Premature discontinuation of interferon plus ribavirin for adverse effects: a multicentre survey in ‘real world’ patients with chronic hepatitis C.

SUMMARY Background : Interferon-α 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. Aim : To examine the causes and predictive factors for therapy discontinuation in patients treated in current clinical practice. Methods : We retrospectively enrolled 441 consecutive patients, scheduled to receive interferon-α + ribavirin for chronic hepatitis C, in five centres. Patients had been treated with 3 or 6 MU interferon-α three times a week plus ribavirin, 800–1200 mg daily, for 6 or 12 months. Results : 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-α dose > 15 MU/week (HR = 1.79; CI, 1.12–2.86) and no previous interferon-α 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]. Conclusions : The study identified some predictive factorsfor adverse event-related discontinuation, which may improve the safety profile and effectiveness of interferon-α + ribavirin combination therapy in chronic hepatitis C. [ABSTRACT FROM AUTHOR]