Glossary

Glossary

Glossary of HIV Terms and Other Definitions

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A-F

AIDS: Acquired Immunodeficiency Syndrome or Acquired Immune Deficiency Syndrome—the late stage of infection caused by the Human Immunodeficiency Virus (HIV).

Antiretroviral therapy: treatment with drugs that inhibit HIV or other types of viruses called "retroviruses" from multiplying in the body.

Bilirubin: a product that results from the breakdown of hemoglobin. Total and direct bilirubin are usually measured to screen for or to monitor liver or gallbladder problems.

cART: "Combination Antiretroviral Therapy" is a type of combination therapy used to treat HIV infection, which typically uses three drugs from at least two different classes of drugs (for example, nucleoside reverse transcriptase inhibitors and protease inhibitors).

CD4+ cell (T cell): one of the types of cells that your immune system uses to protect your body from infection. HIV attacks these types of cells and uses them to make more copies of HIV. CD4+ cell counts are one way your doctor tests how your body and HIV drugs are fighting HIV. The higher the number of CD4+ cells, the stronger your immune system.

Clinical trial: a research study that tests the safety of and how well a drug works in humans.

Drug resistance: the mutation of an organism, such as HIV, in such a way that it changes its sensitivity to a drug. HIV drugs are often used in combination to prevent drug resistance.

G-L

HIV: Human Immunodeficiency Virus. The virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Immune system: your body's defense system against infection and certain diseases. It includes specialized cells such as B cells, T cells, and antibodies that protect the body.

Jaundice: a yellowing of the skin, eyes, and urine due to excess bilirubin in the body.

M-S

Mutation: a change in a gene or unit of hereditary material in a virus or cell that changes the process of making copies of itself.

Opportunistic infections: an infection that occurs because of a weakened immune system (for example tuberculosis, Pneumocystis jiroveci pneumonia, and thrush).

Protease inhibitor (PI): a type of anti-HIV drug that prevents the virus from making new copies of itself. PIs work by disrupting the normal function of the enzyme HIV protease and prevents virus replication. Protease inhibitors are taken in combination with other anti-HIV medications. PIs in combination therapy are able to lower the HIV level in the blood until it cannot be measured with current tests.

Regimen: a systematic treatment plan that a doctor prescribes to treat a medical condition, such as HIV.

Scleral icterus: a medical condition in which the whites of your eyes take on a yellowish color.

Side effects: unwanted events like headache, fever, and nausea that may occur when taking medications.

T-Z

Undetectable: When the amount of HIV in the blood is too low to be detected with a viral load test.

Viral load: the amount of HIV circulating in your body (usually measured in “copies per milliliter” or “copies/mL”). Measuring viral load is important because it determines the amount of HIV in the blood and the severity of disease.

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More Important Safety Information

SELECTED IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Who should not take EVOTAZ (atazanavir and cobicistat)?

Do not take EVOTAZ if you:

  • Are allergic to any of the ingredients in EVOTAZ
  • Are taking the following medicines because taking them with EVOTAZ may cause serious, life-threatening side effects: alfuzosin (Uroxatral®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), cisapride (Propulsid®, Propulsid® Quicksolv®), colchicine (Mitigare®, Colcrys®) if you have liver or kidney problems, dronedarone hydrochloride (Multaq®), ergot containing medicines (D.H.E. 45®, Embolex®, Migranal®, Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®, Methergine®), indinavir (Crixivan®), irinotecan (Camptosar®), lovastatin (Advicor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), nevirapine (Viramune®, Viramune XR®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rimactane®, Rifadin®, Rifater®, Rifamate®), sildenafil (Revatio®) when used for lung problems, simvastatin (Zocor®, Vytorin®, Simcor®), triazolam (Halcion®) or products that contain St. John’s wort (Hypericum perforatum)

What should I tell my healthcare provider before taking EVOTAZ?

  • If you have heart problems, liver problems, including hepatitis B or C virus infection, kidney problems, diabetes, or hemophilia or any other medical condition
  • If you are pregnant or plan to become pregnant. It is not known if EVOTAZ will harm your unborn baby. Pregnant women have developed a serious condition called lactic acidosis (a buildup of lactic acid in the blood)
  • If you take hormonal forms of birth control, such as injections, rings, implants, contraceptive patches or birth control pills, as some of these may not work when you are taking EVOTAZ
  • After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV or if you take EVOTAZ. HIV can be passed to the baby in breast milk. It is not known if EVOTAZ passes into breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with EVOTAZ. Keep a list of your medicines and show it to your healthcare provider and pharmacist. Do not start taking any new medicines without first talking to your healthcare provider.

What are the possible side effects of EVOTAZ?

EVOTAZ can cause serious side effects. Call your healthcare provider right away if you have any of the following:

  • A change in the way your heart beats (heart rhythm change). You may feel dizzy or lightheaded, as these could be symptoms of a heart problem
  • Skin rash is common with EVOTAZ, and can sometimes be severe. Skin rash usually goes away within 2 weeks. Severe rash may develop with other symptoms which can be serious. If you develop a severe rash with any of the following symptoms, call your healthcare provider or go to the nearest hospital emergency room right away: general feeling of discomfort (“flu like” symptoms); fever; muscle or joint aches; red or inflamed eyes; blisters; mouth sores; swelling of your face; painful, warm, or red lump under your skin
  • Kidney problems can occur when EVOTAZ is taken with certain other medicines, as this can cause new or worse kidney problems, including kidney failure. Kidney stones have happened in some people who take atazanavir, one of the medicines in EVOTAZ. Symptoms may include pain in your low back or low stomach area, blood in your urine, pain when you urinate
  • Gallbladder problems have happened in some people who take atazanavir, one of the medicines in EVOTAZ. Symptoms may include pain in the right or middle upper stomach area, fever, nausea and vomiting, and your skin or the white part of your eyes turns yellow
  • Liver problems, including hepatitis B or C, may get worse when taking EVOTAZ. Your healthcare provider will do blood tests before and during treatment with EVOTAZ. Symptoms of liver problems may include: your skin or the white part of your eyes turns yellow, dark (tea colored) urine, light colored stools, nausea, itching, or stomach-area pain
  • Yellowing of the skin or the white part of your eyes. This may occur due to increases in bilirubin levels in the blood
  • Changes in your immune system (Immune Reconstitution Syndrome). Tell your healthcare provider if you start having new symptoms after starting EVOTAZ
  • Diabetes and high blood sugar can happen or get worse in some people who take protease inhibitor medicines like EVOTAZ. Some people may need to start diabetes medicine or change their diabetes medicine
  • Changes in body fat can happen in people taking HIV medicines. The exact cause and long-term health effects are not known
  • Increased bleeding problems in people with hemophilia have happened when taking protease inhibitors including EVOTAZ

The most common side effects of EVOTAZ are yellowing of the skin and rash.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see U.S. Full Prescribing Information and Patient Information

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.