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https://www.readbyqxmd.com/read/29669332/paritaprevir-ritonavir-ombitasvir-plus-dasabuvir-regimen-in-the-treatment-of-genotype-1-chronic-hepatitis-c-infection-in-patients-with-severe-renal-impairment-and-end-stage-renal-disease-a-real-life-cohort
#1
Jan Sperl, Miluse Kreidlova, Dusan Merta, Klara Chmelova, Renata Senkerikova, Sona Frankova
BACKGROUND/AIMS: Chronic hepatitis C (HCV) virus infection reactivates under immunosuppressive drugs and therefore has a negative impact on long-term survival of kidney transplant recipients. Treatment-induced clearance of hepatitis C virus (HCV) in kidney transplant candidates prevents virus reactivation after transplantation. Paritaprevir/Ritonavir/Ombitasvir with Dasabuvir (PrOD) represents a highly effective treatment regimen for HCV genotype 1 (GT1), also suitable for patients with end-stage renal disease (ESRD)...
April 13, 2018: Kidney & Blood Pressure Research
https://www.readbyqxmd.com/read/29661883/unexpected-replication-boost-by-simeprevir-for-simeprevir-resistant-variants-in-genotype-1a-hepatitis-c-virus
#2
Kazuhisa Murai, Tetsuro Shimakami, Christoph Welsch, Takayoshi Shirasaki, Fanwei Liu, Juria Kitabayashi, Shiho Tanaka, Masaya Funaki, Hitoshi Omura, Tomoki Nishikawa, Ariunaa Suminyadorj, Masao Honda, Shuichi Kaneko
Simeprevir is a novel NS3/4A protease inhibitor (PI) of hepatitis C virus (HCV). The baseline polymorphism NS3-Q80K is frequently observed in genotype (gt) 1a HCV and often associated with treatment failure in simeprevir-containing regimens. We aimed to elucidate mechanisms of treatment failure due to NS3-Q80K. We included a Q80R mutation in our study and generated a series of Huh-7.5 cells, each of which harbored either wild-type gt 1a H77S.3 or one of the variants, Q80K or Q80R. The cells were cultured with increasing concentrations of simeprevir, and NS3 domain sequences were determined...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29661458/ombitasvir-paritaprevir-ritonavir-therapy-in-a-kidney-transplant-recipient-with-chronic-hepatitis-c-virus-genotype-1-infection-a-case-report-on-the-importance-of-considering-drug-drug-interactions-and-monitoring-cyclosporine-levels
#3
S Takeuchi, M Takamura, T Yoshida, K Takahashi, K Hayashi, S Hashimoto, S Yamagiwa, M Tasaki, Y Nakagawa, K Saito, Y Tanabe, Y Tomita, S Terai
A 74-year-old Japanese man with a history of chronic hepatitis C and kidney transplant (KT) was administered pegylated-interferon plus ribavirin therapy. However, this therapy was ineffective. The patient was then hospitalized to receive ombitasvir (OBV) plus paritaprevir (PTV) plus ritonavir (r) antiviral combination therapy. He tested negative for the virus after 4 weeks, and completed 12 weeks of treatment. The patient ultimately achieved a sustained virological response after the 12 weeks of treatment. Cyclosporine (CyA) trough levels, during the OBV-PTV-r therapy, reached a peak within 5 days of initiating therapy, and increases in serum creatinine and total bilirubin were also observed...
April 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29660224/shortened-therapy-of-eight-weeks-with-paritaprevir-ritonavir-ombitasvir-and-dasabuvir-is-highly-effective-in-people-with-recent-hcv-genotype-1-infection
#4
Marianne Martinello, Sanjay Bhagani, Edward Gane, Chloe Orkin, Graham Cooke, Gregory J Dore, Kathy Petoumenos, Tanya L Applegate, Elise Tu, Philippa Marks, Nicole Pagani, Jason Grebely, Mark Nelson, Gail V Matthews
Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12 weeks is approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for eight weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12 months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotype 1a and 1, no subtype) for eight weeks...
