Amantadine therapy for chronic hepatitis C: A randomized double-blind placebo-controlled trial

Jill P. Smith, Thomas Riley III, Attila Devenyi, Sandra I. Bingaman, Allen Kunselman

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

OBJECTIVE: Although treatment of hepatitis C has improved, up to 50% do not respond to standard therapy with interferon regimes or cannot tolerate the treatment due to side effects. The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferon. DESIGN: A prospective double-blind randomized placebo-controlled trial. SETTING: Outpatient research clinic of a teaching hospital. PATIENTS/PARTICIPANTS: One hundred fifty-two patients with confirmed hepatitis C with abnormal liver enzymes, detectable hepatitis C RNA in the blood, and abnormal liver histology by biopsy were randomized to receive treatment or placebo. MEASUREMENTS AND MAIN RESULTS: Patients received either amantadine 100 mg twice daily by mouth or placebo for 6 months. After 6 months, placebo-treated patients were crossed over and treated with amantadine for 6 months and amantadine-treated subjects received 6 additional months of therapy. Amantadine therapy resulted in a significant decline in seram alanine aminotransferase compared to placebo (P = .03). Nine percent cleared the virus at the end of therapy and 6.8% had a sustained virologie response 6 months after discontinuation of amantadine, but this was not statistically significant. Side effects were minimal, and the social quality of life survey improved with 12 months of amantadine (P = .02). CONCLUSIONS: Oral amantadine may provide a safe alternative treatment for those patients who are intolerant or unresponsive to interferon.

Original languageEnglish (US)
Pages (from-to)662-668
Number of pages7
JournalJournal of general internal medicine
Volume19
Issue number6
DOIs
StatePublished - Jun 1 2004

Fingerprint

Amantadine
Chronic Hepatitis C
Placebos
Hepatitis C
Interferons
Therapeutics
Liver
Ambulatory Care Facilities
Alanine Transaminase
Teaching Hospitals
Antiviral Agents
Mouth
Histology
Randomized Controlled Trials
Quality of Life
RNA
Viruses
Biopsy
Safety

All Science Journal Classification (ASJC) codes

  • Internal Medicine

Cite this

@article{e52ae4dbf87a44bd8bbb8eba23a9544b,
title = "Amantadine therapy for chronic hepatitis C: A randomized double-blind placebo-controlled trial",
abstract = "OBJECTIVE: Although treatment of hepatitis C has improved, up to 50{\%} do not respond to standard therapy with interferon regimes or cannot tolerate the treatment due to side effects. The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferon. DESIGN: A prospective double-blind randomized placebo-controlled trial. SETTING: Outpatient research clinic of a teaching hospital. PATIENTS/PARTICIPANTS: One hundred fifty-two patients with confirmed hepatitis C with abnormal liver enzymes, detectable hepatitis C RNA in the blood, and abnormal liver histology by biopsy were randomized to receive treatment or placebo. MEASUREMENTS AND MAIN RESULTS: Patients received either amantadine 100 mg twice daily by mouth or placebo for 6 months. After 6 months, placebo-treated patients were crossed over and treated with amantadine for 6 months and amantadine-treated subjects received 6 additional months of therapy. Amantadine therapy resulted in a significant decline in seram alanine aminotransferase compared to placebo (P = .03). Nine percent cleared the virus at the end of therapy and 6.8{\%} had a sustained virologie response 6 months after discontinuation of amantadine, but this was not statistically significant. Side effects were minimal, and the social quality of life survey improved with 12 months of amantadine (P = .02). CONCLUSIONS: Oral amantadine may provide a safe alternative treatment for those patients who are intolerant or unresponsive to interferon.",
author = "Smith, {Jill P.} and {Riley III}, Thomas and Attila Devenyi and Bingaman, {Sandra I.} and Allen Kunselman",
year = "2004",
month = "6",
day = "1",
doi = "10.1111/j.1525-1497.2004.30057.x",
language = "English (US)",
volume = "19",
pages = "662--668",
journal = "Journal of General Internal Medicine",
issn = "0884-8734",
publisher = "Springer New York",
number = "6",

}

Amantadine therapy for chronic hepatitis C : A randomized double-blind placebo-controlled trial. / Smith, Jill P.; Riley III, Thomas; Devenyi, Attila; Bingaman, Sandra I.; Kunselman, Allen.

