Impact case study database

Verma and team, via the ITTREAT and VALID projects, provided the research-based evidence essential to the development and implementation of an innovative community-based HCV model of care for high-risk populations. This led to a substantial increase in access to and treatment of HCV in the Brighton and Hove area, improving the care experience for vulnerable members of the community. It also provided a robust good practice care model that is now leading the way for further replication of improved care services in England.

4.1 Increased access to and treatment for HCV

As of June 2018, ITTREAT and VALID studies have linked 700 homeless individuals and PWUD to care services in Brighton and Hove. The number of PWUDs and homeless individuals referred from the community to receive treatment increased from 0 in 2011 to 153 between 2014 – 2018 [3.3, 3.5]. The then local lead commissioner (Alcohol and Substance Misuse), Ms Kathy Caley, linked the increased number of individuals accessing HCV treatment services to the successful delivery of the BSMS innovative model: ‘ *The intensive support provided by the [ITTREAT] HCV nurse means that service users are more open to being tested, and are more informed about treatment options. The integrated nature of the HCV nurse with substance misuse treatment services has been very important in driving forward the success of this project [ITTREAT]. The outcomes of the service have been very positive with a significant increase in the number of individuals that are now accessing HCV treatment services (October 2015)*’ [5.1]. This view is seconded by Dr Tim Worthley, GP at the only homeless surgery in Brighton (Arch Healthcare), one of the VALID study sites, who notes: ‘ The significant impact that BSMS VALID study had is that it immediately removed all major blocks for our patients to access HCV care: patients did not need to go to hospital to receive treatment, they did not have to stop using drugs or alcohol, and the treatment was not based on interferons thus rendering the treatment protocol more acceptable for adherence. In a short space of time, our GP surgery went from 5% to approximately a third of our patients [total registered patients 1400] accessing treatment for HCV’ [5.2].

In Brighton and Hove, the percentage of PWUDs tested for HCV has increased from 87.6% in 2012 – 2013 (prior to ITTREAT project) to 96.4% in 2017/18 (5 years into the ITTREAT project). This represents the highest rate in South East England [5.3a]. Mortality from advanced HCV-related liver disease/ liver cancer, has reduced by 48% from 2012 – 2014 to 2016 – 2018, compared to a 9% reduction in mortality nationally over the same period [5.3b]. ITTREAT and VALID studies were the only clinical research conducted in the area during this period, specifically targeted at improving HCV testing and treatment of these high-risk populations. Dr Worthley acknowledged the impact of BSMS research on their approach to provide HCV care, noting that ‘[they] were able to emphasise with other healthcare services the importance of getting this population tested for HCV because for the first time there was the possibility of treatment’ [5.2]. The BSMS HCV care model has since been adapted to other services in the area, and in the last 5 years Dr Worthley has run specialist community clinics in diabetes and respiratory diseases.

4.2 Improved patients’ HCV care experience, understanding of HCV, and other health-related outcomes

The community-based HCV cure was associated with significant improvements in HRQoL, including improved mental and physical health, decreased distress and, most importantly, a reduction in the stigma associated with HCV [3.3]. This innovative model of care also contributed to an improved treatment experience in this group with the trusting client-provider relationship being instrumental in the individual’s recovery pathway and their own health awareness [3.4]. This is illustrated by patient testimonials: ‘ I thought it was a little less, err, impersonal. You just feel like you’re a cow being forced through, like a sheep dip kind of system in hospitals. But here you know they know your name and they’re a little bit more personal with you. I think a little bit more caring cos they have a little bit more time’ [3.4]. By providing a simplified HCV care pathway, patients experienced benefits over and above that related to the liver. According to Dr Worthley: ‘ patients […] immediately became more engaged with their healthcare, knowing they no longer had to face the numerous hurdles for them to access care. It thus provided them with the opportunity to regain control of their health. It also had a significant impact on their understanding of the disease and their ability to access treatment. As a result, once treated for HCV, they were able to address other issues in their lives such as their drug or alcohol use’ [5.2].

