Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C

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Alimentary Pharmacology & Therapeutics

Volume 31 Issue 7, Pages 719 - 734

Published Online: 12 Jan 2010

Journal compilation © 2010 Blackwell Publishing Ltd

Changes in quality of life and sexual health are associated with low-dose

peginterferon therapy and disease progression in patients with chronic hepatitis

C

K. K. SNOW*, H. L. BONKOVSKY?, R. J. FONTANA?, H.-Y. KIM*, R. K. STERLING§, A.

M. DI BISCEGLIE?, T. R. MORGAN**, J. L. DIENSTAG??, M. G. GHANY?? & The HALT-C

Trial Group

*New England Research Institutes, Watertown, MA, USA ; ?Departments of Medicine

and Molecular & Structural Biology and The Liver-Biliary-Pancreatic Center,

University of Connecticut Health Center, Farmington, CT, USA ; ?Department of

Internal Medicine, University of Michigan Medical Center, Ann Arbor, MI, USA ;

§Hepatology Section, Virginia Commonwealth University Medical Center, Richmond,

VA, USA ; ?Division of Gastroenterology and Hepatology, Saint Louis University

School of Medicine, St Louis, MO, USA ; **Division of Gastroenterology,

University of California - Irvine, Irvine, CA and Gastroenterology Service, VA

Long Beach Healthcare System, Long Beach, CA, USA ; ??Gastrointestinal Unit

(Medical Services), Massachusetts General Hospital and the Department of

Medicine, Harvard Medical School, Boston, MA, USA ; ??Liver Diseases Branch,

National Institute of Diabetes and Digestive and Kidney Diseases, National

Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA

Correspondence to Dr K. K. Snow, New England Research Institutes, 9 Galen

Street, Watertown, MA 02472, USA.

E-mail: ksnow@...

Aliment Pharmacol Ther 31, 719-734

ABSTRACT

Background Primary analysis of the Hepatitis C Antiviral Long-Term Treatment

against Cirrhosis (HALT-C) Trial showed long-term peginterferon therapy did not

reduce complications in patients with chronic hepatitis C and advanced fibrosis

or cirrhosis.

Aim To assess the effects of long-term peginterferon therapy and disease

progression on health-related quality of life (HRQOL), symptoms and sexual

health in HALT-C patients.

Methods A total of 517 HALT-C patients received peginterferon alfa-2a (90

ìg/week); 532 received no additional treatment for 3.5 years. Patients were

followed up for outcomes of death, hepatocellular carcinoma and hepatic

decompensation. Sexual health, SF-36 scores and symptoms were serially assessed

by repeated-measures analyses of covariance.

Results Patients with cirrhosis (n = 427) reported lower general well-being and

more fatigue (P < 0.001) than patients with fibrosis (n = 622). Physical scores

declined significantly over time, independent of treatment, and patients with

cirrhosis reported lower scores. Vitality scores were lower in those with

cirrhosis, and treated patients experienced a greater decline over time than

untreated patients; HRQOL rebounded after treatment ended. Patients with a

clinical outcome had significantly greater declines in all SF-36 and symptom

scores. Among men, Sexual Health scores were significantly worse in treated

patients and in those with a clinical outcome.

Conclusion Clinical progression of chronic hepatitis C and maintenance

peginterferon therapy led to worsening of symptoms, HRQOL and, in men, sexual

health in a large patient cohort followed up over 4 years (NCT00006164).

Publication data Submitted 30 June 2009 First decision 25 July 2009 Resubmitted

3 December 2009 Accepted 7 January 2010 Epub Accepted Article 12 January 2010

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1365-2036.2010.04235