Decentralisation of HCV treatment to harm reduction services in a large Italian city
Background: People who Inject drugs (PWID) have an elevated prevalence of HCV and of HIV-HCV co-infection and are at higher risk of acquisition (infection/re-infection) and transmission of HCV. PWID are one of the key populations to target in the efforts to achieve HCV elimination. Despite unrestricted access to treatment with direct-active antivirals (DAA) was authorised in Italy in May 2017, only 34% of PWID accessing harm reduction (HR) services in Italy is tested for HCV. Linkage to care for those diagnosed is sub-optimal and few are initiated on treatment. With the aim to overcome most commonly reported barriers we developed and implemented a patient-centred testing and care pathway for PWID accessing HR services in a large Italian city.
Methods: A multi-sectorial team of healthcare professionals from penitentiary health services and hepathology wards was set up around one HR centre (HRC) under the coordination of San Paolo Hospital in Milan, Italy. Through an iterative and consultative process, a protocol was developed covering clinical aspects, task allocation and monitoring framework.
Results: The adopted protocol proposes an integrated care approach for HCV and drug dependencies in HRC by streamlining and fast-tracking diagnosis, DAA-treatment initiation and follow-up. HR clients are offered rapid HCV test (to detect potential candidate for treatment) and counselled on novel treatment options as most of the clients are either discouraged by previous experiences (IFN-based regimens) or, having no sign of liver disease, had been advised to defer treatment. Blood withdrawal is organized inside HRC to perform confirmatory test, HCV RNA and other tests in order to evaluate liver functionality using a standardized non-invasive scoring model (APRI Score). Assessment of treatment eligibility and DAA-treatment initiation are done within 21 days by an infectious disease (ID) specialist who visits the HRC weekly. DAA-treatment is dispensed on-site alongside opioid substitution treatment under supervision of HRC staff and monitored by visiting ID specialist. Simplified referral protocol to specialised care in San Paolo Hospital were created for patients with advanced liver disease (for elastometry, ultrasound and additional investigation as per cirrhosis protocol). Training activities were conducted for all participating staff covering issues related to HCV infections and drug dependencies, with a special focus on nurses providing counselling to clients. Leaflets and posters were designed and made available for users. A set of indicators was defined to monitor outputs and impact of the program. Mid-term results will be available by August 2019.
Conclusions: PWID in Italy still face barriers to access Hep C care and treatment. Our proposal of an innovative multi-sectorial and collaborative approach to decentralise and simplify HCV diagnosis and care pathways for PWID, if successful, could be adapted and transferred to more HRCs in Italy to further expand access to HCV care.