Sunlenca (Lenacapavir) for HIV

Sunlenca (lenacapavir) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with human immunodeficiency virus type 1 (HIV-1) infection with other antiretroviral medicines.

How Sunlenca Works and How It’s Taken

Sunlenca is an antiretroviral medicine called a capsid inhibitor. The capsid is a protein shell that is important for HIV-1 to make new copies of itself. Sunlenca blocks several steps that HIV-1 needs to reproduce.

Doctors prescribe Sunlenca with other HIV medicines for adults who have received many HIV treatments before, have HIV-1 that is resistant to several medicines, and whose current HIV treatment is failing because of resistance, side effects they cannot tolerate, or safety concerns.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Sunlenca treatment includes tablets taken by mouth and injections given under the skin of the abdomen. The injections are given by a healthcare provider. Sunlenca tablets can be taken with or without food.

Typical Dosing for HIV

There are two recommended ways to start Sunlenca treatment.

Option 1:

Day 1 — 927 milligrams by injection, given as two injections of 1.5 milliliters each, plus 600 milligrams by mouth, given as two tablets of 300 milligrams each
Day 2 — 600 milligrams by mouth, given as two tablets of 300 milligrams each

Option 2:

Day 1 — 600 milligrams by mouth, given as two tablets of 300 milligrams each
Day 2 — 600 milligrams by mouth, given as two tablets of 300 milligrams each
Day 8 — 300 milligrams by mouth, given as one tablet
Day 15 — 927 milligrams by injection, given as two injections of 1.5 milliliters each

After either starting option, the recommended maintenance dose is 927 milligrams by injection every six months, or 26 weeks, from the date of the last injection, plus or minus two weeks.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Sunlenca Side Effects

In clinical studies of Sunlenca, the most common side effects occurred in about 4 percent to 65 percent of people. These include:

Injection site reactions (such as swelling, pain, discoloration, a lump or small mass, skin hardening, or itching where the shot is given)
Nausea

Serious Side Effects and Warnings

Sunlenca can cause serious side effects that may require immediate medical attention. These include:

Immune reconstitution syndrome — Changes in the immune system can trigger inflammation related to past infections, or, less commonly, autoimmune conditions.
Serious injection site reactions — These reactions can include skin breakdown, such as necrosis or ulcer, at the injection site.

Get medical help right away if you think you are having a serious reaction.

How To Save on Sunlenca

Gilead Sciences, Inc, the manufacturer of Sunlenca, offers the Gilead Advancing Access Co-pay Savings Program. Eligible people with commercial insurance may pay as little as $0. If you have government insurance or no insurance, the program also provides information about other financial assistance options.

The Gilead Advancing Access Program also offers help understanding copay costs and identifying potential financial support options.

To learn more, visit the Gilead Advancing Access Program website or call 800-226-2056.

What To Know Before Taking Sunlenca

Tell your doctor if you have any allergies to lenacapavir or any ingredients in Sunlenca.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Sunlenca can interact with other medicines. Some medicines can lower the amount of Sunlenca in your body and make it less effective. Strong CYP3A inducers should not be taken with Sunlenca. St. John’s wort is also contraindicated because it may lower Sunlenca levels and increase the risk that the treatment stops working or the virus becomes resistant.

Sunlenca may also affect certain other medicines for up to nine months after your last injection.

Do not take or receive Sunlenca if you are taking a strong CYP3A inducer.

It is important to keep your scheduled Sunlenca injection visits and take the other HIV medicines in your treatment plan as directed. Missing treatment may cause the amount of HIV-1 in your blood to increase and may make the virus harder to treat.

If you plan to miss a scheduled injection by more than two weeks, contact your healthcare provider. You may be able to take 300 milligrams of Sunlenca by mouth once every seven days for up to six months until injections resume.

If more than 28 weeks have passed since your last injection and you have not taken Sunlenca tablets for oral bridging, your healthcare provider may restart treatment using initiation option 1 or option 2.

If you are pregnant or plan to become pregnant, tell your healthcare provider.

A pregnancy registry tracks pregnancy outcomes in people exposed to Sunlenca. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry or calling 800-258-4263.

If you are breastfeeding or plan to become breastfeed, tell your healthcare provider. Possible risks include:

Passing HIV-1 to a baby who does not have HIV-1
Development of drug-resistant HIV-1 in a baby who has HIV-1
Side effects in the breastfed baby similar to those seen in adults

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Sunlenca for HIV?

In a 52-week study of adults with multidrug-resistant HIV-1, 83 percent of participants in one study group had a viral load below 50 copies per milliliter at week 52 while taking Sunlenca with other HIV medicines. In a second study group, 72 percent reached the same level at week 52.

During the first 14 days of the study, 87.5 percent of participants receiving Sunlenca had at least a 0.5 log10 decrease in viral load, compared with 16.7 percent receiving placebo.

How often is Sunlenca taken for HIV?

After starting treatment, the maintenance dose is two injections under the skin every six months, or 26 weeks. There are two recommended ways to start treatment, and both include Sunlenca tablets.

Sunlenca is used with other antiretroviral medicines, not by itself.

What other medicines can interact with Sunlenca?

Sunlenca can interact with several medicines. Some drugs can lower the amount of Sunlenca in your body and make it less effective, while others may increase the risk of side effects.

Examples of medicines that may interact with Sunlenca include certain seizure medicines, tuberculosis medicines, HIV medicines, blood thinners, cholesterol medicines, opioid pain medicines, corticosteroids, and sedatives. St. John’s wort can also interact with Sunlenca.

Some strong CYP3A inducers, including carbamazepine, phenytoin, rifampin, and St. John’s wort should not be taken with Sunlenca.

Sunlenca may also affect certain other medicines for up to nine months after your last injection. Tell your healthcare provider about all prescription medicines, over-the-counter medicines, and herbal products you take before starting anything new.