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Peginterferon Alfa-2b

Ricardo Zwirtes, Premkumar Narasimhan, Megan M Wind-Rotolo, Dong Xu, Matthew W Hruska, Narendra Kishnani, Elizabeth M Colston, Subasree Srinivasan
The phase 2b EMERGE study compared the efficacy/safety of peginterferon lambda-1a (Lambda) and peginterferon alfa-2a (Alfa), both with ribavirin (RBV), for treatment of chronic hepatitis C virus (HCV) infection. A key safety finding was a higher frequency of hyperbilirubinemia with Lambda/RBV versus Alfa/RBV. To characterize mechanisms of hyperbilirubinemia associated with Lambda/RBV, we conducted a retrospective analysis of safety data from the HCV genotype 1 and genotype 4 cohort of the EMERGE study. Subjects were randomized to once-weekly Lambda (120/180/240 μg) or Alfa (180 μg), with daily RBV, for 48 weeks...
October 6, 2016: Journal of Interferon & Cytokine Research
Shuhei Nishiguchi, Yasuhisa Urano, Keiko Suzaki, Atsushi Taniguchi, Joseph Scherer, Kristi L Berger, Anne-Marie Quinson, Jerry O Stern, Masao Omata
AIM: We evaluated the safety and efficacy of the HCV NS3/4A protease inhibitor faldaprevir, plus peginterferon alfa-2b and ribavirin (PegIFNα-2b/RBV) in Japanese patients with HCV genotype-1 infection. METHODS: Treatment-naïve patients were randomized (1:1) to faldaprevir 120 mg QD for 12 or 24 weeks (response-guided therapy [RGT], n = 44), or faldaprevir 240 mg QD for 12 weeks (n = 43), each combined with PegIFNα-2b/RBV for 24 or 48 weeks (RGT)...
May 6, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Hiromitsu Kumada, Fumitaka Suzuki, Naohiro Kamiya, Madori Orihashi, Yoshiyuki Nakayasu, Ichimaro Yamada
AIMS: To assess the efficacy and safety of telaprevir (TVR) in combination with peginterferon alfa-2a (PEG-IFNα-2a) and ribavirin (RBV) for treatment naïve patients and relapsed patients compared to previous TVR-based triple therapy in Japan. METHODS: The study group included 35 treatment-naïve (median age of 55.0 years) and 19 relapsed patients (median age of 55.0 years) with genotype 1 hepatitis C virus (HCV) infection. Patients received TVR (750 mg every 8 h) for 12 weeks, in combination with PEG-IFNα-2a and RBV...
April 7, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Hiromitsu Kumada, Satoshi Mochida, Fumitaka Suzuki, Kazuaki Chayama, Yoshiyasu Karino, Keisuke Nakamura, Go Fujimoto, Anita Y M Howe, Steve W Ludmerer, Niloufar Mobashery
BACKGROUND AND AIM: Vaniprevir is a macrocyclic hepatitis C virus (HCV) non-structural (NS)3/4A protease inhibitor. The objective of these phase 3 multicenter, open-label trials was to evaluate the safety and efficacy of vaniprevir + peginterferon alfa-2b + ribavirin (PR) in Japanese patients with HCV genotype (GT)1 infection who had previously failed treatment with interferon-based regimens. METHODS: Japanese patients with chronic HCV GT1 were enrolled...
March 2, 2016: Journal of Gastroenterology and Hepatology
Henry L Y Chan, Sang Hoon Ahn, Ting-Tsung Chang, Cheng-Yuan Peng, David Wong, Carla S Coffin, Seng Gee Lim, Pei-Jer Chen, Harry L A Janssen, Patrick Marcellin, Lawrence Serfaty, Stefan Zeuzem, David Cohen, Linda Critelli, Dong Xu, Megan Wind-Rotolo, Elizabeth Cooney
BACKGROUND & AIMS: Peginterferon lambda-1a (lambda) is a Type-III interferon, which, like alfa interferons, has antiviral activity in vitro against hepatitis B virus (HBV) and hepatitis C virus (HCV); however, lambda has a more limited extra-hepatic receptor distribution. This phase 2b study (LIRA-B) evaluated lambda in patients with chronic HBV infection. METHODS: Adult HBeAg+ interferon-naive patients were randomized (1:1) to weekly lambda (180 μg) or peginterferon alfa-2a (alfa) for 48 weeks...
