| East Bay Getting to Zero and California Prevention Training Center PrEP Learning Collaborative held session 2 of the Lenacapavir for PrEP series on Thursday, August 21, 2025. ‘Implementing Lenacapavir in your PrEP Program‘ was the second in a three-part series focusing on Lenacapavir as injectable, long-acting PrEP. Lenacapavir (brand name Yeztugo®) is the new twice-yearly injectable PrEP option. PrEP providers and navigators met to describe their plans and processes for adding Lenacapavir to their injectable and oral PrEP programs. Programs shared successes and challenges of this work so far. Resources from session Please click on these links to access slides and other resources. – A brief review of Yeztugo® slides, Dr. Sami Lubega – Gilead publications – Injectable Access Roadmap – Injectable Advancing Access Co-pay Savings Brochure – Injectable Advancing Access HCP Brochure – Injectable Buy and Bill Product Acquisition Pathway Overview – Injectable In-House Pharmacy Product Acquisition Pathway Overview – Injectable Specialty Pharmacy Product Acquisition Pathway Overview Q&A: The questions below were raised during the session. Some of the responses were given during the session, but we wanted to provide clarification and additional details. What is the time to protection after injection and taking the 2 days of oral meds? There’s no officially established time to protection for any PrEP treatment (as it would be unethical to run such a study in humans). The Yeztugo prescribing information states that the time to maximal protection is unknown. However, the best estimate we have is based on pharmacokinetics (PK). PK modeling shows that plasma concentrations associated with antiviral activity (IQ4 threshold) are reached within approximately 2 hours after the second oral dose on Day 2. What is the lab monitoring for people on Lenacapavir? The only required testing at initiation and follow-up is HIV testing. No additional lab monitoring is recommended. STI testing is also strongly recommended. What should people do if they know they will miss an injection? People who know they will miss their injection window due to travel or other reasons can take one-weekly oral Lenacapavir until they can return for their injection. Once-weekly Lenacapavir can be taken for up to six months as a bridge between injections. What is the protocol for people wanting to switch from cabotegravir to Lenacapavir for PrEP? There are no contraindications or meaningful drug interactions anticipated between Lenacapavir and other PrEP medications. People who wish to switch from Cabotegravir to Lenacapavir should start Lenacapavir on or before their scheduled cabotegravir injection. What is the protocol for patients who stop this method of PrEP/do not adhere to subsequent shots? Patients should be counseled before starting Lenacapavir that the medication can stay in their body for up to 12 months or longer after they stop injections due to its long-acting PK. However, drug interaction risks are specifically relevant for up to 9 months post-discontinuation, as Lenacapavir continues to moderately inhibit CYP3A during that time. If a patient discontinues Lenacapavir and remains at risk for HIV acquisition, they should be offered another form of PrEP within 28 weeks of the last injection. It is also recommended to offer HIV testing every 3 months after they stop. If HIV is acquired during this time, there is a risk of developing resistance to capsid inhibitors, since Lenacapavir alone is not a complete treatment regimen. Regarding injection site reaction, what is the message for patients who DON’T have a nodule after injection? It is not a problem to not feel the nodule. In the studies about 35% of patients didn’t feel nodules at all with the first injection, and fewer people felt nodules with subsequent injections. Are there patients that are not the best candidates based on their body mass composition? What can be done if client does not have any subcutaneous fat? So far there isn’t any adjustment needed for body mass composition for this one. Since it is subcutaneous (just below the skin) instead of intramuscular like cabotegravir, body habitus should not be an issue in the same way. Consider and injection angle down to 45 degrees (but not lower because you want to make sure still in subcutaneous space, not dermal space) in someone with little subcutaneous tissue. Are there any requirements for birth control for those of child bearing age? Any risk to baby if patient gets pregnant during the 6 months they have the medication in their body? No requirements. We allowed participants in PURPOSE 1 who became pregnant to stay in the trial. Data from the PURPOSE 1 trial (which included 208 pregnancies exposed to Lenacapavir) did not identify any drug-associated risk for miscarriage or adverse maternal or fetal outcomes. The rate of major birth defects in the Lenacapavir group was within the background prevalence rate, and the two reported defects (ventricular septal defects) were not higher than expected. Animal studies also showed no adverse developmental effects at exposures significantly higher than those seen in humans. Is the ice applied prior to the injection or after the injection, and if so for how long? Ice can be applied before AND after, and patients can also take acetaminophen, ibuprofen ahead of time or after to help mitigate pain. Icing for up to 10 minutes prior to injection (at both injection sites) is the main recommendation for reducing pain. Are there any side effects relating to mental health and increase in depression? Not that were reported in the FDA approval guidance or study results to my knowledge. As was mentioned, some medications or street drugs may have interactions that will require monitoring or dose adjustments. If you missed Session 1 in our Lenacapavir for PrEP series, you can access the slides here. |
