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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
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:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbasvir / Grazoprevir Oral Tablet | Drug | HCV treatment according to Norwegian guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response | HCV RNA undetectable 12 weeks post treatment | 12 weeks |
| Reinfection | HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Dalgard, MD PhD | Contact | 92616800 | 47 | odalgard@medisin.uio.no |
| Kjersti Ulstein, MD | Contact | 41226162 | 47 | kjersti.ulstein@vel.oslo.kommune |
| Name | Affiliation | Role |
|---|---|---|
| Olav Dalgard, MD PhD | University Hospital, Akershus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AkershusUH | Recruiting | Lørenskog | Select A State Or Province | 0278 | Norway |
depends on patient privacy decission
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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Plasma collected at baseline and stored frozen -70 C
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |