Eltrombopag
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Eltrombopag: HIV infectious disease
One-Sentence Summary
Eltrombopag is an oral thrombopoietin receptor (TPO-R) agonist marketed in Australia. The TxGNN model predicts it may be relevant to HIV infectious disease, with a score of 0.9926. The studies found concern platelet and blood-count problems in people with HIV, or other conditions. None tests eltrombopag as a treatment for HIV infection itself, so the evidence level is L5.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | HIV infectious disease |
| TxGNN Prediction Score | 0.9926 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Eltrombopag is known to be a TPO-R agonist. It stimulates megakaryocyte growth and platelet production.
In people with HIV, low platelets can be immune-mediated or caused by bone marrow suppression. Stimulating the TPO receptor could raise platelet counts in these patients. This benefit would be supportive, correcting a blood-count problem. It would not be antiviral.
One laboratory screen of approved drugs (PMID 32977702) suggests eltrombopag might modulate HIV-1 proviral transcription. This is hypothesis-generating only. The published clinical reports describe eltrombopag treating HIV-associated blood-count problems, not HIV infection.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT00678587 | Phase 3 | Terminated | 292 | Placebo-controlled study of eltrombopag to reduce platelet transfusion in thrombocytopenic patients with chronic liver disease undergoing elective invasive procedures. The record does not show an HIV-specific population, so it does not directly address HIV infection. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25504472 | 2015 | Case series | J Int Assoc Provid AIDS Care | Early experience with thrombopoietin receptor agonists, including eltrombopag, in refractory HIV-associated immune thrombocytopenia |
| 22992580 | 2012 | Case report | AIDS | Eltrombopag used successfully, without splenectomy, in refractory HIV-related immune reconstitution thrombocytopenia |
| 25333665 | 2014 | Case report | AIDS | Eltrombopag treated aplastic anaemia associated with HIV, with a possible immunomodulatory effect |
| 19932434 | 2009 | Review | Hematol Oncol Clin North Am | Infections including HIV as causes of chronic thrombocytopenia |
| 19245929 | 2009 | Review | Semin Hematol | Treatment approaches for hepatitis- and other infection-related immune thrombocytopenias |
| 32977702 | 2020 | In vitro screen | Viruses | Screen of approved drugs for modulators of HIV-1 proviral transcription |
| 24128106 | 2013 | Case report | Farm Hosp | Eltrombopag for thrombocytopenia in chronic hepatitis C (two cases) |
| 28043314 | 2016 | Case report | J Coll Physicians Surg Pak | Hepatitis B leading to megaloblastic anaemia and severe thrombocytopenia (does not involve eltrombopag) |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14107L | Revolade | Tablet 50 mg (as olamine) | Not available in the data compiled for this report |
Safety Considerations
- Drug Interactions (100 interactions were recorded, and the main ones listed in the data are below):
- Major: eluxadoline.
- Moderate:
- Calcium-, magnesium- and aluminium-containing products (e.g. calcium carbonate, calcium acetate, magnesium oxide, magnesium hydroxide, aluminium hydroxide, magaldrate).
- Iron.
- Kaolin and attapulgite.
- Glyburide.
Please refer to the TGA-approved Product Information (PI) for warnings, contraindications and full interaction guidance.
Conclusion and Next Steps
Decision: Hold
Rationale: No cited study tests eltrombopag as a treatment for HIV infection. The available reports concern platelet or blood-count problems in people with HIV, and the one registered Phase 3 trial was terminated and involved chronic liver disease. This is model prediction only (L5).
To proceed, the following is needed:
- Clarify whether the intended goal is treating HIV infection or supporting HIV-associated thrombocytopenia or marrow failure, since the existing reports support only the latter.
- Prospective controlled studies in the chosen HIV population, with clear platelet-count and bleeding endpoints.
- Mechanism of action data to assess the preliminary in vitro finding on HIV-1 transcription.
- Review of the TGA Product Information for safety, and a monitoring plan for people with HIV who take antiretroviral therapy.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.