Patient-reported outcomes of the Treatment and Prevention Study: A real-world community-based trial of direct-acting antivirals for hepatitis C among people who inject drugs.

The impact of hepatitis C cure with direct-acting antivirals (DAAs) on patient-reported outcomes (PROs) in community settings remains unclear. We aimed to assess changes in PROs over time and whether treatment was associated with sustained improved PROs in a cohort of people who inject drugs. This study is a sub-analysis of the Treatment and Prevention Study, a nurse-led trial where people who inject drugs and their injecting partners were recruited in a community setting, in Melbourne, Australia. Three participant groups were characterized: treatment, untreated and non-viremic (hepatitis C RNA negative at screening). PROs included assessment of health-related quality of life using the Short Form-8 (SF-8) Survey and life satisfaction using Personal Wellbeing Index (PWI). PROs were measured at baseline and every 12 weeks until week 84. Generalized estimating equations were used to measure whether treatment was associated with longitudinal PRO change. A total of 215 participants were included in this analysis. PWI scores were significantly higher at week 12 for both treatment group (p = 0.0309) and non-viremic group (p = 0.0437) compared to baseline. However, treatment was not associated with longitudinal change in PRO scores. In conclusion, we found DAA treatment did not significantly improve PRO scores compared to those not receiving treatment and without hepatitis C. The measures used in this study may not be sensitive enough to capture the hepatitis C specific improvements in quality of life that treatment affords or factors other than treatment may be influencing quality of life scores in this cohort.

Perceived physical health outcomes of direct-acting antiviral treatment for hepatitis C: a qualitative study.

BACKGROUND: Novel health promotion and treatment uptake initiatives will be necessary to ensure Australia meets 2030 hepatitis C elimination targets. Increasing treatment uptake will be assisted by a better understanding of the treatment experience and patient-perceived benefits. This study describes the perceived physical health benefits from direct-acting antiviral (DAA) hepatitis C treatment among people who inject drugs in Melbourne, Australia. METHODS: Twenty participants were recruited from a community treatment trial and community health clinics. Semi-structured interviews were performed with each participant before, during and following treatment. Interviews focused on treatment experiences, attitudes and motivations. Interviews were recorded, transcribed and thematically analysed. RESULTS: Two themes relating to the physical experience of treatment developed; intersection between physical and mental health and "maybe it's working". Participants reported various physical benefits, most prominently, reduced fatigue. Reductions in fatigue resulted in instant and meaningful changes in everyday life. Some participants did experience side effects, which they described as mild. Experiencing noticeable physical benefits during treatment was perceived as validation that treatment was working. CONCLUSION: Physical health benefits of DAA treatment may have carry-on effects on cognitive, emotional or social wellbeing and should be incorporated into how treatment is promoted to those who require it.

Improving hepatitis C direct-acting antiviral access and uptake: A role for patient-reported outcomes and lived experience.

Hepatitis C virus contributes to substantial and growing mortality and morbidity. Fortunately, the advent of highly effective interferon-free direct-acting antiviral (DAA) medications and new diagnostic tests has the potential to dramatically alter the epidemiologic trajectory of hepatitis C, particularly for "hard-to-reach" populations. Treatment advances and cure will also likely alter the individual experience of living with hepatitis C. However, it is not yet known in what capacity. This paper provides an overview of the population-level impact of DAA treatment, highlighting the need to further our understanding of the impact of treatment on behaviour, health and wellbeing through lived experience and more sensitive patient-reported outcome measures.

Staying hepatitis C negative: A systematic review and meta-analysis of cure and reinfection in people who inject drugs.

