Trial Outcomes & Findings for The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study (NCT NCT03987503)

Results Overview

The number and percent attaining SVR12 after POD HCV treatment, overall, using an intention to treat (participants taking one or more doses of SOF/VEL) and per-protocol analysis (participants completing treatment). Test Details: Blood serum was collected by venipuncture to quantitatively test for HCV RNA. The lower limit of quantification for this polymerase chain reaction test was 15 IU/mL (1.18 log IU/mL) and the minimum level of blood plasma needed was 1.8 mL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

87 participants

Primary outcome timeframe

12 weeks from treatment completion

Results posted on

2025-05-28

Participant Flow

Between July 1 2020 and October 31, 2021 street-outreach recruitment targeted people experiencing homelessness and injecting drugs. Eligibility included being 18 years or older and reporting either lifetime injection drug use or having a blood transfusion in or before 1992.

Of the 492 screened for hepatitis C infection, 403 were excluded. Reasons for exclusion included: 3 untreated HIV, 246 anti-HCV negative, 102 anti-HCV positive and RNA negative, 18 unsuccessful blood draw, 12 other clinical criteria (treatment experience, untreated HIV, HBsAg positivity, or decompensated cirrhosis), and 22 did not return for RNA results. Of the 89 participants eligible for treatment, 87 accepted and 2 declined treatment. All 87 received "at Point-of-Diagnosis HCV Treatment".

Participant milestones

Participant milestones
Measure	at Point-of-Diagnosis HCV Treatment At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.
Overall Study STARTED	87
Overall Study Treatment Completion	69
Overall Study Attended Sustained Virologic Response at 12-weeks (SVR12) Blood Draw Visit	65
Overall Study Undetectable Result at SVR12	58
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	at Point-of-Diagnosis HCV Treatment At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.
Overall Study Lost to Follow-up	20
Overall Study Withdrawal by Subject	2

Baseline Characteristics

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	at Point-of-Diagnosis HCV Treatment n=87 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	22 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks from treatment completion

Population: Participants who started HCV treatment at the point of diagnosis (Intention-to-treat analysis)

The number and percent attaining SVR12 after POD HCV treatment, overall, using an intention to treat (participants taking one or more doses of SOF/VEL) and per-protocol analysis (participants completing treatment). Test Details: Blood serum was collected by venipuncture to quantitatively test for HCV RNA. The lower limit of quantification for this polymerase chain reaction test was 15 IU/mL (1.18 log IU/mL) and the minimum level of blood plasma needed was 1.8 mL.

Outcome measures

Outcome measures
Measure	at Point-of-Diagnosis HCV Treatment n=87 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.	Per-Protocol Analysis n=69 Participants Among those who completed 12-week course of treatment
Sustained Virologic Response at 12-weeks (SVR-12)	58 Participants	58 Participants

SECONDARY outcome

Timeframe: 12 weeks

Time from HCV testing visit to treatment initiation

Outcome measures

Outcome measures
Measure	at Point-of-Diagnosis HCV Treatment n=87 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.	Per-Protocol Analysis Among those who completed 12-week course of treatment
Time From Anti-HCV Testing to Treatment Initiation	7 days Interval 6.0 to 14.0	—

SECONDARY outcome

Timeframe: 24 weeks

Percent of those who started treatment who completed course of treatment

Outcome measures

Outcome measures
Measure	at Point-of-Diagnosis HCV Treatment n=87 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.	Per-Protocol Analysis Among those who completed 12-week course of treatment
Treatment Completion	69 Participants	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Three of the 69 participants could not receive end-of-treatment HCV RNA testing because of blood draw challenges. This is represented in the 61/66 reported with undetectable RNA at treatment completion.

Percent of people who had undetectable RNA at end of treatment. Test Details: Blood serum was collected by venipuncture to quantitatively test for HCV RNA. The lower limit of quantification for this polymerase chain reaction test was 15 IU/mL (1.18 log IU/mL) and the minimum level of blood plasma needed was 1.8 mL.

Outcome measures

Outcome measures
Measure	at Point-of-Diagnosis HCV Treatment n=66 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.	Per-Protocol Analysis Among those who completed 12-week course of treatment
Undetectable RNA at Treatment Completion	61 Participants	—

SECONDARY outcome

Timeframe: 1 day

Population: The number of participants analyzed for this endpoint is greater than in other analyses . since were are studying acceptability of the intervention. Specifically, of participants eligible for treatment (n=89), 87 accepted and enrolled in the study.

Number of persons who decline POD treatment

Outcome measures

Outcome measures
Measure	at Point-of-Diagnosis HCV Treatment n=89 Participants At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site. Epclusa (SOF/VEL): a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.	Per-Protocol Analysis Among those who completed 12-week course of treatment
Acceptability: Number of Persons Who Decline POD Treatment	87 Participants	—

Adverse Events

HCV Treatment at the Point of Diagnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Meghan D. Morris, Associate Professor

University of California, San Francisco

Phone: 415-574-0651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place