You may have heard about Idvynso, a medicine approved by the FDA in April 2026 to treat HIV. It is used to replace a current HIV treatment regimen in certain people whose virus is already under control.
Idvynso is a complete treatment regimen for HIV. This means it can be taken by itself and does not need to be combined with other HIV medicines.
This article covers how Idvynso works for HIV, how it was studied, and how to take it. You may also be interested in learning more about Idvynso side effects and Idvynso drug interactions.
How Does Idvynso Work for HIV?
HIV is a virus that attacks your immune system. It spreads in your body by making copies of itself. To do this, the virus uses an important protein called reverse transcriptase. This protein helps HIV turn its genetic material into DNA so it can take over your cells and continue to spread.
Idvynso is an oral tablet that contains two medicines that target this process in different ways.
- Doravirine blocks reverse transcriptase, preventing the virus from copying itself. It works by attaching to this protein and stopping it from doing its job. This slows down the spread of HIV in your body.
- Islatravir works in a slightly different way. In your body, it changes into an active form. This active form gets built into the virus’s DNA as it is being made. Once it is added, it stops the DNA chain from being completed. It also causes changes that prevent the virus from continuing to grow.
By working in these two ways, the medicines in Idvynso help stop HIV from making new copies of itself. This helps lower the amount of virus in your body and protect your immune system.
How Was Idvynso Studied for HIV?
Idvynso was studied in two large clinical trials that included adults living with HIV whose virus was already under control. These studies looked at what happened when people switched from their current HIV treatment to Idvynso.
To be included in the studies, participants needed to meet certain requirements:
- Be on a stable HIV treatment regimen for at least three months
- Have no history of HIV treatment failure
- Have no known resistance to one of the medicines in Idvynso (meaning that one of the medicines in Idvynso did not work)
- Have a very low or undetectable amount of virus in your body, defined as a viral load below 50 copies/mL
Viral load is a measure of how many copies of the virus are found in your blood. Lower numbers mean the virus is better controlled or suppressed.
People with active hepatitis B infection were not included in these studies.
In both studies, participants were randomly assigned to either switch to Idvynso or continue their current HIV treatment regimen.
In one study, neither the participants nor the researchers knew who was taking Idvynso or the comparison treatment during the study. In the other study, both participants and researchers knew which treatment was being used.
The main goal was to see how well Idvynso worked to keep HIV under control. This was done by measuring how many people maintained viral suppression (low or undetectable HIV levels) after 48 weeks.
Who Was Included in These Studies?
More than 1,000 adults took part in the two studies.
In one study, researchers looked at what happened when people switched from their current HIV treatment to Idvynso. A total of 551 adults took part in this study:
- The average age of participants was about 50 years, with ages ranging from 18 to 83.
- Most participants were men (60%).
- The group included people from different racial backgrounds, including White (39%), Black or African American (45%), Asian (5%), and other or unknown races (11%). About 15% identified as Hispanic or Latino.
- At the start of the study, most participants had strong immune systems, with high CD4 cell counts, which are a type of white blood cell that helps fight infections. Some had evidence of a past hepatitis B infection.
In the other study, researchers focused on people who were taking a specific HIV treatment combination —bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) — and then switched to Idvynso. This study included 513 adults:
- The average age was about 48 years, with participants ranging from 19 to 77 years old.
- Most participants were men (79%).
- The study also included a mix of racial and ethnic groups, including people who were White (61%), Black or African American (31%), Asian (6%), and other or unknown races (3%). About 23% identified as Hispanic or Latino.
- Similar to the first study, most participants had strong immune systems at the start, and some had a history of hepatitis B infection.
What Are the Main Benefits of Idvynso Based on Studies?
After 48 weeks, most people who switched to Idvynso were able to keep their HIV under control. The table below summarizes the main results:
Trial 1 | Trial 2 | |||
|---|---|---|---|---|
| People who switched to Idvynso | People who stayed on current HIV treatment | People who switched to Idvynso | People who stayed on BIC/FTC/TAF | |
| Virus controlled (low or undetectable viral load) | 96% | 92% | 92% | 94% |
| Virus not controlled (viral load of 50 copies/mL or higher) | 1% | 5% | 1% | 1% |
| No results available (missed visits or stopped treatment) | 3% | 3% | 7% | 5% |
In both studies, Idvynso worked just as well as the treatments people were already taking. Most people maintained a low or undetectable viral load.
Keep in mind that your results may differ from those seen in studies.
How Do I Take Idvynso?
Idvynso is a tablet that you take by mouth once daily. It can be taken with or without food.
It is important to take Idvynso exactly as your health care provider prescribes. Try to take it at the same time every day.
Taking your medicine every day without missing doses is one of the most important parts of HIV treatment. Missing doses can allow the virus to increase and may lead to medicine resistance, which can make HIV harder to treat.
Before starting Idvynso, talk to your health care provider about anything that may make it harder to take your medicine every day. This may include changes in your daily schedule, trouble remembering doses or paying for your medicine, or other challenges. Together, you can create a plan that works for your routine.
Here are some helpful tips:
- Take your medicine at the same time each day.
- Set an alarm or reminder.
- Link your dose to a daily habit, such as brushing your teeth.
- Plan ahead for travel or schedule changes.
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take two doses at the same time.
Idvynso is not a cure for HIV. But when taken as directed, it keeps the HIV infection under control.
Contact your health care provider about any questions or concerns while taking Idvynso, and keep all scheduled appointments. Do not stop taking Idvynso without talking to your health care provider first.
Is There Any Cost Assistance Available?
Merck, the company that makes Idvynso, offers a patient assistance program that may help lower the cost of the medicine. Whether you qualify depends on whether you have insurance and what it covers. You can visit the program website to check your eligibility and learn more. You can also call 877-709-4455 to speak with someone about your options for financial support.
