Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs (BYE-C)
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ClinicalTrials.gov Identifier: NCT02609893 |
Recruitment Status :
Completed
First Posted : November 20, 2015
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C | Other: modified directly observed therapy (mDOT) Other: unobserved dosing Other: Motivational Interviewing-based counseling | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs |
Study Start Date : | December 2015 |
Actual Primary Completion Date : | April 2018 |
Actual Study Completion Date : | August 2019 |
Arm | Intervention/treatment |
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Active Comparator: Modified Directly Observed Therapy
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
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Other: modified directly observed therapy (mDOT) Other: Motivational Interviewing-based counseling Motivational Interviewing-based risk reduction and medication adherence counseling |
Active Comparator: Unobserved Dosing
Ledipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) provided weekly (7 tablets) for unobserved daily dosing for 8 weeks
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Other: unobserved dosing Other: Motivational Interviewing-based counseling Motivational Interviewing-based risk reduction and medication adherence counseling |
- Number of people who inject drugs (PWIDs) with HCV who were recruited and retained [ Time Frame: 44 weeks ]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.
- Medication adherence to study drug [ Time Frame: 44 weeks ]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.
- Challenges of medication adherence [ Time Frame: 44 weeks ]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.
- SVR (end-of-treatment response) [ Time Frame: 12 weeks ]We will compare the proportion of participants with undetectable HCV RNA at week 8 and post-treatment week 12 between arms.
- SOF/metabolite levels [ Time Frame: 8 weeks ]SOF/metabolite-positivity rates will be calculated by week in both arms.
- HCV relapse and reinfection [ Time Frame: 36 weeks ]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.
- Social and injector networks of participants [ Time Frame: 44 weeks ]We will characterize injector network sizes at baseline and follow-up through ACASI surveys.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥18 years of age;
- 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;
- HCV genotype 1;
- HCV RNA <6 million copies by Roche TaqMan Assay
- No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25-an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]);
- Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),
- injected with others in past 12 months by self-report;
- Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN);
- Able to speak English;
- No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly;
- for women of childbearing age, pregnancy test negative, not actively nursing, and agree to use birth control during treatment (although LDV-SOF has a "B" rating, consistent with no known evidence of harm, treatment is not urgent for these patients so we will err on the side of caution).
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]);
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History of any of the following:
- Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
- History of solid organ or bone marrow transplantation.
- Current treatment for cancer
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609893
United States, California | |
Substance Use Research Unit | |
San Francisco, California, United States, 94102 |
Principal Investigator: | Phillip O Coffin, M.D. | San Francisco Department of Public Health | |
Study Director: | Emily Behar, MS | San Francisco Department of Public Health |
Responsible Party: | Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health |
ClinicalTrials.gov Identifier: | NCT02609893 |
Other Study ID Numbers: |
1R34DA039333 ( U.S. NIH Grant/Contract ) |
First Posted: | November 20, 2015 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
HCV |
Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis, Chronic |