Lamivudine
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
- Lamivudine
- Pharmacist Assessment Report
- Lamivudine: From Chronic Hepatitis B and HIV Infection to Feline Acquired Immunodeficiency Syndrome
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Lamivudine: From Chronic Hepatitis B and HIV Infection to Feline Acquired Immunodeficiency Syndrome
One-Sentence Summary
Lamivudine is a nucleoside reverse transcriptase inhibitor originally used to treat chronic hepatitis B virus infection, HIV infection and AIDS. The TxGNN model predicts it may be effective for feline acquired immunodeficiency syndrome (FIV infection in cats), but there are no registered clinical trials and only 3 publications, all from veterinary or animal research.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Chronic hepatitis B virus infection; HIV infection; AIDS (the Health Canada licence records contain no indication text) |
| Predicted New Indication | Feline acquired immunodeficiency syndrome |
| TxGNN Prediction Score | 0.9993 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 19 of 20; dormant: 1) |
| Number of DINs | 20 (marketed: 19) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI), and its efficacy in HIV and hepatitis B has been established.
Feline immunodeficiency virus (FIV) is a lentivirus that uses reverse transcriptase in the same way as HIV-1. It causes an AIDS-like disease in cats and is widely used as an animal model of HIV. Several reverse transcriptase inhibitors that work against HIV also work against FIV, so a shared mechanism is plausible.
An important caveat: the supporting studies are veterinary or in-vitro studies. They support the antiviral mechanism but do not translate into a new human indication. The same applies to the second-ranked prediction, simian immunodeficiency virus infection, which is backed only by macaque studies used as models for HIV therapy. The third- and fourth-ranked predictions (a rare neurodevelopmental disorder and an obsolete hyperlipidemia term) have no mechanistic link or evidence. The fifth, chronic hepatitis C, has only general reviews, and lamivudine is not known to inhibit the HCV polymerase.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 22816032 | 2012 | Cohort | Viruses | Compared zidovudine alone and with interferon, lamivudine or valproic acid in naturally FIV-infected cats over one year, tracking clinical status, viral load and CD4+/CD8+ ratios |
| 25855689 | 2016 | Cohort | J Feline Med Surg | Follow-up of long-term antiretroviral therapy (5–6 years, starting with zidovudine) in FIV-infected cats |
| 11684314 | 2002 | In vitro | Antiviral Res | Zidovudine, lamivudine and abacavir combination suppressing FIV replication in cell culture |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02369052 | APO-LAMIVUDINE | Not listed | Not listed |
| 02512467 | JAMP LAMIVUDINE HBV | Not listed | Not listed |
| 02192683 | 3TC | Not listed | Not listed |
| 02507129 | JAMP LAMIVUDINE | Not listed | Not listed |
| 02491753 | DOVATO | Not listed | Not listed |
These are 5 of the 20 valid single-entry licences. The others include lamivudine/zidovudine and abacavir/lamivudine products, TRIUMEQ and DELSTRIGO.
Safety Considerations
- Contraindication or risk signals from the knowledge graph (not label text): liver failure, liver disease, fatty liver disease, non-alcoholic steatohepatitis, kidney disease, pancreatitis, gallbladder disease, lactic acidosis, neutropenia, agranulocytosis, anemia, myopathy, myositis, dermatomyositis, hypertriglyceridemia, and obesity-related disorders.
- Drug Interactions: 100 interactions were found. Moderate-level ones include lactitol, mannitol, naltrexone, orlistat and sorbitol. Others, such as metformin, cimetidine, pantoprazole, omeprazole, morphine and vancomycin, are of unknown severity.
Please refer to the package insert for authoritative warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is supported only by veterinary cohort studies and in-vitro work. There are no clinical trials, and the prediction is not a new human indication. Lamivudine is already marketed for HIV and hepatitis B.
To proceed, the following is needed:
- Clarify whether a veterinary indication is within scope, since there is no human target population
- Detailed mechanism of action data
- Health Canada package insert warnings and contraindications for formal safety screening
- Indication text and dosage forms for the Canadian licences
- Re-evaluation of the other predicted indications, which currently lack support
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.