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

Hepatitis C, Chronic Clinical Trial

— NOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987503
• Other study ID #: IN-US-342-5516
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: December 29, 2022

Study information

• Verified date: January 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 29, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• =18 years of age

• anti-HCV and HCV RNA positive,

• 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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.
• Standard of care
Standard of HCV care provided by medical care provider

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR-12	The number and proportion attaining SVR12 after POD HCV treatment, overall,using a modified intention to treat analysis (participants taking one or more doses of SOF/VEL).	24 weeks from the start of treatment
Primary	SVR-12, by project site	The number and proportion attaining SVR12 after POD HCV treatment, by site, using a modified intention to treat analysis (participants taking one or more doses of SOF/VEL).	24 weeks from the start of treatment
Secondary	Time from HCV testing to treatment initiation	Time from HCV testing visit to treatment initiation	24 weeks
Secondary	Time from HCV testing to treatment completion	Time from HCV testing visit to treatment completion	24 weeks
Secondary	Time from HCV testing to SVR-12.	Time from HCV testing visit to SVR-12	24 weeks
Secondary	Treatment adherence	Adherence as estimated by pill count at 4-week intervals, week 4 HCV viral load, and self-disclosure treatment adherence.	12 weeks
Secondary	Treatment adherence at 4 weeks	Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 28 pills.	4 weeks from treatment initiation
Secondary	Treatment adherence at 8 weeks	Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 56 pills.	8 weeks from treatment initiation
Secondary	Treatment adherence at 12 weeks	Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 84 pills.	12 weeks from treatment initiation
Secondary	Treatment adherence	Adherence as estimated by HCV viral load test (PCR) at 4 weeks	4 weeks from treatment initiation
Secondary	Treatment adherence	Adherence as estimated by HCV viral load test (PCR) at 12 weeks	12 weeks from treatment initiation
Secondary	Acceptability: Number of persons who decline POD treatment	Number of persons who decline POD treatment	1 day
Secondary	Acceptability: median age by declined	Comparison of median age by declined POD treatment group vs POD treatment initiate group.	1 day
Secondary	Acceptability: percent female by declined	Comparison of percent female by declined POD treatment group vs POD treatment initiate group.	1 day
Secondary	Acceptability: percent non-white race/ethnicity by	Comparison of percent non-white race/ethnicity by declined POD treatment group vs POD treatment initiate group.	1 day
Secondary	Acceptability: percent homeless in past 30 days	Comparison of percent homeless in past 30 days by declined POD treatment group vs POD treatment initiate group.	1 day
Secondary	Acceptability: percent injected drugs in past 30 days	Comparison of percent injected drugs in past 30 days by declined POD treatment group vs POD treatment initiate group.	1 day
Secondary	Acceptability: percent jail/prison stay in past 30 days	Comparison of percent jail/prison stay in past 30 days by declined POD treatment group vs POD treatment initiate group.	1 day