4.3 Developed a good practice care model for replication by HCV healthcare professionals

The BSMS holistic model of care for HCV has been commended by NHSE following its review of the Sussex ODN in 2018: ‘ the ‘one-stop shop’ model of community service provision provided easy access for clients and provided a great model to replicate around the country’ [5.4]. This view was seconded by Professor Graham Foster (ODNs National Clinical Lead) and Peter Huskinson (NHSE Commercial Director of Specialised Commissioning) who stated that ‘ Brighton’s initiative to treat people who are homeless [...] indicate the ingenuity and determination of colleagues who are pushing the boundaries of treatment access’ [5.5]. Consequently, Sussex ODN treats the highest number of people with HCV in addiction centres nationally, representing >20% of all its total treatments [5.6]. Public Health England’s HCV in England 2020 Report states: ‘ The majority of patients (78.5%) were treated in secondary care, with the remainder receiving treatment in either drug services, prisons or elsewhere […] with Nottingham and Sussex, [each] treating around a fifth of [their] patients in drug services’ [5.6]. The research by Verma and colleagues has been credited by the Sussex ODN manager as being key to the Brighton and Sussex University Hospital Trust ‘ achieving the NHS targets because it allowed the Trust to address the long patients’ waiting list’ [5.7]. It provided the evidence-base to convince Trust executives across the 3 Trusts in the Sussex ODN to support business cases for 3 community nurses, thereby ensuring roll out of the HCV care model across East and West Sussex. In 2016 – 2017, 11% of the Sussex ODN patients were treated in the community, with the majority of them in Brighton, but as of 2019 – 2020, approximately half of the ODN patients are treated via the community-based HCV services. This has become the principal HCV service delivery within the Sussex ODN.

The BSMS HCV care model has been endorsed as a good practice model by the British Viral Hepatitis Group and the largest national charity (HCV Trust/HCV Action) as evidenced by the HCV Action website hosting the ITTREAT case study and related business case template for other ODNs to consult. Since April 2018, the case study has had 585 views and the template 748 [5.8]. Birmingham ODN and Nottingham ODN – two of the largest ODNs in England – credited BSMS work as ‘ leading the way of HCV care in the community’ [5.9a] and providing ‘ an innovative set of solutions to a very difficult clinical problem’ [5.9b] to find, test and treat high-risk groups with HCV. Professor Stephen Ryder, Clinical Lead at the Nottingham ODN added that ‘ *Verma’s HCV care model was innovative […] it triggered a complete overhaul of the way we provide HCV care to this high-risk population (ie homeless and PWUDs)*’ [5.9b]. Both ODNs adopted elements of the BSMS HCV care model, adapting to their patients’ needs and local settings. This resulted in the Birmingham ODN being able to cure >200 patients whom they would have struggled to reach before [5.9a]. Similarly, Nottingham ODN used the BSMS model to expand their services and in particular their HCV care delivery to the homeless [5.9a]. As Chair of the HCV Coalition (a group of stakeholders working together to influence HCV policy and ensuring that HCV elimination target in England is met), Ryder and colleagues have used BSMS research data to advocate for HCV treatment for hard-to-reach groups, specifically the homeless. They used the BSMS model as an effective and successful clinical intervention for HCV care targeting this high-risk group [5.9b]. Both ODNs agreed that the work conducted by Verma and colleagues was one of the significant drivers for England to reach the target set to eliminate HCV by 2025, and that without this research-based evidence it will be difficult if not impossible to achieve it [5.9a, 5,9b]. [text removed for publication] [5.10].

Internationally, data from the ITTREAT study are contributing to the 2021 revised guidelines on Recommendations for the management of hepatitis C virus infection among people who inject drugs published by the International Network for Hepatitis in Substance Users [5.11].

4.4 Contributed to Gilead Sciences new patient access to care pathway initiatives leading to their successful NHSE tender in 2019

Gilead Sciences, an international pharmaceutical company (total revenue of USD22,400,000,000, 2019), has pioneered DAA development. Dr Murad Ruf, Director of Public Health Strategy and Implementation Science for Gilead Sciences, acknowledged the key role BSMS research played in their company’s understanding of HCV care in England [5.12a]: ‘ Professor Verma and her team were key in Gilead’s successful care implementation initiatives around HCV as they not only provided the research-based evidence that inform the new model of care, they also actively contributed to Gilead’s understanding of the integrated care pathway and the importance of the patient centric approach.’ This understanding in turn informed Gilead’s own patients’ access to care initiatives that were a key element of the company’s successful bid in response to the 2019 NHSE tender. Peter Smethurst, Director of the Patient Access to Care, Gilead Sciences, explained [5.12b]: ‘BSMS *ITTREAT study provided robust scientific evidence that co-location of care was a more effective way to deliver HCV care to this population, providing a measurable impact. The supporting principles of ITTREAT (co-location and patient-centric provision of care) have informed Gilead’s strategy for this patient group to be more effectively diagnosed and treated in addiction settings.*’ In partnership with Change Grow Live (CGL) – the largest provider of drug treatment services in England – the company demonstrated that this model of care could be successfully scaled up to more than 50 different drug services in England. This evidence formed part of Gilead Sciences elimination initiatives submitted in response to the NHSE tender, and for which the company was awarded Gold status (ie winning the greatest share of patients treated with the company’s drugs). Gilead Sciences have since expanded the partnership with CGL to 4 other providers, thus covering most of the third sector and NHSE Addictions Providers. Approximately 90% of the clients in drug treatment services are being cared for by one of Gilead Sciences elimination partners who are moving towards greater co-location and integration of care, as per the ITTREAT work [5.12b].