A Sustained Virologic Response Is Durable in Patients With Chronic Hepatitis C Treated With Peginterferon Alfa-2a and Ribavirin

被引:269
作者
Swain, Mark G. [1 ]
Lai, Ming-Yang [2 ]
Shiffman, Mitchell L. [3 ]
Cooksley, W. Graham E. [4 ]
Zeuzem, Stefan [5 ]
Dieterich, Douglas T. [6 ]
Abergel, Armand [7 ]
Pessoa, Mario G. [8 ,9 ]
Lin, Amy [10 ]
Tietz, Andreas [11 ]
Connell, Edward V. [10 ]
Diago, Moises [12 ]
机构
[1] Univ Calgary, Hlth Res Innovat Ctr, Calgary, AB T2N 4Z6, Canada
[2] Natl Taiwan Hosp, Taipei, Taiwan
[3] Bon Secours Hlth Syst, Liver Inst Virginia, Newport News, VA USA
[4] Univ Queensland, Royal Brisbane Hosp, Brisbane, Qld, Australia
[5] JW Goethe Univ Hosp, Frankfurt, Germany
[6] Mt Sinai Sch Med, New York, NY USA
[7] Hop Hotel Dieu, Clermont Ferrand, France
[8] Univ Sao Paulo, Sch Med, Sao Paulo, Brazil
[9] Inst Infectol Emilio Ribas, Sao Paulo, Brazil
[10] Roche, Nutley, NJ USA
[11] Roche, Basel, Switzerland
[12] Gen Univ, Valencia, Spain
关键词
PEGASYS; Cure; Safety Analysis; Clinical Outcome; QUALITY-OF-LIFE; TERM-FOLLOW-UP; HIV-INFECTED PATIENTS; PLUS RIBAVIRIN; VIRUS-INFECTION; HCV RNA; COMBINATION THERAPY; INTERFERON; LONG; LIVER;
D O I
10.1053/j.gastro.2010.07.009
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
BACKGROUND & AIMS: A sustained virologic response (SVR) to therapy for hepatitis C virus (HCV) infection is defined as the inability to detect HCV RNA 24 weeks after completion of treatment. Although small studies have reported that the SVR is durable and lasts for long periods, it has not been conclusively shown. METHODS: The durability of treatment responses was examined in patients originally enrolled in one of 9 randomized multicenter trials (n = 1343). The study included patients who received pegylated interferon (peginterferon) alfa-2a alone (n = 166) or in combination with ribavirin (n = 1077, including 79 patients with normal alanine aminotransferase levels and 100 patients who were coinfected with human immunodeficiency virus and HCV) and whose serum samples were negative for HCV RNA (<50 IU/mL) at their final assessment. Patients were assessed annually, from the date of last treatment, for a mean of 3.9 years (range, 0.8-7.1 years). RESULTS: Most patients (99.1%) who achieved an SVR had undetectable levels of HCV RNA in serum samples throughout the follow-up period. Serum samples from 0.9% of the patients contained HCV RNA a mean of 1.8 years (range, 1.1-2.9 years) after treatment ended. It is not clear if these patients were reinfected or experienced a relapse. CONCLUSIONS: In a large cohort of patients monitored for the durability of an SVR, the SVR was maintained for almost 4 years after treatment with peginterferon alfa-2a alone or in combination with ribavirin. In patients with chronic hepatitis C infection, the SVR is durable and these patients should be considered as cured.
引用
收藏
页码:1593 / 1601
页数:9
相关论文
共 47 条
[11]   Sustained virological response rates and durability of the response to interferon-based therapies in hepatitis C patients treated in the clinical setting [J].
Desmond, CP ;
Roberts, SK ;
Dudley, F ;
Mitchell, J ;
Day, C ;
Nguyen, S ;
Pianko, S .
JOURNAL OF VIRAL HEPATITIS, 2006, 13 (05) :311-315
[12]   American Gastroenterological Association medical position statement on the management of hepatitis C [J].
Dienstag, JL ;
McHutchison, JG .
GASTROENTEROLOGY, 2006, 130 (01) :225-230
[13]   Long-term follow-up of chronic hepatitis C patients with sustained virological response to various forms of interferon-based anti-viral therapy [J].
Formann, E ;
Steindl-Munda, P ;
Hofer, H ;
Jessner, W ;
Bergholz, U ;
Gurguta, C ;
Ferenci, P .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2006, 23 (04) :507-511
[14]   Improved outcomes in patients with hepatitis C with difficult-to-treat characteristics:: Randomized study of higher doses of peginterferon α-2a and ribavirin [J].
Fried, Michel W. ;
Jensen, Donald M. ;
Rodriguez-Torres, Maribel ;
Nyberg, Lisa M. ;
Di Bisceglie, Adrian M. ;
Morgan, Timothy R. ;
Pockros, Paul J. ;
Lin, Amy ;
Cupelli, Lisa ;
Duff, Frank ;
Wang, Ka ;
Nelson, David R. .
HEPATOLOGY, 2008, 48 (04) :1033-1043
[15]   Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. [J].
Fried, MW ;
Shiffman, ML ;
Reddy, KR ;
Smith, C ;
Marinos, G ;
Goncales, FL ;
Haussinger, D ;
Diago, M ;
Carosi, G ;
Dhumeaux, D ;
Craxi, A ;
Lin, A ;
Hoffman, J ;
Yu, J .
NEW ENGLAND JOURNAL OF MEDICINE, 2002, 347 (13) :975-982
[16]   Clinical, Virologic, Histologic, and Biochemical Outcomes After Successful HCV Therapy: A 5-Year Follow-up of 150 Patients [J].
George, Sarah L. ;
Bacon, Bruce R. ;
Brunt, Elizabeth M. ;
Mihindukulasuriya, Kusal L. ;
Hoffmann, Joyce ;
Di Bisceglie, Adrian M. .
HEPATOLOGY, 2009, 49 (03) :729-738
[17]   Diagnosis, Management, and Treatment of Hepatitis C: An Update [J].
Ghany, Marc G. ;
Strader, Doris B. ;
Thomas, David L. ;
Seeff, Leonard B. .
HEPATOLOGY, 2009, 49 (04) :1335-1374
[18]   Sustained virological response to pegylated interferon and ribavirin is maintained during long-term follow-up of chronic hepatitis C patients [J].
Giannini, E. G. ;
Basso, M. ;
Savarino, V. ;
Picciotto, A. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2010, 31 (04) :502-508
[19]   Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C -: A randomized study of treatment duration and ribavirin dose [J].
Hadziyannis, SJ ;
Sette, H ;
Morgan, TR ;
Balan, V ;
Diago, M ;
Marcellin, P ;
Ramadori, G ;
Bodenheimer, H ;
Bernstein, D ;
Rizzetto, M ;
Zeuzem, S ;
Pockros, PJ ;
Lin, A ;
Ackrill, AM .
ANNALS OF INTERNAL MEDICINE, 2004, 140 (05) :346-355
[20]   The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C [J].
Hassanein, T ;
Cooksley, G ;
Sulkowski, M ;
Smith, C ;
Marinos, G ;
Lai, MY ;
Pastore, G ;
Trejo-Estrada, R ;
Vale, AHE ;
Wintfeld, N ;
Green, J .
JOURNAL OF HEPATOLOGY, 2004, 40 (04) :675-681