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

Chronic Hepatitis C Clinical Trial

— BYE-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609893
• Other study ID #: 1R34DA039333
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: August 2019

Study information

• Verified date: October 2020
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Other:
• modified directly observed therapy (mDOT)

• unobserved dosing

• Motivational Interviewing-based counseling
Motivational Interviewing-based risk reduction and medication adherence counseling

Locations

Country	Name	City	State
United States	Substance Use Research Unit	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Phillip Coffin, MD, MIA	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	SOF/metabolite levels	SOF/metabolite-positivity rates will be calculated by week in both arms.	8 weeks
Secondary	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
Secondary	Social and injector networks of participants	We will characterize injector network sizes at baseline and follow-up through ACASI surveys.	44 weeks