458 FINAL RESULTS OF THE PHARMACOKINETICS, EFFICACY, AND SAFETY/TOLERABILITY OF 400 AND 600 MG ONCE-DAILY DOSING OF ACH-1625 (HCV NS3 PROTEASE INHIBITOR) IN HCV GENOTYPE 1

Background and Aims:In patients with chronic hepatitis C, therapy is considered effective when the sustained virological response (SVR) (undetectable HCV-RNA in serum 6 months after the end of therapy) is achieved.Although the persistence of HCV eradication in short or medium-term period (3-5 years) is well-established, little is known about the long-term follow-up.The aim of the study was to evaluate the long-term persistence of HCV eradication in patients with chronic hepatitis C (CHC) who obtained SVR.In particular, we wanted to assess the risk of longterm virological relapse and liver related-complications.Methods: From January 1989 to April 2008, 150 consecutive subjects (M/F 100/50, median age 47.69 years, range 22-67) with CHC and SVR after interferon-based therapy, were enrolled in a long-term clinical follow-up study.137 patients had pre-treatment diagnosis of CHC and 13 patients had cirrhosis.All patients received interferon-based therapy (66 with conventional IFN-monotherapy, 25 with conventional IFN and ribavirin, and 59 with pegylated IFN and ribavirin).The patients were followed with clinical, biochemical, virological and ultrasonographic assessments every 6 months until the 3 th year of follow-up and than every 12 months.HCV-RNA assessment in serum was determined by quantitative RT-PCR (cut-off <50 UI/ml).Results: The median follow-up was 8.6 years (range:2-19.8years).Serum HCV-RNA remained undetectable in all patients, indicating no risk of HCV recurrence independently from the schedule of therapy used.During the observation period 3 liver-related complications (2 HCC, 1 bleeding) were observed.The incidence rate of complication was 0.23%/person/year.All 3 of the events occurred in patients with pre-treatment cirrhosis.Only 1 out of 150 patients deceased for liver-related causes (HCC) with a mortality rate of 0.08%/person/year.Conclusions: In this large cohort of CHC patients with SVR, the eradication of the virus lasted up to 20 years after treatment.Overall, patients with CHC and SVR show an excellent prognosis with no risk of viral recurrence and a very low rate of mortality, so they can be considered healed.Patients with pre-treatment evidence of cirrhosis show a rate of liver complications that cannot be neglected.