Pibrentasvir
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Pibrentasvir
- Pharmacist Assessment Report
- Pibrentasvir: From Hepatitis C Virus Infection to Hepatitis B Virus Infection
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Pibrentasvir: From Hepatitis C Virus Infection to Hepatitis B Virus Infection
One-Sentence Summary
Pibrentasvir is an NS5A inhibitor, used in the glecaprevir/pibrentasvir combination (Maviret) to treat chronic hepatitis C virus (HCV) infection. The TxGNN model predicts it may be effective for hepatitis B virus infection, but the data compiled for this report contain no clinical trials and no publications showing anti-HBV activity. The high score appears to reflect network proximity among viral hepatitis conditions rather than a demonstrated mechanism.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Chronic hepatitis C virus infection (from the knowledge graph; no approved indication text is recorded for the ARTG entry) |
| Predicted New Indication | Hepatitis B virus infection |
| TxGNN Prediction Score | 0.9984 |
| Evidence Level | L4 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the compiled data. Pibrentasvir is known to be an HCV NS5A inhibitor, and its efficacy in HCV is well established. Its role in treating HBV is not supported mechanistically.
HBV has no NS5A homologue, so there is no clear shared drug target. HBV and HCV are both hepatotropic viruses and cause chronic liver disease, which is probably why the model sees them as related. The score of 0.9984 comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
The literature retrieved concerns HCV treatment. Some general viral hepatitis reviews mention HBV, but none shows anti-HBV activity of pibrentasvir. The prediction should therefore be treated as a hypothesis only.
Clinical Trial Evidence
Currently no clinical trials are registered for pibrentasvir in hepatitis B virus infection.
Literature Evidence
The retrieved items below were matched to the predicted indication. All concern HCV or general viral hepatitis, and none tests pibrentasvir against HBV.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31981264 | 2020 | Cohort | J Viral Hepat | Real-world GLE/PIB use in HCV with severe renal impairment (CKD 4-5, n=108, Taiwan) |
| 30982721 | 2019 | Review | Lancet Gastroenterol Hepatol | HCV infection in children and adolescents; direct-acting antivirals have transformed treatment |
| 31041789 | 2019 | Review | Semin Liver Dis | Retreatment of HCV patients after direct-acting antiviral failure |
| 31114957 | 2019 | Review | Clin Pharmacokinet | Pharmacokinetics and pharmacodynamics of HCV therapies, including GLE/PIB |
| 34092970 | 2021 | Review | World J Gastroenterol | Paediatric viral hepatitis; notes HBV treatment is currently far from curative |
| 35579223 | 2022 | Review | Eur J Gen Pract | HCV diagnosis and treatment for family physicians |
| 29369303 | 2018 | Conference report | AIDS Rev | International Conference on Viral Hepatitis 2017 summary |
| 42127258 | 2026 | Conference report | Top Antivir Med | CROI 2026 viral hepatitis advances; HBV outcomes and investigational agents |
| 30964552 | 2019 | Preclinical | Hepatology | HCV protease inhibitor resistance variants |
| 34344581 | 2021 | Case report | J Infect Chemother | GLE/PIB for HCV exacerbation triggered by a daratumumab-based regimen |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 11332K | Maviret | Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir | Not recorded in the data compiled for this report |
Safety Considerations
Please refer to the TGA-approved Product Information (PI) for safety information. No drug interaction records were found in the data compiled for this report. This does not mean there are no interactions; the PI should be consulted.
Conclusion and Next Steps
Decision: Hold
Rationale: There is no clinical or published evidence of anti-HBV activity, and no shared target between pibrentasvir (an HCV NS5A inhibitor) and HBV. The high TxGNN score likely reflects network proximity among viral hepatitis nodes, so this prediction is a model output only.
To proceed, the following is needed:
- In vitro HBV antiviral activity data for pibrentasvir
- Mechanism of action data to support any proposed HBV target
- The approved indication text and Product Information for the Australian ARTG entry
- Safety review, including HBV reactivation considerations in HBV/HCV co-infected patients, using the TGA PI
Other predictions in the data (HIV infection, hepatitis E, hepatitis A, animal viral hepatitis, Omsk haemorrhagic fever, Kyasanur forest disease, simian and feline immunodeficiency, and a neurodevelopmental disorder) were reviewed. None had mechanistic support or direct evidence. The HIV and hepatitis A trials are HCV studies (including HIV co-infected patients) that support the original HCV indication, not a new one. All are also rated Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.