TY - JOUR
T1 - Single centre experience with pegylated interferon and ribavirin for hepatitis C: looking back before moving foward
T2 - Looking back before moving forward
AU - Muller, Kate
AU - Rodgers, Alexander
AU - Wundke, Rachel
AU - Waddell, Victoria
AU - Altus, Rosalie
AU - Gordon, David
AU - Wigg, Alan
PY - 2012/7/1
Y1 - 2012/7/1
N2 - 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.
AB - 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.
KW - Clinical medicine
KW - Hepatitis C
KW - Pegylated interferon alpha
KW - Ribavirin
KW - Sustained virological response
UR - http://www.scopus.com/inward/record.url?scp=84864058958&partnerID=8YFLogxK
U2 - 10.1111/j.1445-5994.2012.02798.x
DO - 10.1111/j.1445-5994.2012.02798.x
M3 - Article
SN - 1445-5994
VL - 42
SP - 765
EP - 772
JO - Internal Medicine Journal
JF - Internal Medicine Journal
IS - 7
ER -