Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 300 mg); Injection (subcutaneous; 463.5 mg/1.5 mL [309 mg/mL]) |
| Drug Class | Human immunodeficiency virus type 1 (HIV-1) capsid inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HIV-1 infection 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
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Lenacapavir (LEN) + optimized background regimen (OBR) demonstrated significantly higher odds of achieving virologic suppression at weeks 24 to 28 compared to Fostemsavir + OBR (6.57 times higher, 95% confidence interval (CI) 1.34-32.28), Ibalizumab + OBR (8.93 times higher, 95% CI 2.07-38.46), and OBR alone (12.74 times higher, 95% CI 1.70-95.37).
- The change in CD4 cell count from baseline was similar across all groups, including LEN + OBR, Fostemsavir + OBR, and Ibalizumab + OBR.
- There is no safety information available in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sunlenca (lenacapavir) Prescribing Information. | 2024 | Gilead Sciences Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Indirect Treatment Comparisons of Lenacapavir Plus Optimized Background Regimen Versus Other Treatments for Multidrug-Resistant Human Immunodeficiency Virus | 2023 | Value in Health |