Atazanavir

Evidence Level: L4

Predicted Indications: 4

Atazanavir

Pharmacist Assessment Report

Atazanavir: From HIV Infection to Simian Immunodeficiency Virus Infection

One-Sentence Summary

Atazanavir is an HIV-1 protease inhibitor, originally used to treat HIV infection and AIDS. The TxGNN model predicts it may be effective for simian immunodeficiency virus infection, but this rests on only 1 preclinical publication and no registered clinical trials. SIV infection is an animal-model disease rather than a human indication, so the prediction mainly supports the mechanism and has little direct translational value.

Quick Overview

Item	Content
Original Indication	HIV infectious disease; AIDS
Predicted New Indication	Simian immunodeficiency virus infection
TxGNN Prediction Score	0.9998
Evidence Level	L4
India Market Status	Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data
Number of Listed Products	11 (valid: 11)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Atazanavir is a well-known HIV-1 protease inhibitor, and its efficacy in HIV infection and AIDS is established. Mechanistically, it may be applicable to SIV, a closely related lentivirus with a homologous protease.

The only supporting study is a 2010 macaque study in which SIV-infected animals on highly active antiretroviral therapy (HAART) showed reduced central nervous system viral replication and inflammation, although viral DNA persisted. This is indirect, because it tested a combination regimen rather than atazanavir alone. SIV infection is also not a human therapeutic indication, so the finding mainly supports the biological plausibility of protease inhibition and does not point to a new human use.

Other predictions from the model are also worth noting. Two are better-supported but amount to extensions of the existing HIV indication: congenital HIV (perinatal setting) and AIDS-related complex (an older term for symptomatic HIV disease). The remaining predictions (feline AIDS, a rare neurodevelopmental disorder, and an obsolete familial hyperlipidemia term) have no trials or literature and no credible mechanistic link.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
20497048	2010	Preclinical animal study	The Journal of Infectious Diseases	SIV-infected macaques on HAART had reduced CNS viral replication and inflammation, but viral DNA persisted

India Market Information

The compiled data does not include approved indication text for these licences.

Authorization Number	Product Name	Dosage Form	Manufacturer
9126	Atazor-R 300mg/100mg Kit	Packet of 6 kit	Emcure Pharmaceuticals Ltd
234666	Virataz R 300mg/100mg Tablet	Strip of 30 tablets	Hetero Drugs Ltd
5827	Atazor 200mg Capsule	Box of 60 capsules	Emcure Pharmaceuticals Ltd
3482	Anzavir-R Tablet	Strip of 30 tablets	Mylan Pharmaceuticals Pvt Ltd
201156	Synthivan Tablet	Strip of 30 tablets	Cipla Ltd

Showing 5 of 11 valid licences; all 11 are products and none are cancelled.

Review correction (2026-11-06): Originally stated: “Showing 5 of 11 valid licences; all 11 are single-ingredient products and none are cancelled.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Disease-related cautions (from the knowledge graph, not label text): The knowledge graph links atazanavir to possible contraindications or cautions in liver failure and liver disease, gallbladder disease, hyperglycemia, diabetes mellitus and diabetic ketoacidosis, chronic hepatitis B and C infection, hemophilia, hyperbilirubinemia (including Gilbert syndrome), nephrolithiasis and acute urate nephropathy, atrioventricular block, and lactic acidosis.
Drug Interactions: 277 interactions were identified. Major-level examples include:
- Acid-suppressing drugs: famotidine, ranitidine, rabeprazole, omeprazole
- Corticosteroids: triamcinolone, budesonide
- Loperamide
Moderate-level examples include acarbose, metformin, pioglitazone, alogliptin, albiglutide, hydrocortisone, betamethasone, aprepitant, alosetron, aluminum hydroxide and calcium carbonate.

Package insert warnings and contraindications were not available; please refer to the package insert for label safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported by a single indirect preclinical macaque study and no clinical trials. SIV infection is an animal-model disease with no human therapeutic relevance, so there is no actionable repurposing opportunity here.

To proceed, the following is needed:

Package insert warnings and contraindications from the India regulatory source, which are required before safety screening can begin
Detailed mechanism of action data
If a human-relevant direction is wanted, evaluate the better-supported perinatal HIV (congenital HIV) setting, where cohort data on pregnancy pharmacokinetics and in utero exposure exist, and review the safety of the large DDI burden

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

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