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https://www.readbyqxmd.com/read/28818546/glecaprevir-plus-pibrentasvir-for-chronic-hepatitis-c-virus-genotype-1-2-4-5-or-6-infection-in-adults-with-compensated-cirrhosis-expedition-1-a-single-arm-open-label-multicentre-phase-3-trial
#1
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa
BACKGROUND: The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. METHODS: We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA...
August 14, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28804248/effect-of-chronic-hepatitis-c-virus-treatment-by-combination-therapy-on-cardiovascular-system
#2
Reda Biomy, Mohamed Abdelshafy, Ahmed Abdelmonem, Hesham Abu-Elenin, George Ghaly
BACKGROUND: The prevalence of hepatitis C virus (HCV) in Egypt is quite high, and the combined oral direct-acting antiviral agents (DAAs) may have impressive results. OBJECTIVE: To assess the cardiovascular effects of DAAs in patients with HCV. METHODS: A total of 170 patients with HCV were divided into 2 groups: first group (100 patients) received triple combination therapy (pegylated interferon alfa, sofosbuvir, and ribavirin, whereas the second group (70 patients) received dual combination therapy (sofosbuvir and simeprevir)...
2017: Clinical Medicine Insights. Cardiology
https://www.readbyqxmd.com/read/28777714/serious-adverse-events-with-sofosbuvir-combined-with-interferon-and-ribavirin-real-life-egyptian-experience
#3
Tamer Elbaz, Magdy Elserafy, Wafaa Elakel, Mohammad A Mohey, Mahmoud Abdo, Mohamed Hassany, Mai Mehrez, Mahmoud Abouelkhair, Ayman Yosry, Ashraf Omar, Imam Waked, Manal Hamdy Elsayed, Zakaria Mahran, Yahia Elshazly, Noman Elgarem, Aly Gaballa, Wahid Doss, Gamal Esmat
Viral hepatitis is a serious problem worldwide that was under-recognized till recently. The prevalence of chronic hepatitis C virus (HCV) is estimated to be 180 million people worldwide. Treatment of chronic HCV using combined pegylated interferon and ribavirin (PEG/RIBA) has long been the standard of care with modest response. In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment...
August 2017: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/28708211/direct-acting-antivirals-for-hepatitis-c-virus-in-patients-on-maintenance-dialysis
#4
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/28688129/grazoprevir-ruzasvir-and-uprifosbuvir-for-hcv-after-ns5a-treatment-failure
#5
David Wyles, Heiner Wedemeyer, Ziv Ben-Ari, Edward J Gane, Jesper Bach Hansen, Ira M Jacobson, Alex L Laursen, Annie Luetkemeyer, Ronald Nahass, Stephen Pianko, Stefan Zeuzem, Patricia Jumes, Hsueh-Cheng Huang, Joan Butterton, Michael Robertson, Janice Wahl, Eliav Barr, Hee-Koung Joeng, Elizabeth Martin, Lawrence Serfaty
People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks...
July 7, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
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
#6
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/28608973/high-hepatitis-c-cure-rates-among-black-and-non-black-hiv-infected-adults-in-an-urban-center
#7
Oluwaseun Falade-Nwulia, Catherine Sutcliffe, Juhi Moon, Geetanjali Chander, Tanyaporn Wansom, Jeanne Keruly, Jennifer Katzianer, Amy Nathanson, Jillian Marks, Shruti Mehta, David Thomas, Richard Moore, Mark Sulkowski
Background Hepatitis C virus (HCV) cure rates have been similar in patients with and without HIV co-infection; however, in the ION-4 study, black patients treated with ledipasvir/sofosbuvir were significantly less likely to achieve cure (90%) compared to non-black patients (99%). There are limited real world data on the effectiveness of oral direct acting antivirals (DAAs) in predominantly minority HIV/HCV co-infected populations. Methods We analyzed HCV treatment outcomes among 255 HCV co-infected patients initiating DAAs between February 2014 and March 2016 in an urban clinic in Baltimore, Maryland...
