Darunavir
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
- Darunavir
- Pharmacist Assessment Report
- Darunavir: HIV protease inhibitor → feline acquired immunodeficiency syndrome
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Darunavir: HIV protease inhibitor → feline acquired immunodeficiency syndrome
One-Sentence Summary
Darunavir is an HIV-1 protease inhibitor. The TxGNN model predicts it may be effective for feline acquired immunodeficiency syndrome, a veterinary indication, with a score of 0.9997. There are currently no clinical trials and no publications directly studying this disease, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | feline acquired immunodeficiency syndrome |
| TxGNN Prediction Score | 0.9997 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 7 of 8; dormant: 1) |
| Number of DINs | 8 (marketed: 7) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available. Darunavir is known as an HIV-1 protease inhibitor, which blocks the viral enzyme needed to mature new virus particles.
Feline immunodeficiency virus (FIV) is a lentivirus related to HIV-1, so a mechanistic rationale exists in principle. However, FIV protease differs from HIV-1 protease in substrate specificity and inhibitor sensitivity. Published work suggests HIV-1 protease inhibitors have reduced activity against FIV protease.
The high score reflects a model prediction only. No trials or literature support it. This is also a veterinary indication, which falls outside the scope of human drug repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02486121 | AURO-DARUNAVIR | Not recorded | Not recorded |
| 02487241 | APO-DARUNAVIR | Not recorded | Not recorded |
| 02486148 | AURO-DARUNAVIR | Not recorded | Not recorded |
| 02487268 | APO-DARUNAVIR | Not recorded | Not recorded |
| 02521350 | DARUNAVIR | Not recorded | Not recorded |
The list shows 5 of the 8 valid licences.
Safety Considerations
- Drug Interactions: 100 interactions were found. Examples from the list include the following.
- Major: cisapride.
- Moderate: antidiabetic drugs (acarbose, metformin, pioglitazone, alogliptin, canagliflozin, dapagliflozin, saxagliptin, chlorpropamide), corticosteroids (hydrocortisone, dexamethasone, betamethasone, budesonide, triamcinolone), clarithromycin and aprepitant.
- Darunavir is typically boosted with ritonavir or cobicistat and has strong CYP3A4-related interaction potential.
For warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting trials or publications, and FIV protease is likely less sensitive to HIV-1 protease inhibitors. The indication is veterinary, so it is not a human repurposing opportunity.
To proceed, the following is needed:
- Laboratory data on darunavir activity against FIV protease
- Veterinary-specific efficacy and safety studies in cats
- Mechanism of action data and package insert safety information
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.