BACKGROUND:Hepatitis C Virus is a global health burden, particularly affecting people who inject drugs. Direct-acting antiviral treatment can cure almost all people infected with hepatitis C. However, the longer-term impacts on within people's life trajectories are unknown, although some suggest it may lead to fundamental behavioural changes. DESIGN:A cross-sectional exploratory retrospective qualitative design. METHODS:We interviewed 30 people who inject(ed) drugs and who had previously been treated with direct-acting antivirals on average 18 months before the interview (range: 12-24 months). Most were male, aged 36-55 years, and had been treated in urban community-based needle and syringe programmes in Scotland. All interviews were semi-structured, conducted over the phone by either peer or academic researchers, and analysed thematically. RESULTS:We present three discernible post-treatment life-trajectories. Firstly, 'A cure that was like totally new life' involved identity transformation, often associated with controlled or zero drug use, and improved physical and mental health. Secondly, 'There isn't much afterwards' comprised poor quality of life and social isolation, often due to participants' disengagement from former drug use and support networks. Thirdly, 'I'm getting tested every year now' detailed a few life changes but normalized hepatitis C testing and treatment. CONCLUSION:Our thematic analysis reinforces the positive impacts on mental well-being, physical health and self-transformation of direct-acting antiviral treatment in the short- and long-term. However, there is an urgent need for psychosocial interventions to maintain health behaviour changes and self-management, and social support for individuals post hepatitis C treatment.
Background: People Who Use Drugs (PWUD) are at high risk of non-fatal overdose and other drug-related harms. The United Kingdom drugs policy landscape makes it challenging to support those at risk. Tayside, in East Scotland, has a sizeable population at risk of drug-related harms. In 2021, the National Health Service implemented a care pathway for PWUD to provide multidimensional healthcare interventions. We aimed to quantify drug-related harms; assess wider health and well-being; and understand substance use trends and behaviours, among those engaged in the pathway.Methods: Existing community-embedded blood-borne virus pathways were adapted to provide multiple healthcare assessments over three visits. We undertook an observational cohort study to analyse uptake and outcomes for the initial cohort of PWUD engaged at appointment one.Results: From August 2021-September 2022, 150 PWUD engaged with the pathway. Median age was 39 (34-42) years, 108 (72%) were male, and 124 (83%) lived in deprived areas. Seventy (47%) had been disengaged from healthcare for over a year. Polysubstance use was reported by 124 (83%), 42 (28%) disclosed injecting daily, and 54 (36%) shared equipment. Fifty-four (36%) experienced recent non-fatal overdose, and there were six overdose fatalities (4.1 [1.5-9.0] per 100PY). The offer of take-home naloxone was accepted by 108 (72%). Fourteen (9%) were diagnosed with Hepatitis C and two (1%) with HIV. Renal, hepatological, and endocrine impairment were observed among 30 (20%), 23 (15%), and 11 (7%), people respectively. Ninety-six (65%) had high risk of clinical depression. Forty-eight (32%) declined Covid-19 vaccination.Conclusion: The pathway engaged PWUD with high exposure to recent non-fatal overdose and other drug-related harms, alongside co-morbid health issues. Our results suggest multi-dimensional health assessments coupled with harm reduction in community settings, with appropriate linkage to care, are warranted for PWUD. Service commissioners should seek to integrate these assessments where possible.