May 2016: Journal of Hepatology
Norio Hayashi, Makoto Nakamuta, Tetsuo Takehara, Hiromitsu Kumada, Akiko Takase, Anita Yee Mei Howe, Steven W Ludmerer, Niloufar Mobashery
BACKGROUND: Vaniprevir is a potent macrocyclic hepatitis C virus (HCV) nonstructural protein 3/4A protease inhibitor. This phase III study evaluated the safety and efficacy of vaniprevir in combination with peginterferon alfa-2b and ribavirin (PR) for 24 weeks compared with PR alone for 48 weeks in treatment-naive Japanese patients with HCV genotype 1 infection. METHODS: Treatment-naive Japanese patients with HCV genotype 1 infection were randomly assigned to receive vaniprevir (300 mg twice daily) plus PR for 12 weeks then PR alone for 12 weeks, vaniprevir (300 mg twice daily) plus PR for 24 weeks, or PR alone for 48 weeks...
April 2016: Journal of Gastroenterology
Paul Fredlund, Jan Hillson, Todd Gray, Lynn Shemanski, Dessislava Dimitrova, Subasree Srinivasan
Peginterferon alfa (alfa) increases the risk of autoimmune disease. Peginterferon lambda-1a (Lambda) acts through a receptor with a more liver-specific distribution compared to the alfa receptor. In a phase-2b study, 525 treatment-naive patients with chronic hepatitis C virus (HCV) infection received ribavirin and Lambda interferon (120, 180, or 240 μg) or alfa interferon (180 μg) for 24 (genotypes 2 and 3) or 48 (genotypes 1 and 4) weeks. Retrospective analysis found that adverse events of MedDRA-coded thyroid dysfunction and abnormal levels of thyroid-stimulating hormone (TSH) were significantly more frequent with alfa versus Lambda (12% versus 2...
November 2015: Journal of Interferon & Cytokine Research
Shelby Chopp, Rebecca Vanderwall, Amanda Hult, Michael Klepser
PURPOSE: The pharmacology, pharmacokinetics, efficacy, safety, costs, and place in therapy of simeprevir and sofosbuvir in the management of hepatitis C virus (HCV) infection are reviewed. SUMMARY: Sofosbuvir and simeprevir are classified as direct-acting agents because they target specific proteins essential to the replication of HCV. Phase III trials demonstrated that simeprevir in combination with peginterferon alfa and ribavirin was superior to placebo combined with peginterferon alfa and ribavirin in achieving a sustained virological response in both treatment-naive patients and patients who relapsed after treatment with peginterferon alfa-2a or alfa-2b and ribavirin...
September 1, 2015: American Journal of Health-system Pharmacy: AJHP
Mona Abdelmonem Esmail, Noha A Hassuna, Khalda Sayed Amr, Eman Ramadan Ghazawy, Mohamed Abdel-Hamid
Chronic HCV is one of the commonest causes of chronic liver disease worldwide with about 15% of population infected in Egypt. Certain single nucleotide polymorphisms (SNPs) lying near the IL28B gene were found to affect the spontaneous clearance as well as treatment outcome of HCV. To examine the association between different IL28B variants and the relapse of HCV infection after combined therapy with ribavirin and pegylated interferon (pegIFN). Hundered HCV genotype four patients received 1.5 mg/kg/week peginterferon alfa-2b plus 800-1400 mg/d ribavirin (weight-adjusted) for 48 weeks...
March 2016: Journal of Medical Virology
Chun-Jen Liu, Pei-Jer Chen, Ding-Shinn Chen, Tai-Chung Tseng, Jia-Horng Kao
Dual hepatitis C virus (HCV) and hepatitis B virus (HBV) infection is not rare in HBV or HCV endemic areas, and can be found in populations at risk of parenteral viral transmission. Clinical observatory studies suggest a higher risk of liver disease progression in patients with dual HCV/HBV infection than in HBV or HCV monoinfected patients. Recent trials confirmed that combination therapy of peginterferon alfa-2a or alfa-2b and ribavirin was effective and safe in dually infected patients with positive HCV RNA...
