NCT03627546: HCV ST&RT

HCV Seek, Test and Rapid Treatment for Young PWID

Completed NA Results posted Last updated 29 April 2024

What this trial tests

NA trial testing Rapid Treatment strategy in Hepatitis C in 39 participants. Completed in 30 June 2021.

Timeline

18 September 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	18 September 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Rapid Treatment strategy
• Usual Care (facilitated referral)

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →
• Drug Use — all drugs for Drug Use →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 29, any sex, with Hepatitis C or Drug Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care Primary · Week 48

The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48.

Group	Value	95% CI
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	9
Usual Care (Control Arm)	1

The Proportion of Participants Who Initiate Treatment for HCV Secondary · Week 48

The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48.

Group	Value	95% CI
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	13
Usual Care (Control Arm)	3

Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 Secondary · 48 wks

Group	Value	95% CI
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	1
Usual Care (Control Arm)	0
Baseline RNA Negative	1

Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors Secondary · Baseline and 48 weeks

Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals

Entry

Group	Value	95% CI
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	3
Usual Care (Control Arm)	2
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	10
Usual Care (Control Arm)	5
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	1
Usual Care (Control Arm)	4
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	0
Usual Care (Control Arm)	0

Week 48

Group	Value	95% CI
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	1
Usual Care (Control Arm)	1
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	3
Usual Care (Control Arm)	4
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	1
Usual Care (Control Arm)	0
Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)	5
Usual Care (Control Arm)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm)

Serious: 6/14 (43%)

Deaths: 0/14

Usual Care (Control Arm)

Serious: 5/11 (45%)

Deaths: 0/11

Baseline RNA Negative

Serious: 0

Deaths: 0

Serious adverse events (8 terms)

Reaction	System	Rapid Treatment With Sofos…	Usual Care (Control Arm)	Baseline RNA Negative
Drug overdose	Injury, poisoning and procedural complications	—	—	—
Skin/soft tissue infection	Infections and infestations	—	—	—
pneumonia	Infections and infestations	—	—	—
miscarriage	Pregnancy, puerperium and perinatal conditions	—	—	—
Spleen laceration	Injury, poisoning and procedural complications	—	—	—
Seizure from withdrawal	Nervous system disorders	—	—	—
GI bleed	Gastrointestinal disorders	—	—	—
Sepsis	Infections and infestations	—	—	—

Most-reported serious reactions: Drug overdose, Skin/soft tissue infection, pneumonia, miscarriage, Spleen laceration, Seizure from withdrawal, GI bleed, Sepsis.

Data from ClinicalTrials.gov NCT03627546 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.