 1b. We report the first case of life-threatening allergic pneumonitis associated with VIEKIRA PAK. This unexpected serious adverse event occurred in a 68-year-old Chinese female with genotype 1b chronic hepatitis C and Child-Pugh A cirrhosis...
2017: Case Reports in Medicine
https://www.readbyqxmd.com/read/28404110/ombitasvir-paritaprevir-and-ritonavir-plus-ribavirin-for-chronic-hepatitis-c-virus-genotype-4-infection-in-egyptian-patients-with-or-without-compensated-cirrhosis-agate-ii-a-multicentre-phase-3-partly-randomised-open-label-trial
#7
Imam Waked, Gamal Shiha, Roula B Qaqish, Gamal Esmat, Ayman Yosry, Mohamed Hassany, Reham Soliman, Mohammad A Mohey, Naglaa Allam, Naglaa Zayed, Tarik Asselah, Coleen Hall, Rebecca Redman, Niloufar Mobashery, Wahid Doss
BACKGROUND: In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections worldwide, the prevalence in Egypt is more than 90%. We assessed the efficacy and safety of the two direct-acting antiviral drugs ombitasvir, an NS5A inhibitor, and paritaprevir, an NS3/4A protease inhibitor dosed with ritonavir, plus ribavirin in treatment of chronic HCV infection in Egypt...
September 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404108/ombitasvir-paritaprevir-and-ritonavir-plus-ribavirin-in-adults-with-hepatitis-c-virus-genotype-4-infection-and-cirrhosis-agate-i-a-multicentre-phase-3-randomised-open-label-trial
#8
Tarik Asselah, Christophe Hézode, Roula B Qaqish, Magdy ElKhashab, Tarek Hassanein, George Papatheodoridis, Jordan J Feld, Christophe Moreno, Stefan Zeuzem, Peter Ferenci, Yao Yu, Rebecca Redman, Tami Pilot-Matias, Niloufar Mobashery
BACKGROUND: Hepatitis C virus (HCV) genotype 4 infection is most commonly reported in sub-Saharan Africa and the Middle East; however, prevalence is increasing worldwide through immigration. HCV genotype 4 accounts for 20% of all infections, but clinical trial data for treatment remain limited. We assessed the combination of two direct-acting antivirals, ombitasvir (NS5A inhibitor) and paritaprevir (NS3/4A protease inhibitor; co-dosed with ritonavir) plus ribavirin in patients with HCV genotype 4 infection and compensated cirrhosis...
September 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404015/management-of-hepatitis-c-virus-infection-in-the-asia-pacific-region-an-update
#9
REVIEW
Seng Gee Lim, Alessio Aghemo, Pei-Jer Chen, Yock Young Dan, Edward Gane, Rino Gani, Robert G Gish, Richard Guan, Ji Dong Jia, Kieron Lim, Teerha Piratvisuth, Samir Shah, Mitchell L Shiffman, Frank Tacke, Soek Siam Tan, Tawesak Tanwandee, Khin Maung Win, Cihan Yurdaydin
The Asia-Pacific region has disparate hepatitis C virus (HCV) epidemiology, with prevalence ranging from 0·1% to 4·7%, and a unique genotype distribution. Genotype 1b dominates in east Asia, whereas in south Asia and southeast Asia genotype 3 dominates, and in Indochina (Vietnam, Cambodia, and Laos), genotype 6 is most common. Often, availability of all-oral direct-acting antivirals (DAAs) is delayed because of differing regulatory requirements. Ideally, for genotype 1 infections, sofosbuvir plus ledipasvir, sofosbuvir plus daclatasvir, or ombitasvir, paritaprevir, and ritonavir plus dasabuvir are suitable...
January 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28386057/real-world-safety-and-efficacy-of-ombitasvir-paritaprevir-ritonavir-dasabuvir%C3%A2-ribavirin-obv-ptv-r-dsv%C3%A2-rbv-therapy-in-recurrent-hepatitis-c-virus-hcv-genotype-1-infection-post-liver-transplant-amber-cee-study
#10
Olga Tronina, Magdalena Durlik, Marta Wawrzynowicz-Syczewska, Arida Buivydiene, Krum Katzarov, Limas Kupcinskas, Ieva Tolmane, Ewa Karpińska, Arkadiusz Pisula, Kornelia Magdalena Karwowska, Beata Bolewska, Maciej Jabłkowski, Karolina Rostkowska, Jolita Jakutiene, Marieta Simonova, Robert Flisiak
BACKGROUND The introduction of direct-acting antivirals (DAAs) has considerably improved therapeutic outcomes for patients with chronic hepatitis C virus (HCV) infections. The AMBER-CEE study aimed to assess real-world efficacy and safety of ombitasvir/paritaprevir/ritonavir/+ dasabuvir ±ribavirin (OBV/PTV/r/ +DSV±RBV) in the treatment of post-transplant recurrence of HCV infection. MATERIAL AND METHODS Liver transplant recipients with recurrent HCV genotype 1 infection, scheduled for OBV/PTV/r/+DSV±RBV according to therapeutic guidelines, were eligible...
