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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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