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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

modified directly observed therapy (mDOT)

Intervention Type OTHER

Motivational Interviewing-based counseling

Intervention Type OTHER

Motivational Interviewing-based risk reduction and medication adherence counseling

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

Group Type ACTIVE_COMPARATOR

unobserved dosing

Intervention Type OTHER

Motivational Interviewing-based counseling

Intervention Type OTHER

Motivational Interviewing-based risk reduction and medication adherence counseling

Interventions

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modified directly observed therapy (mDOT)

Intervention Type OTHER

unobserved dosing

Intervention Type OTHER

Motivational Interviewing-based counseling

Motivational Interviewing-based risk reduction and medication adherence counseling

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No