BACKGROUND AND AIMS: Direct-acting antivirals (DAAs) are highly effective in treating hepatitis C. However, there is concern that cure rates may be lower, and reinfection rates higher, among people who inject drugs. We conducted a systematic review of treatment outcomes achieved with DAAs in  people who inject drugs (PWID). METHODS: A search strategy was used to identify studies that reported sustained viral response (SVR), treatment discontinuation, adherence or reinfection in recent PWID and/or opioid substitution therapy (OST) recipients. Study quality was assessed using the Newcastle-Ottawa Scale. Meta-analysis of proportions was used to estimate pooled SVR and treatment discontinuation rates. The pooled relative risk of achieving SVR and pooled reinfection rate were calculated using generalized mixed effects linear models. RESULTS: The search identified 8075 references; 26 were eligible for inclusion. The pooled SVR for recent PWID was 88% (95% CI, 83%-92%) and 91% (95% CI 88%-95%) for OST recipients. The relative risk of achieving SVR for recent PWID compared to non-recent PWID was 0.99 (95% CI, 0.94-1.06). The pooled treatment discontinuation was 2% (95% CI, 1%-4%) for both recent PWID and OST recipients. Amongst recent PWID, the pooled incidence of reinfection was 1.94 per 100 person years (95% CI, 0.87-4.32). In OST recipients, the incidence of reinfection was 0.55 per 100 person years (95% CI, 0.17-1.76). CONCLUSIONS: Treatment outcomes were similar in recent PWID compared to non-PWID treated with DAAs. People who report recent injecting or OST recipients should not be excluded from hepatitis C treatment.

Experiences of liver health related uncertainty and self-reported stress among people who inject drugs living with hepatitis C virus: a qualitative study.

BACKGROUND: People who inject drugs (PWID) are most at risk of hepatitis C virus infection in Australia. The introduction of transient elastography (TE) (measuring hepatitis fibrosis) and direct acting antiviral medications will likely alter the experience of living with hepatitis C. We aimed to explore positive and negative influences on wellbeing and stress among PWID with hepatitis C. METHODS: The Treatment and Prevention (TAP) study examines the feasibility of treating hepatitis C mono-infected PWID in community settings. Semi-structured interviews were conducted with 16 purposively recruited TAP participants. Participants were aware of their hepatitis C seropositive status and had received fibrosis assessment (measured by TE) prior to interview. Questions were open-ended, focusing on the impact of health status on wellbeing and self-reported stress. Interviews were voice recorded, transcribed verbatim and thematically analysed, guided by Mishel's (1988) theory of Uncertainty in Illness. RESULTS: In line with Mishel's theory of Uncertainty in Illness all participants reported hepatitis C-related uncertainty, particularly mis-information or a lack of knowledge surrounding liver health and the meaning of TE results. Those with greater fibrosis experienced an extra layer of prognostic uncertainty. Experiences of uncertainty were a key motivation to seek treatment, which was seen as a way to regain some stability in life. Treatment completion alleviated hepatitis C-related stress, and promoted feelings of empowerment and confidence in addressing other life challenges. CONCLUSION: TE scores seemingly provide some certainty. However, when paired with limited knowledge, particularly among people with severe fibrosis, TE may be a source of uncertainty and increased personal stress. This suggests the need for simple education programs and resources on liver health to minimise stress.

Stigma Associated with Alcohol and Other Drug Use Among People from Migrant and Ethnic Minority Groups: Results from a Systematic Review of Qualitative Studies.

Stigma reduces access to alcohol and other drug (AOD) support. This systematic review explored perceptions and experiences of stigma associated with AOD use among migrant and ethnic minority groups. Qualitative studies published in English were identified using six databases. Two reviewers screened and critically appraised articles using the Joanna Briggs Institute Critical Appraisal Checklist for qualitative studies. Data were synthesised using best fit framework synthesis. Twenty-three studies were included. Stigma drivers and facilitators included stereotypes, socio-cultural norms, legal responses and precarious lived experiences. Stigma intersected with gender, citizenship, race and ethnicity and manifested though shame, exclusion, secondary stigma and discrimination in treatment. Outcomes and impacts included avoidance of services, emotional distress, isolation and loneliness. This review identified similar stigma experiences to other populations, however outcomes were complicated by precarious lived experiences and multiple stigmatised identities. Multi-level interventions are required to reduce AOD-related stigma for migrant and ethnic minority groups.

"Like a pickle that's been unpickled": Emotional, identity and behavioural transformations throughout hepatitis C treatment.

