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https://www.readbyqxmd.com/read/28319996/oral-direct-acting-agent-therapy-for-hepatitis-c-virus-infection-a-systematic-review
#1
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
#2
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
#3
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
#4
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
https://www.readbyqxmd.com/read/28280374/optimizing-choice-of-oral-interferon-free-treatment-for-genotype-1-hepatitis-c-virus-using-testing-for-ns5a-resistance-a-cost-utility-analysis-from-the-perspective-of-the-italian-national-health-service
#5
Kirsten Y Westerhout, Walter Bouwmeester, Inge Duchesne, Marta Pisini, Marjanne A Piena, Francesco Damele, Beatrice Gueron, Maarten Treur, Jonathan Belsey
BACKGROUND: Patients with genotype-1 hepatitis C virus infection who have failed to respond to standard therapy or who relapse following treatment may be considered for an interferon-free regimen incorporating a nonstructural protein 5A (NS5A) inhibitor. Sustained virologic response (SVR) with these regimens is typically >90%, but this is reduced in patients with NS5A resistance. European Association for Study of the Liver guidelines recommend simeprevir + sofosbuvir ± ribavirin (SMV+SOF±R) for re-treating patients failing an NS5A inhibitor-containing regimen...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28272163/real-world-efficacy-of-daclatasvir-and-sofosbuvir-with-and-without-ribavirin-in-hiv-hcv-co-infected-patients-with-advanced-liver-disease-in-a-french-early-access-cohort
#6
Karine Lacombe, Hélène Fontaine, Catherine Dhiver, Sophie Metivier, Eric Rosenthal, Teresa Antonini, Marc Antoine Valantin, Patrick Miailhes, Stanislas Harent, Dominique Batisse, Georges-Philippe Pageaux, Julie Chas, Hugues Aumaitre, Stephanie Dominguez, Thierry Allegre, Alain Lafeuillade, Eric Billaud, Pierre De Truchis, Philippe Perre, Vincent Leroy, Victor De Ledinghen, Philippe Sogni, Francois Dabis, Yue Zhao, Anne Filipovics, Larysa Fedchuk, Raoudha Akremi, Yacia Bennai, Dominique Salmon Ceron
BACKGROUND: Efficacious, well-tolerated direct antiviral agents have drastically changed the prognosis of hepatitis C virus (HCV) disease, but real-world data for oral treatments are limited in key populations such as human immunodeficiency virus (HIV)/HCV co-infection with advanced liver disease. Daclatasvir (DCV) efficacy and safety was assessed in the French "Autorisation Temporaire d'Utilisation" (ATU) program providing DCV ahead of market authorization to patients with advanced HCV disease without other treatment options...
March 6, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28271646/two-treatment-cases-of-severe-fever-and-thrombocytopenia-syndrome-with-oral-ribavirin-and-plasma-exchange
#7
In Park, Hye In Kim, Ki Tae Kwon
Severe fever with thrombocytopenia syndrome (SFTS) is an emerging tick-borne disease. The primary symptoms associated with SFTS are fever, thrombocytopenia, leukopenia, nausea, and vomiting. Disease progression shows high mortality rate accompanied with multiple organ failure, bleeding tendency, and altered mentality. However, only supportive care has been the basis for the treatment of SFTS. We are reporting two patients who showed central nervous system manifestation, but cured them with ribavirin together with plasma exchange in an early state...
January 19, 2017: Infection & Chemotherapy
https://www.readbyqxmd.com/read/28263460/asunaprevir-an-hcv-protease-inhibitor-with-preferential-liver-distribution
#8
Timothy Eley, Tushar Garimella, Wenying Li, Richard J Bertz
Asunaprevir is an inhibitor of the hepatitis C virus (HCV) NS3/4A protease, demonstrating efficacy in clinical studies in patients infected with HCV genotype 1 or 4, with either peginterferon/ribavirin or combinations of direct-acting antivirals. Because of preferential distribution of asunaprevir to the liver via organic anion-transporting polypeptide (OATP)-mediated transport, asunaprevir demonstrates high apparent oral clearance and very low plasma concentrations. Asunaprevir plasma concentrations are markedly increased by single-dose rifampin (an OATP inhibitor) and in subjects with moderate to severe hepatic impairment...
March 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28235612/efficacy-and-safety-of-direct-acting-antiviral-regimens-in-hiv-hcv-coinfected-patients-french-anrs-co13-hepavih-cohort
#9
Lionel Piroth, Linda Wittkop, Karine Lacombe, Eric Rosenthal, Camille Gilbert, Patrick Miailhes, Patrizia Carrieri, Julie Chas, Isabelle Poizot-Martin, Anne Gervais, Stéphanie Dominguez, Didier Neau, David Zucman, Eric Billaud, Philippe Morlat, Hugues Aumaitre, Caroline Lascoux-Combe, Anne Simon, Olivier Bouchaud, Elina Teicher, Firouzé Bani-Sadr, Laurent Alric, Daniel Vittecoq, François Boué, Claudine Duvivier, Marc-Antoine Valantin, Laure Esterle, François Dabis, Philippe Sogni, Dominique Salmon
BACKGROUND & AIMS: Few data are available on the use of new oral direct-acting antiviral (DAA) regimens to treat HIV/HCV-coinfected patients in real-life settings. METHODS: HIV/HCV-coinfected patients enrolled in the ANRS CO13 HEPAVIH observational cohort were included if they began an all-oral DAA-based regimen before 1 May 2015 (12-week regimens) or 1 February 2015 (24-week regimens). Treatment success (SVR12) was defined by undetectable HCV-RNA 12 weeks after treatment cessation...
