Atorvastatin
| Evidence Level: L2 | Predicted Indications: 4 |
Table of Contents
- Atorvastatin
- Pharmacist Assessment Report
- Atorvastatin: HMG-CoA reductase inhibitor (statin) → HIV infectious disease
- 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
Atorvastatin: HMG-CoA reductase inhibitor (statin) → HIV infectious disease
One-Sentence Summary
Atorvastatin is a statin that blocks HMG-CoA reductase, the enzyme that drives cholesterol production in the liver. The TxGNN model predicts it may be useful for HIV infectious disease, mainly for lowering cardiovascular risk and calming chronic immune activation rather than for direct antiviral effects. The data compiled for this report include 14 clinical trials and 20 publications, but most studies are small and measure surrogate markers.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | HIV infectious disease |
| TxGNN Prediction Score | 0.9931 |
| Evidence Level | L2 |
| 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 | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Atorvastatin belongs to the statin class, which inhibits HMG-CoA reductase and lowers LDL cholesterol.
Statins also have anti-inflammatory and immune-modulating effects. These include reduced monocyte and macrophage activation and lower systemic inflammation. People with treated HIV often have persistent immune activation, which is linked to higher cardiovascular risk. Antiretroviral regimens, especially protease inhibitors, can also raise cholesterol and triglycerides. Atorvastatin has been tested for this protease inhibitor-associated lipid problem.
The strongest rationale is therefore cardiovascular and metabolic risk reduction in people living with HIV, not suppression of the virus itself. Trials of viral load and immune markers are small and do not show a clear antiviral effect.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00367458 | Phase 2 | Completed | 24 | Randomized, placebo-controlled trial of atorvastatin on HIV viral load and immune activation markers in patients not on antiretroviral therapy |
| NCT01766076 | Phase 3 | Completed | 30 | Randomized trial of atorvastatin as add-on therapy in suboptimal responders to antiretroviral therapy; outcome is immune activation |
| NCT03037372 | Phase 3 | Unknown | 320 | Atorvastatin vs rosuvastatin over 36 months as add-on therapy; outcomes are immune activation, inflammation and immune aging |
| NCT02081638 | Phase 2 | Completed | 53 | Statin vs aspirin in elite controllers and ART-treated people with HIV; looks at inflammation and clotting |
| NCT00663234 | Phase 1/2 | Terminated | 28 | Escalating atorvastatin doses for protease inhibitor-associated high LDL cholesterol in HIV-infected children and adolescents |
| NCT00965185 | N/A | Completed | 40 | Statin therapy to reduce plaque inflammation and improve endothelial function in HIV patients |
| NCT01600170 | Phase 4 | Completed | 11 | Statin modulation of monocyte/macrophage activation for HIV-associated neurocognitive disorder |
| NCT01263938 | Phase 4 | Completed | 5 | Pilot study of atorvastatin on monocyte activation in HAART-treated patients; too small to draw conclusions |
| NCT00355251 | Phase 4 | Terminated | 5 | Atorvastatin and plasma viral replication around treatment interruption; essentially uninformative |
| NCT00017758 | Phase 1 | Completed | 56 | Effect of efavirenz and nelfinavir on statin blood levels; interaction study, not efficacy |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37450602 | 2023 | Open-label RCT | AIDS | Atorvastatin vs aspirin in elite controllers and ART-treated people with HIV, targeting residual inflammation |
| 18991624 | 2008 | Randomized open-label study | Current HIV Research | Rosuvastatin, pravastatin and atorvastatin for high cholesterol in 94 patients on protease inhibitors |
| 25907504 | 2015 | Systematic review | American Journal of Cardiology | Usefulness of statins in HIV-infected patients, who have higher rates of dyslipidemia and atherosclerosis |
| 29804227 | 2018 | Review | Current Infectious Disease Reports | Recent summary of statin therapy and cardiovascular risk reduction in HIV patients on antiretrovirals |
| 26658651 | 2016 | Review | Current Opinion in Infectious Diseases | Evidence that statins reduce cardiovascular risk in treated HIV infection |
| 22770622 | 2012 | Review | Expert Opinion on Pharmacotherapy | Safety and effectiveness of statins for HIV-related dyslipidemia |
| 29770749 | 2018 | Cohort | HIV Clinical Trials | Rosuvastatin and atorvastatin and kidney function in HIV patients with chronic kidney disease and hyperlipidemia |
| 36549898 | 2023 | Clinical study | HIV Medicine | Atorvastatin exposure, vitamin D levels and lipid outcomes in people with HIV |
| 28364370 | 2017 | Review | American Journal of Cardiovascular Drugs | Recommendations for managing drug interactions between statins and HIV medications |
| 41774493 | 2026 | Preclinical (mouse) | JCI Insight | Atorvastatin reduced HIV/antiretroviral-induced cardiac fibrosis in mice by blocking platelet TGF-β1 signaling |
India Market Information
Atorvastatin is marketed in India, and all recorded single-ingredient licences are valid. The approved indication text is not recorded in the local data. The table lists 5 examples, and the local records may be partial.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 10042 | Astat 20mg Tablet | Strip of 10 tablets | Not recorded |
| 12750 | Atorway 10mg Tablet | Strip of 10 tablets | Not recorded |
| 122781 | Lipivas 20mg Tablet | Strip of 10 tablets | Not recorded |
| 153630 | Nigtor 10mg Tablet | Strip of 10 tablets | Not recorded |
| 225165 | Trava 20mg Tablet | Strip of 14 tablets | Not recorded |
Safety Considerations
- Drug Interactions: The data list 301 recorded interactions.
- Major: clarithromycin.
- Moderate (examples): aprepitant, omeprazole and other proton pump inhibitors, cimetidine, dexamethasone, metronidazole, rosuvastatin, simvastatin.
- Minor (examples): aluminum hydroxide, magnesium hydroxide, liraglutide.
- HIV-specific interaction risk: Ritonavir- or cobicistat-boosted antiretrovirals inhibit CYP3A4 and raise atorvastatin exposure. They therefore require dose limits. Interaction studies with protease inhibitors and efavirenz are among the trials above.
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for them.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Atorvastatin is widely marketed, and several controlled studies in HIV exist (a Phase 2 and a Phase 3 trial completed). They are small and focus on immune activation and lipid or cardiovascular markers, with no clear antiviral benefit shown. The evidence supports further research on cardiovascular and inflammation outcomes, not a claim of treating HIV itself. Interaction risk with boosted antiretrovirals is significant.
To proceed, the following is needed:
- Results from the large ongoing or unknown-status trial (NCT03037372) and from larger outcome-based trials
- Package insert warnings and contraindications
- Detailed mechanism of action data
- A dosing and interaction management plan for patients on boosted protease inhibitors or cobicistat
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.