TY - JOUR
T1 - Liver Disease and Poor Adherence Limit Hepatitis C Cure
T2 - A Real-World Australian Treatment Cohort
AU - Clark, Paul J.
AU - Valery, Patricia C.
AU - Strasser, Simone I.
AU - Weltman, Martin
AU - Thompson, Alexander J.
AU - Levy, Miriam
AU - Leggett, Barbara
AU - Zekry, Amany
AU - Rong, Julian
AU - Angus, Peter
AU - George, Jacob
AU - Bollipo, Steven
AU - McGarity, Bruce
AU - Sievert, William
AU - Macquillan, Gerry
AU - Tse, Edmund
AU - Nicoll, Amanda
AU - Wade, Amanda
AU - Chu, Geoff
AU - Harding, Damian
AU - Cheng, Wendy
AU - Farrell, Geoff
AU - Roberts, Stuart K.
N1 - Funding Information:
Open Access funding enabled and organized by CAUL and its Member Institutions. Funding and in-kind support was received from the Commonwealth Department of Health, the Gastroenterological Society of Australia (GESA), and unrestricted research grants from Gilead Sciences, Merck, and Abbvie.
Funding Information:
Project governance was overseen by the Project Steering Committee, via the GESA Liver Clinical Research Network. QIMR Berghofer was the administering institution. We thank the patients for participating in the study. We also thank David Roche (GESA), Karen Martin (QIMR Berghofer) for their support in coordinating the study, Therese Lawton (QIMR Berghofer) for data management, and the research nurses from each study site for recruitment and data collection.
Publisher Copyright:
© 2022, The Author(s).
PY - 2023/1
Y1 - 2023/1
N2 - Background and Aims: In 2016, direct-acting antiviral (DAA) treatment for hepatitis C (HCV) became available through Australia’s universal health care system, with the aim of HCV elimination. We report real-world effectiveness of DAA HCV treatment in Australia from a clinically well-informed cohort, enriched for cirrhosis and prior HCV treatment. Methods: 3413 patients were recruited from 26 hospital liver clinics across Australia from February 2016 to June 2020. Clinical history and sustained viral response (SVR) were obtained from medical records and data linkage to the Australian Pharmaceutical Benefits Scheme. Factors associated with SVR were assessed by multivariable logistic regression (MVR). Results: At recruitment, 32.2% had cirrhosis (72.9% Child Pugh class B/C), and 19.9% were treatment experienced. Of the 2,939 with data, 93.3% confirmed SVR. 137 patients received second-line therapy. Patients with cirrhosis had lower SVR rate (88.4 vs. 95.8%; p < 0.001). On MVR, failure to achieve SVR was associated with Genotype 3 (adj-OR = 0.42, 95%CI 0.29–0.61), male gender (adj-OR = 0.49, 95%CI 0.31–0.77), fair/poor adherence (adj-OR = 0.52, 95%CI 0.28–0.94), cirrhosis (adj-OR = 0.57, 95%CI 0.36–0.88), FIB-4 > 3.25 (adj-OR = 0.52, 95%CI 0.33–0.83) and MELD score ≥ 20 (adj-OR = 0.25, 95%CI 0.08–0.80). Consistent results were seen in cirrhotic sub-analysis. Conclusions: Excellent SVR rates were achieved with DAAs in this real-world cohort of patients with chronic HCV infection. More advanced liver disease and clinician impression of poor adherence were associated with HCV treatment failure. Supports to improve liver fibrosis assessment skills for non-specialist DAA prescribers in the community and to optimize patient adherence are likely to enable more effective pursuit of HCV elimination in Australia.
AB - Background and Aims: In 2016, direct-acting antiviral (DAA) treatment for hepatitis C (HCV) became available through Australia’s universal health care system, with the aim of HCV elimination. We report real-world effectiveness of DAA HCV treatment in Australia from a clinically well-informed cohort, enriched for cirrhosis and prior HCV treatment. Methods: 3413 patients were recruited from 26 hospital liver clinics across Australia from February 2016 to June 2020. Clinical history and sustained viral response (SVR) were obtained from medical records and data linkage to the Australian Pharmaceutical Benefits Scheme. Factors associated with SVR were assessed by multivariable logistic regression (MVR). Results: At recruitment, 32.2% had cirrhosis (72.9% Child Pugh class B/C), and 19.9% were treatment experienced. Of the 2,939 with data, 93.3% confirmed SVR. 137 patients received second-line therapy. Patients with cirrhosis had lower SVR rate (88.4 vs. 95.8%; p < 0.001). On MVR, failure to achieve SVR was associated with Genotype 3 (adj-OR = 0.42, 95%CI 0.29–0.61), male gender (adj-OR = 0.49, 95%CI 0.31–0.77), fair/poor adherence (adj-OR = 0.52, 95%CI 0.28–0.94), cirrhosis (adj-OR = 0.57, 95%CI 0.36–0.88), FIB-4 > 3.25 (adj-OR = 0.52, 95%CI 0.33–0.83) and MELD score ≥ 20 (adj-OR = 0.25, 95%CI 0.08–0.80). Consistent results were seen in cirrhotic sub-analysis. Conclusions: Excellent SVR rates were achieved with DAAs in this real-world cohort of patients with chronic HCV infection. More advanced liver disease and clinician impression of poor adherence were associated with HCV treatment failure. Supports to improve liver fibrosis assessment skills for non-specialist DAA prescribers in the community and to optimize patient adherence are likely to enable more effective pursuit of HCV elimination in Australia.
KW - Cirrhosis
KW - Data linkage
KW - Liver fibrosis
KW - Patient adherence
KW - Retreatment
KW - Sustained viral response
UR - http://www.scopus.com/inward/record.url?scp=85132621931&partnerID=8YFLogxK
U2 - 10.1007/s10620-022-07483-y
DO - 10.1007/s10620-022-07483-y
M3 - Article
C2 - 35552941
AN - SCOPUS:85132621931
SN - 0163-2116
VL - 68
SP - 291
EP - 303
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 1
ER -
