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https://www.readbyqxmd.com/read/28708211/direct-acting-antivirals-for-hepatitis-c-virus-in-patients-on-maintenance-dialysis
#1
Fabrizio Fabrizi, Francesca M Donato, Piergiorgio Messa
The frequency of hepatitis C virus (HCV) infection remains high in patients with chronic kidney disease (CKD) and plays a detrimental role in mortality in this population. According to the latest survey, the adjusted hazard ratio for HCV-positive versus HCV-negative patients on long-term dialysis was 1.12 (95% CI, 1.05 to 1.20) and 1.10 (95% CI, 0.98 to 1.22) for all-cause and cardiovascular mortality, respectively. An impairment on quality of life has also been documented in HCV-infected patients undergoing regular dialysis...
July 8, 2017: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/28700519/managing-drug-drug-interaction-between-ombitasvir-paritaprevir-ritonavir-dasabuvir-and-mycophenolate-mofetil
#2
Florian Lemaitre, Zeineb Ben Ali, Camille Tron, Caroline Jezequel, Christelle Boglione-Kerrien, Marie-Clémence Verdier, Dominique Guyader, Eric Bellissant
No drug-drug interaction study has been conducted to date for the combination of ombitasvir, paritaprevir/ritonavir, dasabuvir (3D), and mycophenolic acid (MPA). We here report the case of a hepatitis C virus-infected patient treated with 3D and MPA for vasculitis. In light of the threat of drug-drug interaction, the concentration of MPA was measured before, during, and 15 days after the end of the 3D treatment. Similar values were found at all 3 time points, thus indicating that there is probably no need to adapt MPA dosage to 3D...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28690490/a-hepatitis-c-virus-associated-cirrhotic-patient-developing-interstitial-pneumonia-during-the-course-of-antiviral-therapy-with-ombitasvir-paritaprevir-ritonavir
#3
Kazuo Tarao, Kouzo Yamada
Oral direct-acting antivirals (DAAs) are the main therapy for hepatitis C virus (HCV)-associated liver disease in Japan. Daclatasvir/asunaprevir is the first agent and sofosbuvir/ledipasvir is the secondary agent for HCV genotype 1b. More recently, ombitasvir/paritaprevir/ritonavir is also recommended as a potent therapy for HCV genotype 1b. Among the adverse events associated with these oral DAAs, interstitial pneumonia is one of the most severe ones. Regarding treatment with daclatasvir plus asunaprevir or sofosbuvir plus ledipasvir, a few cases have already been reported in a postmarketing surveillance...
May 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/28686590/effectiveness-of-dasabuvir-ombitasvir-paritaprevir-ritonavir-for-hepatitis-c-virus-in-clinical-practice-a-population-based-observational-study
#4
Maya Leventer-Roberts, Ariel Hammerman, Ilan Brufman, Moshe Hoshen, Marius Braun, Yaffa Ashur, Nicky Lieberman, Ran Balicer
BACKGROUND: Direct acting antivirals for hepatitis C virus have shown dramatic results in clinical trials. However, their effectiveness has yet to be demonstrated within observational cohorts which lack exclusion criteria found in randomized control trials. AIM: To determine the effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response. METHODS: Retrospective observational cohort study of all Clalit Health Services members with hepatitis C virus genotype 1 who were dispensed dasabuvir/ombitasvir/paritaprevir/ritonavir from January 1, 2015 to-November 31, 2015...
2017: PloS One
https://www.readbyqxmd.com/read/28685397/application-of-exposure-response-analyses-to-establish-the-pharmacodynamic-similarity-of-a-once-daily-regimen-to-an-approved-twice-daily-dosing-regimen-for-the-treatment-of-hcv-infection
#5
Akshanth R Polepally, Haoyu Wang, Patrick J Marroum, Mukul Minocha, Balakrishna Hosmane, Amit Khatri, Sven Mensing, Thomas J Podsadecki, Daniel E Cohen, Walid M Awni, Rajeev M Menon
The triple direct-acting antiviral (3-DAA) regimen (two co-formulated tablets of ombitasvir/paritaprevir/ritonavir once daily and one tablet of dasabuvir twice daily) for patients with hepatitis C virus (HCV) genotype 1 infection has been reformulated for once-daily administration containing all three active DAAs (3QD regimen). Two bioequivalence studies compared the 3-DAA and 3QD regimens. In study 1, fed, single-, and multiple-dose crossover comparisons revealed exposures for drug components that were slightly outside the bioequivalence criteria, i...
July 6, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28680834/direct-acting-anti-hepatitis-c-virus-drugs-clinical-pharmacology-and-future-direction
#6
Ayman Geddawy, Yasmine F Ibrahim, Nabil M Elbahie, Mohammad A Ibrahim
Chronic hepatitis C virus (HCV) infection is a leading cause of chronic liver disease. The introduction of direct acting antiviral agents (DAAs) for its treatment represents a major advance in terms of sustained virologic response (SVR) rates and adverse effect profiles. Mechanistically, DAAs inhibit specific HCV non-structural proteins (NS) that are vital for its replication. Boceprevir, telaprevir, simeprevir, asunaprevir, grazoprevir and paritaprevir are NS3/4A inhibitors. Ombitasvir, ledipasvir, daclatasvir, elbasvir and velpatasvir are NS5A inhibitors...
