[TuPe1.1C21] Histological response to peginterferon α-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) in HIV-HCV co-infected patients with bridging fibrosis or cirrhosis in the AIDS PEGASYS Ribavirin International Co-infection Trial (APRICOT)

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

HISTOLOGICAL RESPONSE TO PEGINTERFERON α-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®) IN HIV-HCV CO-INFECTED PATIENTS WITH BRIDGING FIBROSIS OR CIRRHOSIS IN THE AIDS PEGASYS RIBAVIRIN INTERNATIONAL CO-INFECTION TRIAL (APRICOT)

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C21

Lissen E.¹, Clumeck N.², Sola R.³, Mendes-Correa M.⁴, Montaner J.⁵, Nelson M.⁶, Sette Jr. H.⁷, Buggisch P.⁸, Main J.⁹, DePamphilis J.¹⁰, Dieterich D.T.¹¹
¹Hospital Virgen del Rocio, Seville, Spain, ²CHU St-Pierre, Brussels, Belgium, ³Universitat Autónoma de Barcelona, Barcelona, Spain, ⁴University of Sao Paolo, Sao Paolo, Brazil, ⁵St Paul's Hospital, Vancouver, Canada, ⁶Chelsea and Westminster Hospital, London, United Kingdom, ⁷Instituto de Infectologia, "Emilio Ribas"Ambulatorio De Hepatologia, Sao Paulo, Brazil, ⁸Universitat Klinik Hamburg, Medical Klinik und Poliklinik, Hamburg, Germany, ⁹Imperial College School of Medicine, St Mary's Hospital, London, United Kingdom, ¹⁰Roche, Nutley, United States of America, ¹¹Mount Sinai School of Medicine, New York, United States of America

INTRODUCTION: In APRICOT, peginterferon α-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) produced significantly higher sustained virological response (SVR) rates than PEGASYS® monotherapy or conventional interferon combination therapy (40% vs 20% and 12%, respectively, p<0.001) (N Engl J Med. 2004 Jul 29;351(5):438-50). In this analysis, the histological response (HR) to treatment was assessed in patients with a baseline histological diagnosis of bridging fibrosis or cirrhosis who had paired biopsies.

METHODS: In APRICOT, HIV-HCV co-infected patients were randomized to PEGASYS® 180 µg/wk plus ribavirin 800 mg/d, PEGASYS® monotherapy or interferon 3 MIU tiw plus ribavirin for 48 weeks followed by 24-weeks observation. All patients with bridging fibrosis/cirrhosis and paired biopsies (taken ≤15 months prior to baseline and ≥56 days after treatment) were analyzed. Biopsies were scored by local pathologists using the Ishak-modified system. HR (≥2-point decrease in histological activity index [HAI]) and SVR (HCV RNA <50 IU/mL; COBAS AMPLICOR® HCV Test, v2.0) at the end of follow-up were assessed.

RESULTS: Improvements in fibrosis and overall HAI inflammation scores were greatest in patients treated with PEGASYS® plus COPEGUS®; highest HR and SVR rates were reported in this group. HR was independent of SVR.

CONCLUSIONS: Consistent with the overall population, HR was greatest in patients with bridging fibrosis/cirrhosis who received PEGASYS® plus COPEGUS®. Thus, even in patients with advanced liver disease, fibrosis and HAI inflammation scores can be improved with PEGASYS® plus COPEGUS®.

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Clinical | TuPe1.1C21 | Eduardo Lissen
Hepatitis viruses

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