Cobicistat

Evidence Level: L5

Predicted Indications: 3

Cobicistat

Pharmacist Assessment Report

Cobicistat: CYP3A inhibitor (pharmacokinetic booster) → feline acquired immunodeficiency syndrome

One-Sentence Summary

Cobicistat is a CYP3A inhibitor used as a pharmacokinetic booster in HIV-1 antiretroviral combinations. The TxGNN model predicts it may be relevant to feline acquired immunodeficiency syndrome, but no clinical trials and no publications were found to support this prediction.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	feline acquired immunodeficiency syndrome
TxGNN Prediction Score	0.9992
Evidence Level	L5
Australia Market Status	Listed on the PBS Schedule (4 of 4 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	4 (valid: 4)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Cobicistat has no antiviral activity of its own. It inhibits the CYP3A enzymes, which raises blood levels of co-administered antiretrovirals such as atazanavir, darunavir and elvitegravir. Detailed mechanism-of-action data were not available in the data compiled for this report.

The high score most likely reflects how closely the predicted disease sits to HIV-related conditions in the model’s network. Feline immunodeficiency virus is a lentivirus related to HIV. Any benefit would depend on a partner antiretroviral that is active against that virus, and this has not been established. Veterinary use is also outside the scope of human drug repurposing.

The two other predictions in the compiled data, simian immunodeficiency virus infection (0.9992) and a rare neurodevelopmental disorder (0.9991), carry no supporting trials or literature either. The neurodevelopmental disorder has no identifiable mechanistic link to cobicistat.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 10903W	Prezcobix	Tablet containing darunavir 800 mg with cobicistat 150 mg	Not recorded in the local data
ARTG 10692R	Evotaz	Tablet containing atazanavir 300 mg and cobicistat 150 mg	Not recorded in the local data
ARTG 11114Y	Genvoya	Tablet containing tenofovir alafenamide 10 mg, emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg	Not recorded in the local data
ARTG 11955F	Symtuza	Tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg	Not recorded in the local data

Safety Considerations

Drug Interactions: 420 interactions were recorded in the data compiled for this report. Examples of those rated Major include:
- loperamide
- triamcinolone
- cisapride
- budesonide
Moderate examples include hydrocortisone, dexamethasone, aprepitant, clarithromycin, repaglinide and metoclopramide.

Warnings and contraindications were not available. Please refer to the TGA-approved Product Information (PI) for full safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on model output alone. No trials or publications address this disease. Cobicistat only boosts other drugs, and the predicted condition is a veterinary one, not a human indication.

To proceed, the following is needed:

Studies that directly examine this disease, with a defined partner antiretroviral
Mechanism-of-action data
Product Information safety data (warnings and contraindications)
A review of the 420 recorded drug interactions for any proposed new use
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.