Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs (BYE-C)

October 20, 2020 updated by: Phillip Coffin, MD, MIA
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Substance Use Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥18 years of age;
  2. 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;
  3. HCV genotype 1;
  4. HCV RNA <6 million copies by Roche TaqMan Assay
  5. 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%]);
  6. Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),
  7. injected with others in past 12 months by self-report;
  8. 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);
  9. Able to speak English;
  10. 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;
  11. 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:

  1. HIV+ by rapid test or pooled viral load;
  2. HBV surface antigen +;
  3. Non-definitive HCV genotype results;
  4. Previously received treatment for HCV (interferon, ribavirin, or DAA);
  5. 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]);

  6. History of any of the following:

    1. Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
    2. History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
    3. History of solid organ or bone marrow transplantation.
    4. Current treatment for cancer
  7. Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);
  8. Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and
  9. Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.
  10. No other conditions that preclude study involvement as determined by PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other: Motivational Interviewing-based counseling
Motivational Interviewing-based risk reduction and medication adherence counseling
Other: unobserved dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
44 weeks
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.
44 weeks
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.
44 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
SOF/metabolite levels
Time Frame: 8 weeks
SOF/metabolite-positivity rates will be calculated by week in both arms.
8 weeks
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.
36 weeks
Social and injector networks of participants
Time Frame: 44 weeks
We will characterize injector network sizes at baseline and follow-up through ACASI surveys.
44 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phillip Coffin, MD, MIA

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Study Director: Emily Behar, MS, San Francisco Department of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DA039333 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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