Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial.

BACKGROUND: We aimed to evaluate the efficacy of opportunistic treatment of hepatitis C virus (HCV) infection among hospitalized people who inject drugs (PWID). METHODS: We performed a pragmatic, stepped wedge cluster randomized trial recruiting HCV RNA positive individuals admitted for inpatient care in departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo, Norway. Seven departments were sequentially randomized to change from control conditions (standard of care referral to outpatient care) to intervention conditions (immediate treatment initiation). The primary outcome was treatment completion, defined as dispensing the final package of the prescribed treatment within six months after enrolment. RESULTS: A total of 200 HCV RNA positive individuals were enrolled between 1 October 2019 and 31 December 2021 (mean age 47.4 years, 72.5% male, 60.5% injected past 3 months, 20.4% cirrhosis). Treatment completion was accomplished by 67 of 98 (68.4% [95% confidence interval {CI}: 58.2-77.4]) during intervention conditions and by 36 of 102 (35.3% [95% CI: 26.1-45.4]) during control conditions (risk difference 33.1% [95% CI: 20.0-46.2]; risk ratio 1.9 [95% CI: 1.4-2.6]). The intervention was superior in terms of treatment completion (adjusted odds ratio [aOR] 4.8 [95% CI: 1.8-12.8]; P = .002) and time to treatment initiation (adjusted hazard ratio [aHR] 4.0 [95% CI: 2.5-6.3]; P < .001). Sustained virologic response was documented in 60 of 98 (61.2% [95% CI: 50.8-70.9]) during intervention and in 66 of 102 (64.7% [95% CI: 54.6-73.9]) during control conditions. CONCLUSIONS: An opportunistic test-and-treat approach to HCV infection was superior to standard of care among hospitalized PWID. The model of care should be considered for broader implementation. Clinical Trials Registration. NCT04220645.

Peer support in small towns: A decentralized mobile Hepatitis C virus clinic for people who inject drugs.

BACKGROUND & AIMS: New models of HCV care are needed to reach people who inject drugs (PWID). The primary aim was to evaluate HCV treatment uptake among HCV RNA positive individuals identified by point-of-care (POC) testing and liver disease assessment in a peer-driven decentralized mobile clinic. METHODS: This prospective study included consecutive patients assessed in a mobile clinic visiting 32 small towns in Southern Norway from November 2019 to November 2020. The clinic was staffed by a bus driver and a social educator offering POC HCV RNA testing (GeneXpert®), liver disease staging (FibroScan® 402) and peer support. Viremic individuals were offered prompt pan-genotypic treatment prescribed by local hospital-employed specialists following a brief telephone assessment. RESULTS: Among 296 tested individuals, 102 (34%) were HCV RNA positive (median age 51 years, 77% male, 24% advanced liver fibrosis/cirrhosis). All participants had a history of injecting drug use, 71% reported past 3 months injecting, and 37% received opioid agonist treatment. Treatment uptake within 6 months following enrolment was achieved in 88%. Treatment uptake was negatively associated with recent injecting (aHR 0.60; 95% CI 0.36-0.98), harmful alcohol consumption (aHR 0.44; 95% CI 0.20-0.99), and advanced liver fibrosis/cirrhosis (aHR 0.44; 95% CI 0.25-0.80). HCV RNA prevalence increased with age (OR 1.81 per 10-year increase; 95% 1.41-2.32), ranging from 3% among those <30 years to 55% among those ≥60 years. CONCLUSIONS: A peer-driven mobile HCV clinic is an effective and feasible model of care that should be considered for broader implementation to reach PWID outside the urban centres.

Large and non-specific somatic disease burdens among ageing, long-term opioid maintenance treatment patients.

