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BILN 2061 For Hepatitis C Revisited

December 7, 2004

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We have reported on BILN 2061 before because of its exciting promise as a Hepatitis C therapy. Unfortunately, testing has been suspended because of animal studies that indicated possible cardiac toxicity with the substance.

The November issue of the medical journal, Gastroenterology, further reported on the promising results and also mentioned the subsequent suspension of human studies.

We will keep you posted on any change or progress we hear of regarding BILN 2061.

Further Human Trials of BILN 2061 on Hold Pending Resolution of Animal Toxicity Issues

Novel, potent, and well-tolerated hepatitis C virus (HCV) drugs are needed. BILN 2061 is a potent and specific inhibitor of HCV serine protease in vitro. Preclinical toxicology data and studies in healthy volunteers supported the administration of BILN 2061 to patients with HCV infection.

The antiviral efficacy, pharmacokinetics, and tolerability of 25, 200, and 500 mg BILN 2061 twice daily given as monotherapy for 2 days in 31 patients infected with chronic genotype 1 HCV infection and with minimal liver fibrosis (Ishak score of 0–2) were assessed in a placebo-controlled, double-blind pilot study.

In 2 subsequent placebo-controlled studies of similar design, 200 mg BILN 2061 twice daily was administered for 2 days to 10 patients with advanced liver fibrosis (Ishak score of 3 or 4) and to 10 patients with compensated cirrhosis (Ishak score of 5 or 6).

Results

Viral RNA reductions of 2–3 log10 copies/mL were achieved in most of the patients. There was a trend toward a higher number of patients receiving 500 mg BILN 2061 achieving a viral RNA reduction ≥3 log10 copies/mL as compared with patients receiving 25 mg BILN 2061.

Advanced fibrosis or compensated cirrhosis did not affect the antiviral efficacy of BILN 2061. BILN 2061 was well tolerated in all studies.

Conclusions

The authors conclude, “BILN 2061 is a well-tolerated and very active compound that reduced serum viral RNA concentrations after 2 days of treatment in patients infected with genotype 1 HCV independent of the degree of fibrosis. Nevertheless, further clinical trials are on hold pending resolution of animal toxicity issues.”

12/01/04

Reference
H Hinrichsen and others. Short-term antiviral efficacy of BILN 2061, a hepatitis C virus serine protease inhibitor, in hepatitis C genotype 1 patients. Gastroenterology 127(5): 1347-1355. November 2004.

 

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