Can hepatitis c be cured in just 4 weeks? a new trial puts it to the test
NCT ID NCT03855917
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This pilot study is testing whether a 4-week course of two antiviral drugs—sofosbuvir plus glecaprevir/pibrentasvir—can cure chronic hepatitis C in people who have not been treated before and have only mild liver scarring. Participants who relapse after the short treatment will receive a standard 12-week course of glecaprevir/pibrentasvir. The goal is to see if a shorter, simpler treatment regimen is effective and safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of sofosbuvir and glecaprevir/pibrentasvir
- What this could lead to
- If successful, this could shorten hepatitis C treatment from the standard 8-12 weeks to just 4 weeks, making cure faster and more convenient.
- What could go wrong
- This is a small pilot study with only 30 participants, so results may not apply to everyone. There is a risk of virological relapse after such a short treatment course.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Participants must meet all inclusion criteria to be eligible to participate in this study: 1. Have voluntarily signed the informed consent form. 2. 18 years of age or older. 3. Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months. 4. Quantifiable HCV RNA at screening. 5. HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication). 6. Liver fibrosis stage F0-F2, defined by at least one of the following: 1. Liver stiffness measurement \<9.5 kPa by transient elastography (FibroScan®) 2. AST to platelet ratio index (APRI) \<0.5 3. Liver biopsy 7. 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. 8. Negative pregnancy test at screening and baseline (females of childbearing potential only). 9. All fertile females must be using effective contraception during treatment and during the 30 days after treatment end. Exclusion Criteria: * Participants who meet any of the exclusion criteria are not to be enrolled in this study. 1. History of any of the following: 1. 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. 2. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage). 3. Solid organ transplant. 4. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. 2. Any of the following lab parameters at screening: 1. ALT \> 10 x ULN 2. AST \> 10 x ULN 3. Direct bilirubin \> ULN 4. Platelets \< 150,000/μL (cells/mm3) 5. Creatinine clearance (CLcr) \< 50 mL/min 6. Albumin \< LLN 7. INR \> 1.5 ULN 3. Pregnant or breastfeeding female. 4. HBV infection (HBsAg positive). 5. Use of prohibited concomitant medications as described in protocol section 6.3. 6. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks). 7. Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug. 8. Any investigational drug ≤6 weeks prior to the first dose of study drug. 9. Ongoing severe psychiatric disease as judged by the treating physician. 10. Inability or unwillingness to provide informed consent or abide by the requirements of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Blacktown Mt Druitt Hospital
RECRUITINGSydney, New South Wales, 2148, Australia
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Royal Adelaide Hospital
RECRUITINGAdelaide, South Australia, 5000, Australia
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St Vincent's Hospital
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
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