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Chronic Hepatitis CPhase 4BYE-CNCT02609893

Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs

A Phase 4 study testing modified directly observed therapy (mDOT), unobserved dosing and Motivational Interviewing-based counseling in people with Chronic Hepatitis C, run by Phillip Coffin, MD, MIA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
modified directly observed therapy (mDOT), unobserved dosing and Motivational Interviewing-based counseling
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
Dec 2015to Aug 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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),
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  • 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).

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Substance Use Research Unit

    San Francisco, California, 94102

Other trials in United States

About this study

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.

Being tested
modified directly observed therapy (mDOT), unobserved dosing, Motivational Interviewing-based counseling
Keywords
HCV
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified directly observed therapy (mDOT)Other

  • unobserved dosingOther

  • Motivational Interviewing-based counselingOther

    Motivational Interviewing-based risk reduction and medication adherence counseling

Study groups in NCT02609893
Study groupRoleWhat they receive
Modified Directly Observed TherapyActive comparatorLedipasvir/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
Receives: Other: modified directly observed therapy (mDOT); Other: Motivational Interviewing-based counseling
Unobserved DosingActive comparatorLedipasvir/Sofosbuvir Fixed-Dose Combination (LDV-SOF) tablet (LDV 90mg/SOF 400mg) provided weekly (7 tablets) for unobserved daily dosing for 8 weeks
Receives: Other: unobserved dosing; Other: Motivational Interviewing-based counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 44 weeks

  2. 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.

    Measured: 44 weeks

  3. 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.

    Measured: 44 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 12 weeks

  2. SOF/metabolite levels

    SOF/metabolite-positivity rates will be calculated by week in both arms.

    Measured: 8 weeks

  3. 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.

    Measured: 36 weeks

  4. Social and injector networks of participants

    We will characterize injector network sizes at baseline and follow-up through ACASI surveys.

    Measured: 44 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionApr 2018
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02609893
Sponsor's protocol ID
1R34DA039333
Acronym
BYE-C
Status last verified
Oct 2020
First submitted
5 Oct 2015
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31158245

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing modified directly observed therapy (mDOT), unobserved dosing and Motivational Interviewing-based counseling in people with Chronic Hepatitis C, run by Phillip Coffin, MD, MIA at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of people who inject drugs (PWIDs) with HCV who were recruited and retained (time frame: 44 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02609893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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