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https://www.readbyqxmd.com/read/28994141/potential-drug-drug-interactions-of-ombitasvir-paritaprevir-ritonavir-%C3%A2-dasabuvir-%C3%A2-ribavirin-in-clinical-practice
#1
Elena González-Colominas, María-Carlota Londoño, Rosa M Morillas, Xavier Torras, Sergi Mojal, Sabela Lens, Dulce López, Adolfo Gallego, Zoe Mariño, Mercè Ardèvol, Neus Pagès, Ricard Solà, Jose A Carrión
BACKGROUND & AIMS: Drug-drug interactions (DDIs) with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin (OBV/PTV/r ± DSV ± RBV) are common in clinical trials. Our aim was to analyze the prevalence and management of potential DDIs and adverse events (AEs) related to DDIs in patients with chronic hepatitis C (CHC) receiving OBV/PTV/r ± DSV ± RBV in clinical practice. METHODS: 177 CHC patients started OBV/PTV/r ± DSV ± RBV in 4 Spanish hospitals and were screened for potential DDIs using the University of Liverpool database...
October 10, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28992878/peginterferon-alfa-2a-for-the-treatment-of-chronic-hepatitis-c-in-the-era-of-direct-acting-antivirals
#2
REVIEW
Yan Huang, Ming-Hui Li, Min Hou, Yao Xie
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population...
October 15, 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28990653/mechanism-of-in-vitro-inhibition-of-ugt1a1-by-paritaprevir
#3
Novera Alam, Mia G Angeli, David J Greenblatt
OBJECTIVES: The direct-acting protease inhibitor paritaprevir is a new pharmaco-logic option available for treatment of chronic hepatitis C (HCV). Paritaprevir is reported to inhibit human UGT 1A1, but the mechanism of inhibition and its possible clinical consequences are not established. Our objective was to evaluate the in-vitro metabolic interaction between paritaprevir and the oral contraceptive steroid ethinyl estradiol (EE), a UGT 1A1 substrate. METHODS: Enzyme kinetic parameters were determined using human liver microsomes for the biotransformation of EE to its glucuronide metabolites, and the potency and mechanism of inhibition by paritaprevir...
October 9, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28986139/restrictions-for-reimbursement-of-interferon-free-direct-acting-antiviral-drugs-for-hcv-infection-in-europe
#4
Alison D Marshall, Evan B Cunningham, Stine Nielsen, Alessio Aghemo, Hannu Alho, Markus Backmund, Philip Bruggmann, Olav Dalgard, Carole Seguin-Devaux, Robert Flisiak, Graham R Foster, Liana Gheorghe, David Goldberg, Ioannis Goulis, Matthew Hickman, Patrick Hoffmann, Ligita Jancorienė, Peter Jarcuska, Martin Kåberg, Leondios G Kostrikis, Mihály Makara, Matti Maimets, Rui Tato Marinho, Mojca Matičič, Suzanne Norris, Sigurður Ólafsson, Anne Øvrehus, Jean-Michel Pawlotsky, James Pocock, Geert Robaeys, Carlos Roncero, Marieta Simonova, Jan Sperl, Michele Tait, Ieva Tolmane, Stefan Tomaselli, Marc van der Valk, Adriana Vince, Gregory J Dore, Jeffrey V Lazarus, Jason Grebely
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions...
October 3, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28984012/sustained-virological-response-to-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-treatment-for-hepatitis-c-real-world-data-from-a-large-healthcare-provider
#5
Clara Weil, Darshan Mehta, Gideon Koren, Brett Pinsky, Jennifer C Samp, Gabriel Chodick, Varda Shalev
Treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin (OPrD±RBV) was the first interferon-free direct-acting antiviral for hepatitis C virus (HCV) introduced to Israel's national basket of health services in February 2015. Patients with HCV genotype 1 (GT1) and advanced fibrosis (F3-F4) were eligible for treatment in 2015. This study aims to characterize patients initiating OPrD± RBV and assess sustained virological response (SVR). A retrospective cohort study was performed using the database of Maccabi Healthcare Services (MHS), a 2-million-member health plan in Israel...
October 6, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28980064/anti-hcv-treatment-with-ombitasvir-paritaprevir-ritonavir%C3%A2-%C3%A2-dasabuvir-is-associated-with-increased-bile-acid-levels-and-pruritus
#6
Rudolf E Stauber, Günter Fauler, Florian Rainer, Bettina Leber, Andreas Posch, Andrea Streit, Walter Spindelboeck, Vanessa Stadlbauer, Harald H Kessler, Harald Mangge
BACKGROUND: Direct acting antiviral (DAA)-based treatment with ombitasvir/paritaprevir/ritonavir ± dasabuvir (OBV/PTV/r ± DSV) is highly effective in HCV genotype 1 or 4 infection and well-tolerated with only few side effects. However, pruritus has been observed in several trials in up to 20% of patients and seems to be unique for this DAA combination. OBJECTIVES: The aim of this preliminary study was to investigate the effect of OBV/PTV/r ± DSV on bile acid levels and to correlate them to the emergence of pruritus during treatment...
