Generic name: cobicistat, elvitegravir, emtricitabine, and tenofovir (koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir)
Brand name: Genvoya, Stribild
Drug class: Antiviral combinations
Stribild is a tablet containing a combination of cobicistat, elvitegravir, emtricitabine, and tenofovir. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.
Elvitegravir, emtricitabine and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV can cause acquired immunodeficiency syndrome (AIDS).
Stribild is a combination medicine used to treat HIV in adults and children who are at least 12 years old and who weigh at least 55 pounds (25 kilograms).
Stribild is not a cure for HIV or AIDS.
Warnings
Stribild can harm your liver. Call your doctor at once if you have: upper stomach pain, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
Do not stop using Stribild without your doctor's advice. Get your prescription refilled before you run out of medicine completely.
If you've ever had hepatitis B, it may become active or get worse after you stop using Stribild. You may need frequent liver function tests for several months.
Many drugs can interact with cobicistat, elvitegravir, emtricitabine, and tenofovir and some should not be used at the same time. Tell your doctor about all the medicines you use.
Before taking Stribild
You should not take Stribild if you are allergic to cobicistat, elvitegravir, emtricitabine, or tenofovir.
Some medicines can cause unwanted or dangerous effects when used with Stribild. Your doctor may change your treatment plan if you also use:
- alfuzosin;
- cisapride;
- oral midazolam, or triazolam;
- rifampin;
- sildenafil (Revatio, for treating pulmonary arterial hypertension);
- St. John's wort;
- antipsychotic medicine - lurasidone, pimozide;
- cholesterol medication - lomitapide, lovastatin, simvastatin;
- ergot medicine - dihydroergotamine, ergotamine, methylergonovine; or
- seizure medicine - carbamazepine, phenobarbital, phenytoin.
Stribild is a complete combination treatment and should not be used with other antiviral medications, especially those that contain adefovir, cobicistat, elvitegravir, emtricitabine, lamivudine, ritonavir, or tenofovir: Atripla, Biktarvy, Cimduo, Combivir, Complera, Descovy, Epivir, Epzicom, Evotaz, Hepsera, Kaletra, Norvir, Odefsey, Prezcobix, Symfi, Symtuza, Technivie, Triumeq, Trizivir, Tybost, Viekira, and others.
To make sure Stribild is safe for you, tell your doctor if you have ever had:
- hepatitis B or other liver problems;
- kidney disease; or
- bone problems.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.
Stribild may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.
If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. Use all medications properly to control your infection.
HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.
If you do not plan to get pregnant, ask your doctor about using a non- hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. Cobicistat, elvitegravir, emtricitabine, and tenofovir can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).
Women with HIV or AIDS should not breastfeed. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
How should I take Stribild?
Stribild is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take with food.
You will need frequent medical tests. Your kidney function may also need to be checked.
Use Stribild regularly to get the most benefit. Your disease may become resistant if you miss doses. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.
Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.
If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Stribild. You may need frequent liver function tests while using Stribild and for several months after your last dose.
Dosing information
Usual Adult Dose for HIV Infection:
1 tablet orally once a day with food
Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF).
Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug
Usual Pediatric Dose for HIV Infection:
12 years or older and at least 35 kg:
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: 1 tablet orally once a day with food
Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir DF.
Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Avoid taking an antacid within 2 hours before or 2 hours after you take Stribild. Some antacids can make it harder for your body to absorb cobicistat, elvitegravir, emtricitabine, and tenofovir.
While Stribild can substantially reduce the risk of HIV transmission, there is still a chance the disease can spread. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Stribild side effects
Get emergency medical help if you have signs of an allergic reaction to Stribild: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or unusual bone pain;
- kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
- liver problems - swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Antiviral medicine affects your immune system, which may cause certain side effects (even weeks or months after you've taken Stribild). Tell your doctor if you have:
- signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
- trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
- swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
Common Stribild side effects may include:
- nausea; or
- diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Stribild?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with Stribild. Some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.