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

NCT03855917 | Recruiting Phase 4

• 1 other identifier: VHCRP1901
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Hepatitis C

Outcome Measures

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.

  16 weeks

Secondary Outcomes (5)

• Virological relapse

  16 weeks

• Relapse characteristics

  32 weeks

• Re-treatment SVR

  32 weeks

• Adherence

  32 weeks

• Cost-effectiveness

  32 weeks

Study Arms (1)

Sof plus G/P

EXPERIMENTAL

Four weeks of sofosbuvir (400mg) plus glecaprevir-pibrentasvir (300mg/120mg) will be administered, followed by immediate retreatment of virological relapse with glecepravir/pibrentasvir (300mg/120mg) for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).

Drug: Sofosbuvir 400mg [Sovaldi]; Drug: Glecaprevir/pibrentasvir (300mg/120mg)

Interventions

Sofosbuvir 400mg [Sovaldi] DRUG

Four weeks.

Also known as: Sovaldi

Sof plus G/P

Glecaprevir/pibrentasvir (300mg/120mg) DRUG

Four weeks.

Also known as: Maviret

Sof plus G/P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have voluntarily signed the informed consent form.
• 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.
• HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
• Liver fibrosis stage F0-F2, defined by at least one of the following:
• Liver stiffness measurement \<9.5 kPa by transient elastography (FibroScan®)
• AST to platelet ratio index (APRI) \<0.5
• Liver biopsy
• If co-infection with HIV is documented, the subject must meet the following criteria:
• ART naïve with CD4 T cell count \>500 cells/mm3; OR
• On a stable ART regimen (containing only permissible ART - see protocol section 6.3) for \>8 weeks prior to screening visit, with CD4 T cell count \>200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
• Negative pregnancy test at screening and baseline (females of childbearing potential only).
• All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.

You may not qualify if:

• History of any of the following:
• 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.
• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
• Any of the following lab parameters at screening:
• ALT \> 10 x ULN
• AST \> 10 x ULN
• Direct bilirubin \> ULN
• Platelets \< 150,000/μL (cells/mm3)
• Creatinine clearance (CLcr) \< 50 mL/min
• Albumin \< LLN
• INR \> 1.5 ULN
• Pregnant or breastfeeding female.
• HBV infection (HBsAg positive).

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (3)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Blacktown Mt Druitt Hospital

Sydney, New South Wales, 2148, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; glecaprevir; pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Marianne Martinello, MD, PhD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Martinello, MD, PhD

CONTACT

+61293850900; mmartinello@kirby.unsw.edu.au

Pip Marks, MPH Hons

CONTACT

+61293850900; pmarks@kirby.unsw.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: February 11, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)