Tenofovir Alafenamide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Tenofovir Alafenamide
- Tenofovir Alafenamide: From HIV Infection to Simian Immunodeficiency Virus Infection
Tenofovir Alafenamide: From HIV Infection to Simian Immunodeficiency Virus Infection
One-Sentence Summary
Tenofovir alafenamide (TAF) was originally developed for HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus (SIV) infection, but the evidence is limited to 8 preclinical publications (mostly macaque studies) and no registered clinical trials. SIV infection is an animal-model disease, not a human clinical target, so this prediction is better read as a confirmation of TAF's anti-retroviral activity than as a new human indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV infection / AIDS |
| Predicted New Indication | Simian immunodeficiency virus infection |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the compiled data. TAF is known to be a prodrug of tenofovir and a nucleotide reverse transcriptase inhibitor. It is used in HIV treatment and in several fixed-dose combinations. SIV and the chimeric SHIV viruses are close relatives of HIV that also depend on reverse transcription, so activity against them is mechanistically coherent.
The original indication (HIV) and the predicted indication (SIV) are essentially the same virus family studied in a different host. Macaque SIV/SHIV models are widely used to test HIV prevention (PrEP, PEP) and cure strategies. The prediction therefore mostly reflects the drug's use as a research tool in these models, not a new treatment opportunity for patients.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
All retrieved publications are preclinical. No randomised human trials exist for this indication.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27465645 | 2016 | Preclinical (macaque) | J Infect Dis | Oral emtricitabine + TAF protected macaques from repeated rectal SHIV exposure, supporting TAF for PrEP |
| 31362305 | 2019 | Preclinical (macaque) | J Infect Dis | Tested oral TAF/emtricitabine and TAF alone against repeated vaginal SHIV exposure |
| 35913838 | 2022 | Preclinical (implant, animal) | J Antimicrob Chemother | Biodegradable TAF-releasing implant evaluated for safety and vaginal protection in macaques |
| 38134382 | 2024 | Preclinical (macaque) | J Infect Dis | TAF/elvitegravir vaginal inserts gave extended post-exposure protection (earlier work: 93% protection before and 100% after exposure) |
| 39632836 | 2024 | Preclinical (macaque) | Nat Commun | Early treatment with oral emtricitabine/TAF plus long-acting cabotegravir/rilpivirine, with or without an immune agent, aimed at SHIV remission |
| 41342257 | 2026 | Preclinical (macaque, topical insert) | J Infect Dis | TAF/elvitegravir rectal inserts gave partial post-exposure protection (82.9%) |
| 39559349 | 2024 | Preclinical (humanized mouse) | Front Immunol | Dual-purpose mouse model for testing antivirals against both SIV and HIV |
| 31730629 | 2019 | Preclinical (methods) | PLoS One | Protocol for training macaques to take daily oral antiretrovirals, for HIV prevention and treatment research |
Singapore Market Information
TAF is registered in Singapore in 5 valid single-ingredient-listed licences, all oral film-coated tablets. The registration records do not include approved-indication text.
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| SIN15392P | VEMLIDY 25 mg | Film-coated tablet |
| SIN15322P | DESCOVY 200 mg/25 mg | Film-coated tablet |
| SIN15321P | DESCOVY 200 mg/10 mg | Film-coated tablet |
| SIN16015P | ODEFSEY 200 mg/25 mg/25 mg | Film-coated tablet |
| SIN15604P | BIKTARVY 50 mg/200 mg/25 mg | Film-coated tablet |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The supporting evidence is entirely preclinical (macaque and mouse studies) and there are no registered trials. SIV infection is an animal-model disease, so there is no human repurposing opportunity. The prediction mainly confirms TAF's anti-retroviral activity, which is already established in its approved HIV use.
To proceed, the following is needed:
- A clinically relevant human target. The data compiled for this report suggest chronic hepatitis B virus infection (lower-ranked in the model, but with Phase 3 evidence, L1) is a far stronger candidate to evaluate.
- Detailed mechanism of action data (MOA).
- Package insert warnings and contraindications from the Singapore regulator (HSA) to support safety screening.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.