II. Indications
III. Contraindications
- HIV positive status (or status unknown)
- Body Weight <35 kg
IV. Mechanism
- Long-acting HIV capsid inhibitor
V. Medications
- Lenacapavir Oral Tablet (Sunlenca): 300 mg
- Lenacapavir SQ Injection (Yeztugo): 463.5 mg/1.5 mL in single dose vial
VI. Dosing
- Precautions
- Injection must be administered by a healthcare professional (not the patient)
- Start
- Day 0: TWO Lenacapavir SQ Injections (927 mg and 3 ml total)
- Day 1: Lenacapavir 600 mg (two tablets) orally once
- Day 2: Lenacapavir 600 mg (two tablets) orally once
- Maintain
- TWO Lenacapavir SQ Injections (927 mg and 3 ml total) every 6 months
- Injections must be 26 weeks apart (+/- 14 days)
- Bridge with Lenacapavir 300 mg orally once weekly if SQ Injection delay >14 days
- If delayed injection >14 days, repeat the starting protocol (see above)
VII. Adverse Effects
- Nausea
- Headache
- Local injection skin reactions
- Local redness or swelling
- Subcutaneous Nodules
VIII. Drug Interactions
- P-Glycoprotein (P-gp) Substrate (and moderate inhibitor)
-
CYP3A Substrate (and moderate inhibitor)
- Avoid with strong CYP3A Inducers (e.g. Carbamazepine, Phenobarbital)
IX. Safety
- Unknown safety in pregnancy and Lactation
- Balance risk versus benefit when using Lenacapavir in these populations
- Monitoring
- HIV Antigen/Antibody testing
- Baseline before starting PrEP
- Every 6 months (at time of SQ Injection)
- Consider every 3 months if frequent exposure risk
- HIV Antigen/Antibody testing
X. Efficacy: HIV Preexposure Prophylaxis (PrEP)
- As effective (>99%) as other PrEP options (FTC/TAF or TDF, Cabotegravir)
- Costs $28,000/year (may be covered by ACA, or with manufacturer cost assistance)
XI. Resources
XII. References
- (2025) Presc Lett 32(9): 53