April 16, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29624809/characterization-of-demographics-and-ns5a-genetic-diversity-for-hcv-genotype-4-infected-patients-with-or-without-cirrhosis-treated-with-ombitasvir-paritaprevir-ritonavir
#5
Gretja Schnell, Rakesh Tripathi, Jill Beyer, Thomas Reisch, Preethi Krishnan, Tatyana Dekhtyar, Michelle Irvin, Coleen Hall, Yao Yu, Niloufar Mobashery, Rebecca Redman, Tami Pilot-Matias, Christine Collins
Hepatitis C virus (HCV) genotype 4 (GT4) is genetically diverse with 17 confirmed and 4 provisional subtypes. In this report, HCV GT4-infected patient samples from Phase 2/3 clinical studies were analyzed to characterize global demographics and genetic diversity of GT4 infection among patients treated with ombitasvir (OBV, NS5A inhibitor) plus paritaprevir/r (NS3/4A inhibitor co-dosed with ritonavir). Among 17 subtypes isolated from GT4-infected patients in the PEARL-I and AGATE-I studies, subtype prevalence by country of enrollment and country of origin suggested that subtypes 4a and 4d were likely circulating in Europe, while heterogeneous GT4 subtypes and a portion of GT4a detected in European and North American countries were likely due to immigration of HCV-infected patients from Africa...
April 6, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29601403/differential-timing-of-cholesterol-increase-during-successful-hcv-therapy-impact-of-type-of-drug-combination
#6
Antonio Rivero-Juarez, Angela Camacho, Teresa Brieva, Mario Frias, Pedro Lopez-Lopez, María A Risalde, Isabel Machuca, Juan J Caston, Antonio Martínez Peinado, Antonio Rivero
OBJECTIVE: to evaluate factors associated with increased serum cholesterol levels during Interferon-free (IFN-free) Hepatitis C virus (HCV) therapy. DESIGN: Prospective longitudinal study METHODS:: HIV-infected patients who started and successfully completed IFN-free therapy for chronic HCV infection were included. Patients were treated using two different regimens, based on the clinician's opinion: sofosbuvir and ledipasvir (SOF/LDV), or paritaprevir co-administered with ombitasvir and Dasabuvir (PrOD)...
March 27, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29575060/real-life-3d-therapy-failure-analysis-of-ns5a-93h-ras-plus-108k-polymorphism-in-complex-with-ombitasvir-by-molecular-modeling
#7
Nadia Marascio, Grazia Pavia, Isabella Romeo, Carmine Talarico, Sebastiano Di Salvo, Mariaconcetta Reale, Vito Marano, Giorgio Settimo Barreca, Fernanda Fabiani, Nicola Perrotti, Massimo De Siena, Francesca Giancotti, Tiziana Gravina, Stefano Alcaro, Anna Artese, Carlo Torti, Maria Carla Liberto, Alfredo Focà
We report a real-life 3D therapy failure in a patient treated with ombitasvir (OMV)/paritaprevir/ritonavir and dasabuvir without ribavirin (3D-R). He had therapy failure at week 12 after the end of treatment. We detected resistance-associated substitutions (RASs) plus polymorphisms on NS3, NS5A and NS5B target regions by population sequencing (15% cut-off) at baseline, at relapse and during follow-up. About this, NS5A RASs generally persist longer than resistances in the other target genes and may impact treatment outcome...
March 25, 2018: Journal of Medical Virology
https://www.readbyqxmd.com/read/29572333/risk-of-clinically-relevant-pharmacokinetic-based-drug-drug-interactions-with-drugs-approved-by-the-u-s-food-and-drug-administration-between-2013-and-2016
#8
Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, Rene H Levy, Isabelle Ragueneau-Majlessi
A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions...
March 23, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29562372/safety-assessment-in-child-a-cirrhotic-patients-treated-with-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-with-ribavirin
#9
E D Manea, I Stefan, C Olariu, O C Calina, R E Jipa, A Hristea
BACKGROUND: In our country, the national program for hepatitis C virus treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir was approved for patients with stage four of liver fibrosis and stage three associated with specific comorbidities. Our aim was to analyze the characteristics associated with the presence of adverse events in patients receiving this antiviral regimen, with ribavirin in cirrhotic patients. METHODS: We prospectively studied a cohort of adults with hepatitis C virus infection with Child A cirrhosis, treated for 12 weeks with ombitasvir/paritaprevir/ritonavir/dasabuvir and ribavirin, which have been followed in an infectious diseases tertiary-care hospital...
January 2018: Acta Gastro-enterologica Belgica
https://www.readbyqxmd.com/read/29546644/retreatment-efficacy-of-sofosbuvir-ombitasvir-paritaprevir-ritonavir-ribavirin-for-hepatitis-c-virus-genotype-4-patients
#10
Adel Abdel-Moneim, Alaa Aboud, Mohamed Abdel-Gabbar, Mohamed Zanaty, Mohamed Ramadan
BACKGROUND: The current standard of care for patients with chronic hepatitis C virus (HCV) infection is a combination of direct-acting antiviral agents (DAAs). However, rare clinical trials have been reported on the combination regimen of sofosbuvir (SOF) with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) plus ribavirin (RBV) for treated patients with HCV genotype 4 (GT4) infection. AIMS: To clarify the retreatment efficacy and safety of the recent regimen, SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens...