BACKGROUND: Little is known about the emotional experience and benefits of undertaking direct acting antiviral (DAA) treatment for hepatitis C. A better understanding of individual treatment outcomes can inform acceptable treatment delivery and promotion. We aimed to explore participant-perceived emotional benefits and transformations throughout DAA treatment among people who inject drugs, who were initiating treatment. METHODS: Participants were recruited from either a community based clinical trial or community health clinics. Semi structured interviews were conducted with each participant before, during and following treatment. Interviews focussed on treatment perceptions, physical and mental wellbeing and modifiable health behaviours. Interviews were recorded, transcribed verbatim and thematically analysed. Participant and cohort matrices were produced to assess at which time point themes were present and whether themes changed or remained stable over time. RESULTS: This paper presents analysis from 19 participants interviewed between 2017-2019. Most participants were male, with no or mild fibrosis. At baseline, all but one participant had injected drugs in the past month. Three themes relating to the emotional wellbeing and behaviour change described a common treatment experience; 'hopes for better wellbeing', 'lifting the weight' and 'closing the chapter'. Participants were hopeful treatment would improve their emotional wellbeing. Hopes were actualised during treatment as participants began to feel uncertainty and stress easing. Completing treatment improved some participants perceptions of self. Some participants consciously changed their injecting behaviours during treatment. CONCLUSION: Undertaking and completing treatment was an emotionally and behaviourally transformative period. Participant perceived benefits should be used to inform how treatment benefit is conceptualised and how treatment is promoted in primary care settings.

Peer to peer communication about hepatitis C treatment amongst people who inject drugs: A longitudinal qualitative study.

BACKGROUND: Little is known about how information on direct-acting antiviral treatment for hepatitis C circulates through peer networks of people who inject drugs. In this study we aimed to explore what and how treatment-related information is shared between people undergoing treatment and their peers. METHODS: Participants were recruited from two general practice clinics and the community-based hepatitis C Treatment and Prevention Study. Semi-structured interviews were conducted with each participant (N = 20) before, during and following treatment. Interviews explored hepatitis C treatment experiences, key sources of DAA information and the impact of receiving and sharing knowledge. Inductive thematic analysis was conducted. Time sequential matrices were generated to understand thematic change over time. RESULTS: Fifty-four interviews were conducted with 20 participants across seven field-sites in Melbourne, Australia. Key themes were: 'peers as a source treatment information', 'do it together' and 'becoming a treatment advocate'. Peers were a crucial trusted source of information. Positive treatment anecdotes were important for building confidence in and motivation to initiate treatment. Many participants adopted a 'treatment advocate' role in their close peer networks, which was described as empowering. Some participants described benefits of undertaking treatment alongside members of their close network. CONCLUSION: Findings illustrate the importance of close peers in shaping treatment perceptions and engagement. This will be important in designing health promotion messaging and interventions to increase treatment uptake.

Increasing amphetamine use and forensic involvement among clients of three residential Indigenous alcohol and other drug services in Victoria, Australia.

INTRODUCTION AND AIMS: Indigenous people seeking residential alcohol and other drug (AOD) rehabilitation in Victoria are most frequently referred to the Ngwala Willumbong Co-operative (Ngwala). This study aimed to describe socio-demographic changes in clients of Ngwala's residential rehabilitation services between 2015 and 2016. DESIGN AND METHODS: Self-assessment surveys completed upon screening for rehabilitation between May 2015 and November 2016 (n = 117) were analysed for socio-demographic data, AOD use and mental health status. Ngwala's monthly summary reports from January 2015 to December 2016 were analysed to compare primary drugs of concern, proportion of forensic clients assessed and admitted across 2015-2016. Independent t-tests and tests of two proportions were used to compare variables between years, with differences considered significant when P < 0.05. RESULTS: Clients were predominantly Indigenous (n = 100, 91%), male (n = 92, 71%) and unemployed (n = 106, 93%). Most clients (n = 92, 88%) were at high risk of serious mental illness (by Kessler Psychological Distress Scale). A significantly higher proportion of forensic clients were admitted in 2016 (n = 221, 60%) compared to 2015 (n = 158, 43%; P < 0.001; 95% confidence interval -0.24, -0.10). The mean monthly number of clients listing amphetamines as their primary drug of concern upon assessment was greater in 2016 (21 ± 7.19 people) compared to 2015 (12 ± 2.78 people; P = 0.01; 95% confidence interval 3.13, 15.37). DISCUSSION AND CONCLUSIONS: These findings suggest the proportion of Indigenous people in AOD treatment with amphetamine use problems or forensic involvement is increasing. These trends should be considered in service design and funding decisions.