Objective: Paired liver biopsies from patients enrolled in the multinational AIDS PEGASYS Ribavirin International Co-infection Trial were analysed to investigate a possible correlation between virological and histological responses.
Design and methods: A total of 860 HIV–hepatitis C virus (HCV)-co-infected patients were randomly assigned to receive pegIFNα-2a (40KD) 180 μg/week plus 800 mg daily ribavirin, pegIFNα-2a (40KD) plus placebo or conventional IFNα-2a 3 MIU three times a week plus ribavirin for 48 weeks. Paired biopsies were obtained from 401 patients and scored locally using the Ishak-modified histological activity index (HAI). The second biopsy was obtained, on average, 26 weeks or more after the end of treatment. Histological response was defined as a 2-point or greater reduction in the HAI score.
Results: The histological response rate was significantly higher in patients receiving pegIFNα-2a (40KD) plus ribavirin (57%) than in patients receiving pegIFNα-2a (40KD) plus placebo (39%; P < 0.017) or IFNα-2a plus ribavirin (41%; P = 0.04). Histological response was correlated with virological response, with the histological response rate ranging from 62 to 74% in patients who achieved a sustained virological response (SVR). Histological response was also seen in 32–43% of patients not achieving an SVR. A higher total HAI score was the only prognostic factor for achieving histological response.
Conclusion: The histological response rate was significantly higher in HIV–HCV-co-infected patients who received pegIFNα-2a (40KD) plus ribavirin than in those receiving pegIFNα-2a (40KD) plus placebo or IFNα-2a plus ribavirin. Histological response was correlated with virological response, although a substantial proportion of patients who did not achieve an SVR experienced histological improvement.
From the aDepartment of Internal Medicine, Virgen del Rocio University Hospital, Seville, Spain
bDepartment of Infectious Diseases, CHU St Pierre, Brussels, Belgium
cUniversitat Autónoma de Barcelona, Hospital del Mar, Barcelona, Spain
dHospital das Clínicas, São Paulo Medical School, São Paulo University, São Paulo, Brazil
eSt Paul's Hospital, University of British Columbia, Vancouver, BC, Canada
fSt Stephen's Centre, Chelsea and Westminster Hospital, London, UK
gRoche, Nutley, New Jersey, USA
hInstituto de Infectologia Emilio Ribas, São Paulo, Brazil
iUniversitätsklinik Eppendorf, Hamburg, Germany
jDepartment of Medicine A, Imperial College, St Mary's Hospital, London, UK
kMount Sinai School of Medicine, New York, New York, USA.
Received 10 October, 2005
Revised 3 March, 2006
Accepted 19 July, 2006
Correspondence to Eduardo Lissen, Department of Internal Medicine, Virgen del Rocio University Hospital, Avda. Manuel Siurot s/n, 41013, Seville, Spain. Tel: +34 955 01 23 89; fax: +34 954 23 83 54; e-mail: email@example.com