Treatment of chronic hepatitis c with interferon with or without ursodeoxycholic acid: A randomized prospective trial

Manal F. Abdelmalek, M. Edwyn Harrison, John B. Gross, John J. Poterucha, Andrea A. Gossard, James R. Spivey, Jorge Rakela, Keith Lindor

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

The only effective and approved therapy for chronic hepatitis C is interferon-alpha. Because sustained response rates with interferon alone are disappointingly low, multidrug treatment regimens are currently being investigated. Ursodeoxycholic acid has been used in other chronic liver diseases and can limit hepatocyte injury. To evaluate the potential benefit of ursodeoxycholic acid in combination with interferon-alpha for the treatment of chronic hepatitis C, we conducted a prospective, double-blinded, randomized, placebo-controlled trial comparing the combination therapy of interferon-alpha 2b and ursodeoxycholic acid with interferon alone. Thirty- one patients with chronic hepatitis C were randomized to receive 3 million units of interferon-alpha 2b subcutaneously three times per week and either 13 to 15 mg/kg/day ursodeoxycholic acid or placebo orally for 6 months. The 6-month treatment period was followed by 6 months of observation. Biochemical normalization at the end of treatment occurred in 5 of 14 (36%) patients receiving monotherapy versus 8 of 15 (53%) patients (p = 0.34) receiving combination therapy. No patient treated with interferon alone had a sustained biochemical response 6 months after therapy; however, 3 of 12 patients (25%) treated with combination interferon and ursodeoxycholic acid maintained biochemical normalization at 6 months after therapy (p = 0.08). No difference in liver histology or clearance of hepatitis C viral RNA was noted 6 months after treatment. We conclude that combination therapy with ursodeoxycholic acid and interferon-alpha 2b was no more effective than interferon monotherapy in inducing a biochemical response in previously untreated patients with chronic hepatitis C. Ursodeoxycholic acid, however, may be useful in prolonging the biochemical response to interferon therapy.

Original languageEnglish (US)
Pages (from-to)130-134
Number of pages5
JournalJournal of Clinical Gastroenterology
Volume26
Issue number2
DOIs
StatePublished - Mar 1998
Externally publishedYes

Fingerprint

Ursodeoxycholic Acid
Chronic Hepatitis
Interferons
interferon alfa-2b
Chronic Hepatitis C
Therapeutics
Interferon-alpha
Placebos
Viral RNA
Hepatitis C
Liver Diseases
Hepatocytes
Histology
Chronic Disease
Randomized Controlled Trials

Keywords

  • Chronic hepatitis C
  • Interferon
  • Treatment
  • Ursodeoxycholic acid

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Treatment of chronic hepatitis c with interferon with or without ursodeoxycholic acid : A randomized prospective trial. / Abdelmalek, Manal F.; Harrison, M. Edwyn; Gross, John B.; Poterucha, John J.; Gossard, Andrea A.; Spivey, James R.; Rakela, Jorge; Lindor, Keith.

In: Journal of Clinical Gastroenterology, Vol. 26, No. 2, 03.1998, p. 130-134.

Research output: Contribution to journalArticle

Abdelmalek, Manal F. ; Harrison, M. Edwyn ; Gross, John B. ; Poterucha, John J. ; Gossard, Andrea A. ; Spivey, James R. ; Rakela, Jorge ; Lindor, Keith. / Treatment of chronic hepatitis c with interferon with or without ursodeoxycholic acid : A randomized prospective trial. In: Journal of Clinical Gastroenterology. 1998 ; Vol. 26, No. 2. pp. 130-134.
@article{b4255d2950f04a04b3df6769aee9ac49,
title = "Treatment of chronic hepatitis c with interferon with or without ursodeoxycholic acid: A randomized prospective trial",
abstract = "The only effective and approved therapy for chronic hepatitis C is interferon-alpha. Because sustained response rates with interferon alone are disappointingly low, multidrug treatment regimens are currently being investigated. Ursodeoxycholic acid has been used in other chronic liver diseases and can limit hepatocyte injury. To evaluate the potential benefit of ursodeoxycholic acid in combination with interferon-alpha for the treatment of chronic hepatitis C, we conducted a prospective, double-blinded, randomized, placebo-controlled trial comparing the combination therapy of interferon-alpha 2b and ursodeoxycholic acid with interferon alone. Thirty- one patients with chronic hepatitis C were randomized to receive 3 million units of interferon-alpha 2b subcutaneously three times per week and either 13 to 15 mg/kg/day ursodeoxycholic acid or placebo orally for 6 months. The 6-month treatment period was followed by 6 months of observation. Biochemical normalization at the end of treatment occurred in 5 of 14 (36{\%}) patients receiving monotherapy versus 8 of 15 (53{\%}) patients (p = 0.34) receiving combination therapy. No patient treated with interferon alone had a sustained biochemical response 6 months after therapy; however, 3 of 12 patients (25{\%}) treated with combination interferon and ursodeoxycholic acid maintained biochemical normalization at 6 months after therapy (p = 0.08). No difference in liver histology or clearance of hepatitis C viral RNA was noted 6 months after treatment. We conclude that combination therapy with ursodeoxycholic acid and interferon-alpha 2b was no more effective than interferon monotherapy in inducing a biochemical response in previously untreated patients with chronic hepatitis C. Ursodeoxycholic acid, however, may be useful in prolonging the biochemical response to interferon therapy.",
keywords = "Chronic hepatitis C, Interferon, Treatment, Ursodeoxycholic acid",
author = "Abdelmalek, {Manal F.} and Harrison, {M. Edwyn} and Gross, {John B.} and Poterucha, {John J.} and Gossard, {Andrea A.} and Spivey, {James R.} and Jorge Rakela and Keith Lindor",
year = "1998",
month = "3",
doi = "10.1097/00004836-199803000-00009",
language = "English (US)",
volume = "26",
pages = "130--134",
journal = "Journal of Clinical Gastroenterology",
issn = "0192-0790",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Treatment of chronic hepatitis c with interferon with or without ursodeoxycholic acid

