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PENTOXIFYLLINE enhances response of chronic hepatitis C to
INTERFERON [alpha]2b: A double-blind randomized controlled
trial
Tumor necrosis factor [alpha] (TNF[alpha]) mRNA levels are
elevated in liver and mononuclear cells in chronic hepatitis C
(CHC). Responders to interferon (IFN) have lower baseline levels
and normalize post- therapy (Hepatology 1996;23:210).
Pentoxifylline (PTX) inhibits TNF[alpha] mRNA expression and
TNF[alpha] activity, and may enhance endogenous IFN production. We
postulated that adding PTX would enhance response of CHC to IFN.
Methods: Patients with CHC, ALT > 1.5X normal and compensated
liver disease referred for therapy with IFN[alpha]2b 3 MU 3X/wk for
24 weeks were randomized to receive PTX 400 mg PO QID or placebo
for the same 24 weeks. Complete response (CR) is defined as normal
ALT at the end of therapy and sustained response (SR) as normal ALT
6 months post-therapy. Results: 14 patients in each group completed
the treatment phase. Baseline data showed no significant
differences in age, risk factor for CHC, duration of disease, ALT,
or hepatic histopathology (stage, grade, activity index). CR
occurred in 8/14 (57%) PTX patients vs. 2/14 (14%) placebo patients
(p.018). HCV RNA by PCR at end of therapy is currently available in
7 CR patients and was absent in 3/5 (60%) PTX patients and 1/2
(50%) placebo patients. 9/9 non-responders remained HCV RNA
positive. 3/8 PTX CR patients stopped PTX with normal ALT after 3-7
weeks (2 for adverse effects and 1 for personal reasons) but
continued IFN alone. No significant difference in IFN adverse
effects was evident. 7/8 PTX CR patients and 1/2 placebo CR
patients have relapsed off IFN within 6 months. Conclusion: In
patients with CHC treated with IFN[alpha]2b, addition of PTX
increases the likelihood of CR. No improvement in SR is
demonstrated in this study of 6 month IFN therapy. Study of IFN-PTX
for 12-18 months duration is warranted.
This study was funded in part by Schering Corp., Kenilworth,
NJ.
Author: E. Lebovics, A Casellas, B. Dworkin, S. Chan, W.S.
Rosenthal. Division of Hepatobiliary Disease, New York Medical
College, Valhalla, NY
Source: American Association for the Study of Liver Diseases - 1996
Annual Meeting
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