April 7, 2017: Annals of Transplantation: Quarterly of the Polish Transplantation Society
https://www.readbyqxmd.com/read/28378135/exposure-safety-response-relationship-for-ombitasvir-paritaprevir-ritonavir-dasabuvir-and-ribavirin-in-patients-with-chronic-hepatitis-c-virus-genotype-1-infection-analysis-of-data-from-five-phase-ii-and-six-phase-iii-studies
#11
Chih-Wei Lin, Rajeev Menon, Wei Liu, Thomas Podsadecki, Nancy Shulman, Barbara DaSilva-Tillmann, Walid Awni, Sandeep Dutta
BACKGROUND AND OBJECTIVES: All-oral direct-acting antiviral regimens that include combinations of ombitasvir, paritaprevir, ritonavir, and dasabuvir with or without ribavirin were evaluated in hepatitis C virus-infected patients in phase II/III clinical studies. The objective of these analyses was to quantify the relationship between exposures of the components of the regimen and laboratory values and to determine covariates that could influence the relationship. METHODS: Exposure-safety response relationships between individual components of the direct-acting antiviral regimens and clinically important laboratory values were explored using data from 2998 patients from 11 phase II/III clinical studies...
April 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28370222/ombitasvir-paritaprevir-ritonavir-dasabuvir%C3%A2-%C3%A2-%C3%A2-ribavirin-is-safe-and-effective-in-hcv-infected-patients-in-a-real-life-cohort-from-latin-america
#12
M Mendizabal, L Haddad, P E Gallardo, A Ferrada, A Soza, R Adrover, E Aravena, J P Roblero, J Prieto, C Vujacich, G Romero, A Muñoz, M M Anders, N Hernández, D Coccozella, F Gruz, V Reggiardo, A E Ruf, A Varón, M Cartier, R Pérez Ravier, E Ridruejo, M Peralta, D Poncino, J Vorobioff, G Aballay Soteras, M O Y Silva
Information about the use of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) in real-clinical practice in Latin America is scarce. We aimed to confirm safety and effectiveness of OBV/PTV/r/DSV ± RBV therapy in real-world setting. We analyzed a cohort of patients with genotype 1 infection treated with OBV/PTV/r/DSV ± RBV. Data on demographics, clinical features, safety and virological response were retrospectively collected from 21 centers in Latin America. A total of 96 patients received OBV/PTV/r/DSV, associated with RBV in 68% of the cases...
March 29, 2017: Journal of Medical Virology
https://www.readbyqxmd.com/read/28365413/ultra-performance-liquid-chromatography-tandem-mass-spectrometry-for-determination-of-direct-acting-antiviral-drugs-in-human-liver-fine-needle-aspirates
#13
Andrew J Ocque, Colleen E Hagler, Robin DiFrancesco, Gene D Morse, Andrew H Talal
An ultra-performance liquid chromatography with triple quadrupole mass spectrometry method was developed and validated for the determination of direct acting antiviral drug concentrations in human liver fine needle aspirates. Liver fine needle aspirate (FNA) biopsy samples were homogenized in acetonitrile to stabilize the analytes and precipitate protein. The acetonitrile supernatants were diluted with internal standards and mobile phase. Separation was achieved with a Waters Acquity BEH C18 column (50×2.1mm, 1...
March 24, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28359920/hcv-core-antigen-as-an-alternate-test-to-hcv-rna-for-assessment-of-virologic-responses-to-all-oral-interferon-free-treatment-in-hcv-genotype-1-infected-patients
#14
Jürgen Kurt Rockstroh, Jordan J Feld, Stéphane Chevaliez, Kevin Cheng, Heiner Wedemeyer, Christoph Sarrazin, Benjamin Maasoumy, Christine Herman, John Hackett, Daniel E Cohen, George J Dawson, Gavin Cloherty, Jean-Michel Pawlotsky
In light of the advances in HCV therapy, simplification of diagnosis confirmation, pre- treatment diagnostic workup and treatment monitoring is required to ensure broad access to interferon-free therapies. HCV core antigen (HCV cAg) testing is rapid, giving results in approximately 60min, and less expensive than HCV RNA methods. While extensive data on the analytical performance of HCV cAg relative to RNA or comparisons in longitudinal studies of patients on interferon based (response guided) therapy there is very limited data on the relative performance of HCV cAg in diagnosis and monitoring patients receiving all-oral interferon free regimens...
March 27, 2017: Journal of Virological Methods
https://www.readbyqxmd.com/read/28342229/real-world-experience-with-the-all-oral-interferon-free-regimen-of-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-for-the-treatment-of-chronic-hepatitis-c-virus-infection-in-the-german-hepatitis-c-registry
#15
Tania M Welzel, Holger Hinrichsen, Christoph Sarrazin, Peter Buggisch, Axel Baumgarten, Stefan Christensen, Thomas Berg, Stefan Mauss, Gerlinde Teuber, Kerstin Stein, Katja Deterding, Florian van Bömmel, Renate Heyne, Christine John, Tim Zimmermann, Thomas Lutz, Eckart Schott, Jan Hettinger, Henning Kleine, Bettina König, Dietrich Hüppe, Heiner Wedemeyer
Real-world studies are relevant to complement clinical trials on novel antiviral therapies against chronic hepatitis C, however clinical practice data are currently limited. This study investigated effectiveness and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) for treatment of HCV genotype (GT) 1 and GT4 infection in a large real-world cohort. The German Hepatitis C Registry is an observational cohort study prospectively collecting clinical practice data on DAA therapies...
