N/A
Completed N=39
HCV Seek, Test and Rapid Treatment for Young PWID
Hepatitis C · Drug Use
Source: ClinicalTrials.gov NCT03627546 ↗
Enrolled (actual)
39
Serious AEs
44.0%
Results posted
Apr 2024
Primary outcomePrimary: The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care — 9; 1 Participants — p=.01
Summary
The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care |
9; 1 | .01 sig |
| SECONDARY The Proportion of Participants Who Initiate Treatment for HCV |
13; 3 | 0.0007 sig |
| SECONDARY Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure |
— | — |
| SECONDARY Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 |
1; 0; 1 | — |
| SECONDARY Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors |
3; 2; 10; 5; 1; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking
Exclusion Criteria
- Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir
Data sourced from ClinicalTrials.gov (NCT03627546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.