Scale-up of Direct-Acting Antiviral Treatment in Prisons Is Both Cost-effective and Key to Hepatitis C Virus Elimination.

Background: The Surveillance and Treatment of Prisoners With Hepatitis C (SToP-C) study demonstrated that scaling up of direct-acting antiviral (DAA) treatment reduced hepatitis C virus (HCV) transmission. We evaluated the cost-effectiveness of scaling up HCV treatment in statewide prison services incorporating long-term outcomes across custodial and community settings. Methods: A dynamic model of incarceration and HCV transmission among people who inject drugs (PWID) in New South Wales, Australia, was extended to include former PWID and those with long-term HCV progression. Using Australian costing data, we estimated the cost-effectiveness of scaling up HCV treatment in prisons by 44% (as achieved by the SToP-C study) for 10 years (2021-2030) before reducing to baseline levels, compared to a status quo scenario. The mean incremental cost-effectiveness ratio (ICER) was estimated by comparing the differences in costs and quality-adjusted life-years (QALYs) between the scale-up and status quo scenarios over 40 years (2021-2060) discounted at 5% per annum. Univariate and probabilistic sensitivity analyses were performed. Results: Scaling up HCV treatment in the statewide prison service is projected to be cost-effective with a mean ICER of A$12 968/QALY gained. The base-case scenario gains 275 QALYs over 40 years at a net incremental cost of A$3.6 million. Excluding DAA pharmaceutical costs, the mean ICER is reduced to A$6 054/QALY. At the willingness-to-pay threshold of A$50 000/QALY, 100% of simulations are cost-effective at various discount rates, time horizons, and changes of treatment levels in prison and community. Conclusions: Scaling up HCV testing and treatment in prisons is highly cost-effective and should be considered a priority in the national elimination strategy. Clinical Trials Registration: NCT02064049.

Testing, diagnosis, and treatment following the implementation of a program to provide dried blood spot testing for HIV and hepatitis C infections: the NSW DBS Pilot.

BACKGROUND: Dried blood spot (DBS) testing provides an alternative to phlebotomy and addresses barriers to accessing healthcare experienced by some key populations. Large-scale evaluations of DBS testing programs are needed to understand their feasibility. This study evaluated the implementation of a state-wide DBS HIV and hepatitis C virus (HCV) testing pilot. METHODS: The New South Wales (NSW) DBS Pilot is an interventional cohort study of people testing for HIV antibody and/or HCV RNA from DBS samples in NSW, Australia. Participants at risk of HIV/HCV participated in testing via: 1) self-registration online with a DBS collection kit delivered and returned by conventional postal service; or 2) assisted DBS sample collection at 36 community health sites (including drug treatment and harm-minimisation services) and prisons. Participants received results by text (HIV antibody/ HCV RNA not detected) or a healthcare provider (HIV antibody/ HCV RNA detected). The RE-AIM framework was used to evaluate reach, effectiveness, adoption, and implementation. RESULTS: Reach: Between November 2016 and December 2020, 7,392 individuals were tested for HIV and/or HCV (21% self-registration, 34% assisted in community, and 45% assisted in prison). EFFECTIVENESS: Of 6,922 people tested for HIV (19% men who have sex with men, 13% living outside major cities, 21% born outside Australia), 51% (3,521/6,922) had no HIV test in the past two years, 0.1% (10/6,922) were newly diagnosed with HIV, and 80% (8/10) initiated HIV treatment within six months. Of 5,960 people tested for HCV (24% women, 35% Aboriginal and/or Torres Strait Islander, 55% recently injected drugs), 15% had detectable HCV RNA (878/5,960), and 45% (393/878) initiated treatment within six months. Adoption: By the end of 2020, DBS via assisted registration was available at 36 community sites and 21 prisons. IMPLEMENTATION: 90% of DBS cards arriving at the laboratory had the three full spots required for testing; the proportion was higher in assisted (94%) compared to online (76%) registration. CONCLUSIONS: This study demonstrated the feasibility of DBS testing for HIV and HCV in key populations including Aboriginal and Torres Strait Islander peoples, men who have sex with men, people who inject drugs, and demonstrated the utility of DBS in the prison setting.

Hepatitis C Treatment Uptake Following Dried Blood Spot Testing for Hepatitis C RNA in New South Wales, Australia: The NSW DBS Pilot Study.

Background: Dried blood spot (DBS) testing for hepatitis C virus (HCV) RNA provides a sampling option that avoids venepuncture and can be carried out in a nonclinical setting. Large-scale evaluations are needed to understand how DBS testing can reduce HCV burden. This study estimated prevalence of, and factors associated with, HCV RNA and treatment initiation among people enrolled in a state-wide pilot of people testing in the NSW DBS Pilot in New South Wales, Australia. Methods: People at risk of HIV/HCV could participate via (1) self-registration online with a DBS collection kit delivered and returned by conventional postal service; or (2) assisted DBS sample collection at a community site or prison. Logistic regression was used to identify factors associated with detectable HCV RNA and treatment initiation within 6 months of testing. Results: Between September 2017 and December 2020, 5960 people were tested for HCV (76% men, 35% Aboriginal and/or Torres Strait Islander, 55% recently injected drugs): 21% online self-registration, 34% assisted registration in the community, 45% assisted registration in prison. Fifteen percent had detectable HCV RNA (878/5960). Overall, 44% (n = 386/878) of people with current HCV initiated treatment within 6 months (13% online self-registration, 27% assisted registration in the community, 61% assisted registration in prison). Testing in prison compared with the community (adjusted odds ratio [aOR], 4.28; 95% CI, 3.04-6.03) was associated with increased odds of treatment initiation. Being a woman compared with a man (aOR, 0.68; 95% CI, 0.47-0.97) was associated with reduced treatment initiation. Conclusions: The NSW DBS Pilot demonstrates the feasibility of using DBS to promote HCV testing and treatment in community and prison settings.

A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study.

BACKGROUND & AIMS: Prisons are key venues for scaling-up hepatitis C virus (HCV) testing and treatment. Complex clinical pathways and frequent movements of people in prison remain barriers to HCV care. This study evaluated the impact of a 'one-stop-shop' point-of-care HCV RNA testing intervention on treatment uptake compared with standard of care among people recently incarcerated in Australia. METHODS: PIVOT was a prospective, non-concurrent, controlled study comparing HCV treatment uptake during 'standard of care' (n = 239; November 2019-May 2020) and a 'one-stop-shop' intervention (n = 301; June 2020-April 2021) in one reception prison in Australia. The primary endpoint was uptake of direct-acting antiviral treatment at 12 weeks from enrolment. Secondary outcomes included the time taken from enrolment to each stage in the care cascade. RESULTS: A total of 540 male participants were enrolled. Median age (29 vs. 28 years) and history of injecting drug use (48% vs. 42%) were similar between standard of care and intervention phases. Among people diagnosed with current HCV infection (n = 18/63 in the standard of care phase vs. n = 30/298 in the intervention phase), the proportion initiating direct-acting antiviral treatment within 12 weeks from enrolment in the intervention phase was higher (93% [95% CI 0.78-0.99] vs. 22% [95% CI 0.64-0.48]; p <0.001), and the median time to treatment initiation was shorter (6 days [IQR 5-7] vs. 99 days [IQR 57-127]; p <0.001) compared to standard of care. CONCLUSIONS: The 'one-stop-shop' intervention enhanced treatment uptake and reduced time to treatment initiation among people recently incarcerated in Australia, thereby overcoming key barriers to treatment scale-up in the prison sector. IMPACT AND IMPLICATIONS: This study provides important insights for policymakers regarding optimal HCV testing and treatment pathways for people newly incarcerated in prisons. The findings will improve health outcomes in people in prison with chronic HCV infection by increasing testing and treatment, thereby reducing infections, liver-related morbidity/mortality, and comorbidities. The findings will change clinical practice, clinical guidelines, and international guidance, and will inform future research and national and regional strategies, in particular regarding point-of-care testing, which is being rapidly scaled-up in various settings globally. The economic impact will likely include health budget savings resulting from reduced negative health outcomes relating to HCV, and health system efficiencies resulting from the introduction of simplified models of care. CLINICAL TRIALS REGISTRATION: This study is registered at Clinicaltrials.gov (NCT04809246).

