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

NCT03987503 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: IN-US-342-5516
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Keywords

People who inject drugs; Homeless; Community-based testing and treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time From Anti-HCV Testing to Treatment Initiation

  12 weeks

• Treatment Completion

  24 weeks

• Undetectable RNA at Treatment Completion

  12 weeks

• Acceptability: Number of Persons Who Decline POD Treatment

  1 day

Study Arms (2)

at Point-of-Diagnosis HCV treatment

EXPERIMENTAL

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); Device: Fibroscan® 430 Mini Plus

Passive observation

ACTIVE COMPARATOR

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

Interventions

Epclusa (SOF/VEL) DRUG

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.

at Point-of-Diagnosis HCV treatment

Standard of care DRUG

Standard of HCV care provided by medical care provider

Passive observation

Fibroscan® 430 Mini Plus DEVICE

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.

Also known as: Fibroscan

at Point-of-Diagnosis HCV treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94153, United States

Location

Related Publications (2)

• Kim RG, McDonell C, McKinney J, Catalli L, Price JC, Morris MD. Staff-Facilitated Telemedicine Care Delivery for Treatment of Hepatitis C Infection among People Who Inject Drugs. Healthcare (Basel). 2024 Mar 25;12(7):715. doi: 10.3390/healthcare12070715.

  PMID: 38610138 DERIVED

• Morris MD, McDonell C, Luetkemeyer AF, Thawley R, McKinney J, Price JC. Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2338792. doi: 10.1001/jamanetworkopen.2023.38792.

  PMID: 37862013 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

sofosbuvir-velpatasvir drug combination; Standard of Care

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Meghan D. Morris, Associate Professor
• Organization: University of California, San Francisco

meghan.morris@ucsf.edu

415-574-0651

Study Officials

• Meghan D Morris, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: July 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: December 29, 2022
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)