October 4, 2017: Wiener Klinische Wochenschrift
https://www.readbyqxmd.com/read/28964443/cost-utility-of-elbasvir-grazoprevir-in-patients-with-chronic-hepatitis-c-genotype-1-infection
#7
COMPARATIVE STUDY
Shelby Corman, Elamin H Elbasha, Steven N Michalopoulos, Chizoba Nwankwo
OBJECTIVE: To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection. METHODS: A Markov cohort state-transition model was constructed to evaluate the cost-utility of EBR/GZR ± RBV over a lifetime time horizon from the payer perspective...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28954630/multi-disciplinary-patient-centered-model-for-the-expedited-provision-of-costly-therapies-in-community-settings-the-case-of-new-medication-for-hepatitis-c
#8
Nitzan Avisar, Yael Heller, Clara Weil, Aviva Ben-Baruch, Shani Potesman-Yona, Ran Oren, Gabriel Chodick, Varda Shalev, Nachman Ash
BACKGROUND: In January 2015, the first interferon-free direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection was approved for inclusion in Israel's national basket of health services. During 2015, HCV genotype 1 patients with advanced liver fibrosis (stage F3-F4) were eligible for treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir (OMB/PTV/r + DSV) provided through the four national health plans. As all health plans committed to identifying eligible patients nationwide, risk-sharing agreements created an additional incentive to develop an innovative model for rapid treatment delivery...
September 28, 2017: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/28948366/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-japanese-patients-with-chronic-genotype-1-hepatitis-c-virus-infection-with-and-without-cirrhosis
#9
Kazuaki Chayama, Fumitaka Suzuki, Yoshiyasu Karino, Yoshiiku Kawakami, Ken Sato, Tomofumi Atarashi, Atsushi Naganuma, Tsunamasa Watanabe, Yuichiro Eguchi, Hitoshi Yoshiji, Masataka Seike, Yoshiyuki Takei, Koji Kato, Katia Alves, Margaret Burroughs, Rebecca Redman, David L Pugatch, Tami J Pilot-Matias, Preethi Krishnan, Rajneet K Oberoi, Wangang Xie, Hiromitsu Kumada
BACKGROUND: The once-daily, all oral, RBV-free, pangenotypic direct-acting anti-viral regimen consisting of co-formulated NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir (G/P), demonstrated high rates of sustained virologic response (SVR) in phase 2 and 3 studies outside Japan. METHODS: CERTAIN-1 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in Japanese patients with chronic HCV GT1 infection...
September 25, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28948180/safety-and-efficacy-of-ombitasvir-paritaprevir-with-ritonavir-%C3%A2-dasabuvir-with-or-without-ribavirin-in-patients-with-human-immunodeficiency-virus-1-and-hepatitis-c-virus-genotype-1-or-genotype-4-coinfection-turquoise-i-part-2
#10
Jürgen K Rockstroh, Chloe Orkin, Rolando M Viani, David Wyles, Anne F Luetkemeyer, Adriano Lazzarin, Ruth Soto-Malave, Mark R Nelson, Sanjay R Bhagani, Hartwig H F Klinker, Giuliano Rizzardini, Pierre-Marie Girard, Cristina Tural, Nancy S Shulman, Niloufar Mobashery, Yiran B Hu, Linda M Fredrick, Tami Pilot-Matias, Roger Trinh, Edward Gane
BACKGROUND: Ombitasvir, paritaprevir with ritonavir, and dasabuvir (OBV/PTV/r ± DSV) ±ribavirin (RBV) are approved to treat hepatitis C virus (HCV) genotype 1 and 4 infection. Here, we investigate the safety and efficacy of OBV/PTV/r + DSV ±RBV for HCV genotype 1, and OBV/PTV/r + RBV for HCV genotype 4, in human immunodeficiency virus (HIV)-1 coinfected patients with or without compensated cirrhosis. METHODS: TURQUOISE-I, Part 2 is a phase 3 multicenter study...