June 13, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28596225/increased-warfarin-requirements-in-a-patient-with-chronic-hepatitis-c-infection-receiving-sofosbuvir-and-ribavirin
#8
Daisy Peterson, Amy Van Ermen
PURPOSE: A case of increased warfarin requirements during treatment with sofosbuvir and ribavirin for chronic hepatitis C virus (HCV) infection is reported. SUMMARY: A 63-year-old white man receiving long-term anticoagulation with warfarin for atrial fibrillation and a history of cardioembolic stroke was initiated in September 2014 on a 12-week course of sofosbuvir 400 mg orally daily and weight-based ribavirin 600 mg orally twice daily for HCV genotype 2 infection...
June 15, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28586597/identification-of-mutation-sites-in-hepatitis-c-virus-genotype-3a-in-non-responders-to-combination-therapy-with-interferon-%C3%AE-lfa-and-ribavirin-in-residents-of-khyber-pakhtunkhwa-province-pakistan
#9
Sardar Muhammad, Mehmud Ur Rehman, Najibul Ul Haq, Muhammad Mumtaz Khan, Sajjad Ahmad
BACKGROUND: This study was carried out to search for mutations in the gene encoding for Non- Structural Protein 5A, specifically in the interferon sensitivity determining region of hepatitis C virus (HCV) genotype 3a, isolated from serum samples of patients not responding to treatment with oral Ribavirin and Interferon alpha injections. METHODS: This descriptive case series was conducted on HCV patients reporting in the attached teaching hospitals of Peshawar Medical College selected by consecutive sampling technique from 1st July to 31st December 2012...
October 2016: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28585554/interferon-free-therapy-in-elderly-patients-with-advanced-liver-disease
#10
Sabela Lens, Inmaculada Fernández, Sergio Rodríguez-Tajes, Vanessa Hontangas, Mercedes Vergara, Montserrat Forné, Jose Luis Calleja, Moisés Diago, Jordi Llaneras, Susana Llerena, Xavier Torras, Begoña Sacristán, Merce Roget, Conrado Manuel Fernández-Rodríguez, Mari Carmen Navascués, Javier Fuentes, Juan-José Sánchez-Ruano, Miguel-Ángel Simón, Federico Sáez-Royuela, Carmen Baliellas, Rosa Morillas, Xavier Forns
OBJECTIVES: Interferon-free therapies have an improved safety and efficacy profile. However, data in elderly patients, who have frequently advanced liver disease, associated comorbidities, and use concomitant medications are scarce. The im of this study was to assess the effectiveness and tolerability of all-oral regimens in elderly patients in real-life clinical practice. METHODS: Retrospective analysis of hepatitis C virus (HCV) patients aged ≥65 years receiving interferon-free regimens within the Spanish National Registry (Hepa-C)...
June 6, 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/28585404/frequency-of-and-factors-associated-with-hepatitis-b-virus-reactivation-in-hepatitis-c-patients-treated-with-all-oral-direct-acting-antivirals-analysis-of-a-japanese-prospective-cohort
#11
Akira Doi, Ryotaro Sakamori, Yuki Tahata, Ayako Urabe, Naoki Morishita, Ryoko Yamada, Kunimaro Furuta, Takahiro Kodama, Hayato Hikita, Takayuki Yakushijin, Kazuyoshi Ohkawa, Akira Kaneko, Yasuharu Imai, Tomohide Tatsumi, Tetsuo Takehara
AIM: Several case reports have shown that hepatitis B virus (HBV) reactivation developed in hepatitis C patients with a current or previous HBV infection during direct-acting antiviral (DAA) treatment, which led to severe hepatitis or death in some cases. However, its precise frequency and risk factors are not entirely clear. We analyzed a prospective cohort. METHODS: We analyzed HBV reactivation in 461 consecutive hepatitis C patients who received 12 weeks of ledipasvir/sofosbuvir for genotype 1 or sofosbuvir plus ribavirin for genotype 2 at multiple centers...
