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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Integrated treatment of hepatitis C virus infection among patients with injecting drug abuse: a randomised controlled trial (INTRO HCV)

Alternative title: Integrert behandling av hepatitt C hos pasienter med injiserende rusavhengighet: en randomisert kontrollert intervensjonsstudie (INTRO HCV)

Awarded: NOK 16.7 mill.

Patients with drug addiction have a high disease burden, generally have more difficulties in obtaining adequate health care compared with the general population, on top of knowledge gaps on health status and how to deliver proper treatment and follow-up. Reports from clinics delivering opioid agonist therapy (OAT) in Norway indicate that more than half of the patients receiving OAT had a chronic hepatitis C virus infection (HCV). Chronic HCV substantially increases the risk of severe complications such as liver failure and death within two to three decades. However, only around a third of OAT patients with chronic HCV had received HCV treatment when we started our study in 2017. Thus, there is a need for new approaches to reach more of patients with drug addiction in need of treatment while ensuring high-quality care. To succeed in this, a model of health care focusing on inter-disciplinarity, accessibility, close and frequent follow-ups was tested in a large randomized controlled clinical trial where we assessed integrated HCV treatment within the OAT clinics compared to standard treatment. In the trial, half of 298 persons were randomized to receive integrated treatment and the other half received treatment; all with direct acting antiviral medications. The results confirmed our hypotheses. Among those receiving integrated treatment, 98% initiated treatment for HCV while 77% initiated among those receiving standard treatment. Treatment was initiated double as fast among those receiving integrated treatment. Further, 83% of those randomized to integrated treatment had sustained virologic response compared to 64% among those receiving standard treatment. Time to sustained virologic response was halved among those receiving integrated treatment. There were no serious adverse events considered to be related with the treatment. The treatment was effective both for women and men, among the youngest and oldest participants, among those receiving opioid agonist therapy and those receiving municipal care services, those with stable and unstable living conditions, and among those who still injected drugs. If this treatment model is scaled up, this could contribute to elimination of HCV, both locally, nationally and internationally.

Patients with drug addiction have a high disease burden, generally have more difficulties in obtaining adequate health care compared with the general population, on top of knowledge gaps on health status and how to deliver ¬proper treatment and follow-up. Reports from clinics delivering opioid substitution therapy (OST) in Norway indicate that more than half of the patients receiving OST have a chronic hepatitis C virus infection (HCV). Chronic HCV substantially increases the risk of severe complications such as liver failure and death within two to three decades. However, only around 14% of OST patients with chronic HCV have received HCV treatment yet. Thus, there is a need for new approaches to reach more of patients with drug addiction in need of treatment while ensuring high-quality care. To succeed in this, a model of health care focusing on interdisciplinarity, accessibility, close and frequent follow-ups, seems to be necessary. Such a model has been adopted by Department of Addiction Medicine in Bergen and OST in Stavanger, which is unique in a national and international perspective. This makes it an excellent platform to test out integration of HCV treatment aiming to improve health and life span of a vulnerable group, and at the same time gathering knowledge which traditionally has been difficult to obtain. We will conduct a large randomised controlled clinical trial where we will assess integrated HCV treatment within the OST clinics compared to standard treatment. We will develop a regional OST data registry and biobank as part of the data collection, which will contribute to future research and evidence on drug addiction. The large regional collaboration in this research project between several institutions in Bergen, Stavanger and Sandnes including specialist and municipal primary health care, strong involvement of user organisations, as well as researchers from Bergen, Stavanger and Oslo, could establish a model for potential future national scale-up.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering