HCV Treatment in a Low-threshold Clinic

Hepatitis C Clinical Trial

— Prindsen  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063839
• Other study ID #: 17_120
• Status: Recruiting
• Start date: January 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2019
• Source: University Hospital, Akershus
• Contact: Olav Dalgard, MD PhD
• Phone: 92616800
• Email: odalgard[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Elbasvir / Grazoprevir Oral Tablet
HCV treatment according to Norwegian guidelines

Locations

Country	Name	City	State
Norway	AkershusUH	Lørenskog	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response	HCV RNA undetectable 12 weeks post treatment	12 weeks
Primary	Reinfection	HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12	2 years