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