HCV Treatment in a Low-threshold Clinic (Prindsen)

University Hospital, Akershus

Status

Unknown

Conditions

Hepatitis C

Substance Use Disorders

Treatments

Drug: Elbasvir / Grazoprevir Oral Tablet

Study type

Observational

Funder types

Other

Identifiers

NCT04063839

17_120

Details and patient eligibility

About

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

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria