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

• Status: Enrolling by invitation
• Trial end date: 2022-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Gilead Sciences
• Treatments: Sofosbuvir-velpatasvir drug combination

Criteria

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