G B, Gaeta, D F, Precone, F M, Felaco, R, Bruno, A, Spadaro, G, Stornaiuolo, M, Stanzione, T, Ascione, R, De Sena, A, Campanone, G, Filice, F, Piccinino, Gaeta, Giovanni Battista, Precone, Df, Felaco, Fm, Bruno, R, Spadaro, A, Stornaiuolo, G, Stanzione, M, Ascione, T, DE SENA, R, Campanone, A, Filice, G, and Piccinino, F.
Interferon-alpha plus ribavirin therapy for chronic hepatitis C is associated with adverse effects that lead to therapy discontinuation in up to 27% of patients in randomized controlled trials.To examine the causes and predictive factors for therapy discontinuation in patients treated in current clinical practice.We retrospectively enrolled 441 consecutive patients, scheduled to receive interferon-alpha + ribavirin for chronic hepatitis C, in five centres. Patients had been treated with 3 or 6 MU interferon-alpha three times a week plus ribavirin, 800-1200 mg daily, for 6 or 12 months.One hundred and eight [24.5%; confidence interval (CI), 20.5-28.8%] patients failed to finish combination therapy because of adverse events. The discontinuation rate was higher during the first 6 months of treatment; anaemia was an important cause (36.1% of discontinuations); unexplained lipothymia resulted in discontinuation in 11 patients. Female gender [hazard ratio (HR) = 1.85; CI, 1.17-2.92], an interferon-alpha dose15 MU/week (HR = 1.79; CI, 1.12-2.86) and no previous interferon-alpha treatment (HR = 1.63; CI, 1.04-2.57) were independent factors associated with discontinuation. The simultaneous presence of these factors identified patients at high risk for discontinuation [odds ratio (OR) = 10; CI, 3.98-25.13].The study identified some predictive factors for adverse event-related discontinuation, which may improve the safety profile and effectiveness of interferon-alpha + ribavirin combination therapy in chronic hepatitis C.