In: Journal of general internal medicine, Vol. 19, No. 6, 01.06.2004, p. 662-668.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Amantadine therapy for chronic hepatitis C

T2 - A randomized double-blind placebo-controlled trial

AU - Smith, Jill P.

AU - Riley III, Thomas

AU - Devenyi, Attila

AU - Bingaman, Sandra I.

AU - Kunselman, Allen

PY - 2004/6/1

Y1 - 2004/6/1

N2 - OBJECTIVE: Although treatment of hepatitis C has improved, up to 50% do not respond to standard therapy with interferon regimes or cannot tolerate the treatment due to side effects. The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferon. DESIGN: A prospective double-blind randomized placebo-controlled trial. SETTING: Outpatient research clinic of a teaching hospital. PATIENTS/PARTICIPANTS: One hundred fifty-two patients with confirmed hepatitis C with abnormal liver enzymes, detectable hepatitis C RNA in the blood, and abnormal liver histology by biopsy were randomized to receive treatment or placebo. MEASUREMENTS AND MAIN RESULTS: Patients received either amantadine 100 mg twice daily by mouth or placebo for 6 months. After 6 months, placebo-treated patients were crossed over and treated with amantadine for 6 months and amantadine-treated subjects received 6 additional months of therapy. Amantadine therapy resulted in a significant decline in seram alanine aminotransferase compared to placebo (P = .03). Nine percent cleared the virus at the end of therapy and 6.8% had a sustained virologie response 6 months after discontinuation of amantadine, but this was not statistically significant. Side effects were minimal, and the social quality of life survey improved with 12 months of amantadine (P = .02). CONCLUSIONS: Oral amantadine may provide a safe alternative treatment for those patients who are intolerant or unresponsive to interferon.

AB - OBJECTIVE: Although treatment of hepatitis C has improved, up to 50% do not respond to standard therapy with interferon regimes or cannot tolerate the treatment due to side effects. The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferon. DESIGN: A prospective double-blind randomized placebo-controlled trial. SETTING: Outpatient research clinic of a teaching hospital. PATIENTS/PARTICIPANTS: One hundred fifty-two patients with confirmed hepatitis C with abnormal liver enzymes, detectable hepatitis C RNA in the blood, and abnormal liver histology by biopsy were randomized to receive treatment or placebo. MEASUREMENTS AND MAIN RESULTS: Patients received either amantadine 100 mg twice daily by mouth or placebo for 6 months. After 6 months, placebo-treated patients were crossed over and treated with amantadine for 6 months and amantadine-treated subjects received 6 additional months of therapy. Amantadine therapy resulted in a significant decline in seram alanine aminotransferase compared to placebo (P = .03). Nine percent cleared the virus at the end of therapy and 6.8% had a sustained virologie response 6 months after discontinuation of amantadine, but this was not statistically significant. Side effects were minimal, and the social quality of life survey improved with 12 months of amantadine (P = .02). CONCLUSIONS: Oral amantadine may provide a safe alternative treatment for those patients who are intolerant or unresponsive to interferon.

UR - http://www.scopus.com/inward/record.url?scp=3042668881&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=3042668881&partnerID=8YFLogxK

U2 - 10.1111/j.1525-1497.2004.30057.x

DO - 10.1111/j.1525-1497.2004.30057.x

M3 - Article

C2 - 15209605

AN - SCOPUS:3042668881

VL - 19

SP - 662

EP - 668

JO - Journal of General Internal Medicine

JF - Journal of General Internal Medicine

SN - 0884-8734

IS - 6

ER -