You may have heard about Biktarvy, a medicine approved by the FDA in 2018 to treat people with HIV who have not been treated yet. It may also be used to replace another medicine for treating HIV in people whose condition is under control and whose infection is not resistant to Biktarvy.
Biktarvy contains three medicines: bictegravir, emtricitabine, and tenofovir alafenamide. Two of these medicines, emtricitabine and tenofovir alafenamide, have been used to treat HIV for many years.
How Does Biktarvy 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 three medicines contained in Biktarvy work together 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.
Biktarvy is a single-tablet regimen for HIV. This means that you only have to take one tablet once per day instead of multiple medicines several times per day. This makes it easier to take the medicine, which is very important in treating HIV and keeping the infection under control.
While Biktarvy can help keep HIV under control, it is not a cure. Also, it does not protect against or prevent the spread of sexually transmitted infections (STIs) like herpes, gonorrhea, or chlamydia.
How Was It Studied for HIV?
Several clinical trials have been conducted to see if Biktarvy is safe and effective for treating people with HIV.
Two studies focused on those who have never been treated for HIV. In these studies, Biktarvy was compared to a first-line HIV treatment regimen recommended by the Department of Health and Human Services (HHS). Both studies lasted 144 weeks, and Biktarvy was shown to be as effective as the other treatment regimens. Also, there were no reports of treatment resistance to Biktarvy.
Several other studies focused on those receiving treatment for HIV whose infection was under control. In these studies, patients either kept taking their current regimen or were switched to Biktarvy. These studies ranged from 24 to 48 weeks. At the end of the studies, Biktarvy was shown to be highly effective in keeping the HIV infection under control. There were no reports of treatment resistance.
Some of these studies were continued to find out about the long-term effects of Biktarvy. Currently, it has been studied for at least 5 years in those who had never been treated for HIV and for at least 3 years in those who were already receiving treatment for HIV. So far, there have been no reports of treatment resistance to Biktarvy.
Who Was Included in These Studies?
Overall, Biktarvy has been studied in a variety of people.
- Adults (including those 65 and older), adolescents, and children
- Males and females
- Asian, Black, Hispanic/Latino, and White people
How Strong Is the Evidence?
Based on the current clinical studies, Biktarvy is a safe and effective treatment for people with HIV. The Department of Health and Human Services recommends Biktarvy as one of several first-line medicines for those who have never been treated for HIV.
How Is Biktarvy Taken?
Biktarvy is a single tablet taken by mouth once daily. It can be taken at any time of the day, with or without food. Taking Biktarvy every day and not missing doses is very important in keeping the HIV infection under control.
Do not stop taking Biktarvy without talking to your health care provider first.
What Can I Do to Prevent or Manage the Side Effects?
The most common side effects seen with Biktarvy are diarrhea, nausea, and headache.
If you experience diarrhea, make sure to drink plenty of fluids to stay hydrated. 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. Getting plenty of rest and drinking enough water can help with headaches.
Over-the-counter (OTC) or prescription medicine can be used to help with side effects. Talk to your health care provider for specific recommendations.
These are not all of the possible 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. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Types of Drug Interactions Can Happen?
Other medicines may alter the blood levels of Biktarvy and vice versa, causing there to be too much or too little medicine in your body. This could lead to serious side effects or the medicine not working well.
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 Biktarvy. 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 Biktarvy every day will help your viral load go down and keep the infection under control.
If your HIV is already being treated and is under control and you are being switched to Biktarvy, your viral load should stay under control if you are taking it every day.
Is There Any Cost Assistance Available?
Yes. There is a co-pay program from 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.biktarvy.com/resources/biktarvy-cost-support .
