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New HIV Treatments in Development

Medically Reviewed by Laura J. Martin, MD on April 18, 2022

HIV treatment has come a long way. With daily medication, most people with HIV can live a normal life span. But unmet needs still remain. Some people, for example, find it hard to remember to take their medicine every day. Others develop drug-resistant strains of HIV that make medications ineffective.

Fortunately, researchers continue to search for new and better HIV treatments that can fill these gaps in care. Here’s a look at some of the most exciting options.

Promising Drugs in Development

When you have HIV, you go on a treatment called antiretroviral therapy (ART) as soon as possible after your diagnosis. ART includes three different HIV medicines from at least three different drug classes. This may mean that you take multiple pills several times a day.

Some people struggle to keep up with all these pills, especially if they have substance use or mental health disorders. Others develop resistance to these drugs. That means the virus changes and the medicine no longer keeps it under control.

Of the many new medications in clinical trials, two are close to getting FDA approval.

Lenacapavir. If approved, lenacapavir will be the second injectable HIV medication. In 2021, the Food and Drug Administration (FDA) approved Cabenuva, which contains two different types of HIV drugs: cabotegravir and rilpivirine. You take it as an injection once a month at your doctor’s office. It makes a much easier option for people who find it hard to remember to take their pills every day.

Lenacapavir could cut those doctor visits down to twice a year. Researchers are studying this new injectable drug that you only need to take every 6 months. A capsid inhibitor, it affects the shell that protects the virus and prevents it from multiplying. That way, you’ll have less HIV in your body. It appears to work against strains that have become resistant to other drugs, too.

Studies show lenacapavir is effective, but the FDA has held off approving it due to manufacturing issues. The company plans to fix these issues and submit another application for approval later this year.

Islatravir. This type of drug is called an NRTTI (nucleoside reverse transcriptase translocation inhibitor). Still in clinical trials, the weekly pill blocks a protein that helps the virus multiply. As a result, HIV levels in the body drop. It seems to work against some drug-resistant strains of HIV, too.

Researchers are also studying a combination of weekly islatravir and the injectable lenacapavir. However, the FDA put trials on hold this past December after reports that some people in the study saw a decrease in their white blood cell counts. A low white blood cell count raises your risk for infections. People already in the trial can continue to take the drug, but new participants aren’t allowed in. It’s not clear when trials will resume.

HIV Vaccines

Researchers are developing a therapeutic HIV vaccine. Therapeutic vaccines treat a condition rather than prevent it. People who already have HIV would get this therapeutic vaccine to help strengthen their immune system’s response to the virus. The hope is that the vaccine alone would prevent HIV from progressing to AIDS without the need for ART.

So far, it’s been hard to develop an HIV vaccine. Most traditional vaccines use a dead or weakened form of a virus to prompt the body to make antibodies against it. But that method hasn’t worked with weakened HIV, and a live form of the virus is too dangerous to use.

But researchers may be making headway on a different type of vaccine. The HTI vaccine teaches immune cells called T cells to attack a specific part of the virus that allows it to make copies of itself. In one small study of 45 patients, 40 percent of those who got the vaccine were able to stay off of ART for 22 weeks.

Researchers are now studying the vaccine in combination with the experimental drug vesatolimod. This drug may enhance the body’s immune response to the vaccine, which could make it effective for more people or make its effects last longer.

Gene Editing

Gene editing could be another approach to HIV treatment. Gene editing technology changes an organism’s DNA. Studies of gene editing are underway in a range of genetic diseases such as cystic fibrosis, hemophilia, and sickle cell disease. Now, researchers are trying to harness it against HIV.

Early experiments on animals suggest that a type of gene editing called CRISPR may disable a virus similar to HIV called simian immunodeficiency virus (SIV), found in animals such as monkeys. Very early human clinical trials began at the end of 2021. In the trials, researchers use CRISPR technology to cut out the HIV that wraps around the DNA in cells and makes it so difficult to treat.

The hope is that unlike ART, which you have to take for life, a one-time CRISPR treatment may cure the disease.

Testing HIV Treatments

A lot of research goes into HIV treatments to make sure, first, that they are safe and then that they work. Researchers ensure this through clinical trials. This allows them to answer many questions about the drugs.

Clinical trials happen in four phases:

  • Phase I. A small group of people (less than 80) get the treatment to make sure it is safe and to identify the side effects.
  • Phase II. Several hundred people receive the treatment as researchers continue to monitor the safety and start to see whether the drug works.
  • Phase III. Several thousand people receive the treatment (usually between 1,000 and 3,000) to confirm it works, watch for side effects, and compare it to existing treatments. After this phase, the drugmaker can use the clinical trial results to apply for FDA approval of the drug.
  • Phase IV. FDA continues to track recently approved drugs to make sure there aren’t any new problems now that more people are using them.

If an HIV treatment doesn't work for you, or you find your medication regimen hard to follow, you may be able to enroll in a clinical trial. To find one near you, use the search feature on clinicaltrials.gov. Sometimes, drug companies get permission from the FDA to make their experimental HIV drugs available to people who are not in the clinical trial. If there’s a drug that you are interested in but you can’t be part of the clinical trial, talk to your doctor to see if you qualify for an expanded access program.

Show Sources

SOURCES:

National Institutes of Health: “What is a Therapeutic HIV Vaccine?” “What is an Investigational HIV Drug?” “Islatravir,” “Lenavcapavir.”

National Institute of Allergy and Infectious Diseases: “Infographic: Progress Towards an HIV Vaccine.”

FDA: "FDA Approves Cabenuva and Vocabria for the Treatment of HIV-1 Infection.”

Gilead: “Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues.”

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