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Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded.
Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.
Chronically HCV-infected participants were recruited and treated at two liver referral clinics in Georgia, but had been referred from opioid substitution therapy clinics, primary care and GI clinics, neighboring hospitals, and correctional centers. Once consented, a nurse navigator was assigned to each participant was responsible for all subjects' appointments, and med supplies. Drug testing was mandated at specified intervals. Patients with recent injection drug use (within 6 months) were assigned to the PWID (people who inject drugs) arm, and those who hadn't injected within 6 months, but agreed to be in the study and signed consents, were assigned to the non-PWID arm. Both groups were treated with velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic). Adherence was assessed by pill counts. Mandatory treatment visits were scheduled for baseline, 4 and 12 weeks (+/- 2 weeks) and follow-up (FU) week 12 (+ 4 months). Long-term FU was flexible and could be virtual, but was mandated once yearly with HCV RNA testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PWID (people who inject drugs) | Experimental | velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had used intravenous drugs at least once in preceding six months. |
|
| Non-PWID | Active Comparator | velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had NOT used intravenous drugs at least once in preceding six months, but were treated concurrently in the same hepatology referral clinics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . | Drug | Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response | Undetectable HCV RNA 12 weeks after completion of antiviral therapy | 24 weeks after medication initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Reinfection rate hepatitis C | Detection of HCV RNA in follow-up period after SVR has been obtained | in follow-up period (expected 2-3 years) |
| Intravenous drug use | rate of IV drug use compared between baseline and end of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| brian pearlman, MD | Wellstar Internal Medicine Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar Atlanta Medical Center | Atlanta | Georgia | 30312 | United States |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000604171 | velpatasvir |
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PWID arm and non-PWID arm prospective, parallel observational cohorts
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| informed consent through end of follow-up (up to 3 years) |
| Opioid Substitution Therapy (OST) | rate of OST compared between baseline and end of follow-up | informed consent through end of follow-up (up to 3 years) |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |