What Is HIV?
The Body’s Immune System
The human body has a natural defense system called the immune system. The immune system is the body’s defense against infection and disease.
A healthy immune system is made up of many types of cells. CD4+ cells are a type of cell in the immune system. CD4+ cells help the body fight infection. They are also called T cells.
HIV is a virus that attacks the CD4+ cells in the immune system. After HIV enters the blood, it gets into the CD4+ cells. HIV uses these cells to copy itself. This destroys the CD4+ cells. When the number of CD4+ cells in your body is low, your immune system becomes weaker. This makes it harder to fight infections.
Progression to AIDS
(Acquired Immunodeficiency Syndrome)
Without treatment for HIV, CD4+ cells will continue to be destroyed. This process will go on until the body has very few CD4+ cells left. This is what happens when HIV progresses to AIDS. AIDS is the advanced stage of HIV disease. When this happens, the body is at high risk of developing serious infections or cancer. While there currently is no cure for HIV or AIDS, early treatment may help you fight HIV infection and delay its becoming AIDS.
The CD4+ Count and Viral Load
To determine the number of CD4+ cells in your body, your healthcare professional will do a simple blood test called a CD4+ cell count. The CD4+ cell count is used to help determine when it’s time for you to start HIV treatment. This test is also used to keep track of how well treatment is working. Your healthcare professional will probably perform this test regularly during your treatment.
Your healthcare professional will also measure the amount of HIV in your blood. This is called your viral load. As HIV progresses, the amount of HIV in the blood—the viral load—will increase. The viral load test will help to decide when treatment should be started and how well treatment is working.
The CD4+ cell is a type of white blood cell that fights infection. The more you have, the healthier your immune system is.
Viral load is the amount of HIV found in a blood sample. It is measured by copies/mL.
Without CD4+ cells:
- Your body can’t fight infection
- You may start to feel sick and weak as well
EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)
- Who have never taken HIV medicines before and
- Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load
- EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines
- It is important that you remain under the care of your healthcare professional during treatment with EDURANT®
- EDURANT® is not recommended for patients less than 18 years of age
EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.
Please read Important Safety Information and talk to your healthcare professional to learn if EDURANT® is right for you.
Important Safety Information
Can EDURANT® be taken with other medicines?
EDURANT® may affect the way other medicines work and other medicines may affect how EDURANT® works and may cause serious side effects. If you take certain medicines with EDURANT®, the amount of EDURANT® in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT® or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT® with a meal. A protein drink alone does not replace a meal.
Do not take EDURANT® if:
- Your HIV infection has been previously treated with HIV medicines
You are taking any of the following medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®), rifapentine (Priftin®)
- Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®, Zegerid®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
- More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
Especially tell your doctor if you take:
- Rifabutin (Mycobutin®), a medicine to treat some bacterial infections. Talk to your doctor or pharmacist about the right amount of EDURANT® you should take if you also take rifabutin
- Medicines used to treat HIV
- An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take EDURANT®
- Medicines to block acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®
- Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), methadone (Dolophine®), posaconazole (Noxafil®), telithromycin (Ketek®), voriconazole (Vfend®)
This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Before taking EDURANT®, also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT® will harm your unborn baby. You and your healthcare professional will need to decide if taking EDURANT® is right for you.
Do not breastfeed if you are taking EDURANT®. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:
- Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain)
- Depression or mood changes. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide), or have tried to hurt yourself
- Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment. Liver problems were also reported during treatment in some people without a history of liver disease. Your healthcare professional may need to do tests to check liver function before and during treatment
- Changes in body shape or body fat have been seen in some patients taking HIV medicines. The exact cause and long-term health effects of these conditions are not known
Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections. Tell your healthcare professional right away if you start having any new symptoms
Other common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare professional.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see accompanying full Product Information for more details.