May 2018: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/29544240/management-of-hepatitis-c-viral-infection-in-chronic-kidney-disease-patients-on-hemodialysis-in-the-era-of-direct-acting-antivirals
#11
Soon Young Ko, Won Hyeok Choe
The advent of novel, direct-acting antiviral (DAA) regimens for hepatitis C viral (HCV) infection has revolutionized its treatment by producing a sustained virologic response of more than 95% with few side effects and no comorbidities in the general population. Until recently, ideal DAA regimens have not been available to patients with severe renal impairment and end-stage renal disease because there are limited data on the pharmacokinetics, safety, and efficacy of treatment in this unique population. In a hemodialysis context, identifying patients in need of treatment and preventing HCV transmission may also be a matter of concern...
March 16, 2018: Clinical and Molecular Hepatology
https://www.readbyqxmd.com/read/29516428/population-pharmacokinetics-of-paritaprevir-ombitasvir-dasabuvir-ritonavir-and-ribavirin-in-hepatitis-c-virus-infected-cirrhotic-and-non-cirrhotic-patients-analyses-across-nine-phase-iii-studies
#12
Sathej Gopalakrishnan, Sven Mensing, Rajeev M Menon, Jiuhong Zha
BACKGROUND: The clinical development program of the direct-acting antiviral (DAA) combination therapy of paritaprevir (coadministered with ritonavir) and ombitasvir, with and without dasabuvir (3-DAA [3D] and 2-DAA [2D] regimens, respectively) used in the treatment of chronic hepatitis C infection has generated a robust dataset across various dosing regimens and patient populations. OBJECTIVE: The current analysis aimed to characterize the population pharmacokinetics in patients without cirrhosis ('non-cirrhotic') and with compensated cirrhosis ('cirrhotic'), while accounting for differences across hepatitis C virus (HCV) genotypes (GT) 1, 2, and 4, multiple regimens (3D regimen ± ribavirin for GT1 in global studies, 2D regimen for subgenotype 1b in Japan, 2D regimen + ribavirin for GT2 in Japan, and 2D regimen + ribavirin for GT4), and ethnicities...
March 7, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29504510/hcv-genotype-3h-a-difficult-to-diagnose-sub-genotype-in-the-daa-era
#13
Carmine Minichini, Mario Starace, Stefania De Pascalis, Margherita Macera, Laura Occhiello, Mara Caroprese, Martina Vitrone, Vincenzo Iovinella, Barbara Guerrera, Mario Masarone, Nicola Coppola
BACKGROUND: No data are available on the clinical presentation and virological pattern in the case of failure to IFN-free regimens in patients with genotype 3h. In this paper authors identified the virological and clinical characteristics of patients with genotype 3h treated with suboptimal or not indicated Interferon (IFN)-free regimens for the misclassification of HCV genotype METHODS: 87 consecutive patients with failure to an IFN-free regimen were re-tested for HCV genotype by HCV NS5B sequencing; the 26 patients identified as harboring HCV-3 were enrolled...
March 5, 2018: Antiviral Therapy
https://www.readbyqxmd.com/read/29504152/the-adverse-effects-of-interferon-free-regimens-in-149-816-chronic-hepatitis-c-treated-egyptian-patients
#14
D Attia, K El Saeed, W Elakel, T Elbaz, A Omar, A Yosry, M H Elsayed, M El Raziky, M Anees, W Doss, Y El Shazly, H Wedemeyer, G Esmat
BACKGROUND: Interferon-free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. AIM: To evaluate the adverse effects associated with the different direct-acting antiviral drug (DAA) regimens in Egyptian patients. METHODS: This multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149 816 chronic hepatitis C treated Egyptian patients...
March 5, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29499903/12-weeks-ombitasvir-paritaprevir-ritonavir-ribavirin-achieve-high-svr-rates-in-hcv-4-patients-with-advanced-fibrosis
#15
Elisabetta Degasperi, Alessio Aghemo, Stefania Paolucci, Roberta D'Ambrosio, Marta Borghi, Riccardo Perbellini, Federica Novazzi, Stella De Nicola, Giovanna Lunghi, Fausto Baldanti, Pietro Lampertico
BACKGROUND: Ombitasvir/paritaprevir-ritonavir (OBT/PTV-r) plus ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype 4 patients with advanced fibrosis has been only investigated in clinical trials. AIMS: To assess safety and efficacy of OBT/PTV-r + RBV for 12 weeks in real-life HCV-4 patients with advanced fibrosis. METHODS: HCV-4 patients with advanced fibrosis consecutively receiving OBT/PTV-r + RBV for 12 weeks in a single center were enrolled...
