Evaluating the Effectiveness of a Population-Level Health Intervention to Increment HCV Treatment Coverage in Tuscany Region, Italy: An Interrupted Time Series Analysis.

Abstract

Worldwide, an estimated 71.1 million people are chronically infected with the Hepatitis C virus (HCV). The advent of direct-acting antivirals (DAAs) has made possible the definition of elimination targets by 2030. This study aimed to evaluate the effectiveness of a population-level health intervention to expand access to HCV treatment in the Tuscany Region, Italy.

We used individual-level administrative data from the Tuscany region, collected between January 2015 and December 2022. Data include monthly observations on i) the number of serological tests to detect HCV, ii) the number of PCR tests to detect HCV and, iii) the number of prescriptions of direct-acting antivirals against HCV.

We implemented an Interrupted Time Series (ITS) model, where the primary outcome was the number of monthly prescriptions of direct-acting antivirals, while the number of tests to detect HCV were included as control variables. The analysis was implemented i) in the general population, ii) in specific sub-population groups.

Results show that the health intervention promoted by the Tuscany Regional Health Authority was highly effective in increasing DAAs treatment coverage in the general population, while no significant effects were observed among sub-population groups.

Findings of this study provide evidence to support policies at national and subnational levels to booster HCV screening and simplify access to DAA prescriptions.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval received by the Regional Ethics Committee of Tuscany Region

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All relevant data are within the manuscript and its Supporting Information files

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