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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Directly Observed Therapy | Active Comparator | Ledipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) observed daily dosing (modified for non-observed Saturday and Sunday dosing) for 8 weeks |
|
| Unobserved Dosing | Active Comparator | Ledipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) provided weekly (7 tablets) for unobserved daily dosing for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified directly observed therapy (mDOT) | Other |
| ||
| unobserved dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of people who inject drugs (PWIDs) with HCV who were recruited and retained | To determine the feasibility of treating active PWIDs for HCV with LDV-SOF by mDOT versus unobserved dosing based on proportion eligible and enrolled among those screened and completion rates overall and by arm. | 44 weeks |
| Medication adherence to study drug | To evaluate the acceptability of mDOT versus unobserved dosing, the percent of treatment medication adherence to LDV-SOF, as measured by the percent of doses taken overall (observed and unobserved), will be assessed using DOT doses and weekend Wise Pill data for the mDOT arm, and WisePill data for the unobserved dosing arm. | 44 weeks |
| Challenges of medication adherence | To assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT versus unobserved dosing for PWIDs treated with LDV-SOF. | 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SVR (end-of-treatment response) | We will compare the proportion of participants with undetectable HCV RNA at week 8 and post-treatment week 12 between arms. | 12 weeks |
| SOF/metabolite levels | SOF/metabolite-positivity rates will be calculated by week in both arms. |
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Inclusion Criteria:
Exclusion Criteria:
HIV+ by rapid test or pooled viral load;
HBV surface antigen +;
Non-definitive HCV genotype results;
Previously received treatment for HCV (interferon, ribavirin, or DAA);
Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]);
History of any of the following:
Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);
Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and
Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.
No other conditions that preclude study involvement as determined by PI.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip O Coffin, M.D. | San Francisco Department of Public Health | Principal Investigator |
| Emily Behar, MS | San Francisco Department of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Use Research Unit | San Francisco | California | 94102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31158245 | Derived | Coffin PO, Santos GM, Behar E, Hern J, Walker J, Matheson T, Kinnard EN, Silvis J, Vittinghoff E, Fox R, Page K. Randomized feasibility trial of directly observed versus unobserved hepatitis C treatment with ledipasvir-sofosbuvir among people who inject drugs. PLoS One. 2019 Jun 3;14(6):e0217471. doi: 10.1371/journal.pone.0217471. eCollection 2019. |
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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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| Other |
|
| Motivational Interviewing-based counseling | Other | Motivational Interviewing-based risk reduction and medication adherence counseling |
|
| 8 weeks |
| HCV relapse and reinfection | Among participants who achieve SVR, we will determine the proportion who experience HCV relapse and reinfection at post-treatment week 36, overall and by arm. | 36 weeks |
| Social and injector networks of participants | We will characterize injector network sizes at baseline and follow-up through ACASI surveys. | 44 weeks |
| 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 |