Hepatitis C virus (HCV) treatment in people who inject drugs (PWID) is delivered within settings frequented by PWID, such as needle and syringe programs (NSP). The optimal direct‐acting antiviral (DAA) dispensing regimen among NSP clients is unknown. This study compared cures (Sustained virologic response 12 weeks post‐treatment, [SVR12]) across three dispensing schedules to establish non‐inferiority of fortnightly dispensing versus directly observed therapy. The ADVANCE HCV study was a randomized, unblinded trial, recruiting PWID attending NSP in Tayside, Scotland, between January 2018 and November 2019. HCV‐positive participants were randomized to receive DAAs via directly observed therapy, fortnightly provision or fortnightly provision with psychological intervention. A modified intention to treat analysis was used to identify differences in cures between the three treatment regimes. The study was registered with clinicaltrials.gov; NCT03236506. A total of 110 participants completed the study. 33 participants received directly observed therapy, with 90.91% SVR12; 37 received fortnightly provision, with 86.49% SVR12 and 40 received fortnightly provision and psychological intervention at treatment initiation, with 92.50% SVR12. Analysis showed no significant difference in SVR12 (p = 0.67). This study did not demonstrate a statistically significant difference in cure rate between groups. This provides evidence of the non‐inferiority of fortnightly dispensing of direct‐acting antivirals (DAAs) compared to directly observed therapy among PWID. It suggests that tight control of adherence through directly observed therapy dispensing of DAAs among this population offers no therapeutic advantage. Therefore, less restrictive dispensing patterns can be used, tailored to patient convenience.
The efficacy of direct-acting antivirals (DAA) provides an excellent opportunity to scale up HCV diagnosis and treatment, achieving the WHO target of HCV elimination by 2030. However, HCV reinfection among people who inject drugs (PWID) remains a concern and may impede elimination efforts. We assessed reinfection rates among PWID across six specialized treatment pathways, following DAA-based and interferon-based therapies in Tayside, Scotland. Data were collected retrospectively for every treatment episode that resulted in a sustained viral response (SVR) after undergoing treatment. Reinfection rates were calculated for each treatment pathway: hospital outpatient clinic; community pharmacy; drug treatment outreach; prison clinic; nurse-led outreach clinic; and injection equipment provision site. Reinfection is defined as a positive RNA test result after SVR. Incidences of reinfection are expressed in 100 person-years (PYs). In total, 916 treatment episodes met selection criteria. Of these, 100 reinfections were identified, generating an overall reinfection rate of 5.27 per 100 PYs (95%CI: 4.36-6.38). The hospital outpatient clinic had the lowest reinfection incidence (1.81 per 100 PYs, 95%CI: 1.11-2.93), with the injection equipment provision site treatment pathway having the highest reinfection incidence (19.89 per 100 PYs, 95%CI: 14.91-26.54). The incidence of reinfection among those treated with interferon-based therapies and those treated with DAA-based therapies was 4.93 per 100 PYs (95%CI: 3.97-6.11) and 7.17 per 100 PYs (95%CI: 4.75-10.82), respectively. Specialized treatment pathways in Tayside yield varying reinfection incidence rates, with different subpopulations of patients at varying risk of reinfection post-SVR. Results suggest that resources should be targeted at the injection equipment provision site pathway in order to reduce the incidence of reinfection and achieve elimination targets. The study found comparable rates of reinfection following interferon-based and DAA-based therapies, providing support for widening access to treatment services.
Introduction Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. Over 85% of individuals who have HCV in Scotland became infected following injecting drug use. Since people who inject drugs (PWID) are the main source of new infections, theoretical modelling has suggested that treatment of HCV infection in PWID may effectively reduce HCV prevalence and accomplish elimination. This protocol describes a clinical trial delivering HCV treatment within injecting equipment provision sites (IEPS) in Tayside, Scotland. Methods and analysis PWID attending IEPS are tested for HCV and, if they are chronically infected with HCV and eligible, invited to receive treatment within the IEPS. They are randomised to one of three treatment regimens; daily observed treatment, treatment dispensed every 2 weeks and treatment dispensed every 2 weeks together with an adherence psychological intervention (administered before treatment begins). The primary outcome is comparison of the rate of successful treatment (SVR12) in each treatment group. Secondary analyses include assessment of adherence, reinfection rates, viral resistance to treatment and interaction of the treatment with illicit drugs. Ethics and dissemination The ADVANCE (A Direct obserVed therApy versus fortNightly CollEction) HCV trial was given favourable opinion by East of Scotland Research Ethics Committee (LR/17/ES/0089) prior to commencement. Trial registration numbers European Clinical Trials Database (EudraCT) (2017-001039-38) and ClinicalTrials.gov (NCT03236506).
