The US Food and Drug Administration (FDA) Delivers a Christmas Present for People living with HIV: The Drug Lenacapravir was just Approved!

By Dr. Keith Crawford

   There have been a handful of individuals who have been completely cured of HIV and I have reported on some of them in articles on A larger number of individuals have been able to keep the virus completely suppressed (undetectable) without the use of medication (functional cure). While there is a large investment in research to find a cure for HIV, we may still be a long way off. So, for now, people living with HIV must take treatment for the remainder of their lives. Therefore, we must have treatment options when a treatment regimen fails. The most common reason why a treatment regimen fails is because the patient doesn’t take their medication as prescribed by their medical provider. Inadequate dosing can allow the HIV virus to develop resistance to the medication, which means the medication is less effective in suppressing the virus. When this occurs, the regimen must be changed to new drugs that can suppress the virus. While people who are recently infected may have many treatment options, people who have been living with HIV for many years, even decades, may have very few options if they fail therapy.

Enter Lenacpravir (Sunlenca). The FDA approved this drug on December 22, 2022 for people with multi-drug resistant virus. I have written about this drug in earlier articles on when it was undergoing clinical trials and I spoke about it in the Blackdoctor 2022 World AIDS Day program (  It is a perfect Christmas present in the battle against HIV disease. Lenacapravir is a very important drug for many reasons. Most importantly, Lenacapravir works differently from all other approved HIV medications. This is important because sometimes, a patient may develop resistance to a particular drug, but this resistance can also affect other related drugs in the same class, so that none of those drug’s work. Lenacapravir works in a unique way, and because it is brand new, it should work in all individuals, even those who have virus that is resistant to other classes of HIV medications.

Lenacapravir is classified as a capsid inhibitor, and it blocks important steps in the HIV replication cycle in our blood cells (lymphocytes). Capsid is a specialized protein that forms a sort of capsule that protects the HIV virus’s genetic material. In order for the virus to replicate, this capsid protein must unravel to expose the virus’s genetic material.  As new virus is produced, genetic material must be packaged back into a Capsid “capsule”, and then incorporated into the new virus particles. Lenacapravir blocks the actions of Capsid protein and therefore, disrupts HIV replication.

In addition to the unique way that it works, Lenacapravir also has unique dosing. It can be injected under the skin, like the way a person with diabetes would administer insulin. But unlike insulin, Lenacapravir isn’t taken every day….or every week……or every month. A single injection of Lenacapravir lasts for six months! This is the longest acting HIV medicine that we have so far. As I have reported earlier this year, we have long-acting injectable HIV medicines available injectable cabotegravir and injectable rilpivirine. These two drugs are administered together for HIV treatment (Cabanuva), but cabotegravir is given alone for HIV prevention (Apretude). Unlike Lenacapravir, they are injected into the muscle, so a medical professional must do it. Also, these products last for two months with each dose. Long-acting therapies for HIV and other medical conditions can really help control the disease, especially for folks who aren’t good at taking pills every day. Some people have complicated schedules, mental health challenges, privacy concerns or other factors that make it difficult to take pills every day. These long-acting medications could be an important breakthrough in helping people with HIV stay undetectable.

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Lenacapravir should not be administered as a single treatment for HIV but needs to be combined with at least one other medicine. It is possible that some people may have to take Lenacapravir combined with other medicines that are daily pills, but hopefully, we will soon develop the best approach for combining it with other long-acting HIV medicines.

Lenacapravir currently is approved for use by patients who have few treatment options, due to their HIV being resistant to several classes of the drugs. But the drug can work in any patient, even newly infected persons. Lenacapravir is important for all people living with HIV because it means there is a new treatment option, whether they need it a year from now or ten years from now (Let’s pray we have a cure by then!). It is also undergoing clinical trials for preventing HIV, so be expected more good news about this drug. If interested in this treatment, have a discussion with your HIV medical provider.

About Carma Henry 21556 Articles
Carma Lynn Henry Westside Gazette Newspaper 545 N.W. 7th Terrace, Fort Lauderdale, Florida 33311 Office: (954) 525-1489 Fax: (954) 525-1861

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