Trial Outcomes & Findings for Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care (NCT NCT03093415)

Last Updated: 2020-11-12

Results Overview

Sustained Viremic Response at 12 weeks post-completion of treatment. SVR12 was determined negative if undetectable (\<20 copies) by polymerase chain reaction and positive if EITHER loss-to-follow up and no lab data or virus was detected greater than 20 copies.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

24 weeks post-initiation of treatment (12 weeks post-completion of treatment)

Results posted on

2020-11-12

Participant Flow

Participants for the medication assisted therapy (MAT) group were all recruited and enrolled from within a single FQHC that provides office based opioid treatment with buprenorphine. Participants in the needle exchange program were similarly recruited in that setting. Retrospective comparison group was an academic hepatology referral clinic.

This is a non-randomized, prospective cohort trial. No washout/run-in occured.

Participant milestones

Participant milestones
Measure	Old Town Clinic, Medication Assisted Therapy Group 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Assessed for Eligibility --> Enrollment STARTED	165	135	50
Assessed for Eligibility --> Enrollment COMPLETED	25	25	50
Assessed for Eligibility --> Enrollment NOT COMPLETED	140	110	0
Enrollment to SVR12 Results STARTED	25	25	50
Enrollment to SVR12 Results COMPLETED	24	17	47
Enrollment to SVR12 Results NOT COMPLETED	1	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Old Town Clinic, Medication Assisted Therapy Group 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Assessed for Eligibility --> Enrollment Lost to Follow-up	17	36	0
Assessed for Eligibility --> Enrollment Inclusion Criteria: No MAT	40	0	0
Assessed for Eligibility --> Enrollment Inclusion Criteria: neg HCV	28	6	0
Assessed for Eligibility --> Enrollment Inclusion Criteria: No active use	0	12	0
Assessed for Eligibility --> Enrollment Inclusion Criteria: Fibrosis > F2	18	12	0
Assessed for Eligibility --> Enrollment Exclusion Criteria: HIV	4	4	0
Assessed for Eligibility --> Enrollment Inclusion Criteria: Wrong Genotype	15	32	0
Assessed for Eligibility --> Enrollment Exclusion Criteria: NS5a Resistance	5	3	0
Assessed for Eligibility --> Enrollment Exclusion Criteria: Treatment Readiness	4	2	0
Assessed for Eligibility --> Enrollment Other Lab exclusion Criteria	9	3	0
Enrollment to SVR12 Results Lost to Follow-up	1	8	3

Baseline Characteristics

\*OHSU clinic did not collect education data for comparison based on study model

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 weeks post-initiation of treatment (12 weeks post-completion of treatment)

Population: All participants enrolled were analyzed using intention to treat (ITT) methodology for sustained viremic response at 12 weeks after end of treatment (SVR12).

Outcome measures

Outcome measures
Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort n=50 Participants 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
SVR 12 SVR12 positive, intention to treat	1 Participants	10 Participants	3 Participants
SVR 12 SVR12 negative, intention to treat	24 Participants	15 Participants	47 Participants

SECONDARY outcome

Timeframe: 60 weeks post-initiation of treatment (48 weeks post-completion of treatment)

Population: Limitations in study funding and delayed recruitment prevented both prospective groups from collecting full SVR48 data. Therefore, PER PROTOCOL (PP) data presented below. Analysis framework for this secondary outcome was not pre-specified but PP analysis most appropriate given reasons for lacking data. OHSU comparison did not collect SVR48 data.

Sustained Viremic Response at 48 weeks post-completion of treatment (SVR48). Participants "Achieving SVR48" had a negative hepatitis C real time polymerase chain reaction (RT-PCR) test at 48 weeks after end of treatment. Participants who "Did Not Achieve SVR48" had a positive hepatitis C RT-PCR test at 48 weeks after end of treatment.

Outcome measures

Outcome measures
Measure	Old Town Clinic, Medication Assisted Therapy Group n=17 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=7 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
SVR 48 Achieved SVR48	17 Participants	3 Participants	0 Participants
SVR 48 Did Not Achieve SVR48	0 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Study duration (60 weeks)

Population: All participants analyzed for this variable

Percentage of patients discontinuing medications prior to completion of 12 weeks or being lost to follow up, defined as inability to reach patient after 3 attempts and patients not following up with primary endpoint labs (SVR 12, 48)

Outcome measures

Outcome measures
Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort n=50 Participants 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Discontinuation Rate or Lost To Follow Up Completed therapy and SVR12 lab confirmation	24 Participants	16 Participants	47 Participants
Discontinuation Rate or Lost To Follow Up Discontinued therapy, or incomplete SVR12 labs	1 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: At Study Screening/Enrollment

Population: 165 potential participants in medication assisted therapy group and 135 potential participants in needle exchange group were analyzed for Non-Structural Protein 5a (NS5a) resistance. OHSU Hepatology cohort only included treated individuals and NS5a resistance data were not collected.

Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)

Outcome measures

Outcome measures
Measure	Old Town Clinic, Medication Assisted Therapy Group n=165 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=135 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
NS5A Resistance NS5a Resistance to Elbasvir-Grazoprevir Detected	5 Participants	3 Participants	0 Participants
NS5A Resistance NS5a Resistance to Elbasvir-Grazoprevir Absent	160 Participants	132 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks (duration of treatment)

Population: Enrolled study participants in prospective arms initiating therapy. Self report combined will pharmacist pill count adherence data assessed by study pharmacist at q4week study visits, including end of treatment. Retrospective comparison group at OHSU did not collect adherence data.

Adherence determined by client/subject self-reported medication adherence measured by percentage of pills taken on a monthly basis. Categorically separated into \< 90% adherence, 90-99% adherence, 100% adherence.

Outcome measures

Outcome measures
Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Medication Adherence 100% adherence	23 Participants	17 Participants	0 Participants
Medication Adherence Less than 90% Adherence	0 Participants	8 Participants	0 Participants
Medication Adherence 90 - 99% adherence	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of study (60 weeks)

Population: These data were not collected. The study group determined that the definition of "relapse" was inappropriate for the study population given the nature of ongoing use in the MAT group and the lack of comparison with the outside in group, that was currently using drugs by definition. Scientific value of these data was thought to be limited.

Self reported relapse IDU following HCV treatment (MAT arm)

Outcome measures

Outcome data not reported

Adverse Events

Old Town Clinic, Medication Assisted Therapy Group

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Outside In Clinic, Needle Exchange Program

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

OHSU Hepatology Clinic, Academic Center Retrospective Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 participants at risk 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 participants at risk 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Infections and infestations Infective Endocarditis	4.0% 1/25 • Number of events 1 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	0.00% 0/25 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.

Other adverse events

Other adverse events
Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 participants at risk 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 participants at risk 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Nervous system disorders Headache	32.0% 8/25 • Number of events 8 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	24.0% 6/25 • Number of events 6 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.
Gastrointestinal disorders Nausea	24.0% 6/25 • Number of events 6 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	28.0% 7/25 • Number of events 7 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.
Psychiatric disorders Fatigue	32.0% 8/25 • Number of events 8 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	40.0% 10/25 • Number of events 10 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.
Nervous system disorders Dizziness	0.00% 0/25 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	8.0% 2/25 • Number of events 2 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.
Gastrointestinal disorders Diarrhea	0.00% 0/25 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	4.0% 1/25 • Number of events 1 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.
Psychiatric disorders Insomnia	0.00% 0/25 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	4.0% 1/25 • Number of events 1 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.	— 0/0 • Between study enrollment and SVR12 = 24 weeks Reporting mirrors clinicaltrials.gov definitions. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the OHSU Hepatology Clinic, Academic Center Retrospective Cohort. All serious and other adverse effects were monitored for the two prospective arms, as reported below.

