Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 300 mg); Injection (subcutaneous; 463.5 mg/1.5 mL [309 mg/mL] single dose vials) |
| Drug Class | HIV-1 capsid inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
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Summary
- Sunlenca (lenacapavir) is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Lenacapavir (LEN) combined with optimized background regimen (OBR) demonstrated significantly higher odds of achieving virologic suppression at weeks 24 to 28 compared to fostemsavir + OBR (OR: 6.57, 95% CI 1.34-32.28), ibalizumab + OBR (OR: 8.93, 95% CI 2.07-38.46), and OBR alone (OR: 12.74, 95% CI 1.70-95.37).
- LEN + OBR showed similar effectiveness in terms of change from baseline in CD4 cell count when compared to fostemsavir + OBR and ibalizumab + OBR.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sunlenca (lenacapavir) prescribing information. | 2022 | Gilead Sciences Inc., Foster City, CA |