Single centre experience with pegylated interferon and ribavirin for hepatitis C: looking back before moving forward

Abstract

Background: Hepatitis C treatment is successful in 40–80% of patients in drug sponsored registration trials. However, few studies have examined treatment outcomes in non‐trial, routine clinical practice settings. Aim: The aim of this study was to investigate the treatment outcomes and predictors of a sustained virological response in a routine clinical setting. Methods: Data were collected retrospectively on patients treated for hepatitis C between January 2004 and March 2010 in a tertiary hospital setting. Demographics, treatment outcomes and potential predictors of outcome (viral genotype, viral load, virological response, platelet count, alanine transaminase level, glucose, ferritin, weight, fibrosis and cirrhosis, compliance, dose reductions, adverse events, psychiatric and alcohol history) were recorded. Univariate and multiple logistic regressions were performed. Results: A total of 405 patients was treated during the study period. On an intention to treat basis, sustained virological response rates were 55%, 82% and 72% in genotypes 1, 2 and 3 respectively. Predictors of response were gender, age, genotype, weight, fibrosis, cirrhosis, platelet count and alanine transaminase on univariate analysis. Age, genotype, cirrhosis and platelet count were independently associated with sustained virological response on multiple logistic regression. Conclusion: In our cohort, treatment outcomes for genotype 1 and 2 were similar to results from clinical trials but results for genotype 3 were inferior. Clinicians should not assume that results from registration trials are transferable to their own clinical practice. This has particular relevance for the new era of triple therapy regimens containing direct antivirals.

Efficacy of Treatment With Pegylated Interferon and Ribavirin in Patients With Chronic HCV Infection “Under Real Life“ Conditions

“…Our results regarding genotypes as the strong predictors of SVR correspond to the data of the majority of other investigators obtained in RCT and in "real life" studies [10,24,25,28,31,32,33,40,42,46,[48][49][50].…”

“…Danish nationwide cohort study [38], presented the data obtained in a routine clinical practice and found them comparable to those observed in controlled clinical trials: overall 57.9 % of patients achieved SVR: it was 46.5 % in patients with genotype 1/4 infection and 77.3 % in those with genotype 2/3 infection. Some other authors [39][40][41][42][43][44][45] and community based studies in Germany, Canada, France and Australia [46][47][48][49][50][51] reported SVR data comparable with those in RCT too. Conversely, results of other investigators were lower [52,53].…”

“…Some investigators found female gender as the positive predictor for SVR in RCT and in "real life condition"studies [9,24,25,56,63,64]. The others did not confirm these results [20,40,42,44,65], or even found that response to combined treatment and SVR in females 50 years old or older was poorer than in males [66]. Low estrogens level in older women could be responsible for their impaired response to antiviral treatment.…”

Hepatitis C Virus Treatment in the ‘Real-World’: How Well Do ‘Real’ Patients Respond?

“…Forty patients were either lost to follow-up (10), early non-responders (14), or ceased treatment early due to side effects (16). Four patients completed treatment but had no end of treatment data available, and 4 patients who ceased treatment early due to side effects had end of treatment data available (Figure 1).…”

“…7 Published clinical trials of the treatment of HCV tend to have more favorable outcomes and are largely multicenter prospective pharmaceutical registration trials, which assess treatment response in treatment-na € õve patients with strict exclusion criteria and differences in treatment conditions. [8][9][10][11][12] To date, there have only been 2 single-centered retrospective audits of HCV treatment in Australia, 13,14 and one multi-centre study, 15 of 'real-world' patients treated in normal clinical practice. Often single hospitals have limited nursing and medical resources compared to large multinational clinical trials, which may affect patient retention in HCV therapy.…”