February 21, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28224352/hcv-management-in-resource-constrained-countries
#10
REVIEW
Seng Gee Lim
With the arrival of all-oral directly acting antiviral (DAA) therapy with high cure rates, the promise of hepatitis C virus (HCV) eradication is within closer reach. The availability of generic DAAs has improved access to countries with constrained resources. However, therapy is only one component of the HCV care continuum, which is the framework for HCV management from identifying patients to cure. The large number of undiagnosed HCV cases is the biggest concern, and strategies to address this are needed, as risk factor screening is suboptimal, detecting <20% of known cases...
February 21, 2017: Hepatology International
https://www.readbyqxmd.com/read/28217259/phase-3-trial-of-first-generation-protease-inhibitor-therapy-for-hepatitis-c-virus-human-immunodeficiency-virus-coinfection
#11
Kenneth E Sherman, Minhee Kang, Richard Sterling, Triin Umbleja, Kristen Marks, Jennifer J Kiser, Beverly Alston-Smith, Wayne Greaves, Adeel A Butt, The Actg Birth Study Team
AIM: To evaluate efficacy/safety of hepatitis C virus (HCV) protease inhibitor boceprevir with pegylated interferon (PEG-IFN) alfa and weight-based ribavirin (RBV) in a phase 3 trial. METHODS: A prospective, multicenter, phase 3, open-label, single-arm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment naïve (TN) and treatment experienced (TE) patients...
February 8, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28198349/impact-of-itpa-gene-polymorphisms-on-the-risk-of-ribavirin-induced-haemolytic-anaemia-using-interferon-free-antivirals-for-chronic-hepatitis-c
#12
Isabella Esposito, Laura Benítez-Gutiérrez, Ana Treviño, Ana Arias, Maria Jesus Citores, Silvia Requena, Vicente Soriano, Valentín Cuervas-Mons, Carmen de Mendoza
BACKGROUND: Single nucleotide polymorphisms (SNPs) at the ITPA gene are associated with hemolytic anemia in chronic hepatitis C patients treated with peginterferon-ribavirin (RBV). Information in patients treated with interferon-free, direct-acting antivirals (DAA) is scarce. METHODS: Median hemoglobin (Hb) levels were compared at baseline and at week 4, when ribavirin concentration achieves steady state, in all consecutive chronic hepatitis C patients treated with oral DAA plus RBV at our clinic...
February 15, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28184373/successful-treatment-of-mixed-hepatitis-c-genotypes-in-a-cirrhotic-patient-with-an-all-oral-interferon-free-regimen
#13
Ayman Ahmed Sakr, Jasmine M Hanifi, Ming Valerie Lin
Mixed hepatitis C virus (HCV) genotype infection is emerging with improved methods of detection. It is commonly seen in hemodialysis patients and intravenous drug users due to repeated HCV exposure and absence of protective immunity, and can contribute to treatment failure. Direct-acting antiviral regimens have been extensively studied in patients with different individual HCV genotypes; however, there are no reported data on their use in patients with mixed HCV genotype. We present a case of mixed HCV genotype 1a and 2 infection in a decompensated cirrhotic patient treated successfully with sofosbuvir, ledipasvir, and ribavirin...
2017: ACG Case Reports Journal
https://www.readbyqxmd.com/read/28182611/use-of-daclatasvir-in-hcv-hiv-coinfected-patients-in-a-real-life-setting
#14
REVIEW
Stefano Bonora, Massimo Puoti
The burden of HIV and HCV coinfection is estimated to affect 5-7 million people worldwide, with approximately 15-30% of people with HIV coinfected with HCV. The first oral direct-acting antivirals have shown to improve the response in patients with HIV/HCV coinfection, and more recently, other direct-acting antivirals that target various stages of the HCV life cycle have been developed, among them daclatasvir. The objective of this article is to examine recent clinical studies investigating the efficacy and safety of daclatasvir in comparison with other antiretroviral drugs, focusing on its efficacy in the coinfected HIV patient and real-life data...
