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What to Know About Sunlenca, a First-in-Class, Twice-Yearly HIV Treatment

Mandeep Sohal, PharmDHope Chang, PharmD, AAHIVP
Published on March 10, 2023

Key takeaways:

  • Sunlenca (lenacapavir) is a medication that treats HIV in people who don’t have many other treatment options. It works differently than other HIV medications; it’s a type of capsid inhibitor.

  • After your initial starter doses, you only need to receive Sunlenca injections every 6 months (twice a year).

  • Like all medications, Sunlenca side effects are possible. The most common ones are injection site reactions and nausea.

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A healthcare provider administers an injection into a patient’s skin.
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With the right medications, life with HIV is very manageable. HIV treatments aim to keep your viral load — or the amount of virus in your body — below a certain level. By keeping levels below this amount, you give yourself the best chance of a long, healthy life, and you’re much less likely to give the virus to others.

However, in certain situations, some HIV medications may not work. If you’ve tried multiple HIV medications with limited success, you may be looking for another option.

Sunlenca (lenacapavir) is a newer HIV medication that may be used in this scenario. It can help you fight HIV and keep it at bay.

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What is Sunlenca?

Sunlenca is a brand-name medication that’s FDA approved to treat HIV in adults. It comes as an under-the-skin (subcutaneous) injection and oral tablet. It’s used in combination with other HIV medications to help keep the condition under control.

However, Sunlenca isn’t meant for everyone living with HIV. It’s specifically meant for people who have tried many medications that have failed to treat their HIV adequately. These medications may not have worked, had too many side effects, or had other safety issues.

Keep in mind: While Sunlenca is a helpful treatment for HIV, it’s not a cure.

How does Sunlenca work to treat HIV?

HIV is a virus. Viruses come in many shapes and sizes, and they often have several protective layers. A “capsid” is a protective layer for HIV viruses. It serves as a protective coating for HIV viral RNA, which is necessary for replication. 

Sunlenca works by blocking the function of this capsid. Because if this capsid isn’t working as it should, HIV can’t spread (replicate) in your body. Sunlenca is the first HIV medication that works this way. Other HIV medications work by fighting the virus at different points of the HIV life cycle.

How is Sunlenca dosed and administered?

Sunlenca’s dosages are designed to be convenient and infrequent. However, there are a few initial steps to take to help your body adjust to it. There are two different ways to start taking Sunlenca.

  1. Start method one: This involves receiving two Sunlenca injections and swallowing two Sunlenca tablets all in one day. On the next day, you’ll swallow another two Sunlenca tablets.

  2. Start method two: Another option is swallowing two Sunlenca tablets two days in a row. Then, one week after your first dose, take one Sunlenca tablet. A week after that, you’d receive your first two Sunlenca injections.

After you’ve gone through one of these two steps, you’re ready to schedule your maintenance injections. You will only need to receive Sunlenca once every 6 months (twice a year) after these initial steps. Each time you receive a dose, you’ll receive two under-the-skin injections (both in one visit).

How effective is Sunlenca?

Sunlenca was studied in a small clinical trial called CAPELLA. The CAPELLA trial included 72 people living with medication-resistant HIV. Here, Sunlenca’s effectiveness was measured by its potential ability to reduce HIV levels to under a certain threshold; this level is less than 50 copies of HIV virus per mL of blood. This is also called an “undetectable viral load” — which is one of the main treatment goals of HIV.

In this study, Sunlenca was compared to placebo (a substance without a medication in it). About 88% of people taking Sunlenca were found to have an initial decrease in viral load after 2 weeks. This was compared to only about 17% of people taking placebo.

Long-term data was also collected. After 26 weeks (6 months), over 80% of people taking Sunlenca had an undetectable viral load.

How does Sunlenca compare to other HIV medications?

Sunlenca isn’t a first-choice HIV medication. It’s specifically reserved for people who don’t have many other options for the treatment of their HIV.

One example of a daily, go-to medication that people take for HIV management is Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Sunlenca and medications like Biktarvy fight the virus that causes HIV in different ways.

What are the known side effects of Sunlenca?

The most common Sunlenca side effects in initial studies were injection site reactions such as pain, redness, and skin hardening where the medication was injected. A number of people also experienced nausea.

More serious side effects are possible, albeit rare.

