Electronic Resource
Efficacy of Sofosbuvir Plus Ribavirin with or Without Peginterferon-Alfa in Patients with Hepatitis C Virus Genotype 3 Infection and Treatment-Experienced Patients with Cirrhosis and Hepatitis C Virus Genotype 2 Infection.
| العنوان: | Efficacy of Sofosbuvir Plus Ribavirin with or Without Peginterferon-Alfa in Patients with Hepatitis C Virus Genotype 3 Infection and Treatment-Experienced Patients with Cirrhosis and Hepatitis C Virus Genotype 2 Infection. |
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| المؤلفون: | Pianko S., Barnes E., Brainard D.M., Massetto B., Lin M., Han B., McHutchison J.G., Subramanian G.M., Cooper C., Agarwal K., George J., Nahass R.G., Forton D., Brown A., Foster G.R. |
| بيانات النشر: | W.B. Saunders United States 2015-11-05 |
| نوع الوثيقة: | Electronic Resource |
| مستخلص: | Background and Aims We conducted an open-label, randomized, phase 3 trial to determine the efficacy and safety of sofosbuvir and ribavirin, with and without peginterferon-alfa, in treatment-experienced patients with cirrhosis and hepatitis C virus (HCV) genotype 2 infection and treatment-naive or treatment-experienced patients with HCV genotype 3 infection. Methods The study was conducted at 80 sites in Europe, North America, Australia, and New Zealand Patients were randomly assigned (1:1:1) to groups given sofosbuvir and ribavirin for 16 weeks (n = 196); sofosbuvir and ribavirin for 24 weeks (n = 199); or sofosbuvir, peginterferon-alfa, and ribavirin for 12 weeks (n = 197). The primary end point was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after stopping therapy (sustained virologic response [SVR12]). From October 2013 until April 2014, we enrolled and treated 592 patients - 48 with genotype 2 HCV and compensated cirrhosis who had not achieved SVR with previous treatments and 544 with genotype 3 HCV (279 treatment-naive and 265 previously treated). Overall, 219 patients (37%) had compensated cirrhosis. The last post-treatment week 12 patient visit was in January 2015. Results Rates of SVR12 among patients with genotype 2 HCV were 87% and 100%, for those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 94% for those receiving sofosbuvir, peginterferon, and ribavirin for 12 weeks. Rates of SVR12 among patients with genotype 3 HCV were 71% and 84% in those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 93% in those receiving sofosbuvir, peginterferon, and ribavirin. On-treatment virologic failure occurred in 3 patients with HCV genotype 3a receiving sofosbuvir and ribavirin for 24 weeks. The most common adverse events were fatigue, headache, insomnia, and nausea. Overall, 1% of patients discontinued treatment due to adverse events. Conclusions Among patients with genotype 3 HCV infection, including a |
| مصطلحات الفهرس: | Hepatitis C virus genotype 3, human, insomnia/si [Side Effect], irritability, liver cirrhosis/dt [Drug Therapy], male, myalgia/si [Side Effect], nausea/si [Side Effect], North America, open study, pancreatitis/si [Side Effect], phase 3 clinical trial, priority journal, pruritus/si [Side Effect], randomized controlled trial, rash/si [Side Effect], side effect/si [Side Effect], thorax pain/si [Side Effect], thrombocyte count, treatment response, vomiting/si [Side Effect], hemoglobin, peginterferon alpha/ae [Adverse Drug Reaction], peginterferon alpha/cb [Drug Combination], peginterferon alpha/dt [Drug Therapy], peginterferon alpha/pd [Pharmacology], peginterferon alpha/sc [Subcutaneous Drug Administration], ribavirin/ae [Adverse Drug Reaction], ribavirin/cb [Drug Combination], ribavirin/dt [Drug Therapy], ribavirin/pd [Pharmacology], sofosbuvir/ae [Adverse Drug Reaction], sofosbuvir/cb [Drug Combination], sofosbuvir/dt [Drug Therapy], sofosbuvir/po [Oral Drug Administration], sofosbuvir/pd [Pharmacology], major clinical study, adult, arthralgia/si [Side Effect], article, atrial fibrillation/si [Side Effect], Australia and New Zealand, chill, controlled study, coughing/si [Side Effect], decreased appetite/si [Side Effect], depression/si [Side Effect], diarrhea/si [Side Effect], dizziness/si [Side Effect], drug efficacy, drug safety, drug substitution, drug withdrawal, dry skin/si [Side Effect], Europe, faintness/si [Side Effect], fatigue/si [Side Effect], female, fever/si [Side Effect], flu like syndrome/si [Side Effect], headache/si [Side Effect], hemoglobin blood level, hepatitis C/dt [Drug Therapy], Hepatitis C virus genotype 2, Article |
| URL: | Gastroenterology Click here for full text options LibKey Link |
| الاتاحة: | Open access content. Open access content Copyright 2018 Elsevier B.V., All rights reserved. |
| Other Numbers: | AUSHL oai:repository.monashhealth.org:1/40636 Gastroenterology. 149 (6) (pp 1462-1470), 2015. Date of Publication: November 2015. 0016-5085 https://repository.monashhealth.org/monashhealthjspui/handle/1/40636 Brown, Ashley; ORCID: http://orcid.org/0000-0002-3167-7087 Barnes, Eleanor; ORCID: http://orcid.org/0000-0002-0860-0831 26248087 [http://www.ncbi.nlm.nih.gov/pubmed/?term=26248087] 606683982 (Foster) Queen Mary University of London, Blizard Institute, 4 Newark Street, London E1 4AT, United Kingdom (Pianko) Monash Health and Monash University, Melbourne, VIC, Australia (Brown) Imperial College Healthcare, National Health Service Trust, London, United Kingdom (Forton) St George's University of London, London, United Kingdom (Nahass) ID Care, Hillsborough, NJ, United States (George) Storr Liver Centre, Westmead Millennium Institute, University of Sydney, Westmead Hospital, Sydney, NSW, Australia (Barnes) Nuffield Department of Medicine, Oxford NHIR BRC and Representing STOP-HCV, United Kingdom (Brainard, Massetto, Lin, Han, McHutchison, Subramanian) Gilead Sciences, Foster City, CA, United States (Cooper) Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada (Agarwal) Institute of Liver Studies, King's College Hospital, London, United Kingdom Foster G.R.; g.r.foster@qmul.ac.uk 1305137976 |
| المصدر المساهم: | MONASH HEALTH LIBRS From OAIster®, provided by the OCLC Cooperative. |
| رقم الانضمام: | edsoai.on1305137976 |
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