Commentary on the harm reduction reference group of justice health and forensic mental health network and corrective services NSW, Australia.

PURPOSE: This commentary aims to reveal how a steering committee has effectively responded to advancing accessibility to harm reduction resources, hepatitis C virus (HCV) policy and health strategies within adult prison settings in New South Wales (NSW). DESIGN/METHODOLOGY/APPROACH: By reviewing the audit approach taken by the of the Justice Health and Forensic Mental Health Network and Corrective Services New South Wales Harm Reduction Reference Group (JHFMHN/CSNSW HRRG), this commentary emphasizes the committee's success in identifying contemporary harm reduction issues that affect people in custodial settings. This commentary is a compilation of data gathered through the 2018 JHFMHN/CSNSW HRRG audit and corresponding program materials. Conclusions regarding the effectiveness of the working group's audit were drawn by critically appraising the JHFMHN/CSNSW HRRG's Final Audit Report (JHFMHN and CSNSW, 2018) with reference to current harm reduction literature. FINDINGS: The HRRG has provided leadership, professional representation and strategic advice on the development, implementation, monitoring and evaluation of best practice harm reduction strategies in prison settings. The HRRG developed and maintained networks and information exchange between the state-wide HCV health network, corrections services and the NSW harm reduction sector at large. Public health partnerships and advocacy that involve all key players, such as the HRRG, will continue to be crucial to remove barriers to enhancing HCV harm reduction measures especially in NSW prison settings. SOCIAL IMPLICATIONS: Strategies such as primary prevention and treatment can mitigate the spread of HCV in the custodial system. This audit of access to harm reduction resources was conducted on behalf of the diverse group of professionals, scholars and stakeholders comprising the HRRG. This audit and other advocacy efforts of this committee can facilitate future access to quality healthcare and the necessary policies required to support a healthier prison population at large. ORIGINALITY/VALUE: Collaborating with health authorities, researchers and social service workers can enable prison health-care systems to be guided by wider health workforce programs and public health standards. This collaboration can reduce the professional isolation of custodial health-care staff and promote a balanced approach to harm reduction policies by ensuring an equitable focus on both health and security imperatives.

Evaluation of hepatitis C treatment-as-prevention within Australian prisons (SToP-C): a prospective cohort study.

