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

Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Epclusa (SOF/VEL); Device: Fibroscan® 430 Mini Plus; Drug: Standard of care

Detailed Description

This study is a non-randomized interventional study.

NOW is an open-label study evaluating the feasibility, acceptability, and effectiveness of an accelerated community-based treatment program of SOF/VEL x 12 weeks started at time of chronic HCV diagnosis (intervention).

The purpose of the proposed study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available direct-acting antiviral (DAA) therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The proposed study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site. The fixed site is located in the Tenderloin Neighborhood of San Francisco: The Quaker Meeting House (QMH). The QMH is the current location for an established drop-in center for young adult (< 30 years old) people who inject drugs, a group at highest risk for acquiring new HCV infection but representing a group with the lowest engagement in HCV treatment. The QMH site is complete with two phlebotomy stations, centrifuge, clinical exam station, interview rooms, and office space. The QMH research site will prioritize study enrollment for young adult people who inject drugs (PWID). The community mobile site (DeLIVER Van) is situated in a mobile van; a 145 sqft space equipped with a phlebotomy station, clinical exam table, centrifuge, and portable Fibroscan® 430 Mini Plus. The DeLIVER Van will serve two neighborhoods in San Francisco with high HCV burden but few community-based medical service organizations: the Bayview neighborhood and Outer Mission neighborhood.

The investigators will (1) implement new tools, notably FIBROSCANS, to measure fibrosis in an at-risk group (HCV positive patients); (2) implement a new standard of care, treatment on-demand in an at-risk group (HCV positive active drug users); (3) assess the feasibility and acceptability of expanding standard of care into non-clinical settings.

At study entry, participants will undergo a combined eligibility screening/entry visit, which includes HCV testing (antibody and RNA), rapid anti-HIV test, and HBsAG (hepatitis B virus surface antigen) testing and consent for medical record linkage. If HCV RNA reactive, participants are offered enrollment into the treatment cohort and provided 2 week supply of SOF/VEL (provided by Gilead as part of the NOW Study) upon completion of a clinical evaluation, baseline survey, and venipuncture for baseline labs. If the participant is actively insured, the study investigators will obtain insurance-authorized SOF/VEL to complete the remainder of the 12 week treatment course. If the participant is not actively insured, the study team will assist with insurance acquisition and subsequently obtain insurance-authorized SOF/VEL to complete the remainder of the 12 week treatment course. For any participants, if insurance-authorized SOF/VEL is delayed beyond the initial 2 week study-provided SOF/VEL, additional supplies of SOF/VEL as needed to ensure an uninterrupted 12 week treatment course. Participants will return every 2 weeks during treatment (12 week course) for medication dispensation and study visit activities. And for two post-treatment visits for clinical monitoring (e.g., HCV RNA testing) and research activities.

Study participants in the intervention study (cohort): Chronic HCV (anti-HCV positive and HCV RNA positive) men and women ages ≥18 years newly diagnosed or re-engaged in care at a fixed or mobile community-based site. Participants should be HBsAg negative, have no known history of decompensated cirrhosis or end stage renal disease, not be pregnant or breastfeeding, and not be taking medications that are contraindicated with SOF/VEL.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94153
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥18 years of age
• anti-HCV and HCV RNA positive,
• Lifetime injection drug use or blood transfusion before 1991
• interested in starting HCV treatment at the time of diagnosis
• Women of childbearing potential engaged in sexual activity that could lead to pregnancy
• must consent to use contraception and agree to pregnancy testing during treatment
• If currently not enrolled in insurance, agree to assistance to enroll in insurance

Exclusion Criteria:

• HBsAg positive from pre-screening visit and no medically controlled hepatitis B virus (HBV) condition
• History of hepatic decompensation (ascites, hepatic encephalopathy, or variceal hemorrhage).
• Current use of medications that is not compatible with SOF/VEL use, according to current prescribing guidelines, including amiodarone or a proton pump inhibitor exceeding 20 mg of omeprazole equivalent.
• Prior treatment with an NS5a based HCV treatment regimen with subsequent viral rebound. Participants who have clear HCV reinfection as defined by an HCV GT that is different from the original genotype may enroll. If genotype results are not available from the initial and subsequent HCV infection, the individual will not be enrolled unless participant can provide SVR-12 record confirming HCV cure.
• Pregnancy or breastfeeding.
• Life expectancy of < 12 months as assessed by study clinical health provider.
• Late exclusion criteria: Participants with the following lab values at week 0 will be evaluated on a case by case basis for continuation of SOF/VEL at the week 2 visit
• Albumin < 3.0
• Hemoglobin < 8.0 (women) and < 9.0 g/dl ( men)
• Platelet count < 50,000
• creatinine (Cr) clearance (estimated by Cockcroft-Gault) < 30 ml/min
• aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 10 x ULN
• Total bilirubin > 1.5x ULN (for participants on atazanavir, > 3 x ULN), international normalized ratio (INR) > 1. 5 x ULN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Device: Fibroscan® 430 Mini Plus; Trained research staff will measure participants liver stiffness using liver ultrasonographic elastography. Research staff place ultrasound gel directly on participant's skin on the area of the torso. Research staff will position the participant's body on the exam table to assure the liver can be located, placing the small probe on the body's surface (skin with gel) and begin recording images of the participant's liver. The procedure will take 15-30 minutes, depending on the ease with which the research staff is able to accurately locate the participant's liver. Results from the FibroScan will be discussed with a trained provider.; Other Names: Fibroscan
Active Comparator: Passive observation; Participants who test positive for HCV chronic infection (HCV RNA positive, and anti-HCV positive) but elect to not enroll in the intervention arm. Electronic medical record data will be reviewed for up to 2 years for HCV related care information (e.g., HCV treatment start date, end date, SVR-12).	Drug: Standard of care; Standard of HCV care provided by medical care provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Virologic Response at 12-weeks (SVR-12)	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.	12 weeks from treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Anti-HCV Testing to Treatment Initiation	Time from HCV testing visit to treatment initiation	12 weeks
Treatment Completion	Percent of those who started treatment who completed course of treatment	24 weeks
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.	12 weeks
Acceptability: Number of Persons Who Decline POD Treatment	Number of persons who decline POD treatment	1 day

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Meghan D Morris, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: People who inject drugs; Homeless; Community-based testing and treatment
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir-velpatasvir drug combination
• Other Study ID Numbers: IN-US-342-5516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary statistics of primary and secondary outcome data and overall sample demographics (e.g., gender, age, ethnicity/race) will be shared with researchers through annual conference presentations and final results related to the study aims will be disseminated via peer-reviewed manuscripts.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No