Triple therapy of interferon and ribavirin with zinc supplementation for patients with chronic hepatitis C: a randomized controlled clinical trial.
OBJECTIVE
To study the therapeutic effect of interferon (IFN) and ribavirin with zinc supplement on patients with chronic hepatitis C viral (HCV) infection.


METHODS
A total of 102 patients confirmed histologically to have chronic HCV infection with genotype 1b and more than 100 KIU/mL of HCV were randomly assigned to each arm of the study and each received 10 million units of pegylated interferon (IFN-alpha-2b) daily for 4 wk followed by the same dose every other day for 20 wk plus ribavirin (600 or 800 mg/d depending on body weight), with or without polaprezinc (150 mg/d) orally for 24 wk. The primary endpoint was sustained virological response (SVR) defined as negative HCV-RNA in the serum 6 mo after treatment.


RESULTS
There were no differences in the clinical background between the two groups except for more females in the dual therapy group than in the other group (P<0.05). SVR was observed in 33.3% of the triple therapy group and 33.3% of the dual therapy group. The side effects were almost the same in both groups except for gastrointestinal symptoms, which were less in the triple therapy group (P=0.019).


CONCLUSIONS
Considered together, triple therapy of zinc plus IFN and ribavirin for HCV infection patients with genotype 1b and high viral load is not better than dual therapy except for lower incidence of gastrointestinal side effects.
Suzuki
Hideyuki
H
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi 3-39, Maebashi, Gunma 371-8511, Japan.
Takagi
Hitoshi
H
Sohara
Naondo
N
Kanda
Daisuke
D
Kakizaki
Satoru
S
Sato
Ken
K
Mori
Masatomo
M
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D002336:Carnosine / Q000031:analogs & derivatives / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D015032:Zinc / Q000009:adverse effects / Q000627:therapeutic use*; D017967:Zinc Compounds
D000897:Anti-Ulcer Agents; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009942:Organometallic Compounds; D012367:RNA, Viral; D011994:Recombinant Proteins; D017967:Zinc Compounds; C061957:polaprezinc; D011092:Polyethylene Glycols; D012254:Ribavirin; D002336:Carnosine; D015032:Zinc; C100416:peginterferon alfa-2a