Genvoya
Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) is a combination antiretroviral therapy (ART) that treats human immunodeficiency virus (HIV) infections in adults and children. It's made up of two nucleoside reverse transcriptase inhibitors (NRTIs), emtricitabine and tenofovir alafenamide; an integrase strand transfer inhibitor (INSTI) called elvitegravir; and a "booster" medication known as cobicistat. Genvoya is taken by mouth, typically once daily. Some common side effects of this medication include nausea and diarrhea. It's not available as a generic medication.
What is Genvoya?
What is Genvoya used for?
Treatment of HIV infection
How Genvoya works
Genvoya is a combination of four medications:
Emtricitabine and tenofovir alafenamide are both nucleoside reverse transcriptase inhibitors (NRTIs). They insert themselves into the genetic material of the virus. This helps to prevent HIV from making copies of itself and spreading.
Elvitegravir is an integrase strand transfer inhibitor (INSTI). Integrase is an enzyme (protein) that HIV uses to insert its genetic information into your cells. Once inserted, HIV uses your cells to make more copies of itself. Elvitegravir works by blocking integrase, which then helps prevent HIV from spreading.
Cobicistat is a "booster" medication. It slows down your body from breaking down other HIV ARVs in Genvoya. This "boosts" the levels of Genvoya in the body. Cobicistat also makes the other HIV ARVs last longer in the body so they can work better to fight the infection.
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What are the side effects of Genvoya?
Common Side Effects
- Nausea (11%)
- Diarrhea (7%)
- Headache (6%)
- Feeling tired (5%)
Other Side Effects
- Rash
- Itching
- Angioedema (swelling)
Serious Side Effects
- Buildup of lactic acid in the blood (lactic acidosis): feeling more tired and weak, belly pain, muscle pain, breathing problems
- Kidney problems: tiredness, confusion, nausea, urinating less than usual, swelling in your legs, joint or bone pain
- Liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool
Source: DailyMed
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The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Pros and cons of Genvoya
Pros
Is a complete regimen for HIV treatment
Only taken once a day
Taken by mouth
Cons
Needs to be taken with food
Can’t take while pregnant
Can worsen hepatitis B if you stop taking the medication all of a sudden
Pharmacist tips for Genvoya
Take Genvoya every day so that it can treat HIV as best as it can. You can use an app on your phone to help you remember.
Take Genvoya with food to help your body absorb the medication better.
Make sure to get your routine blood tests done on time while you’re taking Genvoya. This helps your provider make sure the medication is working for you and not causing side effects.
Taking Genvoya can sometimes put you at risk for kidney problems. It's best to avoid other medications that can raise your risk of kidney damage, such as ibuprofen (Advil) and naproxen (Aleve), while you're taking Genvoya.
Let your provider or pharmacist know what medications you're taking or planning to take, including over-the-counter products and supplements, so they can make sure these medications don't interact with Genvoya.
Speak with your provider before stopping Genvoya or any of your HIV medications. Stopping your HIV medications too soon can cause the virus to spread and become harder to treat. And if you also have hepatitis B, stopping Genvoya suddenly can cause your hepatitis B infection to come back or worsen.
If your child is taking Genvoya and you notice major weight loss in your child, make sure to tell the healthcare team. Your child might not be able to continue taking Genvoya if they weigh below 55 pounds.
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Frequently asked questions about Genvoya
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What are the risks and warnings for Genvoya?
Genvoya can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Worsening of hepatitis B infection
Risk factors: Have hepatitis B and HIV | Stopping Genvoya | Severe liver problems
Before you start Genvoya, your provider will test you for hepatitis B virus (HBV). If you have HBV, suddenly stopping Genvoya might make your liver condition worse (also called an HBV flare-up). Don't stop taking Genvoya without talking with your provider first. Make sure to get your refills on time so that your treatment isn't interrupted. If you need to stop taking Genvoya, your provider might follow up with you for several months after you stop treatment. Your provider will order blood work to check your liver for an HBV flare-up.
