Lamivudine

Evidence Level: L5

Predicted Indications: 5

Lamivudine

Pharmacist Assessment Report

Lamivudine: From HIV/Hepatitis B Infection to Feline Acquired Immunodeficiency Syndrome

One-Sentence Summary

Lamivudine is a nucleoside reverse transcriptase inhibitor whose relations to chronic hepatitis B, HIV infection and AIDS are recorded in the knowledge graph, and it is marketed in India under many single-ingredient registrations. The TxGNN model predicts it may be effective for feline acquired immunodeficiency syndrome (FIV infection in cats), with 0 clinical trials and 3 publications (all veterinary or preclinical) currently supporting this direction. This is a veterinary research question rather than a new human indication.

Quick Overview

Item	Content
Original Indication	Chronic hepatitis B virus infection, HIV infectious disease, AIDS (relations recorded in the knowledge graph; the licence records compiled for this report contain no indication text)
Predicted New Indication	Feline acquired immunodeficiency syndrome
TxGNN Prediction Score	0.9993
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 because no cited study investigates lamivudine alone in this disease. The three cat or in vitro FIV studies test multi-drug regimens, so the contribution of lamivudine cannot be separated. The system’s preliminary rating was L3, but it is lowered here under the evidence ceiling rule.

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Lamivudine is known as a nucleoside reverse transcriptase inhibitor (NRTI), a class that blocks viral DNA synthesis by the viral reverse transcriptase.

Feline immunodeficiency virus (FIV) is a lentivirus that causes an AIDS-like disease in cats. Its reverse transcriptase is homologous to that of HIV-1, and several NRTIs active against HIV also act against FIV. FIV infection in cats is therefore used as an animal model of HIV. A shared mechanism is plausible.

The caveats are important. The studies retrieved are veterinary observations and in vitro work, not human trials. Lamivudine was always given in combination (with zidovudine, or with zidovudine and abacavir), so its individual effect is unknown. This prediction mainly supports the mechanism rather than opening a new human use.

Other predictions in the list were also reviewed:

Simian immunodeficiency virus infection (score 0.9993): macaque studies show viral suppression with combination regimens including lamivudine and the same M184V resistance mutation seen in HIV. This is an animal model of the existing HIV use, not a new human indication.
Chronic hepatitis C (score 0.9911): HCV replicates through an RNA-dependent RNA polymerase without a reverse transcription step, so direct anti-HCV activity is not expected. The retrieved papers are general HBV/HCV reviews, and the link likely reflects co-mention with HBV. Repurposing is not warranted.
A rare neurodevelopmental disorder and an obsolete familial combined hyperlipidemia term: model output only, with no studies and no evident mechanism.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
22816032	2012	Veterinary cohort	Viruses	Compared zidovudine alone and with interferon-α, lamivudine or valproic acid in naturally FIV-infected cats over one year, using clinical, viral load and CD4+/CD8+ measures
25855689	2016	Veterinary long-term follow-up	J Feline Med Surg	Effects of long-term antiretroviral therapy (starting with zidovudine) over 5–6 years in FIV-infected domestic cats
11684314	2002	In vitro / preclinical	Antiviral Res	Combined zidovudine, lamivudine and abacavir suppressed FIV replication in vitro; FIV is discussed as a model for HIV

India Market Information

At least 20 single-ingredient registrations are on record (the list may be partial). The records contain no approved-indication text. Main entries:

Authorization Number	Product Name	Dosage Form	Approved Indication
125461	Lamidac 100mg Tablet (Zydus Cadila)	Strip of 10 tablets	Not stated in records
104911	Heptavir 150mg Tablet (Hetero Drugs Ltd)	Strip of 10 tablets	Not stated in records
124322	Lavir 150mg Tablet (Emcure Pharmaceuticals Ltd)	Bottle of 60 tablets	Not stated in records
239597	Virolam 150mg Tablet (Sun Pharmaceutical Industries Ltd)	Strip of 10 tablets	Not stated in records
226962	Tapivir 100mg Tablet (Taj Pharma India Ltd)	Strip of 10 tablets	Not stated in records

All dosage forms listed are oral.

Safety Considerations

Package insert warnings and contraindications are not available in the data compiled for this report. Please refer to the package insert for label safety information.

Knowledge-graph contraindication relations (these come 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, macrocytic anemia, myopathy, myositis, dermatomyositis, hypertriglyceridemia, obesity disorder, and others.

Drug interactions: 145 interactions were found. Those with a moderate level are lactitol, mannitol, naltrexone, orlistat and sorbitol. Others (for example metformin, omeprazole, pantoprazole, morphine and vancomycin) have an unclassified level.

Conclusion and Next Steps

Decision: Hold

Rationale: The only supporting evidence is a few veterinary and preclinical studies of lamivudine-containing combinations, with no clinical trials and no isolated lamivudine effect. The prediction is mechanistically plausible but offers little new human therapeutic value, and the other high-scoring predictions have no meaningful support.

To proceed, the following is needed:

Studies that test lamivudine alone against FIV, to establish a clear drug-specific effect
Mechanism of action data for lamivudine
Package insert warnings and contraindications from the India regulatory record
A decision on whether a veterinary indication is within the scope of the repurposing programme
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.