Tenofovir Alafenamide
| Evidence Level: L4 | Predicted Indications: 3 |
Table of Contents
- Tenofovir Alafenamide
- Pharmacist Assessment Report
- Tenofovir Alafenamide: From HIV Infection to Simian Immunodeficiency Virus Infection
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Tenofovir Alafenamide: From HIV Infection to Simian Immunodeficiency Virus Infection
One-Sentence Summary
Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor originally used to treat HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus infection, a preclinical extension of its approved HIV use. Support currently comes from 8 publications, mostly macaque studies, and no registered clinical trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV infectious disease; AIDS |
| Predicted New Indication | Simian immunodeficiency virus infection |
| TxGNN Prediction Score | 0.9989 |
| Evidence Level | L4 |
| India Market Status | Listed in a compiled Indian medicine price dataset (9 of 9) – CDSCO approval status is not included in this data |
| Number of Listed Products | 9 (valid: 9) |
| 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, TAF is a prodrug of tenofovir, a nucleotide reverse transcriptase inhibitor. It delivers tenofovir diphosphate efficiently to lymphoid cells after oral administration, and its efficacy in HIV infection is established.
Simian immunodeficiency virus (SIV) and simian/human immunodeficiency virus (SHIV) are lentiviruses closely related to HIV and use the same reverse transcriptase target. Antiviral activity against them is therefore mechanistically expected.
Importantly, this is essentially a preclinical extension of the approved HIV indication, not a new therapeutic use in humans. Its value lies in serving as a translational model for HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), rather than as a separate clinical indication.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
All studies below are preclinical (animal or animal-model studies); no human trials were identified.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27465645 | 2016 | Preclinical (macaque) | J Infect Dis | Oral emtricitabine + TAF protected macaques from repeated rectal SHIV exposure (PrEP) |
| 31362305 | 2019 | Preclinical (macaque) | J Infect Dis | Oral TAF/emtricitabine or TAF alone evaluated against repeated vaginal SHIV exposure |
| 35913838 | 2022 | Preclinical (macaque, implant) | J Antimicrob Chemother | Biodegradable TAF implant evaluated for safety and efficacy in vaginal PrEP |
| 38134382 | 2024 | Preclinical (macaque) | J Infect Dis | TAF/elvitegravir vaginal inserts gave extended post-exposure protection (earlier work: 93% protection pre-exposure, 100% post-exposure) |
| 39632836 | 2024 | Preclinical (macaque) | Nat Commun | Oral emtricitabine/TAF plus long-acting cabotegravir/rilpivirine, with or without an immune agent, tested for SHIV remission |
| 41342257 | 2026 | Preclinical (macaque) | J Infect Dis | Rectal TAF/elvitegravir inserts gave partial post-exposure protection (82.9%) |
| 39559349 | 2024 | Model development (humanized mouse) | Front Immunol | Dual-purpose mouse model for testing antivirals against both SIV and HIV |
| 31730629 | 2019 | Methods (macaque) | PLoS One | Protocol to train macaques to take daily oral antiretrovirals, with high compliance |
India Market Information
Nine valid single-ingredient registrations are listed. The approved indication text is not available for any of them. Five main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 215021 | Tenvir-AF Tablet (Cipla Ltd) | Bottle of 30 tablets | Not available |
| 215460 | Tentide AF 25mg Tablet (Sun Pharmaceutical Industries Ltd) | Bottle of 30 tablets | Not available |
| 215129 | Tafnat Tablet (Natco Pharma Ltd) | Bottle of 30 tablets | Not available |
| 74276 | Emtaf-B Tablet (Emcure Pharmaceuticals Ltd) | Bottle of 30 tablets | Not available |
| 217734 | Tafsure Tablet (Aprazer Healthcare Pvt Ltd) | Bottle of 30 tablets | Not available |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is preclinical macaque and mouse work, with no registered clinical trials, and the prediction is essentially an extension of the already approved HIV indication. SIV infection is not a human therapeutic target, so it is best treated as a translational research question, not a repurposing candidate.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulatory source (currently missing and blocking safety screening)
- Detailed mechanism of action data (MOA)
- A decision on whether the macaque PrEP/PEP data should feed an HIV prevention programme rather than a separate SIV indication
- Approved indication text for the Indian registrations
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.