Amantadine therapy for chronic hepatitis C.
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.


METHODS
A prospective double-blind randomized placebo-controlled trial.


METHODS
Outpatient research clinic of a teaching hospital.


METHODS
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.


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 serum alanine aminotransferase compared to placebo (P =.03). Nine percent cleared the virus at the end of therapy and 6.8% had a sustained virologic 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.
Smith
Jill P
JP
Department of Medicine, Pennsylvania State College of Medicine, The Milton S Hershey Medical Center, Hershey, PA 17033-0850, USA. jsmith2@psu.edu
Riley
Thomas R
TR
Devenyi
Attila
A
Bingaman
Sandra I
SI
Kunselman
Allen
A
D000328:Adult; D000367:Age Factors; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000547:Amantadine / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007223:Infant; D008297:Male; D010352:Patient Dropouts; D011788:Quality of Life; D012367:RNA, Viral / Q000032:analysis; D012737:Sex Factors; D013997:Time Factors
D000998:Antiviral Agents; D012367:RNA, Viral; D000547:Amantadine; D000410:Alanine Transaminase