Trial Outcomes & Findings for A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic (NCT NCT03235154)

Last Updated: 2021-05-13

Results Overview

To assess the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment),

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment

Results posted on

2021-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program. sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Overall Study STARTED	11
Overall Study Completed Epclusa. Treatment	8
Overall Study 12-wk Post-treatment HCV RNA Measured	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program. sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Intervention n=11 Participants 12-week Epclusa Treatment
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Co-morbid axis 1 diagnosis present	11 Participants n=5 Participants
HCV (hepatitis C virus) RNA	2,662,207 IU/ml n=5 Participants
Baseline FibroSure fibrosis stage F0	6 Participants n=5 Participants
Baseline FibroSure fibrosis stage F1	2 Participants n=5 Participants
Baseline FibroSure fibrosis stage F2	0 Participants n=5 Participants
Baseline FibroSure fibrosis stage F3	1 Participants n=5 Participants
Baseline FibroSure fibrosis stage F4	0 Participants n=5 Participants
Baseline FibroSure fibrosis stage Unknown	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment

Population: subjects who completed Epclusa treatment and had HCV RNA measured 12 weeks after completion of treatment

Outcome measures

Outcome measures
Measure	Treatment Arm n=7 Participants In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program. sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12)	7 Participants

SECONDARY outcome

Timeframe: Baseline and 12 weeks post treatment

Population: Subjects who completed questionnaire at baseline and 12 weeks after completion of treatment

Change in mean score on 5-point LIkert Scale to statement "My Health is Excellent" (1=definitely true, 5=definitely false) from baseline and 12 weeks post-treatment

Outcome measures

Outcome measures
Measure	Treatment Arm n=7 Participants In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program. sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Health-Related Quality of Life	-0.44 score on a scale Interval -1.0 to 0.0

SECONDARY outcome

Timeframe: This outcome measure will be assessed for each participant during a 12 week course of study treatment.

Population: The 8 subjects who completed treatment

To assess adherence to velpatasvir/sofosbuvir therapy among participants administered treatment in the context of visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental health care.

Outcome measures

Outcome measures
Measure	Treatment Arm n=8 Participants In this open label, single arm study, all subjects will receive the intervention as prescribed by psychiatrists in the office based opiate addition treatment program. sofosbuvir/velpatasvir: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Adherence to Study Treatment	94 % of prescribed doses taken Interval 83.7 to 100.0

Adverse Events

Single Arm Intervention

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Intervention n=11 participants at risk 12-week Epclusa Treatment
Nervous system disorders Altered Mental Status	9.1% 1/11 • Number of events 1 • From study entrance through treatment period
Nervous system disorders Seizure	9.1% 1/11 • Number of events 1 • From study entrance through treatment period
Nervous system disorders Visual Hallucination	9.1% 1/11 • Number of events 1 • From study entrance through treatment period
Psychiatric disorders Suicidal Ideation	9.1% 1/11 • Number of events 1 • From study entrance through treatment period

Other adverse events

Other adverse events
Measure	Single Arm Intervention n=11 participants at risk 12-week Epclusa Treatment
Gastrointestinal disorders GI distress	18.2% 2/11 • From study entrance through treatment period
Nervous system disorders Fatigue	9.1% 1/11 • From study entrance through treatment period
Skin and subcutaneous tissue disorders Scabies	9.1% 1/11 • From study entrance through treatment period

Additional Information

Amy E. Colson, MD

Community Research Initiative of New England

Phone: 6175021700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place