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Pegasys/RBV Improves Histology in Non-Responders & Cirrhotics
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Reported by Jules Levin
IAS-Rio July 2005
Poster TuPe1.1C21
In this small study analysis from the APRICOT Study: 80% (8/10) of cirrhotics who achieved SVR also had a histologic response (improved liver condition), compared to 69% (51/74) of patients with an SVR in the study who had biopsies & SVR.
Of note, patients in APRICOT who took Pegasys/RBV who did not achieve an SVR (non-responders), 58% (7/12) cirrhotics had a histologic response, compared to all patients in study who were non-responders of whom 43% (26/61) achieved a histologic response (HR).
Patients receiving Pegasys/RBV had better rates of SVR and HR than patients who received Pegasys plus placebo and standard IFN/RBV.
Author conclusion: 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.
"Histological response to peginterferon alfa-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)"
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
ABSTRACT
Introduction: In APRICOT, peginterferon alfa-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) (NEJM, 2004;351:438-50).
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 356 days after treatment) were analyzed.
Biopsies were scored by local pathologists using the Ishak-modified system. HR (32-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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