January 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28137633/week-4-response-predicts-sustained-virological-response-to-all-oral-direct-acting-antiviral-based-therapy-in-cirrhotic-patients-with-hepatitis-c-virus-genotype-3-infection
#15
J A Pineda, L E Morano-Amado, R Granados, J Macías, F Téllez, M García-Deltoro, M J Ríos, A Collado, M Delgado-Fernández, M Suárez-Santamaría, M Serrano, C Miralles-Álvarez, K Neukam
OBJECTIVE: The aim of this study was to determine the predictive capacity of response at treatment week (TW) 4 for the achievement of sustained virological response 12 weeks after the scheduled end of therapy date (SVR12) to treatment against hepatitis C virus (HCV) genotype 3 (GT3) infection with all-oral direct-acting antiviral (DAA) -based regimens. PATIENTS AND METHODS: From a prospective multicohort study, HCV GT3-infected patients who completed a course of currently recommended DAA-based therapy at 33 Spanish hospitals and who had reached the SVR12 evaluation time-point were selected...
January 28, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/28100279/severe-community-acquired-adenovirus-pneumonia-treated-with-oral-ribavirin-a-case-report
#16
Byung Woo Yoon, Yong Geon Song, Seung Hyeun Lee
BACKGROUND: Adenovirus is a common pathogen of acute upper respiratory infection in children and is generally self-limiting. Severe adenovirus infections have been reported in immunocompromised hosts especially bone marrow transplantation recipients due to hematologic malignancy. Severe adenovirus pneumonia in immunocompetent hosts has rarely been reported and optimal treatment has not been established. We report a case of community-acquired severe adenovirus pneumonia which was successfully treated with early administration of oral ribavirin...
January 18, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28077243/effective-use-of-oral-ribavirin-for-respiratory-syncytial-viral-infections-in-allogeneic-haematopoietic-stem-cell-transplant-recipients
#17
C M Gorcea, E Tholouli, A Turner, M Saif, E Davies, E Battersby, F L Dignan
BACKGROUND: Respiratory syncytial virus (RSV) is a frequent cause of respiratory viral infections, increasing the morbidity and mortality in allogeneic haematopoietic stem cell transplantation (HSCT) recipients. Little is known about the best management strategy in this immunocompromised group and there are very few data on oral ribavirin treatment. AIM: To evaluate the effectiveness of oral ribavirin in allogeneic HSCT patients with RSV infection. METHODS: Twenty-three RSV cases treated with oral ribavirin were analysed retrospectively...
February 2017: Journal of Hospital Infection
https://www.readbyqxmd.com/read/28072684/assessment-of-hepatocellular-carcinoma-risk-based-on-peg-interferon-plus-ribavirin-treatment-experience-in-this-new-era-of-highly-effective-oral-antiviral-drugs
#18
Seung Ho Lee, Young-Joo Jin, Jun Young Shin, Jin-Woo Lee
In this new era of highly effective oral antiviral drugs for chronic hepatitis C virus (HCV), indications for antiviral treatment may be extendable. This study undertaken to identify suitable candidates for peg-interferon plus ribavirin (PEG-IFN/RBV) treatment by evaluating hepatocellular carcinoma (HCC) risk in patients with chronic HCV treated or not with PEG-IFN/RBV.This large-scale retrospective study was conducted on 1176 patients with chronic HCV without a history of HCC (treatment group [n = 489] and no-treatment group [n = 687])...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28030579/hcverso3-an-open-label-phase-iib-study-of-faldaprevir-and-deleobuvir-with-ribavirin-in-hepatitis-c-virus-genotype-1b-infected-patients-with-cirrhosis-and-moderate-hepatic-impairment
#19
Christoph Sarrazin, Michael Manns, Jose Luis Calleja, Javier Garcia-Samaniego, Xavier Forns, Renee Kaste, Xiaofei Bai, Jing Wu, Jerry O Stern
This study evaluated the interferon-free, oral combination of deleobuvir (non-nucleoside HCV NS5-RNA-polymerase inhibitor) and faldaprevir (HCV NS3/4A-protease inhibitor) with ribavirin in patients with HCV genotype-1b and moderate (Child-Pugh B [CPB], n = 17) or mild hepatic impairment (Child-Pugh A [CPA], n = 18). Patients received faldaprevir 120 mg and deleobuvir (600 mg [CPA], 400 mg [CPB]) twice-daily with weight-based ribavirin for 24 weeks. Baseline characteristics were similar between groups. Among CPA patients, 13/18 completed treatment; discontinuations were for adverse events (AEs, n = 1), lack of efficacy (n = 3) and withdrawal (n = 1)...
2016: PloS One
https://www.readbyqxmd.com/read/28008868/effect-of-minor-populations-of-ns5a-and-ns5b-resistance-associated-variants-on-hcv-genotype-3-response-to-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin
#20
Fiona McPhee, Dennis Hernandez, Nannan Zhou
BACKGROUND: Treatment of hepatitis C virus (HCV) genotype 3 (GT3) is a medical priority. All-oral treatment of HCV GT3 with daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is recommended by several treatment guidelines. The impact of HCV minority populations at amino acid positions in NS5A and NS5B associated with drug resistance on response to DCV+SOF±RBV was assessed in SOF-naive and SOF-experienced HCV patients. METHODS: The presence of baseline NS5A or NS5B polymorphisms was assessed in 227 and 167 HCV-GT3-infected patients, respectively, from four clinical studies of DCV+SOF±RBV...
December 23, 2016: Antiviral Therapy
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