June 5, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28583525/effective-treatment-with-daclatasvir-and-asunaprevir-in-kidney-transplant-patients-infected-with-hepatitis-c-virus-a-report-of-two-cases
#12
K Koshino, H Ushigome, K Masuda, T Matsuyama, S Harada, T Nakamura, S Nobori, T Iida, N Yoshimura
BACKGROUND: Hepatitis C virus (HCV) infection is known to affect long-term patient and graft survivals after kidney transplantation (KT). Recently, combination therapy with the use of 2 oral direct-acting antivirals, daclatasvir (DCV) and asunaprevir (ASV) reportedly showed a high rate of HCV eradication. We report the safety and efficacy of DCV and ASV therapy in 2 KT patients. METHODS: The safety and viral responses were investigated in a prospective study of KT patients infected with HCV genotype 1...
June 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28546792/hepatitis-c-virus-and-liver-transplantation
#13
Kalyan Ram Bhamidimarri, Sanjaya K Satapathy, Paul Martin
Hepatitis C virus (HCV) is a major cause of death from infectious disease and is still the leading indication for liver transplantation in the United States and other Western countries. All-oral, direct-acting antiviral (DAA) therapies have revolutionized the field, with HCV cure rates of more than 90% among treated patients. The safety and tolerability of these DAA agents have expanded the feasibility of HCV treatment even in the challenging pre- and post-liver transplant settings. However, the unique properties of DAA agents and the host profiles in these settings can limit the generalizability of HCV regimens, and prolongation of treatment duration or addition of ribavirin may be required in certain scenarios to optimize treatment outcomes...
April 2017: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28545127/improvement-of-alt-decay-kinetics-by-all-oral-hcv-treatment-role-of-ns5a-inhibitors-and-differences-with-ifn-based-regimens
#14
Valeria Cento, Thi Huyen Tram Nguyen, Domenico Di Carlo, Elisa Biliotti, Laura Gianserra, Ilaria Lenci, Daniele Di Paolo, Vincenza Calvaruso, Elisabetta Teti, Maddalena Cerrone, Dante Romagnoli, Michela Melis, Elena Danieli, Barbara Menzaghi, Ennio Polilli, Massimo Siciliano, Laura Ambra Nicolini, Antonio Di Biagio, Carlo Federico Magni, Matteo Bolis, Francesco Paolo Antonucci, Velia Chiara Di Maio, Roberta Alfieri, Loredana Sarmati, Paolo Casalino, Sergio Bernardini, Valeria Micheli, Giuliano Rizzardini, Giustino Parruti, Tiziana Quirino, Massimo Puoti, Sergio Babudieri, Antonella D'Arminio Monforte, Massimo Andreoni, Antonio Craxì, Mario Angelico, Caterina Pasquazzi, Gloria Taliani, Jeremie Guedj, Carlo Federico Perno, Francesca Ceccherini-Silberstein
BACKGROUND: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. STUDY DESIGN: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR...
2017: PloS One
https://www.readbyqxmd.com/read/28544152/a-risk-adapted-approach-to-treating-respiratory-syncytial-virus-and-human-parainfluenza-virus-in-allogeneic-stem-cell-transplantation-recipients-with-oral-ribavirin-therapy-a-pilot-study
#15
José Luis Piñana, Juan Carlos Hernández-Boluda, Marisa Calabuig, Isabel Ballester, Manuela Marín, Silvia Madrid, Anabel Teruel, María-José Terol, David Navarro, Carlos Solano
Here we report the applicability of a protocol based on clinical conditions and risk factors (RFs) for managing 35 allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients who developed a total of 52 episodes of respiratory viral infections (RVIs) caused by respiratory syncytial virus (RSV; n=19), human parainfluenza virus (HPIV; n=29), or both (n=4) over a 2-year study period. Risk categories were classified as high risk (cat-1) when the immunodeficiency scoring index was ≥3 and/or ≥3 RFs and/or ≥1 co-infective virus(es) were present; the remaining cases were classified as low risk (cat-0)...
