Treatment-emergent Resistance Associated With SUNLENCA®1
- In CAPELLA, 39% (28/72) of HTE participants met the criteria for resistance analyses through Week 1561
- Participants were analyzed for lenacapavir resistance-associated capsid substitutions 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 resistance-associated capsid substitutions were found in 57% (n=16) of participants with confirmed virologic failure who had post-baseline capsid genotypic resistance data (n=28)1
Treatment-emergent Lenacapavir Resistance Through Week 156 (N=72)1
*Other substitutions include Q67H/K/N, K70N/R/S, N74D, A105T, T107A/C/S.
IN THE CLINICAL TRIAL, 6 OF THE 16 PARTICIPANTS WHO DEVELOPED TREATMENT-EMERGENT RESISTANCE TO SUNLENCA THROUGH WEEK 156 RECEIVED SUNLENCA WITH A BACKGROUND REGIMEN CONTAINING NO FULLY ACTIVE ANTIRETROVIRALS1
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.