Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a prescription medicine used to treat HIV infection. It contains four medicines combined into a single tablet, which can be simple and convenient. It is also a complete HIV regimen, meaning that it does not need to be used with other HIV medicines.
How Does Genvoya Work?
Medicines that treat HIV are called antiretroviral therapy (ART). Genvoya is a combination tablet that contains the following four medicines that work together to treat HIV.
- Elvitegravir is an integrase strand transfer inhibitor. It works by stopping an HIV protein, called integrase, from inserting the virus’s DNA into your body’s healthy DNA. This prevents the virus from multiplying.
- Emtricitabine and tenofovir alafenamide (TAF) are both nucleoside analog reverse transcriptase inhibitors. They block a protein, called reverse transcriptase, that HIV needs to make copies of itself. TAF is a prodrug of tenofovir, which means that it is converted into the active medicine inside your cells. This allows for a lower dose compared to an older form of tenofovir (tenofovir disoproxil fumarate [TDF]).
Cobicistat is a “booster.” It works by slowing down the breakdown of elvitegravir in your body, allowing elvitegravir to work better.
Is Genvoya Right for Me?
Genvoya may be right for you if you have HIV and you are an adult or child who weighs at least 55 pounds (25 kilograms). It can be used for either of the situations below.
- You have never taken HIV medicine before.
- You are using Genvoya to replace your current HIV regimen. This may be an option if you have been taking your current HIV regimen for at least 6 months and the amount of HIV in your body (viral load) is low (less than 50 copies of HIV RNA per milliliter of blood). You must also have no history of HIV treatments not working in the past and no resistance to the medicines in Genvoya.
Genvoya is not recommended during pregnancy because the levels of two of its medicines (cobicistat and elvitegravir) are much lower during the second and third trimesters of pregnancy. This means that Genvoya may not work as well. Tell your health care provider right away if you become pregnant while taking Genvoya.
Before starting Genvoya, your health care provider should test you for hepatitis B virus infection. They will also need to check other labs, such as blood work and urine tests. You may not be able to take Genvoya if you have severe liver problems or severe kidney problems.
How Was Genvoya Studied?
Genvoya’s efficacy and safety were confirmed in several clinical studies. One of the largest included two studies that included 1,733 people with HIV who had never taken HIV medicines before. People were randomly split into the following two main groups.
- One group took Genvoya once daily.
- The other group took a once-daily HIV combination medicine containing elvitegravir, cobicistat, emtricitabine, and TDF.
A key difference between these two treatments is that Genvoya contains TAF, while the other treatment contains TDF. TAF may have a lower risk of bone and kidney problems than TDF, while TDF is linked with lower cholesterol levels.
None of the people knew which medicine they were taking. Most were male (85%), and their average age was 36 years. About 57% of people in the study were White, 25% were Black, 10% were Asian, and 19% identified as Hispanic/Latino.
At the start of these studies, about 23% of people had an HIV RNA viral load over 100,000 copies per milliliter. CD4 count is a measure of the number of CD4 cells (a type of white blood cell) in your blood. Higher CD4 counts can help prevent HIV symptoms and problems. The average CD4 cell count in people at the start of these studies was 427 cells per millimeter (mm)3, and 13% of people had a CD4 count under 200 cells per mm.
What Benefits Were Seen With Genvoya?
less than 50 copies per milliliter (mL) at 48 weeks. This is a measure of how well the medicine is working and may also be called viral suppression.
| Treatment Group | Viral Suppression at Week 48 (HIV RNA less than 50 copies/mL) |
| Genvoya | 92% (800 of 866 people) |
| Elvitegravir/cobicistat/emtricitabine/ TDF | 90% (784 of 867 people) |
The results showed that Genvoya was “non-inferior” to the older TDF-based regimen. This means it was found to not work any worse at keeping the virus suppressed.
Another goal was to look at the effects of the treatments on kidney and bone health. To do this, the researchers looked at two measures of how well the kidneys are working — serum creatinine and protein in the pee (proteinuria) — and how much these readings went up. They also looked at whether there was a loss of bone density in the spine or hip.
Overall, at 48 weeks, there was a lower average increase in serum creatinine and less protein in the pee with Genvoya compared to the other treatment. There was also less average bone loss with Genvoya compared to the other treatment (although there was a slight decrease with both treatments). The long-term impact of these changes is unknown.
Your results may differ from what was seen in clinical studies.
What Are the Side Effects and How Can I Manage Them?
The most common side effect of Genvoya is nausea. In the same two studies discussed above, about 11% of people taking Genvoya had nausea compared to about 13% of people taking the other treatment at 144 weeks (about 2 years and 9 months).
If you have nausea while taking Genvoya, it may help to limit greasy, spicy, fatty, or acidic (such as citrus) foods. Avoid foods or smells that may trigger nausea, such as certain cooking smells or hot foods. If you feel sick, you can also try eating small meals and bland foods, such as toast or crackers.
Other possible side effects of Genvoya include diarrhea, headache, and tiredness.
If you have diarrhea, make sure you are getting enough fluids and avoid caffeine and alcohol. Avoid foods that are greasy, very sweet, spicy, or acidic. It may also help to eat foods with more soluble fiber, such as applesauce, white rice, or bananas.
