December 16, 2013

Eur J Gastroenterol Hepatol. 2014 Jan;26(1):52-8. doi: 10.1097/MEG.0b013e328362dc99.

Durability of the response to peginterferon-α2b and ribavirin in patients with chronic hepatitis C: a cohort study in the routine clinical setting

Giordanino C, Sacco M, Ceretto S, Smedile A, Ciancio A, Cariti G, De Blasi T, Picciotto A, Marenco S, Grasso A, Pirisi M, Smirne C, Colletta C, Traverso A, Mazzucco D, Ciccone G, Simondi D, Rizzetto M, Saracco G.

aDepartment of Oncology, Division of Gastroenterology bDepartment of Internal Medicine, Division of Hepatogastroenterology cDepartment of Infectious Diseases, Amedeo di Savoia Hospital dUnit of Cancer Epidemiology, Molinette Hospital and CPO Piemonte, University of Turin, Turin eDepartment of Internal Medicine, Division of Gastroenterology, University of Genoa, Genoa fDivision of Gastroenterology, San Paolo Hospital, Savona gDepartment of Translational Medicine, Università del Piemonte Orientale 'A. Avogadro', Novara hDivision of Internal Medicine, Ospedale Madonna del Popolo, Omegna iDivision of Infectious Diseases, Ospedale Umberto Parini, Aosta jDivision of Gastroenterology, Ospedale degli Infermi, Rivoli, Italy.

Abstract

OBJECTIVES: To evaluate whether, in chronic hepatitis C-positive naive patients recruited in the routine clinical setting and treated with pegylated-interferon-α2b (Peg-IFN) and ribavirin (RBV), the sustained virologic response (SVR) is durable over the long term and whether it is associated with a decrease in liver complications and incidence of glucose abnormalities.

PATIENTS AND METHODS: This was a prospective long-term follow-up study of 182 naive patients enrolled in 2001-2002 and treated with Peg-IFN and RBV and followed up to December 2010, with clinical, biochemical, and virological evaluations every 6-12 months.

RESULTS: None of the 115 (63.2%) sustained responders showed late viremic relapse during the follow-up. SVR was better defined at 24 weeks (16/16 relapsers, 100%) than at 12 weeks after the end of therapy (14/16 relapsers, 87.5%). On multivariable analysis, viral genotype (odds ratio 0.16, 95% confidence interval 0.07-0.36, P=0.0001) and a greater than 20% RBV reduction (odds ratio 5.21, 95% confidence interval 1.54-17.67, P=0.008) predicted long-term response (LTR) independently. The incidence of cirrhosis was significantly higher among nonresponders (21.3%) compared with long-term responders (0.9%, P≤0.0001), but the risk of developing glucose abnormalities was not significantly reduced in long-term responders (hazard ratio 1.36, P=0.363). Hepatocellular carcinoma occurred only in three cases.

CONCLUSION: SVR achieved in patients treated in the routine clinical setting with Peg-IFN and RBV is durable over the long term and LTR significantly reduces the risk of progression to cirrhosis; however, in a population with mild liver fibrosis, the clinical impact of LTR on the risk of glucose abnormalities seems negligible.

PMID: 23719564 [PubMed - in process]

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