T2 - A randomized prospective trial

AU - Abdelmalek, Manal F.

AU - Harrison, M. Edwyn

AU - Gross, John B.

AU - Poterucha, John J.

AU - Gossard, Andrea A.

AU - Spivey, James R.

AU - Rakela, Jorge

AU - Lindor, Keith

PY - 1998/3

Y1 - 1998/3

N2 - The only effective and approved therapy for chronic hepatitis C is interferon-alpha. Because sustained response rates with interferon alone are disappointingly low, multidrug treatment regimens are currently being investigated. Ursodeoxycholic acid has been used in other chronic liver diseases and can limit hepatocyte injury. To evaluate the potential benefit of ursodeoxycholic acid in combination with interferon-alpha for the treatment of chronic hepatitis C, we conducted a prospective, double-blinded, randomized, placebo-controlled trial comparing the combination therapy of interferon-alpha 2b and ursodeoxycholic acid with interferon alone. Thirty- one patients with chronic hepatitis C were randomized to receive 3 million units of interferon-alpha 2b subcutaneously three times per week and either 13 to 15 mg/kg/day ursodeoxycholic acid or placebo orally for 6 months. The 6-month treatment period was followed by 6 months of observation. Biochemical normalization at the end of treatment occurred in 5 of 14 (36%) patients receiving monotherapy versus 8 of 15 (53%) patients (p = 0.34) receiving combination therapy. No patient treated with interferon alone had a sustained biochemical response 6 months after therapy; however, 3 of 12 patients (25%) treated with combination interferon and ursodeoxycholic acid maintained biochemical normalization at 6 months after therapy (p = 0.08). No difference in liver histology or clearance of hepatitis C viral RNA was noted 6 months after treatment. We conclude that combination therapy with ursodeoxycholic acid and interferon-alpha 2b was no more effective than interferon monotherapy in inducing a biochemical response in previously untreated patients with chronic hepatitis C. Ursodeoxycholic acid, however, may be useful in prolonging the biochemical response to interferon therapy.

AB - The only effective and approved therapy for chronic hepatitis C is interferon-alpha. Because sustained response rates with interferon alone are disappointingly low, multidrug treatment regimens are currently being investigated. Ursodeoxycholic acid has been used in other chronic liver diseases and can limit hepatocyte injury. To evaluate the potential benefit of ursodeoxycholic acid in combination with interferon-alpha for the treatment of chronic hepatitis C, we conducted a prospective, double-blinded, randomized, placebo-controlled trial comparing the combination therapy of interferon-alpha 2b and ursodeoxycholic acid with interferon alone. Thirty- one patients with chronic hepatitis C were randomized to receive 3 million units of interferon-alpha 2b subcutaneously three times per week and either 13 to 15 mg/kg/day ursodeoxycholic acid or placebo orally for 6 months. The 6-month treatment period was followed by 6 months of observation. Biochemical normalization at the end of treatment occurred in 5 of 14 (36%) patients receiving monotherapy versus 8 of 15 (53%) patients (p = 0.34) receiving combination therapy. No patient treated with interferon alone had a sustained biochemical response 6 months after therapy; however, 3 of 12 patients (25%) treated with combination interferon and ursodeoxycholic acid maintained biochemical normalization at 6 months after therapy (p = 0.08). No difference in liver histology or clearance of hepatitis C viral RNA was noted 6 months after treatment. We conclude that combination therapy with ursodeoxycholic acid and interferon-alpha 2b was no more effective than interferon monotherapy in inducing a biochemical response in previously untreated patients with chronic hepatitis C. Ursodeoxycholic acid, however, may be useful in prolonging the biochemical response to interferon therapy.

KW - Chronic hepatitis C

KW - Interferon

KW - Treatment

KW - Ursodeoxycholic acid

UR - http://www.scopus.com/inward/record.url?scp=0031953492&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031953492&partnerID=8YFLogxK

U2 - 10.1097/00004836-199803000-00009

DO - 10.1097/00004836-199803000-00009

M3 - Article

C2 - 9563925

AN - SCOPUS:0031953492

VL - 26

SP - 130

EP - 134

JO - Journal of Clinical Gastroenterology

JF - Journal of Clinical Gastroenterology

SN - 0192-0790

IS - 2

ER -