Kidney problems
Risk factors: History of kidney problems | Taking other medications known to harm kidneys
Some people taking Genvoya have had kidney problems. Before starting and during treatment with Genvoya, your provider will order blood work or urine tests to check on your kidney health. If you develop kidney problems, you might not experience any noticeable symptoms. But your provider will be able to detect it through labs. Some people developed kidney problems as early as 2 weeks after starting treatment. To prevent kidney injury, it's recommended that you avoid taking other medications that can also harm the kidneys, like high doses of nonsteroidal anti-inflammatory drugs (NSAIDs). Let your provider know right away if you experience bone or muscle pain, pain in your arms or legs, and general weakness that don't go away. These might be signs of kidney problems.
Liver problems and lactic acidosis
In some rare cases, people who take medications containing NRTIs, such as Genvoya, have reported liver problems, like fatty liver disease. Genvoya can also cause a buildup of lactic acid in the blood (lactic acidosis). Both conditions can be life-threatening.
Make sure to get blood tests done while you take Genvoya so your provider can check for these harmful side effects and make sure the medication is still safe to take. Talk with your provider right away if you experience signs and symptoms of liver damage, such as upper right stomach pain, yellowing of the skin or whites of the eyes, or dark urine. Also, let your provider know if you have symptoms of lactic acidosis, such as feeling weak, muscle pain, and trouble breathing.
Overactive immune system
Taking Genvoya can cause changes to your immune system called immune reconstitution syndrome. This medical condition happens when your immune system becomes more active after you start Genvoya. Your immune system begins to fight off different infections that it was too weak to fight off before you started treatment. In rare cases, your immune system might improve so much with treatment that it starts to attack normal cells in your body (autoimmune). You can develop immune reconstitution syndrome as early as during the first few weeks of taking Genvoya or many months later. Tell your healthcare provider right away if you start having any new symptoms, such as fever, pain, hair loss, bulging eyes, or sweating, after you start Genvoya.
Interaction with other medications
Taking certain medications for seizures (e.g., carbamazepine (Tegretol)), bacterial infections (e.g., rifampin (Rifadin)), oral steroids (e.g., dexamethasone) or herbal supplements (e.g., St. John's wort) can lower the amount of Genvoya in your body. This can can cause the HIV virus to spread and become harder to treat.
In addition, Genvoya can also raise the amount of other medications in your body when taken together. This raises your risk for side effects from those other medications. For example, taking Genvoya with alfuzosin (Uroxatral) can put you at risk for dangerously low blood pressure. Taking this HIV medication with some blood thinners, like Eliquis (apixaban) or Xarelto (rivaroxaban), can raise your risk for serious bleeds.
Because of the potential for drug interactions with Genvoya, tell your provider and pharmacist about all the medications you take or plan to take. They can make sure your medications are safe to take together.
Genvoya dosage forms
Typical dosing for Genvoya
Each tablet of Genvoya contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide.
Adults and children who weigh at least 55 pounds: The typical dose is 1 tablet by mouth once daily with food.
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How much does Genvoya cost?
Genvoya contraindications
Taking certain medication that interact with Genvoya (e.g., alfuzosin, lovastatin, carbamazepine)
What are alternatives to Genvoya?
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). Clinical guidance for PEP.
Centers for Disease Control and Prevention. (2024). Clinical guidance for PrEP.
ClinicalInfoHIV.gov. (n.d.). Immune reconstitution inflammatory syndrome (IRIS).
ClinicalInfoHIV.gov. (n.d.). Integrase.
ClinicalInfoHIV.gov. (n.d.). Integrase strand transfer inhibitor (INSTI).
ClinicalInfoHIV.gov. (n.d.). Nucleoside reverse transcriptase inhibitor (NRTI).
ClinicalInfoHIV.gov. (n.d.). Protease inhibitor (PI).
Gilead Sciences, Inc. (2022). Genvoya- elvitegravir, cobicstat, emtricitabine, and tenofovir alafenamide tablet [package insert]. DailyMed.
HIVinfo.NIH.gov. (2021). HIV and nutrition and food safety.
Ruderman, S. A., et al. (2021). Weight gain following ART initiation in ART-naïve people living with HIV in the current treatment era. Journal of Acquired Immune Deficiency Syndromes.
Smith, K. J., et al. (1996). Clinical and histopathologic features of hair loss in patients with HIV-1 infection. Journal of the American Academy of Dermatology.
Thapa, S., et al. (2023). Immune reconstitution inflammatory syndrome. StatPearls.
Urbina, A. E., et al. (2022). Selecting an initial ART regimen. Johns Hopkins University.
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