Lenacapavir
Pronunciation: len-a-KAP-a-vir.
- Generic name
- lenacapavir
- Drug class
- HIV-1 capsid inhibitor
- Form
- Injection (463.5 mg/1.5 mL) and tablets (300 mg)
- Route
- Subcutaneous injection plus oral tablets (during initiation)
- Legal status
- Prescription-only, specialist-initiated (HIV/infectious disease)
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia
Australia: Sunlenca (4), Yeytuo (4) · Full directory
Boxed warning: Risk of drug resistance if used for HIV prevention without confirming a negative HIV status (Yeztugo/Yeytuo only)
This boxed warning applies only when lenacapavir is used for HIV prevention (as Yeztugo or Yeytuo), not when it is used to treat existing HIV-1 infection (as Sunlenca). Before starting Yeztugo/Yeytuo, and before every injection, you must be tested for HIV-1 using an approved test. If lenacapavir is used by someone who already has an undiagnosed HIV-1 infection, drug-resistant virus can develop, which can make future HIV treatment options more limited. (1)
What lenacapavir is and how it works
Lenacapavir is a prescription-only HIV-1 capsid inhibitor given as a long-acting injection, roughly twice a year. It has two separate uses under two different brand names: Sunlenca treats multidrug-resistant HIV-1 in people who have already tried many other treatments; Yeztugo/Yeytuo prevents HIV-1 infection in people who do not currently have HIV. (1) (2)
Which product and regimen applies to you depends entirely on whether you are being treated for existing HIV-1 infection or are taking this medicine to prevent HIV-1 infection -- these are different indications with different requirements, including mandatory HIV testing before every dose if you are using it for prevention.
Mechanism of action: how lenacapavir works
Lenacapavir is a first-in-class HIV-1 capsid inhibitor that interferes with multiple steps of the viral capsid's function, disrupting viral replication at several stages of the HIV-1 life cycle. (1)
What lenacapavir is used for
Treatment of multidrug-resistant HIV-1 (Sunlenca)
Used together with other HIV medicines to treat HIV-1 infection in adults who have tried many previous HIV treatments and whose current regimen is failing because of drug resistance, intolerance, or safety concerns. (2)
HIV-1 prevention / PrEP (Yeztugo/Yeytuo)
Used to reduce the risk of getting HIV-1 through sex, in adults and adolescents weighing at least 35 kg who are at risk of HIV-1 and who have tested negative for HIV-1. (1)
Before taking lenacapavir
Do not take / not appropriate for
- For HIV prevention (Yeztugo/Yeytuo): do not use if your HIV-1 status is unknown or if you test positive for HIV-1. (all countries) (1)
Tell your clinician about
- Whether you are being treated for existing HIV or are using this medicine to prevent HIV -- this changes which product and schedule applies to you.
- All other medicines you take, since lenacapavir's effects on drug processing can last many months after your last dose.
- Any liver problems.
- Pregnancy, plans for pregnancy, or breastfeeding.
- For PrEP use: your sexual health history and any recent possible HIV exposure, since you must test negative before starting and before each injection.
How to take lenacapavir
- Lenacapavir starts with a short course of tablets and/or a first injection, then continues as an injection roughly every 6 months.
- For HIV prevention (Yeztugo/Yeytuo), you must have a negative HIV-1 test before starting and before every injection.
- Continue using condoms and other prevention strategies as advised, since no HIV prevention method is 100% guaranteed for every situation.
- Because this medicine's effects last a long time, tell every healthcare provider you see for many months after your last dose that you have taken it.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
For HIV prevention (Yeztugo/Yeytuo): if you miss the Day 2 tablet, take it as soon as possible (do not combine with the Day 1 dose). If an injection will be more than 2 weeks late, your prescriber will likely start weekly bridging tablets until the injection can be given, for up to 6 months. If more than 28 weeks pass without an injection or bridging tablet, the full starting regimen is repeated. For HIV treatment (Sunlenca), contact your HIV specialist promptly about any missed or delayed dose.
Overdose
Contact your prescriber or seek medical advice if too much lenacapavir has been given. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Injection site reactions (redness, swelling, or a firm lump under the skin) are very common and can take many months to fully resolve.
What to notice: Injection site reactions (redness, swelling, or a firm lump under the skin) are very common and can take many months to fully resolve.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache and nausea.
What to notice: Headache and nausea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Possible undiagnosed HIV infection while using lenacapavir for prevention — boxed_warning
Symptoms: Flu-like symptoms, fever, rash, or swollen glands soon after a possible HIV exposure -- or simply not having had a confirmed negative test recently.
Action: You must test negative for HIV-1 before starting Yeztugo/Yeytuo and before every injection. Tell your clinician about any possible recent HIV exposure before your next dose. (1)
Signs of a serious skin or injection-site reaction — high caution
Symptoms: Severe pain, spreading redness, or a large hard lump at the injection site.