March 2017: Journal of Translational Internal Medicine
https://www.readbyqxmd.com/read/28673800/modeling-hcv-cure-after-an-ultra-short-duration-of-therapy-with-direct-acting-agents
#7
Ashish Goyal, Yoav Lurie, Eric G Meissner, Marian Major, Natasha Sansone, Susan L Uprichard, Scott J Cotler, Harel Dahari
BACKGROUND: Cases of sustained-virological response (SVR or cure) after an ultra-short duration (≤27 days) of direct-acting antiviral (DAA)-based therapy, despite HCV being detected at end of treatment (EOT), have been reported. Established HCV mathematical models that predict the treatment duration required to achieve cure do not take into account the possibility that the infectivity of virus produced during treatment might be reduced. The aim of this study was to develop a new mathematical model that considers the fundamental and critical concept that HCV RNA in serum represents both infectious virus (Vi) and non-infectious virus (Vni) in order to explain the observation of cure with ultrashort DAA therapy...
June 30, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28662883/paritaprevir-ritonavir-ombitasvir-plus-dasabuvir-with-ribavirin-for-treatment-of-recurrent-chronic-hepatitis-c-genotype-1-infection-after-liver-transplantation-real-world-experience
#8
Ming-Lung Yu, Yao-Li Chen, Chung-Feng Huang, Kuo-Hua Lin, Ming-Lun Yeh, Ching-I Huang, Meng-Hsuan Hsieh, Zu-Yau Lin, Shinn-Cherng Chen, Jee-Fu Huang, Chia-Yen Dai, Wan-Long Chuang
BACKGROUND/AIMS: The registered trial has demonstrated that paritaprevir/ritonavir/ombitasvir plus dasabuvir (PrOD) with ribavirin was effective for recurrent hepatitis C virus genotype 1 (HCV-1) infection after liver transplantation in patients with mild fibrosis; however, the real-world efficacy and safety of this regimen have not been determined. METHODS: The efficacy (sustained virological response, SVR12, undetectable HCV RNA 12 weeks post-treatment) and safety were evaluated in 12 patients with recurrent HCV-1 infection after liver transplantation...
June 26, 2017: Journal of the Formosan Medical Association, Taiwan Yi Zhi
https://www.readbyqxmd.com/read/28657143/emergence-of-drug-resistance-associated-variants-and-changes-in-serum-lipid-profiles-in-sofosbuvir-plus-ledipasvir-treated-chronic-hepatitis-c-patients
#9
Hiromi Kan, Michio Imamura, Yoshiiku Kawakami, Kana Daijo, Yuji Teraoka, Fumi Honda, Yuki Nakamura, Kei Morio, Tomoki Kobayashi, Takashi Nakahara, Yuko Nagaoki, Tomokazu Kawaoka, Masataka Tsuge, Akira Hiramatsu, Hiroshi Aikata, C Nelson Hayes, Daiki Miki, Hidenori Ochi, Yoji Honda, Nami Mori, Shintaro Takaki, Keiji Tsuji, Kazuaki Chayama
Combination of sofosbuvir plus ledipasvir therapy has been expected to enhance sustained virological response (SVR) rates in hepatitis C virus (HCV) genotype 1 chronic infected patients. We analyzed the emergence of drug resistance-associated variants (RAVs) in treatment failure and changes in lipid profiles in sofosbuvir/ledipasvir-treated patients. 176 patients with chronic HCV genotype 1 infection without decompensated liver cirrhosis were treated with sofosbuvir/ledipasvir for 12 weeks. NS5A and NS5B RAVs were determined by either Invader assay or direct sequencing...
June 28, 2017: Journal of Medical Virology
https://www.readbyqxmd.com/read/28651903/the-elderly-and-direct-antiviral-agents-constraint-or-challenge
#10
Claudia Fabrizio, Annalisa Saracino, Luigia Scudeller, Eugenio Milano, Raffaele Dell'Acqua, Giuseppe Bruno, Sergio Lo Caputo, Laura Monno, Michele Milella, Gioacchino Angarano
BACKGROUND: Direct antiviral agents (DAAs) for chronic hepatitis C showed great effectiveness and good safety profile. So far, few data are available about their use in elderly subjects. AIM: To assess management, safety and outcome of DAAs treatments in the elderly. METHODS: This retrospective, single-centre study enrolled all patients aged ≥65 years, compared by age (group A: 65-74 years, group B: ≥75 years), who completed DAAs between February 2015-November 2016...
June 1, 2017: Digestive and Liver Disease
https://www.readbyqxmd.com/read/28650400/high-need-to-switch-cart-or-co-medication-with-the-initiation-of-daas-in-elderly-hiv-hcv-co-infected-patients
#11
Elise J Smolders, Colette Smit, Clara Tmm De Kanter, Anton Dofferhoff, Joop E Arends, Kees Brinkman, Bart Rijnders, Marc Van Der Valk, Peter Reiss, David M Burger
BACKGROUD: To describe the use of non-antiretroviral co-medication and combination antiretroviral therapy (cART) in HIV/hepatitis C virus (HCV) co-infected patients, and to predict the potential for drug-drug interactions (DDIs) with direct-acting antivirals (DAAs) against HCV. METHODS: This is a retrospective, cross-sectional study, using the Dutch nationwide ATHENA observational HIV cohort database. All patients with a known HIV/HCV co-infection on 1 January 2015 were included...
June 22, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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...
July 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
#18
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
#19
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
#20
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
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