For a headache, getting enough fluids and plenty of rest can be helpful. You may also want to stay in a dark, quiet room until your headache gets better. If you feel tired, it may help to eat healthy, balanced meals and try low-impact exercise, such as walking or aerobics.
It is very important to keep taking Genvoya every day as prescribed. Missing doses can increase the risk of resistance, meaning the medicine may not work as well to treat HIV. If you have any side effects that bother you or that make you not want to take the medicine, tell your health care provider right away. There may be other strategies, including over-the-counter treatments, that they can recommend.
Sometimes side effects could be a sign of a more serious problem. Bring up any concerning changes in how you feel with your health care provider.
What Are Serious Warnings to Know About?
It is very important to watch for symptoms of the following serious problems.
- Worsening of hepatitis B infection. If you have both HIV and hepatitis B and you stop taking Genvoya, your hepatitis B infection could suddenly become much worse (a “flare-up”). It is very important to not stop taking Genvoya without talking to your health care provider first. Be sure to get refills before your medicine runs out. If you stop taking Genvoya, your provider will need to check your liver with blood tests for several months. You may also need to take medicine to treat your hepatitis B.
- New or worsening kidney problems. Some people taking medicines that contain TAF, like Genvoya, have had kidney impairment and kidney failure. Your health care provider should do blood and urine tests to check your kidneys. Tell your provider if you have had kidney problems in the past or are taking other medicines that can affect the kidneys, such as certain pain relievers (nonsteroidal anti-inflammatory drugs).
- Lactic acidosis or severe liver problems. Though rare, these are serious medical emergencies that can be fatal. Tell your health care provider right away if you have any of the following symptoms.
- Lactic acidosis symptoms: Unexplained muscle pain, weakness, unusual tiredness, shortness of breath or fast breathing, nausea and vomiting with stomach pain, feeling dizzy or lightheaded, or a fast or abnormal heartbeat.
- Severe liver problem symptoms: Yellowing of the skin or the whites of the eyes, dark-colored pee, light-colored poop, loss of appetite, nausea, or stomach pain.
Immune reconstitution syndrome. When you start HIV medicine, your immune system may get stronger, which may also allow it to start fighting infections that have been in your body for some time. Tell your provider right away if you have any new symptoms of an infection after starting Genvoya.
What Types of Medicine Interactions Can Happen?
Genvoya can interact with many other prescription and over-the-counter medicines, as well as herbal supplements. Some interactions can cause Genvoya not to work as well, which may increase the risk of resistance. Other interactions may cause serious problems from increased levels of the other medicine.
There are many medicines and supplements that should not be taken with Genvoya. Some examples include certain antiseizure medicines, cholesterol-lowering medicines, sedatives, and St. John’s wort. Be sure to tell all of your health care providers that you take Genvoya before starting or stopping any medicine or supplement. Your pharmacist or other health care provider can let you know if Genvoya interacts with any other medicines.
Genvoya may also interact with certain antacids or supplements that contain aluminum, magnesium, calcium, iron, or zinc. These ingredients may also be found in some multivitamins. If you need to take one of these products, take it at least two hours before or two hours after your dose of Genvoya.
How Do I Take Genvoya?
Genvoya is taken as one tablet, once daily, with food. Taking it with food helps the medicine be absorbed better. Take Genvoya exactly as your health care provider recommends.
It is very important to not miss any doses. This can lead to the virus developing resistance, making it harder to treat. Follow a routine to take your medicine at the same time each day, such as when you brush your teeth. Consider setting an alarm or using a mobile app to help you remember when to take each dose. Although pillboxes can be helpful reminder tools for other medicines, Genvoya must be kept in its original container, tightly closed. Do not put the tablets in a pillbox. Get refills of the medicine before you run out.
If you are on dialysis, take your daily dose of Genvoya after your dialysis treatment. Ask your health care provider if you are not sure when to take Genvoya.
How Can I Tell if Genvoya Is Working?
You might not feel a difference when you start taking Genvoya. That does not mean it is not working. Your health care provider will do tests to make sure the medicine is working well for you, including the following.
- Viral load. Your health care provider will do blood work to check your viral load (HIV RNA). A viral load that is very low and cannot be detected by lab tests (undetectable) is the goal.
- CD4 cell count. Your health care provider will check for your CD4 cell count to go up, which shows that your immune system is getting stronger.
- Overall health. Tell your health care provider how you are feeling. The goal is to keep you feeling healthy and to help reduce your risk of infections or other problems. Your health care provider may do other blood work or tests, such as complete blood counts, to check your overall health and see if you may be having any medicine side effects. Genvoya does not prevent or treat other sexually transmitted diseases, such as chlamydia, gonorrhea, or syphilis, and your health care provider may also do tests to check for these infections.
Talk with your health care provider about other ways to stay healthy, such as not smoking, getting regular exercise, eating a healthy diet, and getting any needed vaccines.
How Can I Get Genvoya?
Genvoya requires a prescription from a health care provider. Your primary care provider or an HIV specialist may prescribe Genvoya. You may only be able to get it through certain pharmacies, called specialty pharmacies. This could include mail-order pharmacies.
There are ways to help you afford this medicine, such as patient assistance programs or co-pay savings programs. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at the drugmaker’s Advancing Access website.
