Abstract
109 Background: Hepatitis C is the most common chronic viral hepatitis in the US today. Because treatment with alpha-interferon (IFN), has been disappointing and complicated by significant side effects, anti-viral therapy with a nucleoside analogue is logical. Aims: To test the efficacy and safety of the anti-viral drug, amantadine hydrochloride in patients with chronic hepatitis C. Methods: Prospective open-labeled uncontrolled study using amantadine-HCL 4mg/kg/d orally in 2 divided doses, for 6 mo in children with chronic hepatitis C. Diagnosis was confirmed by positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in plasma & liver, detectable plasma hepatitis C RNA by Chiron branched chain DNA analysis (bDNA), and abnormal liver histology. Response was defined as complete (normalization of ALT), or partial (>50% reduction in ALT). Virological response was defined as undetectable HCV RNA in serum. Pre and post-treatment liver biopsies were scored using a modified Knodell histology activity index (HAI). Patients: Six patients (4M/2F, median age 12y, range 5-18y), entered the trial. Transmission was vertical in 2. Three pts were liver transplant recipients, 2 of them for chronic hepatitis C, and one for biliary atresia. Two had previously failed therapy with interferon, at least 1 year before starting the amantadine. Results: Amantadine dose was decreased by 50% in pt # 4 secondary to tremor. Four pts. completed the 6 mo course, with 1 achieving a partial response, 2 achieved 20-40% reduction in ALT, and 1 no response. Another pt completed 5 mo of therapy. Pre-treatment Chiron (bDNA) ranged from 3 to 262 × 10E+5/ml. Despite a partial enzyme response in pt # 3, 2.5 fold increase in the chiron bDNA titer, and an RT-PCR increase from 3+ to 4+ were seen. Chiron bDNA increased by 4.5 fold in pt # 6, who had ×3 episodes of rejection. Conclusions: In children with chronic hepatitis C: 1-Amantadine is a safe anti-viral drug. 2-Monotherapy with amantadine does not appear to lower Chiron bDNA values in this select population. Further studies of amantadine as monotherapy or combined with interferon are necessary.
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