BACKGROUND: Limited empirical evidence exists for the effectiveness of hepatitis C virus (HCV) treatment-as-prevention. The Surveillance and Treatment of Prisoners with hepatitis C (SToP-C) study aimed to assess the effect of HCV treatment-as-prevention in the prison setting. METHODS: SToP-C was a prospective study, including a before-and-after analysis, within a cohort of people incarcerated in two maximum-security prisons (male) and two medium-security prisons (one male, one female) in New South Wales, Australia. All prison inmates aged at least 18 years were eligible for enrolment. After HCV testing, participants were monitored for risk behaviours and HCV infection, among three sub-populations: uninfected (HCV antibody-negative); previously infected (HCV antibody-positive, HCV RNA-negative); and infected (HCV antibody and HCV RNA-positive). Uninfected participants were followed up every 3-6 months to detect HCV primary infection and previously infected participants were followed up every 3-6 months to detect re-infection. Participants with HCV infection were assessed for treatment, initially standard-of-care treatment (administered by prison health services) from 2014 to mid-2017, then direct-acting antiviral (DAA) treatment scale-up from mid-2017 onwards (12 weeks of sofosbuvir plus velpatasvir, administered through SToP-C). Participants were followed up until study closure in November, 2019. The primary study outcome was HCV incidence before and after DAA treatment scale-up among participants at risk of HCV primary infection or re-infection. This study is registered with ClinicalTrials.gov, NCT02064049. FINDINGS: Between Oct 30, 2014, and Sept 30, 2019, 3691 participants were enrolled in the SToP-C study. 719 (19%) participants had detectable HCV RNA, 2240 (61%) were at risk of primary HCV infection, and 725 (20%) were at risk of re-infection at baseline. DAA treatment was initiated in 349 (70%) of 499 eligible participants during the treatment scale-up period. The HCV incidence analysis comprised 1643 participants at risk of HCV infection or re-infection during longitudinal follow-up (median age 33 years [IQR 27-42]; 1350 [82%] male). 487 (30%) of 1643 participants reported injecting drugs in prison. HCV incidence decreased from 8·31 per 100 person-years in the pre-treatment scale-up period to 4·35 per 100 person-years in the post-treatment scale-up period (incidence rate ratio [IRR] 0·52 [95% CI 0·36-0·78]; p=0·0007). The incidence of primary infection decreased from 6·64 per 100 person-years in the pre-treatment scale-up period to 2·85 per 100 person-years in the post-treatment scale-up period (IRR 0·43 [95% CI 0·25-0·74]; p=0·0019), whereas the incidence of re-infection decreased from 12·36 per 100 person-years to 7·27 per 100 person-years (0·59 [0·35-1·00]; p=0·050). Among participants reporting injecting drugs during their current imprisonment, the incidence of primary infection decreased from 39·08 per 100 person-years in the pre-treatment scale-up period to 14·03 per 100 person-years in the post-treatment scale-up period (IRR 0·36 [95% CI 0·16-0·80]; p=0·0091), and the incidence of re-infection decreased from 15·26 per 100 person-years to 9·34 per 100 person-years (0·61 [0·34-1·09]; p=0·093). The adjusted analysis (adjusted for age, Indigenous Australian ethnicity, duration of stay in prison, previous imprisonment, injecting drug use status, and prison site) indicated a significant reduction in the risk of HCV infection between the pre-DAA treatment scale-up and post-DAA treatment scale-up periods (adjusted hazard ratio 0·50 [95% CI 0·33-0·76]; p=0·0014). INTERPRETATION: DAA treatment scale-up was associated with reduced HCV incidence in prison, indicative of a beneficial effect of HCV treatment-as-prevention in this setting. These findings support broad DAA treatment scale-up within incarcerated populations. FUNDING: Australian National Health and Medical Research Council Partnership Project Grant and Gilead Sciences.

Keeping COVID out: a collaborative approach to COVID-19 is associated with a significant reduction in self-harm in young people in custody.

OBJECTIVE: To describe the collaboration between Youth Justice New South Wales (YJNSW) and Justice Health and Forensic Mental Health Network (JHFMHN) during the early COVID-19 Response (CR) across the six Youth Justice centres in NSW, and the reduced incidence of self-harm noted over this period. METHODS: Narrative article with analysis of self-harm incident data during the initial CR period of March to May 2020, compared to the same period in 2019. RESULTS: During the initial CR period (March to May 2020), there was a highly significant, four-fold reduction in self-harming incidents recorded by both YJNSW and JHFMHN compared with the equivalent time period in 2019 (p < .00001). CONCLUSION: The greater than four-fold reduction in self-harm by young people during the early CR may relate to the 'interagency response', with an increase in positive interactions between staff, and between staff and young people. The reduction in self-harm and improvements in mental health will be further explored through standardised interviews with the young people and staff.

Lessons learned from keeping NSW's prisons COVID-free.