Action: Contact your clinician -- injections must be given correctly under the skin, and reactions can occur if the technique is not followed. (1)
Interactions
- Lenacapavir stays in the body a long time (its effect on how other medicines are processed can last up to 9 months after your last dose). Always tell any new prescriber you have had this medicine, even months later. (1)
- Certain medicines that strongly affect drug processing (strong CYP3A inducers or the combination of a strong CYP3A inhibitor with certain other inhibitors) can significantly change lenacapavir's levels -- your prescriber will check for these before starting. (1)
- No significant interaction was found with atorvastatin, famotidine, rosuvastatin, tenofovir alafenamide, or voriconazole. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Data from a large PrEP trial did not show an increased risk of miscarriage or other adverse pregnancy/fetal outcomes compared to other HIV prevention methods studied. (1) (2) (3) (4) (5)
Breastfeeding
Lenacapavir has been found in breast milk at low levels; no adverse effects have been seen in breastfed infants in available data. Discuss with your clinician. (1) (2) (3) (4) (5)
Children
PrEP approved for adolescents weighing at least 35 kg (age threshold varies slightly by country); treatment use is for adults. (1) (2) (3) (4) (5)
Elderly
No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3) (4) (5)
Hepatic_impairment
Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5)
Renal_impairment
Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5)
Source_ids
Monitoring
Before starting
- HIV-1 test (must be negative for PrEP use)
- Liver function
- Current medicines review for interactions
During treatment
- Repeat HIV-1 testing before every injection if using this medicine for prevention.
- Monitoring of injection sites for reactions.
- For treatment use, ongoing HIV viral load and resistance monitoring as part of routine HIV care.
Storage
Lenacapavir injections are stored and administered by a healthcare provider; oral tablets should be stored as directed on the product label supplied.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information for both brands; verify against the current full label before prescribing.
United States
Indication: HIV-1 PrEP (Yeztugo)
Dose summary: Day 1: 927mg SC (2x1.5mL) + 600mg oral (2x300mg). Day 2: 600mg oral. Maintenance: 927mg SC every 6 months (+/-2 weeks). Bridging: 300mg oral weekly if injection delayed >2 weeks, up to 6 months; the prescriber should have the patient repeat the full initiation regimen if more than 28 weeks have elapsed without dosing. Contraindicated if HIV-1 status unknown or positive.
Renal context: Not established in the source reviewed for this dossier. (1)
United States
Indication: Multidrug-resistant HIV-1 treatment (Sunlenca)
Dose summary: Oral loading tablets combined with initial injection per specialist-directed initiation option, then 2 injections every 6 months, always in combination with an optimized background antiretroviral regimen.
Renal context: Not established in the source reviewed for this dossier. (2)
Hepatic guidance
Not established in the source reviewed for this dossier.
Overdose note
No specific antidote described in the source reviewed; manage supportively and seek prescriber guidance for suspected overdose. (1)
Frequently asked questions
Is lenacapavir available in the US, UK, Europe, Canada, and Australia?
Yes, but the picture differs by use and country. In the US, EU, and Australia, both the treatment (Sunlenca) and prevention (Yeztugo/Yeytuo) uses are approved. In the UK, only the treatment use (Sunlenca) was approved as of this research -- the prevention indication had not yet been approved by the MHRA, with submission planned for later in 2025. In Canada, the prevention use (Yeytuo) is approved; the treatment use's status was not confirmed in this research. New Zealand status was not found for either use. (1) (2) (3) (4) (5)
Is Sunlenca the same as Yeztugo?
They contain the same active medicine (lenacapavir) but are approved for different, specific uses -- Sunlenca treats existing multidrug-resistant HIV-1 infection, while Yeztugo (Yeytuo in some countries) prevents HIV-1 infection in people who do not have HIV. Only Yeztugo/Yeytuo carries the boxed warning about testing for HIV before each dose. (1) (2)
What happens if I miss my Yeztugo injection appointment?
If your injection will be more than 2 weeks late, your prescriber may have you take a 300 mg tablet by mouth once weekly to keep protection going until you can get the injection. If more than 28 weeks pass without an injection or bridging tablets, you would need to restart the full initiation regimen (injection plus oral tablets) rather than simply resuming the every-6-month schedule. (1)
What is the mechanism of action of lenacapavir?
Lenacapavir is a first-in-class HIV-1 capsid inhibitor that interferes with multiple steps of the viral capsid's function, disrupting viral replication at several stages of the HIV-1 life cycle. (1)
References
- YEZTUGO (lenacapavir) -- full prescribing information (PrEP)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Gilead Sciences, Inc. · United States · accessed 2026-07-29 · source 1
- Sunlenca (lenacapavir) FDA approval for HIV-1 treatmentGilead Sciences corporate press release · United States · accessed 2026-07-29 · source 2
- Lenacapavir (Sunlenca/Yeytuo) approval status in the EU and UKHIV i-Base (patient advocacy/clinical information organisation) · European Union / United Kingdom · accessed 2026-07-29 · source 3
- TGA registration of Sunlenca (treatment) and Yeytuo (PrEP)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4
- Lenacapavir (Yeytuo) approved for HIV prevention in CanadaCATIE (Canada's HIV/hepatitis C information source) · Canada · accessed 2026-07-29 · source 5
Brand names by country
Single-ingredient lenacapavir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Sunlenca300 mg · gilead sciences, inc.
- Yeztugo300 mg · gilead sciences, inc.
United Kingdom
Canada
- Yeytuo (5)reported approved PrEP confirmed · not specified in fetched source · Gilead Sciences Canada, Inc.