Combating Related Epidemics in HCV

Starting soon · Phase 4

Conditions studied: HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV), HEPATITIS C (HCV)

In brief

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

Key facts

Study ID

NCT07560046

Run by

Duke University

People needed

1280

Starts

2026-08-01

Expected to finish

2030-12-30

Last updated by the study team

2026-05-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Can provide written informed consent or assent
• Minimum of 16 years of age
• Willing to undergo HIV, HCV, HBV testing
• Willing to undergo treatment for HCV and complete study activities

You may not qualify if…

• History of HCV treatment for current infection
• Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI
• Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
• History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
• Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.
• Retreatment Inclusion Criteria:
• Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 \& CTP score available within 90-days of retreatment initiation.
• Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA <LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA >LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection
• Retreatment Exclusion Criteria:
• Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.
• Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
• Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
• History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
• Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

Full record on ClinicalTrials.gov

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