PURPOSE: New South Wales (NSW) correctional system houses 30% of prisoners in Australia and at this time has only had a single documented case of COVID-19 amongst its prisoner population. The coordinated response by Justice Health and Forensic Mental Health Network (The Network) undertaken with the support of NSW Ministry of Health, in partnership with Corrective Services NSW (CSNSW), Youth Justice and private jails has ensured that the NSW correctional system has remained otherwise COVID-free. DESIGN/METHODOLOGY/APPROACH: A research study of how a range of partners which support the operations of NSW Correctional System developed an effective approach for the prevention a COVID-19 epidemic amongst its inmates. FINDINGS: Establishment of effective partnerships, early coordination of representatives from all aspects of the NSW correctional system, limited access to the correctional environment, reduced prison population and strict isolation of all new receptions have all contributed to maintaining this COVID-free status despite other NSW settings with similar risk profiles, such as aged care facilities and cruise ship arrivals, experiencing serious outbreaks. RESEARCH LIMITATIONS/IMPLICATIONS: Although Australia/New Zealand context of suppressed community infection rates for COVID-19 (which are approaching elimination in some jurisdictions) is in contrast to the situation in other parts of the world, the principles described in this paper will be useful to most other correctional systems. PRACTICAL IMPLICATIONS: Modelling was used to underline our approach and reinforced the veracity of following this approach. ORIGINALITY/VALUE: The Network and CSNSW has been able to mount an effective, integrated response to the COVID-19 pandemic, which has been sustainable through the first peak of COVID-19 cases. This case study catalogues the process of developing this response and details each intervention implemented with inventive use of tables to demonstrate the impact of the range of interventions used.

Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.

Importance: Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose. Objective: To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose. Design, Setting, and Participants: A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo). Interventions: Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 µg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 µg per 1 mL and intranasal administration of placebo 1 mL. Main Outcomes and Measures: The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 µg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13. Results: A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group. Conclusions and Relevance: This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority. Trial Registration: anzctr.org.au Identifier: ACTRN12611000852954.

Outcomes of a nurse-led model of care for hepatitis C assessment and treatment with direct-acting antivirals in the custodial setting.

BACKGROUND: People in prison have been identified as an important population to prioritise for hepatitis C virus (HCV) treatment to achieve HCV elimination goals. We evaluated the efficacy of the New South Wales Justice Health and Forensic Mental Health Network Hepatitis Nurse Led Model of Care during the 12 months following the widespread availability of HCV direct acting antivirals (DAAs) in Australia. METHODS: A retrospective cohort study was conducted of a network of 36 correctional centres across NSW from April 2016 to March 2017, with approximately 13 000 full time inmates. Population Health Nurses conducted initial clinical assessments and confirmatory testing. Patients were referred to a Hepatitis Clinical Nurse Consultant (CNC) for protocol-driven assessment, including transient elastography to assess hepatic fibrosis. The CNC then discussed the case with an Infectious Diseases physician and DAA therapies were prescribed. The total number of patients who commenced and completed treatment, and sustained virological response 12 weeks post treatment completion (SVR 12) were recorded. RESULTS: During the first 12 months of DAA treatment 698 patients were commenced on HCV treatment. Of those who were tested at the 12-week post treatment completion timepoint the per-protocol SVR12 (cure) rate was 92% (396/430), with 34 patients having a detectable viral load. 52 (7%) patients were released to freedom before completing treatment and a further 211 (30%) were released prior to SVR12 assessment. These outcomes indicate an intention-to-treat SVR 12 cure rate of 57% (396/698). There were no differences in demographic or treatment characteristics between those who underwent SVR12 testing and those released prior. CONCLUSIONS: Treatment for HCV can be delivered safely, efficiently and in high numbers in the prison setting using a nurse-led model of care. This will be an important component of the strategy to eliminate HCV infection as a public health concern by 2030.