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https://www.readbyqxmd.com/read/28442915/efficacy-and-safety-outcomes-of-sofosbuvir-based-treatment-regimens-for-hepatitis-c-virus-infected-patients-with-or-without-cirrhosis-from-phase-iii-clinical-trials
#1
REVIEW
Young-Mo Yang, Eun Joo Choi
BACKGROUND: With the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens. METHODS: A literature search of clinical studies published in PubMed and posted on ClinicalTrials...
2017: Therapeutics and Clinical Risk Management
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
#2
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/28413993/efficacy-of-sofosbuvir-plus-ribavirin-with-or-without-peginterferon-alfa-in-treatment-of-a-cohort-of-egyptian-patients-with-hepatitis-c-virus-infection
#3
Ossama Ashraf Ahmed, Hany Haroun Kaisar, Nehad Hawash, Hossam Samir, Sherif Sadek Taha Shabana, Mohamed Hassan Ahmed Fouad, Fatma Rizk, Sherief Abd-Elsalam
Background &Aims: Sofosbuvir is a powerful drug for treatment of hepatitis C virus (HCV) infection. In comparison to preceding remedies, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and much lower duration of treatment. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ribavirin with or without peginterferon-alfa in treatment of a cohort of Egyptian patients with hepatitis C virus infection. METHODS: Two hundred treatment naive patients who were HCV-antibody positive and HCV RNA by PCR positive aged more than 18 years were enrolled in the study and patients were classified into two groups: Group I which included 100 patients who received dual therapy with sofosbuvir plus oral weight based ribavirin and Group II which included 100 patients triple therapy with sofosbuvir plus oral weight based ribavirin (as with the dual therapy) and a 180 mcg Peg-INF alpha 2a subcutaneous injection weekly for 12 weeks...
April 17, 2017: Infectious Disorders Drug Targets
https://www.readbyqxmd.com/read/28412293/glecaprevir-and-pibrentasvir-yield-high-response-rates-in-patients-with-hcv-genotype-1-6-without-cirrhosis
#4
Paul Y Kwo, Fred Poordad, Armen Asatryan, Stanley Wang, David L Wyles, Tarek Hassanein, Franco Felizarta, Mark S Sulkowski, Edward Gane, Benedict Maliakkal, J Scott Overcash, Stuart C Gordon, Andrew J Muir, Humberto Aguilar, Kosh Agarwal, Gregory J Dore, Chih-Wei Lin, Ran Liu, Sandra S Lovell, Teresa I Ng, Jens Kort, Federico J Mensa
BACKGROUND: and Aims Hepatitis C virus (HCV) therapy that is highly efficacious, pangenotypic, with a high barrier to resistance and short treatment duration is desirable. The efficacy and safety of 8- and 12-week treatments with glecaprevir (ABT-493; NS3/4A protease inhibitor) and pibrentasvir (ABT-530; NS5A inhibitor) was evaluated in non-cirrhotic patients with chronic HCV genotype 1-6 infection. METHODS: SURVEYOR-I and SURVEYOR-II were phase 2, open-label, multicenter, dose-ranging trials including patients with chronic HCV genotype 1-6 infection who were either previously untreated or treated with pegylated interferon plus ribavirin...
April 12, 2017: Journal of Hepatology
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
#5
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
#6
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/28404069/patient-reported-outcomes-with-sofosbuvir-and-velpatasvir-with-or-without-ribavirin-for-hepatitis-c-virus-related-decompensated-cirrhosis-an-exploratory-analysis-from-the-randomised-open-label-astral-4-phase-3-trial
#7
Zobair M Younossi, Maria Stepanova, Michael Charlton, Michael P Curry, Jacqueline G O'Leary, Robert S Brown, Sharon Hunt
BACKGROUND: Hepatitis C virus (HCV) treatment regimens with direct-acting antivirals have not been extensively studied in patients with decompensated cirrhosis. We assessed patient-reported outcomes (PROs) in patients with decompensated cirrhosis given a fixed-dose combination of sofosbuvir and velpatasvir with and without ribavirin. METHODS: This study was an exploratory analysis of data collected in a randomised, open-label phase 3 trial (ASTRAL-4) in which patients with HCV-related decompensated cirrhosis were randomly assigned to an all-oral fixed-dose combination of sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks, sofosbuvir and velpatasvir plus oral ribavirin (weight-based 1000 mg or 1200 mg) for 12 weeks, or sofosbuvir and velpatasvir for 24 weeks...
