Pilot study of triple antiviral therapy for chronic hepatitis C in interferon alpha non-responders.
BACKGROUND
No effective therapy exists for interferon non-responding chronic hepatitis C patients.


OBJECTIVE
Pilot study evaluating the potential efficacy and safety of triple antiviral therapy in interferon-alpha non-responders.


METHODS
Twenty consecutive adult patients with chronic hepatitis C who had failed to respond to a 6-month course of interferon alpha were randomly assigned to receive a combination of interferon alpha + oral ribavirin (double therapy), or the same combination + oral amantadine (triple therapy), for 6 months.


RESULTS
By the end of therapy, normal alanine transaminase (biochemical response) was obtained in 2 out of 10 patients on double therapy but in 7 out of 10 on triple therapy (p < 0.05), and negative serum hepatitis C virus (HCV) RNA (virological response) occurred in 1 out of 10 patients on double therapy but in 7 out of 10 patients on triple therapy (p < 0.01). Six months after therapy, biochemical response was sustained in 1 (double therapy) and 4 patients (triple therapy), respectively, and the virological response was sustained in no patient on double therapy but in 3 patients on triple therapy.


CONCLUSIONS
Triple antiviral therapy seems to be able to induce biochemical and virological responses in interferon alpha non-responders with chronic hepatitis C.
Brillanti
S
S
Department of Internal Medicine and Gastroenterology, Policlinico S. Orsola, University of Bologna, Italy. sbrillanti@csi.com
Foli
M
M
Di Tomaso
M
M
Gramantieri
L
L
Masci
C
C
Bolondi
L
L
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000547:Amantadine / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006526:Hepatitis C / Q000097:blood; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D018709:Statistics, Nonparametric
D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D012254:Ribavirin; D000547:Amantadine; D000410:Alanine Transaminase