Treatment-emergent Resistance Associated With SUNLENCA®1
- In CAPELLA, 31% (22/72) of HTE patients in both study cohorts met the criteria for resistance analyses through Week 52 in both cohorts1
- Patients were analyzed for lenacapavir-associated capsid mutations if they had HIV-1 RNA ≥50 copies/mL at confirmed virologic failure (suboptimal virologic response at Week 4, virologic rebound, or viremia at last visit)1
- Lenacapavir-associated capsid mutations were found in 41% (n=9) of these patients in both cohorts1
- In the randomized cohort (n=36), 4 patients had at least one treatment-emergent capsid mutation2
- In the nonrandomized cohort (n=36), 5 patients had at least one treatment-emergent capsid mutation2
- All 9 patients with capsid treatment-emergent resistance remained on SUNLENCA through Week 522
Treatment-emergent Lenacapavir Resistance (N=72)2
In the clinical trial, patients who had treatment-emergent resistance to SUNLENCA either had inadequate OBR drug levels or lack of active agents in the OBR2,3
Important Safety Information
Warnings and precautions
- Long-acting properties and potential associated risks with SUNLENCA: Residual concentrations of SUNLENCA may remain in the systemic circulation of patients for up to 12 months or longer. SUNLENCA may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing SUNLENCA, begin alternate suppressive ARV regimen within 28 weeks from last injection.