Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV).

BACKGROUND: The standard pathways of testing and treatment for hepatitis C virus (HCV) infection in tertiary healthcare are not easily accessed by people who inject drugs (PWID). The aim of this study was to evaluate the efficacy of integrated treatment of chronic HCV infection among PWID. METHODS AND FINDINGS: INTRO-HCV is a multicenter, randomized controlled clinical trial. Participants recruited from opioid agonist therapy (OAT) and community care clinics in Norway over 2017 to 2019 were randomly 1:1 assigned to the 2 treatment approaches. Integrated treatment was delivered by multidisciplinary teams at opioid agonist treatment clinics or community care centers (CCCs) for people with substance use disorders. This included on-site testing for HCV, liver fibrosis assessment, counseling, treatment, and posttreatment follow-up. Standard treatment was delivered in hospital outpatient clinics. Oral direct-acting antiviral (DAA) medications were administered in both arms. The study was not completely blinded. The primary outcomes were time-to-treatment initiation and sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after treatment completion, analyzed with intention to treat, and presented as hazard ratio (HR) and odds ratio (OR) with 95% confidence intervals. Among 298 included participants, 150 were randomized to standard treatment, of which 116/150 (77%) initiated treatment, with 108/150 (72%) initiating within 1 year of referral. Among those 148 randomized to integrated care, 145/148 (98%) initiated treatment, with 141/148 (95%) initiating within 1 year of referral. The HR for the time to initiating treatment in the integrated arm was 2.2 (1.7 to 2.9) compared to standard treatment. SVR was confirmed in 123 (85% of initiated/83% of all) for integrated treatment compared to 96 (83% of initiated/64% of all) for the standard treatment (OR among treated: 1.5 [0.8 to 2.9], among all: 2.8 [1.6 to 4.8]). No severe adverse events were linked to the treatment. CONCLUSIONS: Integrated treatment for HCV in PWID was superior to standard treatment in terms of time-to-treatment initiation, and subsequently, more people achieved SVR. Among those who initiated treatment, the SVR rates were comparable. Scaling up of integrated treatment models could be an important tool for elimination of HCV. TRIAL REGISTRATION: ClinicalTrials.gov.no NCT03155906.

Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV).

BACKGROUND: A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial. METHODS: INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID. DISCUSSION: This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up. TRIAL REGISTRATION: ClinicalTrials.gov.no. NCT03155906.

Non-financial barriers in oral health care: a qualitative study of patients receiving opioid maintenance treatment and professionals' experiences.

BACKGROUND: People with substance use disorders often have poor oral health, which can negatively impact their quality of life. Since 2005, patients receiving opioid maintenance treatment (OMT) in Norway have been eligible for free oral health care services offered through public oral health clinics. Despite a large need for oral health services amongst patients in OMT, figures suggest that the use of these services is low amongst this patient group. It has been unclear which barriers that contribute to this. This qualitative study explores the underlying barriers to the use of oral health care services amongst patients in OMT, from the perspective of the patients as well as dental health care workers (DHW). METHODS: Through a combination of focus group interviews and individual interviews, data were collected from 63 participants; 30 patients in OMT and 33 DHW. Thematic analysis identified key themes for the use (or not) of oral health care services amongst patients in OMT. RESULTS: Both individual and structural barriers prevent OMT patients from using the free oral health care services offered to them. These barriers include struggling to attend appointments, anxiety and fear of dentists, discrepancies between patients' expectations and the services offered and perceived stigma. OMT patients' lack of information regarding their rights and access to oral health services was also a barrier, as was DHWs' lack of knowledge and information of the OMT system and what they can offer patients. CONCLUSIONS: OMT patients face several barriers in accessing and using oral health care services. However, through a number of relatively simple measures, it is possible that the use of oral health services amongst OMT patients can be increased.

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.