Summary Injecting behaviour in people who inject drugs is the main risk factor for hepatitis C virus (HCV) infection. Psychosocial factors such as having a partner who injects drugs and living with other drug users have been associated with increases in injecting risk behaviour. This study aimed to investigate changes in injecting behaviour during treatment for HCV infection whilst exploring the role of psychosocial factors on patients’ injecting behaviour. Eradicate‐C was a single‐centred clinical trial (ISRCTN27564683) investigating the effectiveness of HCV treatment within the injecting drug‐using population between 2012 and 2017. A total of 94 participants completed up to 24 weeks of treatment, with social and behavioural measures taken at different intervals throughout treatment. Data for 84 participants were analysed retrospectively to explore mechanisms of potential behavioural changes which had occurred during treatment. Injecting frequency reduced significantly between baseline (week 1) and every 4‐weekly interval until week 26. Not being on opiate substitution therapy (OST) was associated with a statistically significant decrease in injecting frequency, χ 2 (1) = 10.412, P = 0.001, as was having a partner who also used drugs, in particular when that partner was also on treatment for HCV infection, Z = −2.312, P = 0.021. Treating a hard‐to‐reach population for HCV infection is not only possible, but also bears health benefits beyond treatment of HCV alone. Enrolling couples on HCV treatment when partners are sero‐concordant has shown enhanced benefits for reduction in injecting behaviour. Implications for practice are discussed.
SummaryTo achieve WHO hepatitis C virus (HCV) elimination targets by 2030, mathematical models suggest there needs to be significant scale‐up of treatment among people who inject drugs (PWID). We tested whether people who actively inject drugs can be recruited and treated successfully through a community needle and syringe programme (NSP), and assessed rates of re‐infection. 105 HCV RNA positive participants were enrolled prospectively. Participants were recruited from the largest NSP in Dundee over 42 months. 94/105 individuals commenced treatment. Genotype 1 (G1) individuals (n = 37) were treated with peg‐interferon+ribavirin+Simepravir/Telaprevir. Genotype 2/3 (G2/3) (n = 57) received peg‐interferon+ribavirin. Weekly study visits took place within the NSP. Mean age of participants was 34.0 years (SD 6.9), 71.3% (61/94) were male. One in five (20/94) participants were homeless. 68.1% (64/94) were on OST (opiate substitution therapy) at enrolment; participants injected median 6.5 times/wk. In terms of clinical outcomes, >80% treatment adherence was 71.3% (67/94). There was no difference in SVR‐12 rates by genotype: 81.0% (30/37) for G1 and 82.5% (47/55) for G2/3. At 18 months post‐treatment, 15/77 participants were reinfected, followed up over 69.8 person‐years, yielding a re‐infection rate of 21.5/100 person‐years (95% CI 13.00‐35.65). This trial demonstrates that HCV treatment can be delivered successfully to the target population of treatment as prevention strategies. We report higher rates of re‐infection than existing estimates among PWID. Scale‐up of HCV treatment should be pursued alongside a comprehensive programme of harm reduction interventions to help minimize re‐infection and reduce HCV transmission.
OBJECTIVE:Comparison of uptake of dried blood spot testing (DBST) for hepatitis C virus (HCV) infection between community pharmacies and established services. DESIGN:Quantitative evaluation of a service development with qualitative process evaluation undertaken in parallel. SETTING:Six pharmacies from 36 community pharmacies within Dundee City, a large urban settlement with high levels of socioeconomic deprivation. PARTICIPANTS:Patients in receipt of opioid substitution therapy (OST) not tested for HCV within 12 months. The 6 pharmacies provided OST for approximately 363 patients from a cohort of 1385 patients within Dundee City. INTERVENTION:Provision of DBST by pharmacists. MAIN OUTCOME MEASURE:Receipt of DBST between January and December 2014. RESULTS:43 of 143 service users with no record of testing from the 6 community pharmacies accepted DBST. Of 561 from the remaining 1022 service users with no record of testing, 75 were tested for HCV (30% vs 13%). The OR for increased uptake of testing within the 6 pharmacies was 2.25 (95% CI 1.48 to 3.41, Z statistic=3.81, p=<0.0001) compared with other services. The DBST taken by the pharmacies provided 12 patients with a reactive test. The process evaluation identified key themes important to staff and recipients of the service. A logic model was constructed. LIMITATIONS:Non-experimental service evaluation performed in community pharmacies records service activity in one location across a single time period. INTERPRETATION:Some evidence that DBST from community pharmacies may be feasible. Service users received the service positively. Staff reported that DBST was straightforward and achievable.
