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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04063839
Acronym
Prindsen
Enrollment
300
Registered
2019-08-21
Start date
2015-01-31
Completion date
2022-12-31
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Substance Use Disorders

Brief 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

Interventions

HCV treatment according to Norwegian guidelines

Sponsors

University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Sustained virological response12 weeksHCV RNA undetectable 12 weeks post treatment
Reinfection2 yearsHCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12

Countries

Norway

Contacts

Primary ContactOlav Dalgard, MD PhD
odalgard@medisin.uio.no92616800
Backup ContactKjersti Ulstein, MD
kjersti.ulstein@vel.oslo.kommune41226162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026