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Combination of filibuvir and peginterferon alfa-2a/ribavirin evaluated in HCV patients

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Filibuvir (PF-00868554; Pfizer) has previously been evaluated as monotherapy in patients with hepatitis C (HCV), and whether the activity seen in that study could be enhanced by combination with peginterferon alfa-2a and ribavirin has now been assessed in a randomized, placebo-controlled trial. Patients with genotype 1 HCV (N = 35) were treated with filibuvir 200, 300 or 500 mg b.i.d. or placebo plus peginterferon alfa-2a 180 mcg/week and ribavirin 1000/1200 mg/day for 4 weeks, with the peginterferon/ribavirin treatment continuing for a further 44 weeks. During the 4-week filibuvir treatment period, the combination therapy was well tolerated, with headache, fatigue, insomnia and nausea the most common adverse events. Adverse events did not appear to be related to filibuvir dose. One serious adverse event related to treatment, elevated creatinine, was seen in the filibuvir 300 mg group. Mean reductions in HCV RNA at day 28 were -2.10, -4.46, -4.67 and -3.62 log10 IU/mL for the placebo and filibuvir 200, 300 and 500 mg groups, respectively. In these groups, 0, 60, 75 and 63% of patients achieved undetectable HCV RNA by week 4 (Jacobson, I. et al. 44th Annu Meet Eur Assoc Study Liver (EASL) (April 22-26, Copenhagen) 2009, Abst).
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