Objective The aim of the study was to evaluate the effectiveness of Dry Blood Spot testing (DBST) for hepatitis C within a geographical area.Design This is a prospective cohort study of all individuals living in Tayside who had received a hepatitis C virus (HCV) DBST between 2009 and 2011.Results During the study, 1123 DBSTs were carried out. 946 individuals had one test. 295 (31.2%) of these individuals were HCV antibody positive on their first test. Overall, 94.3% (902/956) individuals returned for the results of their test. During the course of the study 177 individuals were retested and 29 new cases of hepatitis C were detected. 249 individuals attended for further follow-up, and 164 (65.5%) were PCR positive. All 164 PCR-positive individuals were offered referral into specialist HCV services for further assessment. Data showed 62.5% were genotype 3, 65.1% had a low viral load (<600 000 iu/ml) and 77.5% had a Fibroscan score below 7 KPa. To date, 40 have commenced treatment and a further 16 are currently in the assessment period. Overall, we have retained in services or treated 63.6% (105/164) of patients who were initially referred and with effective support mechanisms in place we have achieved sustained viral response rates of 90%.Conclusions The study has shown that DBST is a complementary technique to conventional venepuncture for the diagnosis of HCV. The majority of patients have low viral loads and low fibrosis scores, so that while this group of patients may be difficult to reach and may be challenging to maintain in therapy, they are easier to cure.
Introduction Within the UK the main source of hepatitis C virus (HCV) infection is injecting drug use however, diagnosing HCV in chaotic drug users has often proved challenging, particularly if venous access is a problem. Aim To evaluate the introduction of HCV dry blood spot testing (DBST) by staff working in addiction services and to determine if individuals who agreed to testing, returned for their results and accessed appropriate follow-up into either drug or HCV treatment. Method The study was carried out over an 18-month period between 2009 and 2010. Testing for HCV was offered to individuals who accessed addiction services during this period. A follow-up appointment was issued for 2 weeks after testing. The numbers tested were monitored and data were collected on follow-up appointments attended. Results During the study, 661 tests were carried out using the DBST method. 479 (72.5%) within needle exchange services and 182 (27.5%) from drug treatment services. 439 (66%) were male, and the age range was 18 to 51 years with a median age of 32 years. 608 (91.3%) individuals returned for the results of their test and 186 (28%) of the 661 tests were HCV antibody positive. Follow-up bloods were offered to all positive patients. Of the 147 (79%) who had blood taken 90 (61.1%) were HCV PCR positive. HCV PCR negative individuals were provided with harm reduction advice, were encouraged to access drug treatment, and discharged from further HCV follow-up. All PCR positive individuals were offered referral onto drug treatment and/or specialist HCV services for assessment and treatment. Abstract P68 table 1 lists summary of outcomes.Abstract P68 Table 1 Engagement of HCV PCR positive individuals Number % In HCV and drug treatment programme 44 48.9 In current contact with addiction services 12 13.3 In drug treatment programme 21 23.3 Disengaged with services/lost to follow-up 12 13.3 Died 1 1.1 Conclusion The study has shown DBST is easy to use and can be carried out without difficulty by staff within drug services. The offer of HCV testing was well received by this particular client group with over 90% of individuals returning for their results. The study has shown that DBST in practice significantly increased the number of new diagnosis within our region by 77% from 245 in 2007–2008 to 435 in 2009–2010. DBST led a significant number of people into drug and HCV treatment services and therefore proves that diagnosing hepatitis C can have life improving benefits for people.