Abacavir
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Abacavir: From HIV Infection / AIDS to Simian Immunodeficiency Virus Infection
One-Sentence Summary
Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) originally used to treat HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus (SIV) infection, a virus that infects non-human primates. Support is very thin: 0 clinical trials and 1 publication, an in vitro laboratory study.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV infectious disease; AIDS |
| Predicted New Indication | Simian immunodeficiency virus infection |
| TxGNN Prediction Score | 99.79% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Abacavir is known to be an NRTI active against HIV-1. It blocks the virus's reverse transcriptase, the enzyme the virus needs to copy its genetic material.
SIV is a close relative of HIV, a lentivirus with a similar reverse transcriptase. It is therefore biologically plausible that abacavir would also act against it, which is probably why the model gives such a high score.
SIV is a virus of non-human primates and is mainly used as an animal model for HIV research. It is not a human disease, so this prediction is better read as a research-model link than as a treatment opportunity for patients. There is no clinical development path for this indication.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15040537 | 2004 | In vitro susceptibility study | Antiviral Therapy | Tested the activity of 16 approved anti-HIV drugs and one experimental drug against HIV-2, SIV and SHIV strains in the laboratory, to inform treatment and post-exposure prophylaxis. |
This is indirect, preclinical evidence only. It does not show benefit in any living host.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| SIN16114P | ABACAR Abacavir Tablets USP 300 mg | Tablet, film coated |
| SIN11098P | ZIAGEN Tablets 300 mg | Tablet, film coated |
| SIN15864P | ABALAM Abacavir Sulfate & Lamivudine Tablets 600/300 mg | Tablet, film coated |
| SIN13230P | Kivexa | Tablet |
| SIN15100P | TRIUMEQ Film Coated Tablet 50 mg/600 mg/300 mg | Tablet, film coated |
All five registrations are currently valid, and all are oral tablets.
Safety Considerations
- Disease associations flagged in the knowledge graph (these come from a knowledge graph, not from package insert text): liver failure, liver disease, fatty liver disease, non-alcoholic steatohepatitis, kidney disease, pancreatitis, lactic acidosis, gallbladder disease, myopathy, myositis, dermatomyositis, neutropenia, agranulocytosis, anaemia, hypertriglyceridaemia, obesity and others.
- Drug Interactions: 93 interacting drugs were identified. Two are rated Moderate: naltrexone and orlistat. The rest, including metformin, morphine, omeprazole, pantoprazole, prednisone and vancomycin, have no severity grade in the source.
Please refer to the package insert for authoritative warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is a 2004 laboratory study, with no clinical trials. SIV is an animal virus, so there is no realistic human development path for this indication.
To proceed, the following is needed:
- The package insert warnings and contraindications from the Singapore regulator, which are currently missing
- Detailed mechanism of action data
- A clear research purpose for this indication, such as use only as a preclinical model, since no clinical use is expected
Note: Among the other candidates compiled for abacavir, congenital HIV has far stronger support (a completed Phase 3 trial and several cohort studies). It is an extension of the already approved HIV use and may be a better focus for further evaluation.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.