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28947525/successful-treatment-of-chronic-hepatitis-c-virus-infection-in-a-patient-receiving-daily-peritoneal-dialysis
#11
Jennifer E Stark, Jennifer Cole
PURPOSE: Successful use of a 4-drug oral fixed-dose combination therapy to treat chronic hepatitis C in a patient receiving peritoneal dialysis (PD) is reported. SUMMARY: New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited. A 73-year-old black man with chronic HCV genotype 1a infection and stage 5 chronic renal disease requiring daily automated PD was referred for HCV treatment prior to renal transplantation...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28939957/effect-of-hepatitis-c-treatment-with-ombitasvir-paritaprevir-r%C3%A2-%C3%A2-dasabuvir-on-renal-cardiovascular-and-metabolic-extrahepatic-manifestations-a-post-hoc-analysis-of-phase-3-clinical-trials
#12
Darshan A Mehta, Eric Cohen, Mariem Charafeddine, Daniel E Cohen, Yanjun Bao, Yuri Sanchez Gonzalez, Tram T Tran
INTRODUCTION: We analyzed phase 3 trial data of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin (RBV) in genotype 1 chronic hepatitis C patients to investigate the impact of 3D ± RBV on renal, cardiovascular and metabolic extrahepatic manifestations (EHMs), including persistency 52 weeks post treatment and differential impact by EHM disease severity. METHODS: Estimated glomerular filtration rate (eGFR), fasting triglyceride and fasting glucose values from clinical trials were used to assess renal, cardiovascular and metabolic EHMs, respectively...
September 22, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28925824/can-we-go-for-a-shorter-treatment-course-in-chronic-hepatitis-c-more-inspiring-cases
#13
Rosa Zampino, Martina Vitrone, Antonio Parrella, Enrico Ragone, Emanuele Durante-Mangoni
Current interest in HCV therapy with direct acting antivirals is focused on shortening treatment length. We managed two cirrhotics who achieved virological cure after 4 weeks of ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin treatment. Analysis to identify potential predictive factors for a successful outcome with a shorter treatment course was conducted.
September 19, 2017: Journal of Chemotherapy
https://www.readbyqxmd.com/read/28922440/real-life-use-of-3-direct-acting-antiviral-regimen-in-a-large-cohort-of-patients-with-genotype-1b-hcv-compensated-cirrhosis
#14
Liana Gheorghe, Speranta Iacob, Manuela Curescu, Ciprian Brisc, Cristina Cijevschi, Florin Caruntu, Carol Stanciu, Iulia Simionov, Ioan Sporea, Cristian Gheorghe, Razvan Iacob, Victoria Arama, Roxana Sirli, Anca Trifan
BACKGROUND AND AIMS: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir (OBV/PTV/r+DSV) is one of the elective direct-acting antivirals (DAAs) recommended by international guidelines and the only one covered by the National Insurance System in Romania until November 2016. Our aim was to present the first prospective Romanian cohort evaluating the effectiveness and safety in clinical practice of this 3DAA combination in patients with HCV genotype-1b Child A liver cirrhosis. METHODS: 681 patients received OBV/PTV/r+DSV+RBV for 12 weeks and were assessed clinically and biologically at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained viral response, SVR)...
September 2017: Journal of Gastrointestinal and Liver Diseases: JGLD
https://www.readbyqxmd.com/read/28918403/successful-twice-interrupted-therapy-of-hcv-infection-in-patients-with-cirrhosis-with-hepatocellular-carcinoma-before-and-after-liver-transplantation
#15
Anna Szymanek-Pasternak, Karolina Rostkowska, Krzysztof Simon
We are presenting the case study of the patient diagnosed at the age of 37 with liver cirrhosis due to genotype 1b hepatitis C virus infection. At the age of 46, he was diagnosed with hepatocellular carcinoma with subsequent resection of the tumour in May 2015. In December 2015, the treatment was started with ombitasvir, paritaprevir/ritonavir and dasabuvir (3D) with ribavirin (RBV) 1000 mg per day. After 24 days of this treatment, the patient received a deceased donor liver transplantation, followed by 18-day interruption of 3D therapy...
September 15, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28903508/effect-of-paritaprevir-ritonavir-ombitasvir-dasabuvir-and-ledipasvir-sofosbuvir-regimens-on-survival-compared-with-untreated-hepatitis-c-virus-infected-persons-results-from-erchives
#16
Adeel Ajwad Butt, Peng Yan, Tracey G Simon, Abdul-Badi Abou-Samra
Background: Interferon-based regimens are associated with a substantial survival benefit for persons infected with hepatitis C virus (HCV). Survival data with direct-acting antiviral agents are not available. We conducted this study to quantify the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) regimens upon mortality. Methods: In the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), a well-established national cohort of HCV-infected Veterans, we identified HCV-infected persons initiated on PrOD or LDV/SOF, excluding those with human immunodeficiency virus, hepatitis B surface antigen positivity, hepatocellular carcinoma, or missing HCV RNA or FIB-4 scores...
