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PTU-055 Safety and tolerability of combination therapy for chronic hepatitis C: the Leeds experience

Introduction Combination therapy is the mainstay of treatment for chronic hepatitis C (CHC). However, some patients report debilitating adverse events (AEs), which may limit efficacy due to need for dose reduction or discontinuation of therapy. We report tolerability and safety of combination therapy in normal clinical practice, in a large cohort of CHC patients treated in a single tertiary referral centre in Leeds, UK. Methods AE data for individuals receiving combination therapy for CHC were collected prospectively between February 2001 and May 2008. Premature discontinuation of therapy due to AEs was recorded. Effect of experiencing an AE on achieving sustained viral response (SVR) 6 months after treatment end was examined by univariate analysis, with an OR and 95% CI. The association between patient demographics, type of interferon (α-2a or 2b), duration of therapy, genotype, presence of cirrhosis and likelihood of experiencing AEs was explored using multivariate analysis, and results expressed as ORs with 95% CIs. Results During the study period 356 individuals with CHC commencing combination therapy had adverse events data recorded (231 (65%) male, mean age 42 years, range 21–73). 228 (64%) reported at least one AE (Abstract 055). Therapy was discontinued due to AEs in 56 patients. Six individuals experienced decompensation, but there were no deaths related to therapy. AEs did not alter likelihood of achieving an SVR (63% (144/228) in those with an AE vs 61% (78/128) in those without (OR 1.10, 95% CI 0.69 to 1.76)). No predictors of AEs were identified. Abstract PTU-055 Adverse event Number of individuals (%) Discontinued therapy as a Depression 58 (16) 11 (19) Skin rash 55 (15) 11 (20) Lethargy 30 (8) 6 (20) Alopecia 29 (8) 3 (10) Nausea 26 (7) 3 (11.5) Thyroid dysfunction 21 (6) 5 (24) Insomnia 17 (5) 2 (12) Anaemia 17 (5) 4 (23.5) Sepsis 16 (4.5) 9 (56) Conclusion Data from this large cohort of CHC patients treated with combination therapy demonstrate >60% experience AEs, though most are minor, do not affect completion of therapy, and do not impact on SVR at 6 months.