Emtricitabine
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
- Emtricitabine
- Pharmacist Assessment Report
- Emtricitabine: 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
Emtricitabine: From HIV Infection to Simian Immunodeficiency Virus Infection
One-Sentence Summary
Emtricitabine is an antiretroviral drug (a nucleoside reverse transcriptase inhibitor) used for HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus infection, a primate model of the same disease family. There are no registered clinical trials, but 20 publications, mostly macaque studies, touch on this direction. This is a preclinical or veterinary question rather than a new human therapeutic use.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV infection and AIDS (relation recorded in the knowledge graph; the licence records compiled for this report contain no indication text) |
| Predicted New Indication | Simian immunodeficiency virus infection |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
The evidence level is L5 even though the macaque literature is substantial. No cited study is a human clinical trial, and the macaque studies mostly examine SHIV (a chimeric virus) challenge for prevention, not SIV infection treatment in humans. Under the evidence rules, no study directly establishes this predicted disease as a human therapeutic target.
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known pharmacology, emtricitabine is a nucleoside reverse transcriptase inhibitor. It acts on the reverse transcriptase enzyme that lentiviruses need to replicate. SIV and HIV have closely related reverse transcriptases, so activity against SIV is mechanistically plausible.
The relationship between the original and predicted indications is close. SIV is the primate counterpart of HIV and is widely used as a model for HIV research. Macaque studies show that emtricitabine combined with tenofovir (TDF or TAF) protected animals from rectal and vaginal SHIV challenge. The M184V mutation, the resistance mutation associated with emtricitabine, has also been characterised in SIV.
This is therefore best read as a preclinical or veterinary model of the drug’s existing antiviral use, not as a new human therapeutic indication.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Most listed studies are macaque or other animal studies, and none is a human RCT. Only a selection is shown.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27465645 | 2016 | Preclinical (macaque) | J Infect Dis | Oral emtricitabine plus tenofovir alafenamide protected macaques from repeated rectal SHIV exposure |
| 31362305 | 2019 | Preclinical (macaque) | J Infect Dis | Oral TAF/emtricitabine or TAF alone tested against vaginal SHIV infection |
| 26743846 | 2016 | Preclinical (macaque) | J Infect Dis | Emtricitabine/TDF prevention was tested in macaques coinfected with Chlamydia and Trichomonas |
| 24914761 | 2014 | Preclinical (macaque) | AIDS Res Hum Retroviruses | A virus-like-particle vaccine combined with partially protective oral PrEP prevented SHIV infection |
| 12021341 | 2002 | Preclinical virology | J Virol | The M184V mutation emerged within 5 weeks in SIV-infected newborn macaques treated with lamivudine or emtricitabine, with reduced viral fitness |
| 22964889 | 2012 | Review | Curr Opin HIV AIDS | Lessons from animal models of antiretroviral prophylaxis |
| 22918448 | 2012 | Review | Curr Opin HIV AIDS | Considerations for antiretroviral chemoprophylaxis in men who have sex with men |
| 20874040 | 2010 | Review | Pharmacotherapy | Systemic pre-exposure prophylaxis for HIV infection |
| 23633402 | 2013 | Preclinical (macaque) | J Infect Dis | Oral emtricitabine/TDF was tested against a tenofovir-resistant SHIV carrying the K65R mutation |
| 21632769 | 2011 | Preclinical (macaque) | J Virol | Intermittent Truvada prophylaxis was tested against an emtricitabine-resistant SHIV (M184V) |
India Market Information
At least 20 valid single-ingredient registrations were found, and the list may be partial. The records compiled for this report contain no approved-indication text, so indications are not shown. The five below are examples.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 80332 | Emfovir Tablet | Bottle of 30 tablets | Not stated in the records |
| Registration No. 216754 | Tafero EM Tablet | Strip of 30 tablets | Not stated in the records |
| Registration No. 215299 | Tenvir-EM Tablet | Strip of 30 tablets | Not stated in the records |
| Registration No. 227746 | Timeovir-EM Tablet | Bottle of 30 tablets | Not stated in the records |
| Registration No. 224996 | Tofocom 200 mg/300 mg Tablet | Strip of 30 tablets | Not stated in the records |
Safety Considerations
Contraindication relations recorded in the knowledge graph (these are not label text and should not be read as official contraindications): long QT syndrome, torsades de pointes, liver failure, liver disease, fatty liver disease, non-alcoholic steatohepatitis, kidney disease, lactic acidosis, Fanconi renotubular syndrome, hypophosphatemia, osteomalacia, rickets, chronic hepatitis B and C virus infection, epilepsy, anxiety disorder, hypertriglyceridemia, and obesity disorder, among others.
Drug interactions (20 recorded, from DDInter):
- Major: leflunomide, teriflunomide
- Moderate: orlistat, naltrexone, cobicistat, methotrexate, cladribine, clofarabine, epirubicin, idelalisib, cabozantinib, interferon beta-1a and beta-1b, peginterferon beta-1a, brentuximab vedotin, asparaginase, pegaspargase, tioguanine, trabectedin
- Minor: eribulin
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The high model score (0.9992) is backed only by animal studies, mainly macaque SHIV prevention studies, and there are no registered clinical trials. The prediction mostly restates the drug’s existing antiviral activity in a primate model. It does not point to a new human therapeutic use.
To proceed, the following is needed:
- A clear definition of the goal, for example use of the SIV/SHIV macaque model for research, or a veterinary use
- Detailed mechanism-of-action data
- Package insert warnings and contraindications from the India regulator
- Approved-indication text for the India licences
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.