Drug updated on 4/18/2024
| 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.
Summary
- Lenacapavir (Sunlenca) is indicated for the treatment of HIV-1 infection, in combination with other antiretrovirals, specifically targeting heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. Its unique mechanism as an HIV-1 capsid inhibitor distinguishes it from other antiretrovirals by enhancing its efficacy against multidrug-resistant infections.
- The information was derived from two systematic reviews/meta-analyses studying the safety and effectiveness of Sunlenca compared to other drugs in its class.
- In terms of effectiveness, lenacapavir combined with an optimized background regimen (LEN + OBR) showed significantly higher odds of achieving virologic suppression at weeks 24 to 28 across all comparators: LEN + OBR had 6.57 times higher odds compared to fostemsavir (FTR) + OBR, 8.93 times higher odds compared to ibalizumab (IBA) + OBR, and 12.74 times higher odds compared to OBR alone.
- Although detailed safety data comparison is limited, lenacapavir appears well-tolerated, given its effectiveness and innovation as a first-in-class capsid inhibitor, focusing on a population with few remaining treatment options.
- The primary focus on heavily treatment-experienced adults underscores lenacapavir's importance in managing complex cases, indicating potential versatility due to combinatory strategies that can be adapted according to individual patient needs, including those suffering from concurrent opportunistic infections such as tuberculosis.
- Lenacapavir presents a significant advancement in treating multidrug-resistant HIV, offering a superior option for virologic suppression and patient compliance compared to treatments like fostemsavir and ibalizumab. Despite similar changes in CD4 cell counts across comparators, this emphasizes the need for further investigation into long-term outcomes and specific subgroup analyses.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sunlenca (lenacapavir) prescribing information. | 2022 | Gilead Sciences Inc., Foster City, CA |