Considering HIV Therapy

Real ATRIPLA Patient

You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate), for a long time.

Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Women with HIV should not breastfeed because they can pass HIV and some of the medicines in ATRIPLA through their milk to the baby.

What You Need to Know When Considering HIV Treatment

If you’ve recently been diagnosed with HIV-1 infection, you may have a lot of questions about what HIV is and what HIV treatment really means. Use the following slide show to help answer some of your questions and help you learn more about starting HIV treatment.

What is HIV?

HIV stands for
Human Immunodeficiency Virus

Type of virus called a retrovirus

The most common type of HIV in the U.S. is HIV-1*

HIV attacks your body’s immune system by killing a type of white blood cell known as a T-cell (or CD4+ cell)

T-cells (CD4+ cells) are a key part of the immune system. They help fight the germs (both viruses and bacteria) that cause disease

*Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed January 2014.

HIV virus and T-cell (CD4+ cell) Next Button

What is AIDS?

AIDS stands for
Acquired ImmunoDeficiency Syndrome, and is an advanced stage of HIV infection

Having AIDS means that HIV has weakened the immune system and killed many T-cells (CD4+ cells), decreasing T-cell (CD4+ cell) count to below 200 cells/mm3

When you have a weakened immune system, your body has a harder time fighting infections and other diseases

HIV virus and T-cell (CD4+ cell) Back Button Next Button

How do you get HIV? And how do you know you have it?

HIV is passed from person to person in bodily fluids (such as blood, semen or pre-ejaculate, vaginal fluids, and breast milk)

You can get or pass HIV in several ways: having unprotected sex, sharing needles with an infected person, or being exposed to HIV before or during birth or through breastfeeding

If you become infected with HIV, your body will try to fight the infection by making special chemicals. These chemicals are called antibodies

HIV virus invades a T-cell (CD4+ cell)

If you have HIV antibodies in your blood, it means that you have been infected with HIV

People who have HIV antibodies will test HIV positive

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How HIV attacks your immune system

HIV cannot multiply on its own, so it invades healthy T-cells (CD4+ cells) in your body

HIV uses T-cells (CD4+ cells) to make copies of itself and kills the T-cells (CD4+ cells) in the process

In order to make more HIV in your body, the virus must infect or “hijack” a T-cell (CD4+ cell) and complete several steps known as the HIV life cycle

HIV virus invades a T-cell (CD4+ cell) Back Button Next Button

What is a T-cell (CD4+ cell) count?

A T-cell (CD4+ cell) count identifies the number of T-cells (CD4+ cells) in a sample of blood

A T-cell (CD4+ cell) count can help identify how well your immune system is working

A T-cell (CD4+ cell) count is one of the ways to determine if someone has AIDS

When an HIV-positive person has fewer than 200 cells/mm3 of blood, he or she now has AIDS

T-cell (CD4+ cell) count

Your healthcare provider may want to measure your T-cell (CD4+ cell) count every 3 to 6 months, before and throughout your treatment

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The importance of T-cell (CD4+ cell) counts

Here is what your T-cell (CD4+ cell) count can tell you

More than 500 T-cells (CD4+ cells)/mm3

Your immune system is considered normal

What your T-cell (CD4+ cell) count can tell you

200-500 T-cells (CD4+ cells)/mm3

Your immune system may be weakened

What your T-cell (CD4+ cell) count can tell you

Less than 200 T-cells (CD4+ cells)/mm3

Your immune system is severely weakened. You are at high risk for getting an opportunistic infection—an infection that develops only when the immune system is weak

What your T-cell (CD4+ cell) count can tell you Back Button Next Button

What is viral load?

Viral load tells you how much HIV is in a sample of your blood

Viral load is usually measured as the number of copies of HIV in 1 milliliter (mL) of blood

You want to have as few copies of the virus as possible

The less the virus copies itself, the lower your viral load

When the amount of virus in your blood becomes so low that the lab test cannot measure it, your viral load is considered undetectable

It is important to note that an undetectable viral load does not mean you are cured. The virus is still multiplying, but at a much slower speed

HIV virus and viral load

Viral load is usually measured 2 to 8 weeks after you start treatment and then every 3 to 4 months to make sure your anti-HIV medicines are still working

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Understanding viral load

Here are 3 examples of viral load levels

High viral load

For example, greater than or equal to 100,000 copies/mL

Three examples of viral load levels

Low viral load

For example, fewer than 10,000-30,000 copies/mL

Three examples of viral load levels

Undetectable viral load

Depending on the test used, less than 400 or
50 copies/mL

Three examples of viral load levels Back Button Review Button

Additional IMPORTANT SAFETY INFORMATION for
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)

Who should not take ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

You and your healthcare provider should decide if ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients.

What should I tell my healthcare provider before taking
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

Tell your healthcare provider if you:

  • Are pregnant or planning to become pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective.
  • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV and some of the medicines in ATRIPLA through their milk to the baby. We do not know if ATRIPLA could harm your baby.
  • Have kidney problems or are undergoing kidney dialysis treatment
  • Have bone problems
  • Have liver problems, including hepatitis B or C virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine.
  • Have ever had mental illness or are using drugs or alcohol
  • Have ever had seizures or are taking medicine for seizures. Seizures have occurred in patients taking efavirenz, a component of ATRIPLA, generally in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.

What important information should I know about taking other medicines with
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses.

MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA

  • Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medications (for example, Wigraine® and Cafergot®).
  • ATRIPLA should not be taken with: Combivir® (lamivudine/zidovudine),
    COMPLERA® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate),
    EMTRIVA® (emtricitabine), Epivir® or Epivir-HBV® (lamivudine),
    Epzicom® (abacavir sulfate/lamivudine),
    STRIBILD® (elvitegravir/cobicistat/emtricitabine/tenofovir DF),
    Trizivir® (abacavir sulfate/lamivudine/zidovudine),
    TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with
    SUSTIVA® (efavirenz) unless recommended by your healthcare provider.
  • Vfend® (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA.
  • Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs.
  • ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil).

These are not all the medicines that may cause problems if you take ATRIPLA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.

What are the possible side effects of
ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate)?

ATRIPLA may cause the following additional serious side effects:

  • Serious psychiatric problems. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
  • Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
  • Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
  • Changes in bone mineral density (thinning bones). Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia), which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to do tests to check your bones or may prescribe medicines to help your bones. Also, bone pain and bone softening may occur because of kidney problems.

Common side effects:

  • Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach; they tend to go away after taking ATRIPLA for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if ATRIPLA is used with alcohol and/or mood-altering (street) drugs.
  • If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
  • Rash is a common side effect with ATRIPLA that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call your healthcare provider right away.
  • Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects:

  • Changes in body fat have been seen in some people taking anti-HIV-1 medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these changes in body fat are not known.
  • Skin discoloration (small spots or freckles) may also happen.
  • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. If you notice any symptoms of infection, contact your healthcare provider right away.
  • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.

This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate).

You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

Please see Full Prescribing Information, including “What is the most important information I should know about ATRIPLA” in the Patient Information section.

Bristol-Myers Squibb    Gilead

© 2014 Bristol-Myers Squibb Company.

ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. COMPLERA, EMTRIVA, GILEAD, GSI, HEPSERA, STRIBILD, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

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