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
- Canada 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 lowers blood cholesterol and triglycerides. The TxGNN model predicts it may be useful for HIV infectious disease. The data compiled for this report include 13 clinical trials and 20 publications, but they mostly concern lipid, inflammation and cardiovascular management in people with HIV, not control of the virus itself.
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 |
| Canada Market Status | Marketed (marketed DINs on record: at least 20) |
| Number of DINs | 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. It lowers LDL cholesterol and triglycerides. Statins also have anti-inflammatory effects that may reduce monocyte and macrophage activation.
People with HIV often develop high lipids, especially when taking antiretroviral therapy (ART) with protease inhibitors. They also have persistent immune activation and a higher cardiovascular risk. Atorvastatin could plausibly help with all three. Several trials test this, looking at immune activation, monocyte activation and plaque inflammation in people with HIV.
The evidence supports managing HIV-associated dyslipidemia and cardiovascular and inflammatory risk. It does not show that atorvastatin treats HIV infection itself. One small randomized trial in people with HIV not on ART looked at viral load, and another small Phase 4 study (terminated, n=5) also looked at viral replication. Neither gives conclusive results here.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01766076 | Phase 3 | Completed | 30 | Randomized trial of atorvastatin as adjuvant therapy in adults with suboptimal CD4 recovery on ART, testing a change in immune activation |
| NCT03037372 | Phase 3 | Unknown | 320 | Atorvastatin vs rosuvastatin over 36 months for immune activation, inflammation and immune aging in ART-treated adults in Africa |
| NCT00367458 | Phase 2 | Completed | 24 | Placebo-controlled trial in HIV-positive patients not on ART, measuring viral load and immune activation markers |
| NCT02081638 | Phase 2 | Completed | 53 | Statin vs aspirin in elite controllers and ART-treated people with HIV, looking at inflammation and clotting |
| NCT00663234 | Phase 1/2 | Terminated | 28 | Escalating atorvastatin doses for protease inhibitor-associated high LDL in children and adolescents with HIV |
| NCT01600170 | Phase 4 | Completed | 11 | Statin modulation of monocyte/macrophage activation in HIV-associated neurocognitive disorder |
| NCT01263938 | Phase 4 | Completed | 5 | Pilot study of atorvastatin on monocyte activation in ART-treated patients |
| NCT00965185 | Not labeled | Completed | 40 | Statin therapy to reduce plaque inflammation and improve endothelial function in HIV patients |
| NCT00355251 | Phase 4 | Terminated | 5 | Effect of atorvastatin on plasma viral replication around ART interruption; too small to be informative |
| NCT00017758 | Phase 1 | Completed | 56 | Pharmacokinetic study of efavirenz and nelfinavir effects on statin blood levels (safety, not efficacy) |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37450602 | 2023 | RCT (open label) | AIDS | Atorvastatin vs aspirin in elite controllers and ART-treated people with HIV, targeting residual inflammation |
| 18991624 | 2008 | Randomized trial (open label) | Current HIV Research | Rosuvastatin, pravastatin and atorvastatin for protease inhibitor-associated high cholesterol in 94 patients |
| 25907504 | 2015 | Systematic review | American Journal of Cardiology | Usefulness of statin therapy in HIV-infected patients, who have a higher cardiovascular risk |
| 29804227 | 2018 | Review | Current Infectious Disease Reports | Benefits and risks of statins for cardiovascular risk reduction in HIV |
| 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 preserved renal function in HIV patients with chronic kidney disease and high lipids |
| 36549898 | 2023 | Pharmacokinetic analysis | HIV Medicine | Atorvastatin levels with different boosted protease inhibitors and their link to lipid outcomes |
| 28364370 | 2017 | Review | American Journal of Cardiovascular Drugs | Recommendations for managing statin interactions with HIV medications |
| 41774493 | 2026 | Preclinical (mice) | JCI Insight | Atorvastatin reduced HIV/ART-induced cardiac fibrosis and dysfunction by blocking platelet TGF-β1 signaling |
Canada Market Information
Health Canada records show 20 valid licences for single-ingredient atorvastatin products, and none are cancelled. The records may be partial. Five examples:
| DIN | Product Name | Status |
|---|---|---|
| 02230714 | LIPITOR | Valid |
| 02295261 | APO-ATORVASTATIN | Valid |
| 02310929 | TEVA-ATORVASTATIN | Valid |
| 02392976 | MYLAN-ATORVASTATIN | Valid |
| 02457768 | ACH-ATORVASTATIN CALCIUM | Valid |
Safety Considerations
- Drug Interactions: The data compiled for this report list 100 recorded interactions.
- The most important is clarithromycin (Major).
- Moderate interactions include aprepitant, omeprazole and other proton pump inhibitors (esomeprazole, lansoprazole, pantoprazole), cimetidine, azole antifungals (clotrimazole, miconazole), dexamethasone, metronidazole, naltrexone, eliglustat, eluxadoline, and other statins (rosuvastatin, simvastatin).
- Antacids such as aluminum hydroxide and magnesium hydroxide are Minor.
- HIV-specific interaction concern: The literature and trials highlight CYP3A4-mediated interactions with ritonavir- or cobicistat-boosted protease inhibitors. These raise atorvastatin exposure and the risk of muscle toxicity such as myopathy, so dose caps and monitoring are needed.
For warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale:
- Several trials and reviews study atorvastatin in people with HIV, including one completed Phase 3 randomized trial and a larger Phase 3 trial of unknown status. The studies are small, and the benefit shown relates to lipids, inflammation and cardiovascular risk rather than control of HIV itself.
- Only one completed Phase 3 randomized trial is available, so the evidence level is L2.
To proceed, the following is needed:
- Results from larger, adequately powered trials with immune activation, cardiovascular or viral endpoints (for example the 320-participant trial NCT03037372).
- Package insert warnings and contraindications from Health Canada, and mechanism-of-action data.
- A dosing and monitoring plan for use with boosted protease inhibitors or cobicistat (dose caps, muscle symptom and liver monitoring).
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.