Additional Information

Andrew Seaman, MD

Oregon Health and Sciences University

Phone: 1 (971) 271 - 6102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Old Town Clinic, Medication Assisted Therapy Group n=25 Participants 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Outside In Clinic, Needle Exchange Program n=25 Participants 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	OHSU Hepatology Clinic, Academic Center Retrospective Cohort n=50 Participants 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. elbasvir-grazoprevir (50 mg/100 mg): 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)	Total n=100 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 11.3 • n=25 Participants	41 years STANDARD_DEVIATION 11.9 • n=25 Participants	60 years STANDARD_DEVIATION 7.5 • n=50 Participants	51 years STANDARD_DEVIATION 12.9 • n=100 Participants
Sex: Female, Male Female	15 Participants n=25 Participants	15 Participants n=25 Participants	33 Participants n=50 Participants	63 Participants n=100 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	10 Participants n=25 Participants	17 Participants n=50 Participants	37 Participants n=100 Participants
Race/Ethnicity, Customized White	22 participants n=25 Participants	22 participants n=25 Participants	50 participants n=50 Participants	84 participants n=100 Participants
Race/Ethnicity, Customized Black / African American	1 participants n=25 Participants	1 participants n=25 Participants	0 participants n=50 Participants	2 participants n=100 Participants
Race/Ethnicity, Customized Native American	1 participants n=25 Participants	1 participants n=25 Participants	0 participants n=50 Participants	2 participants n=100 Participants
Race/Ethnicity, Customized Latinx	1 participants n=25 Participants	1 participants n=25 Participants	0 participants n=50 Participants	2 participants n=100 Participants
Highest Level of Education Did not complete highschool	1 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	4 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	0 Participants \*OHSU clinic did not collect education data for comparison based on study model	5 Participants n=50 Participants • \*OHSU clinic did not collect education data for comparison based on study model
Highest Level of Education High school completion	18 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	11 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	0 Participants \*OHSU clinic did not collect education data for comparison based on study model	29 Participants n=50 Participants • \*OHSU clinic did not collect education data for comparison based on study model
Highest Level of Education Trade school completion	3 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	8 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	0 Participants \*OHSU clinic did not collect education data for comparison based on study model	11 Participants n=50 Participants • \*OHSU clinic did not collect education data for comparison based on study model
Highest Level of Education Bachelors degree or higher	3 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	2 Participants n=25 Participants • \*OHSU clinic did not collect education data for comparison based on study model	0 Participants \*OHSU clinic did not collect education data for comparison based on study model	5 Participants n=50 Participants • \*OHSU clinic did not collect education data for comparison based on study model
Income 0-50% Federal Poverty Level	10 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	19 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	0 Participants \*OHSU group did not collect baseline income data, as per study model	29 Participants n=50 Participants • \*OHSU group did not collect baseline income data, as per study model
Income 51-100% Federal Poverty Level	9 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	3 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	0 Participants \*OHSU group did not collect baseline income data, as per study model	12 Participants n=50 Participants • \*OHSU group did not collect baseline income data, as per study model
Income > 101% Federal Poverty Level	6 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	3 Participants n=25 Participants • \*OHSU group did not collect baseline income data, as per study model	0 Participants \*OHSU group did not collect baseline income data, as per study model	9 Participants n=50 Participants • \*OHSU group did not collect baseline income data, as per study model
Fibrosis Status APRI < 0.7	19 Participants n=25 Participants	23 Participants n=25 Participants	30 Participants n=50 Participants	72 Participants n=100 Participants
Fibrosis Status APRI > 0.7	6 Participants n=25 Participants	2 Participants n=25 Participants	20 Participants n=50 Participants	28 Participants n=100 Participants
Genotype Genotype 1a	22 Participants n=25 Participants	24 Participants n=25 Participants	36 Participants n=50 Participants	82 Participants n=100 Participants
Genotype Genotype 1b	3 Participants n=25 Participants	1 Participants n=25 Participants	14 Participants n=50 Participants	18 Participants n=100 Participants
Genotype Genotype 4	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Established in Primary Care Not established in primary care	0 Participants n=25 Participants • \*OHSU group did not collect this data per study design	4 Participants n=25 Participants • \*OHSU group did not collect this data per study design	0 Participants \*OHSU group did not collect this data per study design	4 Participants n=50 Participants • \*OHSU group did not collect this data per study design
Established in Primary Care Established in primary care < 1 year	6 Participants n=25 Participants • \*OHSU group did not collect this data per study design	7 Participants n=25 Participants • \*OHSU group did not collect this data per study design	0 Participants \*OHSU group did not collect this data per study design	13 Participants n=50 Participants • \*OHSU group did not collect this data per study design
Established in Primary Care Established in primary care > 1 year	19 Participants n=25 Participants • \*OHSU group did not collect this data per study design	14 Participants n=25 Participants • \*OHSU group did not collect this data per study design	0 Participants \*OHSU group did not collect this data per study design	33 Participants n=50 Participants • \*OHSU group did not collect this data per study design
Housing Status Houseless / Unstable Housing	4 Participants n=25 Participants • OHSU group did not collect housing data based on our study model.	8 Participants n=25 Participants • OHSU group did not collect housing data based on our study model.	0 Participants OHSU group did not collect housing data based on our study model.	12 Participants n=50 Participants • OHSU group did not collect housing data based on our study model.
Housing Status Transitional / Stable Housing	21 Participants n=25 Participants • OHSU group did not collect housing data based on our study model.	17 Participants n=25 Participants • OHSU group did not collect housing data based on our study model.	0 Participants OHSU group did not collect housing data based on our study model.	38 Participants n=50 Participants • OHSU group did not collect housing data based on our study model.
Drug of choice Heroin	23 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	16 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants OHSU did not collect drug use data, as per our study model.	39 Participants n=50 Participants • OHSU did not collect drug use data, as per our study model.
Drug of choice Methamphetamines	0 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	9 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants OHSU did not collect drug use data, as per our study model.	9 Participants n=50 Participants • OHSU did not collect drug use data, as per our study model.
Drug of choice Alcohol	1 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants OHSU did not collect drug use data, as per our study model.	1 Participants n=50 Participants • OHSU did not collect drug use data, as per our study model.
Drug of choice Cannabis	1 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants n=25 Participants • OHSU did not collect drug use data, as per our study model.	0 Participants OHSU did not collect drug use data, as per our study model.	1 Participants n=50 Participants • OHSU did not collect drug use data, as per our study model.