February 12, 2018: Digestive and Liver Disease
https://www.readbyqxmd.com/read/29467758/predicting-early-viral-control-under-direct-acting-antiviral-therapy-for-chronic-hepatitis-c-virus-using-pretreatment-immunological-markers
#16
James A Hutchinson, Kilian Weigand, Akinbami Adenugba, Katharina Kronenberg, Jan Haarer, Florian Zeman, Paloma Riquelme, Matthias Hornung, Norbert Ahrens, Hans J Schlitt, Edward K Geissler, Jens M Werner
Recent introduction of all-oral direct-acting antiviral (DAA) treatment has revolutionized care of patients with chronic hepatitis C virus (HCV) infection. Regrettably, the high cost of DAA treatment is burdensome for healthcare systems and may be prohibitive for some patients who would otherwise benefit. Understanding how patient-related factors influence individual responses to DAA treatment may lead to more efficient prescribing. In this observational study, patients with chronic HCV infection were comprehensively monitored by flow cytometry to identify pretreatment immunological variables that predicted HCV RNA negativity within 4 weeks of commencing DAA treatment...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29462201/trend-of-estimated-glomerular-filtration-rate-during-ombistasvir-paritaprevir-ritonavir-plus-dasabuvir-%C3%A2-ribavirin-in-hiv-hcv-co-infected-patients
#17
Lucia Taramasso, Antonio Di Biagio, Francesca Bovis, Laura Ambra Nicolini, Andrea Antinori, Laura Milazzo, Salvatore Sollima, Guido Gubertini, Fosca Niero, Annalisa Saracino, Raffaele Bruno, Vanni Borghi, Francesca Montagnani, Annamaria Cattelan, Hamid Hasson, Gloria Taliani, Antonella D'Arminio Monforte, Claudio Mastroianni, Giovanni Di Perri, Sara Bigoni, Massimo Puoti, Angiola Spinetti, Andrea Gori, Nicola Boffa, Bruno Cacopardo, Andrea Giacometti, Giustino Parruti, Vincenzo Vullo, Antonio Chirianni, Elisabetta Teti, Caterina Pasquazzi, Daniela Segala, Massimo Andreoni
The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal function that have been prospectively collected in the SIMIT compassionate-use program of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) in 144 HIV/HCV genotype 1 co-infected patients. The population was 74% male, 30...
2018: PloS One
https://www.readbyqxmd.com/read/29447085/paritaprevir-ritonavir-ombitasvir-plus-dasabuvir-in-hiv-hcv-coinfected-patients-with-genotype-1-in-real-life-practice
#18
Juan A Pineda, Antonio Rivero-Juárez, Ignacio de Los Santos, Antonio Collado, Dolores Merino, Luis E Morano-Amado, María J Ríos, Montserrat Pérez-Pérez, Francisco Téllez, Rosario Palacios, Ana B Pérez, María Mancebo, Antonio Rivero, Juan Macías
Background Data on the efficacy, safety, and concomitant use with other drugs of the combination ritonavir-boosted paritaprevir/ombitasvir plus dasabuvir (PrOD) in HIV/HCV-coinfected patients in real life are limited. The objectives of this study were to analyze these topics in HIV/HCV-coinfected subjects bearing HCV genotype 1 (GT1). Methods One hundred and eighty-two HIV/HCV-coinfected patients with GT1 (87 1a, 71 1b, 23 other) treated with PrOD, plus ribavirin (RBV) in 119 cases, in routine clinical practice were analyzed...
February 15, 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29435907/sustained-virological-response-in-special-populations-with-chronic-hepatitis-c-using-interferon-free-treatments-a-systematic-review-and-meta-analysis-of-observational-cohort-studies
#19
REVIEW
Vinicius Lins Ferreira, Letícia Paula Leonart, Fernanda Stumpf Tonin, Helena Hiemisch Lobo Borba, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C...
February 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29430226/a-hepatitis-c-virus-associated-chronic-hepatitis-patient-developing-various-adverse-events-including-severe-gingivitis-gingival-bleeding-and-inflammation-of-genital-vulva-during-the-course-of-antiviral-therapy-with-elbasvir-grazoprevir
#20
Kazuo Tarao, Akira Sato
Oral direct-acting antivirals comprise the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the primary agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. Ombitasvir/paritaprevir/ritonavir was also recommended as a therapy for HCV genotype 1b. More recently, elbasvir (NS5A inhibitor)/grazoprevir (NS3/4A protease inhibitor) was also recommended as a potent therapy for HCV genotype 1b infection. This agent achieved an SVR12 as high as 96...
September 2017: Case Reports in Gastroenterology
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