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Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir

ConditionHepatitis C
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

This study aims to evaluate the efficacy, safety and feasibility of four weeks of sofosbuvir plus glecaprevir-pibrentasvir, followed by immediate retreatment of virological relapse with glecepravir-pibrentasvir for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have voluntarily signed the informed consent form.

18 years of age or older.

Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.

Quantifiable HCV RNA at screening.

Disqualifiers

Participants who meet any of the exclusion criteria are not to be enrolled in this study.

Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.

Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).

Solid organ transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sofosbuvir 400mg [Sovaldi]

    Drug

    Four weeks.

  • Glecaprevir/pibrentasvir (300mg/120mg)

    Drug

    Four weeks.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Sof plus G/PExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

SVR12

To evaluate the proportion achieving a sustained virological response at 12 weeks post treatment (SVR12) with sofosbuvir (400 mg) plus glecaprevir/pibrentasvir (300mg/120mg) for four weeks.

Time frame
16 weeks

Secondary outcomes

1

Virological relapse

To evaluate virological relapse following 4 weeks sofosbuvir (400 mg) plus glecaprevir/pibrentasvir (300mg/120mg) in HCV treatment-naïve chronic HCV patients with early liver disease (F0-2).

Time frame
16 weeks
2

Relapse characteristics

In patients with virological relapse, to evaluate the time course of relapse and emergence of treatment-associated resistance substitutions.

Time frame
32 weeks
3

Re-treatment SVR

To evaluate SVR following re-treatment of virological relapse with 12 weeks glecaprevir/pibrentasvir (300mg/120mg).

Time frame
32 weeks
4

Adherence

To evaluate the proportion adherent to treatment and study visits.

Time frame
32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirby Institute

Lead sponsor

Source ClinicalTrials.gov
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