Objective Population-based studies demonstrating the clinical impact of interferon-free direct-acting antiviral (DAA) therapies are lacking. We examined the impact of the introduction of DAAs on HCV-related decompensated cirrhosis (DC) through analysis of population-based data from Scotland.
Design Through analysis of national surveillance data (involving linkage of HCV diagnosis and clinical databases to hospital and deaths registers), we determined i) the scale-up in the number of patients treated and achieving a sustained viral response (SVR), and ii) the change in the trend of new presentations with HCV-related DC, with the introduction of DAAs.
Results Approximately 11 000 patients had been treated in Scotland over the 8-year period 2010/11 to 2017/18. The scale-up in the number of patients achieving SVR between the pre-DAA and DAA eras was 2.3-fold overall and 5.9-fold among those with compensated cirrhosis (the group at immediate risk of developing DC). In the pre-DAA era, the annual number of HCV-related DC presentations increased 4.6-fold between 2000 (30) and 2014 (142). In the DAA era, presentations decreased by 51% to 69 in 2018 (and by 67% among those with chronic infection at presentation), representing a significant change in trend (rate ratio 0.88, 95% CI 0.85 to 0.90). With the introduction of DAAs, an estimated 330 DC cases had been averted during 2015–18.
Conclusions National scale-up in interferon-free DAA treatment is associated with the rapid downturn in presentations of HCV-related DC at the population-level. Major progress in averting HCV-related DC in the short-term is feasible, and thus other countries should strive to achieve the same.
- hepatitis C
- linkage analysis
- antiviral therapy
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Contributors SJH and DG conceived and designed the study. SJH, HV, AY, SS, SB, JFD, RF, PB, AF, NK, RNG, KT, HI, AML, AW, PCH and DG contributed to the implementation of national surveillance of HCV infection in Scotland. SJH, HV, SAMD, AY and SS contributed to the data analysis and generation of result tables and figures. All authors interpreted the findings. SJH, with support from HV, SAMD and KP, drafted the manuscript and all remaining authors contributed to critical review and development of the final manuscript.
Funding This work was supported by funding from Health Protection Scotland.
Competing interests SJH reports grants from Health Protection Scotland, during the conduct of the study; personal fees from Gilead, outside the submitted work. SB reports grants, personal fees and other from Gilead; grants, personal fees and other from AbbVie; all outside the submitted work. RF reports personal fees from Gilead, outside the submitted work. KT reports grants from GenMark, grants from Cepheid, grants from Qiagen, other from SpeedX, all outside the submitted work. PCH reports personal fees from Gilead, personal fees from AbbVie, personal fees from BMS, personal fees from Jannsen, personal fees from Roche, all outside the submitted work. NK reports personal fees from Gilead, personal fees from AbbVie, all outside the submitted work. JFD reports grants and personal fees from Gilead, grants and personal fees from BMS, grants and personal fees from MSD, grants and personal fees from Janssen, grants and personal fees from Roche, grants and personal fees from AbbVie, all outside the submitted work.
Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the 'Methods' section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. The surveillance data that support the findings of this study are available in aggregate form on an open access data portal at Health Protection Scotland (www.hps.scot.nhs.uk/data/shbbv-framework-data-portal/), in line with NHS National Services Scotland policy on statistical disclosure (https://www.isdscotland.org/About-ISD/Confidentiality/disclosure_protocol_v3.pdf). Access to the individual level data can be sought through approval of the Public Benefit and Privacy Panel for Health and Social Care (www.informationgovernance.scot.nhs.uk/pbpphsc/home/for-applicants/).
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