lenacapavir
Risk of Drug Resistance With Use of Yeztugo for Hiv-1 Pre-Exposure Prophylaxis (Prep) In Undiagnosed Hiv-1 Infection
Individuals must be tested for HIV-1 infection prior to initiating YEZTUGO, and with each subsequent injection of YEZTUGO, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of YEZTUGO by individuals with undiagnosed HIV-1 infection. Do not initiate YEZTUGO unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving YEZTUGO must transition to a complete HIV-1 treatment regimen.
Package inserts
Additional information
Yeztugo vs. Sunlenca: Why does Yeztugo have a boxed warning and Sunlenca does not?
Yeztugo (lenacapavir for PrEP): The indication is pre-exposure prophylaxis in people without HIV. The big safety concern is if someone actually has undiagnosed HIV when starting or continuing PrEP. In that case, giving lenacapavir alone is essentially functional monotherapy, which can quickly select for resistant virus.
Sunlenca (lenacapavir for treatment): Approved for heavily treatment-experienced patients with multidrug-resistant HIV-1. Here, lenacapavir is used with an optimized background regimen, not as prophylaxis, and the clinical risk that justified a boxed warning in PrEP isn’t the same. So the label has prominent precautions and contraindications, but no boxed warning.