March 25, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28329334/turquoise-i-part-1b-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-with-ribavirin-for-hepatitis-c-virus-infection-in-hiv-1-coinfected-patients-on-darunavir
#16
David Wyles, Michael Saag, Rolando M Viani, Jacob Lalezari, Oluwatoyin Adeyemi, Laveeza Bhatti, Amit Khatri, Jennifer R King, Yiran B Hu, Roger Trinh, Nancy S Shulman, Peter Ruane
Background.: Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients. In healthy controls, coadministration of OBV/PTV/r + DSV + darunavir (DRV) lowered DRV trough concentration (Ctrough) levels. To assess the clinical significance of this change, TURQUOISE-I, Part 1b, evaluated the efficacy and safety of OBV/PTV/r + DSV + RBV in coinfected patients on stable, DRV-containing antiretroviral therapy (ART)...
February 15, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28321163/optimizing-hepatitis-c-virus-treatment-through-pharmacist-interventions-identification-and-management-of-drug-drug-interactions
#17
Jacob A Langness, Matthew Nguyen, Amanda Wieland, Gregory T Everson, Jennifer J Kiser
AIM: To quantify drug-drug-interactions (DDIs) encountered in patients prescribed hepatitis C virus (HCV) treatment, the interventions made, and the time spent in this process. METHODS: As standard of care, a clinical pharmacist screened for DDIs in patients prescribed direct acting antiviral (DAA) HCV treatment between November 2013 and July 2015 at the University of Colorado Hepatology Clinic. HCV regimens prescribed included ledipasvir/sofosbuvir (LDV/SOF), paritaprevir/ritonavir/ombitasvir/dasabuvir (OBV/PTV/r + DSV), simeprevir/sofosbuvir (SIM/SOF), and sofosbuvir/ribavirin (SOF/RBV)...
March 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28317409/ombitasvir-and-paritaprevir-boosted-with-ritonavir-and-combined-with-dasabuvir-for-chronic-hepatitis-c
#18
Robert Flisiak, Marta Flisiak-Jackiewicz
Hepatitis C is a leading cause of cirrhosis and hepatocellular carcinoma responsible for almost 700,000 deaths worldwide annually. Until 2014, management of HCV infections was based on interferon alfa containing regimens, with efficacy of 40-70% and a high adverse event rate. Interferon-free therapeutic options improved sustained viral response (SVR) rate to >90% and safety profile to placebo-like levels. Areas covered: This article describes all-oral regimen consisting of three direct acting antivirals (DAA) - ombitasvir (OBV), paritaprevir (PTV) and dasabuvir (DSV), which in clinical practice is boosted with ritonavir (r) and sometimes with ribavirin (RBV)...
March 20, 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28286567/grazoprevir-elbasvir-combination-therapy-for-hcv-infection
#19
REVIEW
Anaïs Vallet-Pichard, Stanislas Pol
Interferon-free regimens combine different second-wave direct-acting antiviral agents (DAAs), which target the main viral proteins involved in the replication cycle of hepatitis C virus (HCV): NS3/4A protease inhibitors (simeprevir or paritaprevir boosted by ritonavir), NS5B nucleos(t)idic (sofosbuvir) and nonnucleos(t)idic (dasabuvir) polymerase inhibitors, NS5A replication complex inhibitors (daclatasvir, ledipasvir, elbasvir, velpatasvir). Combinations of two or three DAAs, given for 8-24 weeks reach sustained virology response (SVR) rates greater than 90% with good tolerance...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28276815/effectiveness-of-interferon-free-therapy-for-the-treatment-of-hcv-patients-with-compensated-cirrhosis-treated-through-the-irish-early-access-program
#20
Emma Gray, Aisling O'Leary, Colm Bergin, Suzanne Norris
BACKGROUND: We investigated the real-world effectiveness of interferon-free regimens for the treatment of patients with compensated cirrhosis infected with hepatitis C virus (HCV). METHOD: Using the Irish national HCV treatment registry, the effectiveness and safety of interferon-free regimens for HCV-infected patients treated between April 2015 and August 2016, was determined. RESULTS: A SVR12 was achieved in 86% of subjects treated with sofosbuvir/ledipasvir ± ribavirin (SOF/LDV±RBV), 93% treated with paritaprevir, ombitasvir and ritonavir combined with dasabuvir ± ribavirin (3D±RBV) and 89% treated with sofosbuvir/daclatasvir ± ribavirin (SOF/DCV±RBV)...
February 22, 2017: Expert Review of Gastroenterology & Hepatology
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