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https://www.readbyqxmd.com/read/28816020/real-world-efficacy-and-safety-of-ombitasvir-paritaprevir-r-dasabuvir-ribavirin-in-genotype-1b-patients-with-hcv-liver-cirrhosis
#1
Carmen Monica Preda, Corneliu Petru Popescu, Cristian Baicus, Theodor Voiosu, Mircea Manuc, Corina Silvia Pop, Liana Gheorghe, Ioan Sporea, Anca Trifan, Marcel Tantau, Alina Tantau, Emanoil Ceausu, Doina Proca, Ileana Constantinescu, Simona Maria Ruta, Mircea Diculescu, Alexandru Oproiu
BACKGROUND: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real life data are still needed in order to confirm this profile. MATERIAL AND METHODS: In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C liver cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b...
August 17, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28815028/the-majority-of-hepatitis-c-patients-treated-with-direct-acting-antivirals-are-at-risk-for-relevant-drug-drug-interactions
#2
Elise J Smolders, Floor Ac Berden, Clara Tmm de Kanter, Wietske Kievit, Joost Ph Drenth, David M Burger
BACKGROUND: Direct-acting antivirals have improved treatment of chronic hepatitis C virus infection significantly. Direct-acting antivirals inhibit/induce and can also be substrates of drug-metabolising enzymes and transporters. This increases the risk for drug-drug interactions. OBJECTIVE: The purpose of this study was to predict drug-drug interactions with co-medication used by hepatitis C virus-infected patients. METHODS: We assembled a nationwide cohort of hepatitis C patients and collected cross-sectional data on co-medication use...
August 2017: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/28809742/treatment-of-chronic-hcv-infection-with-the-new-direct-acting-antivirals-daa-first-report-of-a-real-world-experience-in-southern-brazil
#3
Hugo Cheinquer, Hoel Sette-Jr, Fernando H Wolff, Alexandre de Araujo, Silvia Coelho-Borges, Silvia R P Soares, Mauricio F A Barros
INTRODUCTION AND AIM: There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil. MATERIALS AND METHODS: Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis...
August 8, 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28762541/real-world-effectiveness-and-safety-of-paritaprevir-ritonavir-ombitasvir-and-dasabuvir-with-or-without-ribavirin-for-patients-with-chronic-hepatitis-c-virus-genotype-1b-infection-in-taiwan
#4
Chen-Hua Liu, Chun-Jen Liu, Tung-Hung Su, Hung-Chih Yang, Chun-Ming Hong, Tai-Chung Tseng, Pei-Jer Chen, Ding-Shinn Chen, Jia-Horng Kao
BACKGROUND AND AIM: The real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) remain limited for East Asian hepatitis C virus genotype 1b (HCV-1b) patients. We aimed to evaluate the anti-viral responses of PrOD-based regimens for HCV-1b patients in Taiwan. METHODS: We performed a retrospective analysis of 103 HCV-1b patients receiving PrOD with or without ribavirin (RBV) for 12 weeks. Data were analyzed to assess the on-treatment and off-therapy HCV viral load, and on-treatment adverse events (AEs)...
August 1, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28708211/direct-acting-antivirals-for-hepatitis-c-virus-in-patients-on-maintenance-dialysis
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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, Hiroshi Aikata, Clair 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. A total of 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
#14
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
#15
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
#16
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
#17
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
#18
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...
August 1, 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
#19
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
#20
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
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