May 2016: Journal of the Formosan Medical Association, Taiwan Yi Zhi
Paul Martin, Daryl T-Y Lau, Mindie H Nguyen, Harry L A Janssen, Douglas T Dieterich, Marion G Peters, Ira M Jacobson
Chronic hepatitis B (CHB) continues to be an important public health problem worldwide, including in the United States. An algorithm for managing CHB was developed by a panel of United States hepatologists in 2004 and subsequently updated in 2006 and 2008. Since 2008, additional data on long-term safety and efficacy of licensed therapies have become available and have better defined therapeutic options for CHB. The evidence indicates that potent antiviral therapy can lead to regression of extensive fibrosis or even cirrhosis, thus potentially altering the natural history of CHB...
November 2015: Clinical Gastroenterology and Hepatology
Anna Niezgoda, Piotr Niezgoda, Rafał Czajkowski
The incidence of malignant melanoma is increasing. The majority of patients are diagnosed in early stages when the disease is highly curable. However, the more advanced or metastatic cases have always been a challenge for clinicians. The poor prognosis for patients with melanoma is now changing as numerous of promising approaches have appeared recently. The discovery of aberrations of pathways responsible for intracellular signal transduction allowed us to introduce agents specifically targeting the mutated cascades...
2015: BioMed Research International
Jacques Friborg, Petra Ross-Macdonald, Jian Cao, Ryan Willard, Baiqing Lin, Betsy Eggers, Fiona McPhee
Peginterferon lambda-1a (Lambda), a type III interferon (IFN), acts through a unique receptor complex with limited cellular expression outside the liver which may result in a differentiated tolerability profile compared to peginterferon alfa (alfa). In Phase 2b clinical studies, Lambda administered in combination with ribavirin (RBV) was efficacious in patients with hepatitis C virus (HCV) infection representing genotypes 1 through 4, and was associated with more rapid declines in HCV RNA compared to alfa plus RBV...
2015: PloS One
Jorge Luis Sandoval-Ramirez, José Antonio Mata-Marín, Gloria Huerta García, Jesús Enrique Gaytán-Martínez
INTRODUCTION: The WHO estimates that 180 million people are chronically infected with hepatitis C virus (HCV) throughout the world. Despite the emergence of new therapies, the combination of pegylated interferon and ribavirin remains the accepted standard of care in low-income countries, including Mexico. Two types of peginterferon are available (peginterferon alfa-2a and peginterferon alfa-2b), and both are recommended for the treatment of HCV, although there is controversy over which treatment option is most effective...
March 2015: Journal of Infection in Developing Countries
Izumi Sato, Takuro Shimbo, Yohei Kawasaki, Naohiko Masaki
PURPOSE: We aimed to compare the rates of sustained virologic response (SVR) achieved with peginterferon (PEG-IFN) alfa-2a and alfa-2b in combination with ribavinin (RBV) for chronic hepatitis C, using a large database of hepatitis cases to improve the generalizability of these results. METHODS: We identified patients with chronic hepatitis C who were treated with PEG-IFN alfa-2a or alfa-2b and RBV, from the Japanese Interferon Database, between December 2009 and April 2013...
2015: Drug Design, Development and Therapy
Brian L Pearlman, Carole Ehleben, Michael Perrys
BACKGROUND & AIMS: The efficacy and safety of interferon-free regimens for the treatment of chronic hepatitis C virus (HCV) infections require further evaluation and comparison with those of interferon-containing regimens. We compared a regimen of peginterferon, ribavirin, and sofosbuvir with a regimen of simeprevir and sofosbuvir in patients with HCV infection and unfavorable treatment features. METHODS: We performed a prospective open-label study of 82 patients with chronic HCV genotype 1a infection and Child's grade A cirrhosis enrolled from 2 clinics at a single center in Atlanta, Georgia, from December 2013 through January 2014...
