A 24-week course of high-dose interferon-alpha plus ribavirin for Taiwanese chronic hepatitis C patients with persistently normal or near-normal alanine aminotransferase levels.
OBJECTIVE
We aimed to evaluate the efficacy, advantage, and safety of a 24-week regimen with high-dose interferon-alpha (INF-alpha; 6 million units thrice weekly) plus ribavirin (1000-1200 mg/day) combination therapy for 46 Taiwanese chronic hepatitis C (CHC) patients with persistently normal or near-normal alanine aminotransferase (PNALT) levels.


METHODS
Ninety-two age- and sex-matched CHC patients with elevated ALT levels (> 2 times the upper limit of normal range) with a ratio of 1:2, treated with the same regimen, served as a control.


RESULTS
The sustained virologic response (SVR) rate was comparable between PNALT (67.4%) and elevated ALT (65.2%) groups (intention-to-treat analysis). The two groups had similar rates of discontinuation and incidence of adverse effects. Viral genotype 1b, baseline viral loads, body mass index, and age were significant factors negatively associated with SVR. Further decline of ALT levels throughout the follow-up period was observed in sustained responders of the PNALT group. None of the eight patients with ALT flares developed icteric hepatitis. The virologic efficacy was sustained in a 3-year extended follow-up period.


CONCLUSIONS
high-dose INF-alpha with ribavirin combination therapy is effective, safe, and well tolerated in CHC patients with PNALT levels. The ALT assay might not be used as a single biochemical marker for determination of treatment consideration.
Yu
Ming-Lung
ML
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Dai
Chia-Yen
CY
Lee
Li-Po
LP
Hou
Nei-Jen
NJ
Hsieh
Ming-Yen
MY
Huang
Jee-Fu
JF
Lin
Zu-Yau
ZY
Chen
Shinn-Cherng
SC
Hsieh
Ming-Yuh
MY
Wang
Liang-Yen
LY
Chang
Wen-Yu
WY
Chuang
Wan-Long
WL
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin; D000410:Alanine Transaminase