OBJECTIVES: To describe and explore somatic disease burdens of ageing long-term patients in opioid maintenance treatment (OMT), a unique population emerging in countries offering OMT as a long-term treatment. METHODS: We used data from the Norwegian Cohort of Patient in Opioid Maintenance Treatment and Other Drug Treatment Study (NorComt). 156 patients enrolled for at least three of the past five years provided data during structured interviews, including on chronic conditions, somatic treatment received, mental distress (SCL-25), and treatment satisfaction. A somatic disease burden was calculated from a list measuring the recent severity of 16 somatic complaints. A hierarchical multiple linear regression analysis identified correlates of somatic disease burden. RESULTS: Over half of patients reported at least seven somatic complaints. Reported somatic disease burden was associated with higher mental distress, more chronic conditions, fewer years in OMT, and treatment dissatisfaction. Age was unrelated, and there were few gender differences. These five variables explained 43.6% of the variance in disease burden. CONCLUSION: Long-term OMT patients experience a large range of somatic complaints, and at non-acute levels. As OMT secures longevity for opioid-dependent persons, the clinical focus must be adjusted from acute to chronic care. Providers must address how to optimize health and quality of life while in treatment, as treatment may last for many years.

Peer involvement and cross-sector efforts in establishing integrated treatment of hepatitis C virus infection for people with substance use disorders: experiences from Norway.

BACKGROUND: For people with opioid dependence in Norway, chronic hepatitis C virus (HCV) infections contribute to high mortality and high morbidity. Around 50% of patients in medically assisted rehabilitation (MAR) have been shown to have HCV, and the current prevention and control efforts have been mostly unsuccessful. Thus, there is a need for new strategies for people-centred service delivery and innovative methods to improve health outcomes. METHODS: Over the last few years, the city of Bergen, Norway, has developed a cross-sector collaboration with substantial peer involvement in research and health provision related to substance use. User group representatives for people receiving MAR, addiction medicine health personnel, infectious disease specialists, policy makers in the municipality, low-threshold health care centres for people with substance use disorders in Bergen Municipality and researchers in the INTRO-HCV project have made concerted efforts in this regard. We will present here some of the strategies and steps we have taken. RESULTS: We have established an integrated HCV treatment scheme for people who inject drugs or who have opioid dependence. More than 800 persons have been tested for HCV within these frames, and more than 250 persons have been given treatment for HCV within the project. The integrated treatment of HCV is offered both in MAR outpatient clinics, municipal low-threshold healthcare centres, and local and regional prisons. The preliminary results indicate an increase in HCV treatment uptake among those receiving integrated treatment (96% initiating treatment compared to 75%). The user group organisation ProLAR Nett has established an outreach service to screen for HCV, increase awareness and reduce the proportion of people unknowingly living with HCV while informing and motivating people to receive treatment. Together with the other stake holders, peer user group, health care, research planning, concert events, and policy panels have been held. CONCLUSIONS: Peer involvement seems to have increased testing rates for HCV and acknowledgment of its importance. This seems to have improved health care for people with opioid dependence in Bergen over the last few years, particularly relating to the treatment of HCV. These experiences might be helpful in the planning of integrated policies in other settings that seek to eliminate the HCV endemic.

Dissatisfaction with opioid maintenance treatment partly explains reported side effects of medications.

BACKGROUND: Drop-out is a core problem in opioid maintenance treatment (OMT), but patients' reactions to and acceptance of the various OMT medications are insufficiently investigated. In Norway, there has been vocal patient resistance to the newest medication, buprenorphine-naloxone (BNX), and complaints have focused on the side effect profile. There has been no comparison of patient satisfaction and side effects of the three most common OMT medications. AIM: To compare patient satisfaction with OMT and side effects of BNX, buprenorphine monopreparate (BUP), and methadone (MET) as reported by patients. METHODS: Data were drawn from a national peer-to-peer survey developed by a patient advocacy group. The survey engaged more than 1000 OMT patients, corresponding to one seventh of OMT patients in Norway. The associations between side effects, treatment satisfaction, and patient characteristics were tested in multinomial logistic regressions. RESULTS: High patient satisfaction with OMT overall was reported despite lower satisfaction with medication itself and widely prevalent side effects. Among each medication group, dissatisfaction with medications or OMT in general along with poor health status increased the relative risk ratio of reporting the heaviest side effect burden. MET users reported the highest side effect burden and BNX users the lightest, but BNX users were more dissatisfied with their medication. CONCLUSIONS: Side effects are a concern for nearly all OMT patients, and they do not appear to accumulate with age or length of treatment. BNX users' dissatisfaction with their medication is of particular concern, and expectations and preferences of medication may be influencing their dissatisfaction.