April 2015: Gastroenterology
Kazuyoshi Suzuki, Masaya Tamano, Yasumi Katayama, Toru Kuniyoshi, Kagemasa Kagawa, Hiroshi Takada, Kazutomo Suzuki
AIM: To investigate the occurrence and severity of pruritus in chronic hepatitis C patients treated with or without interferon (IFN) therapy. METHODS: A total of 89 patients with chronic hepatitis C and 55 control (non-hepatitis) patients were asked to rate their experience of diurnal and nocturnal pruritus in the preceding week using a visual analogue scale (VAS) and a five-point scale, respectively. Blood samples were taken and serum thymus and activation-regulated chemokine (TARC) levels were measured by enzyme-linked immunosorbent assay...
December 21, 2014: World Journal of Gastroenterology: WJG
Gregory J Dore, Eric Lawitz, Christophe Hézode, Stephen D Shafran, Alnoor Ramji, Harvey A Tatum, Gloria Taliani, Albert Tran, Maurizia R Brunetto, Serena Zaltron, Simone I Strasser, Nina Weis, Wayne Ghesquiere, Samuel S Lee, Dominique Larrey, Stanislas Pol, Hugh Harley, Jacob George, Scott K Fung, Victor de Lédinghen, Peggy Hagens, Fiona McPhee, Dennis Hernandez, David Cohen, Elizabeth Cooney, Stephanie Noviello, Eric A Hughes
BACKGROUND & AIMS: Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus (HCV) genotype 2 or 3 infection produces a sustained virologic response (SVR) in 70%-80% of patients. We performed a randomized, double-blind, phase 2b study to assess whether adding daclatasvir, a nonstructural protein 5A (NS5A) inhibitor that is active against these genotypes, improves efficacy and shortens therapy. METHODS: Patients with HCV genotype 2 or 3 infection (n = 151), enrolled at research centers in North America, Europe, or Australia, were assigned randomly to groups given 12 or 16 weeks of daclatasvir (60 mg once daily), or 24 weeks of placebo, each combined with peginterferon alfa-2a and ribavirin...
February 2015: Gastroenterology
Jun Cheng, Yuming Wang, Jinlin Hou, Duande Luo, Qing Xie, Qin Ning, Hong Ren, Huiguo Ding, Jifang Sheng, Lai Wei, Shijun Chen, Xiaoling Fan, Wenxiang Huang, Chen Pan, Zhiliang Gao, Jiming Zhang, Boping Zhou, Guofeng Chen, Mobin Wan, Hong Tang, Guiqiang Wang, Yuxiu Yang, Rosmawati Mohamed, Richard Guan, Tzong-Hsi Lee, Wen-Hsiung Chang, Huang Zhenfei, Zhang Ye, Daozhen Xu
BACKGROUND: In mainland China, peginterferon (PEG-IFN) alfa-2b 1.0μg/kg/wk for 24 weeks is the approved treatment for HBeAg-positive chronic hepatitis B. OBJECTIVE: This multicenter, randomized trial evaluated the safety and efficacy of regimens utilizing increased dose or treatment duration in treatment-naive Chinese patients with chronic hepatitis B. STUDY DESIGN: 670 HBeAg-positive patients from China, Malaysia, Taiwan area, Singapore, and Thailand were enrolled...
December 2014: Journal of Clinical Virology: the Official Publication of the Pan American Society for Clinical Virology
Hiromitsu Kumada, Ken Sato, Tetsuo Takehara, Makoto Nakamuta, Masatoshi Ishigami, Kazuaki Chayama, Joji Toyota, Fumitaka Suzuki, Yoshiyuki Nakayasu, Miyoko Ochi, Ichimaro Yamada, Takeshi Okanoue
AIM: This study assessed the efficacy and safety of telaprevir in combination with peginterferon-α-2b (PEG IFN) and ribavirin (RBV), for Japanese difficult-to-treat patients with hepatitis C virus (HCV) genotype 2 who had not achieved sustained virological response (SVR) during prior treatment. METHODS: In total, 108 relapsed (median age, 59.0 years) and 10 non-responding (median age, 59.0 years) patients with genotype 2 HCV participated. Patients received telaprevir (750 mg, every 8 h) for 12 weeks and PEG IFN/RBV for 24 weeks...
July 2015: Hepatology Research: the Official Journal of the Japan Society of Hepatology
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