Elvitegravir
| Evidence Level: L4 | Predicted Indications: 3 |
Table of Contents
- Elvitegravir
- Pharmacist Assessment Report
- Elvitegravir: From HIV Infection to Simian Immunodeficiency 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
Elvitegravir: From HIV Infection to Simian Immunodeficiency Virus Infection
One-Sentence Summary
Elvitegravir is an HIV-1 integrase inhibitor, marketed in Australia as part of the Genvoya combination tablet and used to treat HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus (SIV) infection, but there are currently no registered clinical trials and only 8 publications, all preclinical (animal or laboratory) studies.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV infectious disease; AIDS (the ARTG entry has no indication text recorded) |
| Predicted New Indication | Simian immunodeficiency virus infection |
| TxGNN Prediction Score | 0.9989 |
| 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?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, elvitegravir belongs to the integrase strand transfer inhibitor (INSTI) class and is used as part of a fixed-dose combination with cobicistat, emtricitabine and tenofovir alafenamide. Its efficacy in HIV-1 infection is established, and mechanistically it may be applicable to SIV.
HIV-1 and SIV are closely related lentiviruses with a conserved integrase active site. Laboratory studies show that integrase inhibitors are active against SIVmac239 and simian-tropic HIV, and that resistance mutations behave similarly in both viruses.
An important caveat: SIV infects non-human primates, so this “new indication” is relevant mainly as a translational research model for HIV, which is already the approved use. It does not represent a new human therapeutic indication. The other two TxGNN predictions (feline AIDS and a rare neurodevelopmental disorder) have no supporting studies and appear to be TxGNN model (deep learning) artefacts; the feline indication is also veterinary and outside the scope of human drug repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38134382 | 2024 | Preclinical animal study | J Infect Dis | Vaginal tenofovir alafenamide/elvitegravir inserts gave extended post-exposure protection against SHIV in macaques (earlier work: 93% protection when given before and 100% after exposure) |
| 41342257 | 2026 | Preclinical animal study | J Infect Dis | Rectal tenofovir alafenamide/elvitegravir inserts gave partial post-exposure protection (82.9%) against SHIV in macaques |
| 17977962 | 2008 | In vitro study | J Virol | Elvitegravir blocked HIV-1 integration with broad activity across subtypes; resistance profile described |
| 39559349 | 2024 | Preclinical mouse model | Front Immunol | Dual-purpose humanised mouse model for testing antiviral strategies against both SIV and HIV |
| 25583721 | 2015 | In vitro model | Antimicrob Agents Chemother | Simian-tropic HIV used as a model to study resistance to integrase inhibitors |
| 24920794 | 2014 | In vitro study | J Virol | HIV integrase resistance mutations introduced into SIVmac239 changed susceptibility to INSTIs, including elvitegravir |
| 26378179 | 2015 | In vitro study | J Virol | Resistance profiles of INSTIs in SIVmac239 were characterised |
| 28923862 | 2017 | In vitro study | Antimicrob Agents Chemother | Bictegravir and cabotegravir were active against INSTI-resistant SIVmac239 and HIV-1 (indirect relevance to elvitegravir) |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 11114Y | Genvoya | Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg | Not recorded in the data compiled for this report |
Safety Considerations
- Drug Interactions: 27 interactions were identified in total. The main ones listed here are:
- Major: zinc salts (acetate, gluconate, sulfate, chloride), lumacaftor, apalutamide
- Moderate: polyvalent cation antacids (magnesium oxide, magnesium hydroxide, magnesium carbonate, magaldrate, aluminium hydroxide, calcium carbonate), sodium citrate, sodium bicarbonate, dexamethasone, orlistat, diclofenac, elagolix, somatotropin, ethinylestradiol
For warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence is limited to in vitro and animal studies (L4), with no clinical trials. SIV infection occurs in non-human primates, so the prediction does not translate into a new human indication. It is useful mainly as a research model for HIV, where elvitegravir is already approved.
To proceed, the following is needed:
- Confirmation that a human-relevant indication exists (SIV is not a human disease)
- Mechanism of action data for elvitegravir
- Warnings and contraindications from the TGA Product Information
- Approved indication text for the ARTG entry
- Clinical data, if any human use (for example, topical HIV prevention inserts) is to be pursued
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.