August 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28543053/sofosbuvir-and-ribavirin-in-adolescents-12-to-17-years-old-with-hepatitis-c-virus-genotype-2-or-3-infection
#16
Stefan Wirth, Philip Rosenthal, Regino P Gonzalez-Peralta, Maureen M Jonas, William F Balistreri, Lin Chuan-Hao, Winita Hardikar, Kathryn Kersey, Benedetta Massetto, Bittoo Kanwar, Diana M Brainard, Jiang Shao, Evguenia Svarovskaia, Brian Kirby, Ronen Arnon, Karen F Murray, Kathleen B Schwarz
BACKGROUND & AIMS: Children with chronic hepatitis C virus (HCV) infection have limited treatment options. We evaluated the all-oral combination of sofosbuvir and ribavirin in adolescents aged 12-17 with HCV genotype 2 or 3. METHODS: Fifty-two patients received sofosbuvir 400mg once daily and weight-based ribavirin twice daily for 12 (genotype 2) or 24 (genotype 3) weeks. The pharmacokinetics of sofosbuvir and its metabolite GS-331007 were evaluated by intensive plasma sampling at day 7 in the first 10 patients enrolled, and by sparse sampling in all patients throughout treatment...
May 22, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28507928/the-role-of-direct-acting-antivirals-in-the-treatment-of-children-with-chronic-hepatitis-c
#17
REVIEW
Christine Hong Ting Yang, Eric R Yoo, Aijaz Ahmed
In the United States, chronic infection with the hepatitis C virus (HCV) affects an estimated 0.1-2% of the pediatric population, who are consequently at risk for major complications, including cirrhosis, hepatocellular carcinoma, and death. The current standard of treatment for chronic hepatitis C (CHC) in children is pegylated-interferon-alpha (PEG-IFN) in combination with ribavirin. PEG-IFN/ribavirin therapy is approved for children ages 3 and older; however, it is often held from use until adulthood because of its extensive list of potential side effects and high likelihood of causing adverse symptoms...
March 28, 2017: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/28506030/simeprevir-based-triple-therapy-with-reduced-doses-of-pegylated-interferon-%C3%AE-2a-plus-ribavirin-for-interferon-ineligible-patients-with-genotype-1b-hepatitis-c-virus
#18
Hideyuki Tamai, Yoshiyuki Ida, Akira Kawashima, Naoki Shingaki, Ryo Shimizu, Kosaku Moribata, Tetsushi Nasu, Takao Maekita, Mikitaka Iguchi, Jun Kato, Taisei Nakao, Masayuki Kitano
Background/Aims: The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR). Methods: One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose)...
July 15, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28482405/-efficacy-and-safety-of-pegylated-interferon-%C3%AE-2b-injection-y-shape-40-kd-in-treatment-of-patients-with-genotype-1-6-chronic-hepatitis-c
#19
B Feng, J Shang, S H Wu, H Chen, Y Han, Y Q Li, D Z Zhang, L F Zhao, S F Wei, Q Mao, C B Yin, T Han, M R Wang, S J Chen, J Li, Q Xie, Z Zhen, Z L Gao, Y X Zhang, G Z Gong, D L Yang, C Pan, J F Sheng, H Tang, Q Ning, G F Shi, J Q Niu, G H Luo, Y T Sun, H You, G Q Wang, L L Zhang, J Peng, Q Zhang, J J Liu, C W Chen, X Y Chen, W Zhao, R H Wang, L Sun, L Wei
Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1...
March 20, 2017: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://www.readbyqxmd.com/read/28475232/safety-and-efficacy-of-sofosbuvir-based-daa-regimens-for-hepatitis-c-virus-genotypes-1-4-and-6-in-myanmar-real-world-experience
#20
Naomi Khaing Than Hlaing, Robert A Mitrani, Soe Thu Aung, Wai Wai Phyo, Marina Serper, A Mi Mi Kyaw, Aung Hlaing Bwa, Khin Maung Win, K Rajender Reddy
This open-label, clinical experience investigated the safety and efficacy of direct-acting antiviral (DAA) Hepatitis C Virus (HCV) therapy in Myanmar. 344 patients completed treatment between June 2015 and May 2016. Patients with HCV genotypes 1 - 4 and 6 received one of four treatments: (1) Peg-interferon (PEG-IFN) + Sofosbuvir (SOF) + Ribavirin (RBV) for 12 weeks, (2) SOF + RBV for 24 weeks, (3) Ledipasvir (LDV) + SOF for 12 weeks, or (4) Daclatasvir (DCV) + SOF + RBV for 12 or 24 weeks. Genotype 3 was most common (n = 133, 38...
May 5, 2017: Journal of Viral Hepatitis
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