NCT04063839

HCV Treatment in a Low-threshold Clinic

Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Detailed description

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f The secondary aims are to: * Evaluate adherence to DAA treatment (Work Package 1) * Identify factors associated with SVR and adherence (Work Package 1) * Characterize reinfection using next generation sequencing (Work Package 2) * Identify factors associated with reinfection (Work Package 2) * Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2) * Identify factors associated with changes in risk behaviours (Work Package 2) The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours. The study will include 300 patients and are close to achieving that aim the summer of 2019

Conditions

• Hepatitis C
• Substance Use Disorders

Interventions

Type	Name	Description
DRUG	Elbasvir / Grazoprevir Oral Tablet	HCV treatment according to Norwegian guidelines

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-10-31
• Completion: 2022-12-01
• First posted: 2019-08-21
• Last updated: 2019-08-21

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated drug study