October 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404015/management-of-hepatitis-c-virus-infection-in-the-asia-pacific-region-an-update
#8
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/28396749/an-hcv-positive-recipient-of-an-hcv-positive-donor-liver-successfully-treated-before-and-immediately-after-liver-transplant-with-daclatasvir-sofosbuvir-and-ribavirin
#9
Fred Poordad, Eric Lawitz, Julio A Gutierrez, Juan Guerrero, Kermit Speeg, Eugene S Swenson
This case suggests that initiation of HCV therapy immediately after liver transplantation with well-tolerated, all-oral regimens may achieve a virologic cure in HCV-positive recipients, thus preventing post-transplant HCV recurrence and associated disease progression. This strategy may broaden utilization of HCV-positive donor livers, potentially including HCV-negative transplant recipients.
April 2017: Clinical Case Reports
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
#10
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/28370350/daclatasvir-asunaprevir-beclabuvir-dcv-trio-all-oral-fixed-dose-combination-for-patients-with-chronic-hcv-genotype-1
#11
Jia-Horng Kao, Ming-Lung Yu, Cheng-Yuan Peng, Jeong Heo, Chi-Jen Chu, Ting-Tsung Chang, Youn-Jae Lee, Tsung-Hui Hu, Ki Tae Yoon, Seung Woon Paik, Young Suk Lim, Sang Hoon Ahn, Vasily Isakov, Fiona McPhee, Wenhua Hu, E Scott Swenson, Philip D Yin, Michelle Treitel
BACKGROUND AND AIM: This multinational (Taiwan, South Korea, Russia) phase 3 study evaluated the all-oral, ribavirin-free, fixed-dose combination (DCV-TRIO) of daclatasvir (NS5A inhibitor) 30 mg, asunaprevir (NS3 inhibitor) 200 mg, and beclabuvir (NS5B inhibitor) 75 mg, in patients with chronic HCV genotype-1 infection, with or without compensated cirrhosis. METHODS: UNITY-4 (NCT02170727) was an open-label, two-cohort study in which 169 treatment-naive (N = 138) or treatment-experienced (N = 31) patients received twice-daily DCV-TRIO for 12 weeks with 24 weeks of post-treatment follow-up...
March 31, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28362694/the-challenge-of-treating-children-with-hepatitis-c-virus-infection
#12
Giuseppe Indolfi, Claire Thorne, Manal H El-Sayed, Carlo Giaquinto, Regino P Gonzalez-Peralta
The development of oral hepatitis C virus direct acting antivirals has revolutionized the therapeutic field. Nowadays, multiple safe and highly effective antiviral regimens are commercially available to treat adults with hepatitis C infection. These new regimens for the first time, genuinely raise the prospects of eradicating hepatitis C virus. However, many challenges remain: from identifying infected individuals to optimizing treatment and ensuring global access to antiviral therapy to all population groups, including children...
March 30, 2017: Journal of Pediatric Gastroenterology and Nutrition
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
#13
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/28358742/similar-effectiveness-of-direct-acting-antiviral-against-hepatitis-c-virus-in-patients-with-and-without-hiv-infection
#14
María Luisa Montes, Antonio Olveira, Adriana Ahumada, Teresa Aldamiz, Javier García-Samaniego, Ana Clemente, Juan Berenguer, Juan González-García, Luz Martín-Carbonero
OBJECTIVE: We compared the baseline characteristics, effectiveness, and tolerance of DAA-based regimens taken by HCV-monoinfected and HCV-HIV-coinfected individuals in clinical practice. DESIGN: We performed a prospective observational study in 2 tertiary centers in Madrid, Spain that included all HCV-monoinfected and HCV/HIV-coinfected patients undergoing HCV treatment with all-oral DAA regimens in a routine clinical setting from April 2015 to November 2015. We evaluated sustained virological response 12 weeks after the end of therapy (SVR12), adverse events (AEs), and baseline and treatment characteristics...
March 29, 2017: AIDS
https://www.readbyqxmd.com/read/28343408/safety-of-oral-direct-acting-antiviral-regimens-for-chronic-hepatitis-c-in-real-life-conditions
#15
Regina Juanbeltz, Silvia Goñi Esarte, Juan Isidro Úriz-Otano, Ana Martínez Echeverría, Inmaculada Elizalde, José Manuel Zozaya, Jesús Castilla, Ramón San Miguel
OBJECTIVES: Direct acting antivirals (DAA) are extremely effective to treat chronic hepatitis C. The aim of this study was to evaluate, by using objective variables, the safety of DAA combinations under clinical practice conditions. METHODS: A retrospective study was carried out in mono-infected patients with chronic hepatitis C treated with DAA between January and December 2015 in our centre. Discontinuations, treatment modifications, deaths and laboratory parameters were studied (liver function tests, hemoglobin, creatinine and lipid profile at baseline, weeks 4, 8 and post 12)...
April 10, 2017: Postgraduate Medicine
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
#16
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/28319996/oral-direct-acting-agent-therapy-for-hepatitis-c-virus-infection-a-systematic-review
#17
Oluwaseun Falade-Nwulia, Catalina Suarez-Cuervo, David R Nelson, Michael W Fried, Jodi B Segal, Mark S Sulkowski
Background: Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. Purpose: To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. Data Sources: MEDLINE and EMBASE from inception through 1 November 2016. Study Selection: 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs...
March 21, 2017: Annals of Internal Medicine
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/28288791/efficacy-and-safety-of-sofosbuvir-plus-daclatasvir-for-treatment-of-hcv-associated-cryoglobulinemia-vasculitis
#19
David Saadoun, Stanislas Pol, Yasmina Ferfar, Laurent Alric, Christophe Hezode, Si Nafa Si Ahmed, Luc de Saint Martin, Cloé Comarmond, Anne Sophie Bouyer, Lucile Musset, Thierry Poynard, Matthieu Resche Rigon, Patrice Cacoub
Circulating mixed cryoglobulins are detected in 40%-60% of patients with hepatitis C virus (HCV) infection, and overt cryoglobulinemia vasculitis (CryoVas) develops in about 15% of patients. Remission of vasculitis has been associated with viral clearance, but few studies have reported the effectiveness of direct acting antiviral drugs in these patients. We performed open-label, prospective, multi-center study of the effectiveness and tolerance of an all-oral, interferon- and ribavirin-free regimen of sofosbuvir plus daclatasvir in patients with HCV-associated CryoVas...
March 10, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28286560/prevalence-of-end-of-treatment-rna-positive-sustained-viral-response-in-hcv-patients-treated-with-sofosbuvir-combination-therapies
#20
Miguel Malespin, Tamara Benyashvili, Susan L Uprichard, Alan S Perelson, Harel Dahari, Scott J Cotler
BACKGROUND: Some chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients with genotype 1 and other genotypes, as well as whether such patients achieve SVR24 remain in question. The aims of this study were to evaluate the frequency and durability of EOT+/SVR12&24 and other response categories in HCV genotype 1, 2, or 3 infected patients treated with DAA in clinical practice...
January 2017: Therapeutic Advances in Gastroenterology
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