September 15, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28902678/brief-report-high-need-to-switch-cart-or-comedication-with-the-initiation-of-daas-in-elderly-hiv-hcv-coinfected-patients
#17
Elise J Smolders, Colette Smit, Clara T M M de Kanter, Anton S M Dofferiiof, Joop E Arends, Kees Brinkman, Bart Rijnders, Marc van der Valk, Peter Reiss, David M Burger
BACKGROUND: To describe the use of nonantiretroviral comedication and combination antiretroviral therapy (cART) in patients coinfected with HIV/hepatitis C virus (HCV) 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 coinfection on January 1, 2015, were included...
October 1, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28877086/short-article-retreatment-of-chronic-hepatitis-c-virus-infection-after-unsuccessful-therapy-with-all-oral-direct-acting-antiviral-regimens-a-real-life-experience
#18
Laura Milazzo, Carlo Magni, Fosca Niero, Monica Schiavini, Alessia Lai, Valeria Cento, Francesca Binda, Spinello Antinori, Salvatore Sollima
OBJECTIVE: Few real-life data are available on the retreatment of patients who failed direct-acting antiviral (DAA)-regimens. We reported the outcome of retreatment with approved DAA regimens in a real-life cohort of patients who previously failed an all-oral DAAs combination and we analyzed the association with resistance substitutions (RASs) performed at the time of virological failure. AIM AND METHODS: Next-generation sequencing of the NS3, NS5A, and NS5B regions was performed by Illumina deep sequencing...
November 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28871475/safety-and-efficacy-of-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-with-or-without-ribavirin-for-treatment-of-hepatitis-c-virus-genotype-1-a-systematic-review-and-meta-analysis
#19
REVIEW
Hussien Ahmed, Abdelrahman Ibrahim Abushouk, Amr Menshawy, Arwa Mohamed, Ahmed Negida, Samah A Loutfy, Mohamed M Abdel-Daim
BACKGROUND AND OBJECTIVE: Interferon-free regimens are rapidly evolving for patients with chronic hepatitis C virus (HCV) infection. We performed this meta-analysis to investigate the safety and efficacy of a combination regimen (ombitasvir [OBV]/paritaprevir [PTV]/ritonavir [r] ± dasabuvir [DSV]) for the treatment of patients with HCV genotype 1 infection. METHODS: A computerized literature search for relevant clinical trials was conducted during May 2017. Data on sustained virological response (SVR), virological relapse, and safety outcomes were extracted and calculated as pooled proportion (PP) or risk ratio (RR) with their 95% confidence interval (CI), using StatsDirect and RevMan software...
November 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28856278/efficacy-of-hcv-treatment-in-poland-at-the-turn-of-the-interferon-era-the-epiter-study
#20
Robert Flisiak, Joanna Pogorzelska, Hanna Berak, Andrzej Horban, Iwona Orłowska, Krzysztof Simon, Ewelina Tuchendler, Grzegorz Madej, Anna Piekarska, Maciej Jabłkowski, Zbigniew Deroń, Włodzimierz Mazur, Marcin Kaczmarczyk, Ewa Janczewska, Arkadiusz Pisula, Jacek Smykał, Krzysztof Nowak, Marek Matukiewicz, Waldemar Halota, Joanna Wernik, Katarzyna Sikorska, Iwona Mozer-Lisewska, Błażej Rozpłochowski, Aleksander Garlicki, Krzysztof Tomasiewicz, Joanna Krzowska-Firych, Barbara Baka-Ćwierz, Wiesław Kryczka, Dorota Zarębska-Michaluk, Iwona Olszok, Anna Boroń-Kaczmarska, Barbara Sobala-Szczygieł, Bronisława Szlauer, Bogumiła Korcz-Ondrzejek, Jerzy Sieklucki, Robert Pleśniak, Agata Ruszała, Barbara Postawa-Kłosińska, Jolanta Citko, Anna Lachowicz-Wawrzyniak, Joanna Musialik, Edyta Jezierska, Witold Dobracki, Beata Dobracka, Jan Hałubiec, Rafał Krygier, Anna Strokowska, Wojciech Chomczyk, Krystyna Witczak-Malinowska
THE AIM OF THE STUDY: Was to analyze the efficacy achieved with regimens available for chronic hepatitis C (CHC) in Poland between 2013 and 2016. MATERIAL AND METHODS: Data were collected from 29 centers and included 6786 patients with available sustained virologic response (SVR) data between 1 January 2013 and 31 March 2016. RESULTS: The sustained virologic response rate for genotypes (G) 1a, 1b, 2, 3 and 4 was 62%, 56%, 92%, 67% and 56% respectively; 71% patients (n = 4832) were treated with pegylated interferon α (Peg-IFNα) and ribavirin (RBV), with SVR rates of 58%, 49%, 92%, 67% and 55% respectively...
December 2016: Clin Exp Hepatol
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