Immune reconstitution inflammatory syndrome is one risk that’s important to consider. It’s not common, but this is when your immune system becomes overactive and attacks certain parts of your body. It happens most often while you’re recovering from certain infections. Symptoms may include enlarged lymph nodes, fever, and trouble breathing. As a precaution, you should speak with your healthcare provider if you develop any possible symptoms of an infection after starting Sunlenca.

Does Sunlenca interact with other medications?

Yes, Sunlenca can interact with many other medications and supplements.

Medications that impact Sunlenca’s effectiveness

Your liver has enzymes (proteins) that are responsible for breaking down and metabolizing several things, including medications. Some medications make these enzymes do their job faster than normal. This can prompt your liver to break down Sunlenca more efficiently, which could decrease its effectiveness. A less effective treatment means worse HIV control.

Medications and supplements that should be completely avoided with Sunlenca include:

  • Phenytoin (Dilantin, Phenytek)

  • Rifampin (Rifadin)

  • St. John’s wort

Medications that aren’t recommended to take with Sunlenca include, but aren’t limited to:

  • Carbamazepine (Tegretol, Equetro)

  • Oxcarbazepine (Oxtellar XR, Tegretol)

  • Phenobarbital

  • Efavirenz (Sustiva)

  • Nevirapine (Viramune)

  • Tipranavir/ritonavir

If you’re currently taking one or more of these medications and are planning on starting Sunlenca, you should speak to your pharmacist. They can help you figure out a way to manage or avoid these interactions.

Other medications that are affected by Sunlenca

Medication interactions are a two-way street. Not only can other medications affect Sunlenca, but Sunlenca can cause interactions, too.

Sunlenca can raise the levels of other medications in your blood. This can increase the risk of side effects. Some examples include:

  • Digoxin (Lanoxin)

  • Rivaroxaban (Xarelto)

  • Dabigatran (Pradaxa)

  • Edoxaban (Savaysa)

  • Corticosteroids like dexamethasone

  • Dihydroergotamine (Migranal, Trudhesa)

  • Pain medications like fentanyl, oxycodone (OxyContin) and tramadol (ConZip, Qdolo)

  • Sedatives like midazolam

  • Lovastatin

  • Simvastatin (Zocor)

Since Sunlenca lasts for a long time in your body, these interactions can be relevant for many months after your last dose. Your pharmacist can tell you more about what to expect.

Keep in mind: This list does not describe all interacting medications. You should speak to your healthcare provider and/or pharmacist before starting Sunlenca. They can review your medication list to make sure your current medication regimen will get along with Sunlenca, and adjust your medication doses if needed.

Is Sunlenca already available?

Yes, Sunlenca is available for use. It was FDA approved in December 2022, and it was launched in the U.S. soon after.

While you may be able to get Sunlenca tablets at certain pharmacies, the injections will be administered by your healthcare provider. You won’t need to give yourself the injections.

The bottom line

Sunlenca is a medication that helps fight HIV when other medications aren’t an option. It works in a unique way, and it’s only administered twice a year. A clinical study found it to be an effective option when compared to placebo, but you should take it alongside your other HIV medications. The most common side effects of Sunlenca are injection site reactions and nausea.

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Why trust our experts?

Mandeep Sohal, PharmD
Mandeep Sohal, PharmD, has more than 7 years of experience in the pharmaceutical industry and is licensed in California. In his career, he’s had experience with specialty pharmacy, community pharmacy, pharmacy benefit management, and pharmaceutical manufacturers.
Joshua Murdock, PharmD, BCBBS
Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.
Hope Chang, PharmD, AAHIVP
Hope Chang is a freelance writer and content reviewer for GoodRx. She attended Howard University College of Pharmacy in Washington, D.C. and completed post-graduate residency training at the University of California, Davis Medical Center.
View All References (6)

International Association of Providers of AIDS Care. (2021). Viral suppression U=U.

National Institutes of Health. (2021). The HIV life cycle.

Segal-Maurer, S., et al. (2022). Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. The New England Journal of Medicine.

Sharma, S. K., et al. (2011). HIV & immune reconstitution inflammatory syndrome (IRIS). Indian Journal of Medical Research.

Spivack, S., et al. (2022). HIV: How to manage heavily treatment-experienced patients. Drugs in Context.

U.S. Food and Drug Administration. (2022). FDA approves new HIV Drug for adults with limited treatment options.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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