Sunlenca (lenacapavir) is a medicine that was approved by the FDA in 2022 to treat HIV in combination with other HIV medicines. Sunlenca has a unique mechanism of action and is the first medicine in its class (capsid inhibitors). It is used in adults whose HIV treatment is not working because the virus has become resistant or because of side effects or safety issues.
How Does It Treat HIV?
People with HIV have a virus that spreads in their body and damages the immune system, making it easier for them to get very sick from other infections.
The medicine contained in Sunlenca works together with other medicines to stop the spread of HIV in your body. This helps protect and preserve the immune system and can prevent the virus from being spread to other people.
Sunlenca is not a complete treatment regimen for HIV. This means that you will need to take it with other medicines to keep the infection under control. While Sunlenca (when used with other medicines) can help keep the HIV infection under control, it is not a cure.
How Was It Studied for the Treatment of HIV?
The effectiveness and safety of Sunlenca was studied in the CAPELLA trial. The trial included 72 people who were previously receiving regular treatment with a combination of HIV medicines with evidence of treatment failure. Treatment failure was defined by high levels of the HIV virus and resistance to multiple HIV medicines. The main study outcomes found that Sunlenca showed high rates of HIV virus control with meaningful increases in CD4 cell counts (a type of white blood cell that helps fight infections) for up to 52 weeks.
Your results may differ from what was seen in clinical studies.
Who Was Included in These Studies?
The studies included a variety of people.
- Adults
- Males (75%) and females (25%)
- Asian (21%), Black (38%), Hispanic/Latino (21%), and White (41%) people
How Strong Is the Evidence for Sunlenca?
Based on the clinical studies, Sunlenca is a safe and effective treatment for people with HIV. The Department of Health and Human Services recommends Sunlenca (in combination with other medicines) as one of several options to treat people with HIV that is resistant to multiple medicines.
How Is Sunlenca Taken?
Sunlenca treatment includes both injections and tablets. Your health care provider will give you the Sunlenca injections just under the skin in your stomach area.
There are two ways to begin Sunlenca treatment. Your health care provider will decide which option is best for you.
Option 1
- Day 1: Get two Sunlenca injections and take two tablets.
- Day 2: Take two tablets.
Option 2
- Days 1 and 2: Take two tablets each day.
- Day 8: Take one tablet.
- Day 15: Get two Sunlenca injections.
After completing your starting option, you will get two Sunlenca injections every six months (26 weeks) from the date of your last injection.
Continue to stay under your health care provider’s care while being treated with Sunlenca. Make sure to attend all scheduled appointments for your injections. Do not stop taking Sunlenca without talking to your health care provider first.
What Can I Do to Prevent or Manage Side Effects?
The most common side effects seen with Sunlenca are nausea and reactions such as pain, itching, swelling, or redness where the needle went in your skin. If you experience nausea, try taking it with food or a light snack and see if that helps. Eating smaller, more frequent meals may also help.
These are not all of the side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088.
What Types of Drug Interactions Can Happen?
Medicines called CYP3A4 inducers can decrease the blood levels of Sunlenca in your body. This can cause Sunlenca to be less effective and could lead to the HIV infection becoming resistant. These medicines should not be taken while you are taking Sunlenca.
Other medicines called P-gp, UGT1A1, and strong CYP3A inhibitors can also increase the amount of Sunlenca in the blood by a lot and should not be used while you are taking Sunlenca.
Sunlenca is also a moderate CYP3A enzyme inhibitor and may raise the chance of side effects from certain medicines broken down by CYP3A enzymes in your body if these medicines are started within nine months after your last injection.
Sunlenca interacts with many medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have recently taken. This will help make sure your medicines work well together.
How Do I Know If It Is Working?
Your health care provider will order several routine tests while you are taking Sunlenca for the treatment of HIV. One of those tests is called an HIV viral load. This measures the number of HIV viruses in your blood. If you have never been treated for HIV, your viral load may be high. Taking Sunlenca (with other HIV medicines) every day will help your viral load go down and keep the infection under control.
Is There Any Cost Assistance Available?
Yes. There is a cost savings and support program offered by the manufacturer that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.sunlenca.com/support.
