TEMIXYS

About HIV

What is HIV? HIV (Human immunodeficiency virus) is a virus that attacks cells in the human immune system. There is no cure for HIV. Unlike some other viruses, the human body can’t get rid of HIV completely, even with treatment.
So once you get HIV, you have it for life. However, there are treatments available. Talk to your healthcare provider and see below for more information

How can HIV affect your body? HIV attacks and destroys the body’s immune system, specifically the CD4+ T-cells, which help the immune system fight off infections. The more CD4+ T-cells that are destroyed, the weaker your immune system can become. Untreated, HIV reduces the number of CD4+ T-cells in your body, making you more likely to get other infections or infection-related cancers. Over time, HIV can destroy so many of these cells that your body can’t fight off infections and disease. These opportunistic infections or cancers take advantage of a very weak immune system and signal that you have AIDS, the last stage of HIV.

What is the difference between HIV and AIDS? Being HIV positive is not the same as having AIDS (acquired immunodeficiency syndrome). AIDS is the stage of HIV infection that occurs when your immune system is badly damaged and you become vulnerable to opportunistic infections. When the number of your CD4+ T-cells falls below 200 cells per cubic millimeter of blood (200 cells/mm3), you are considered to have progressed to AIDS. (In someone with a healthy immune system, CD4+ T-cell counts are between 500 and 1,600 cells/mm3.) You are also considered to have progressed to AIDS if you develop one or more opportunistic illnesses, regardless of your CD4+ T-cell count. If this happens, it means your immune system has become very weak, and you can quickly become very sick. And if left untreated will eventually lead to death.

How is HIV transmitted? HIV is transmitted through contact with certain bodily fluids of someone with the virus. These fluids can include, semen, vaginal or anal fluid, breast milk, and blood. Contact with these bodily fluids can occur during unprotected sex or when sharing needles or other items with bodily fluids on them. Mothers can pass the HIV to their babies during pregnancy, birth, and breastfeeding. You CANNOT transmit HIV through contact with sweat, tears, saliva, bath or pool water, or by sharing dishes or drinking glasses, hugging or shaking hands. There is not enough HIV virus in other bodily fluids, like saliva, sweat or urine, to transmit it from one person to another.

How do you maintain a healthy life while living with HIV? No effective cure currently exists for HIV infection. But with proper medical care, HIV can often be controlled. To maintain a healthier life while living with HIV, taking HIV medicines can help. HIV treatment can help lower your viral load (the amount of virus in the blood) and, as a result, helps protect your immune system

Ask your healthcare provider about other things you can do to help stay healthier, including : - Avoiding sexually transmitted diseases (STDs).
- Using protection every time you have sex.
- Never sharing or reusing needles.
- Getting help with substance abuse, stress, or depression.
- Exercise and a healthy diet.
- Quitting smoking and drinking alcohol, which can be more harmful to people living with HIV.

What you should know about HIV treatment

How can HIV medicines help you control the HIV virus? Taking HIV medicines can slow the progression of the virus in your body. While there is currently no cure for HIV or AIDS, HIV medicines can help to control HIV infection, which can help to protect your immune system and reduce the risk of other serious infections. HIV is a type of virus called a retrovirus, and the combination of drugs used to treat it is called antiretroviral therapy (ART). ART is recommended for all people living with HIV, regardless of how long they’ve had the virus or how healthy they are. ART must be taken every day, exactly as your health care provider prescribes. To find out which HIV medicines might be right for you, talk to a healthcare provider.

How do HIV medicines work? - Taking your HIV medication reduces the viral load in your body to a very low level. This is called viral suppression. If the viral load is so low that it doesn’t show up in a standard lab test, this is called having an undetectable viral load. Being undetectable does not mean that the virus is gone. - Taking your HIV medication raises the CD4+ T-cell count (the number of cells that fight infections in your body). Reducing the HIV-1 viral load can help raise your CD4+ T-cell number, which can help make your immune system stronger.

Take your HIV medicines exactly as directed Get the most from your HIV treatment by taking your medicines exactly as your healthcare provider prescribes them. The HIV medicines keep HIV under control but they don’t stay in your body for a long time, so you have to continue taking them as prescribed. Your viral load can increase if you don’t take your HIV medicines as prescribed, if you miss doses, or if you stop treatment. If you regularly miss doses of your HIV treatment, there is a risk that the HIV in your body will become resistant to the drugs you are taking. This means that the drugs will no longer work even when you do take them.

HIV medicines cannot cure you Current treatment for HIV is not a cure for HIV, but it can be effective in keeping HIV under control. People living with HIV, who have taken HIV medication as prescribed and have maintained an undetectable viral load, have effectively no risk of sexually-transmitting HIV to their HIV-negative partners through sex. But, even when you are being treated for HIV-1, there is still a risk of passing HIV-1 on to others. Always practice safer sex and use condoms to lower the chance of sexual contact with bodily fluids.

Your healthcare provider will advise you which HIV medicines might be right for you Ask your healthcare provider about your options for treating HIV. Different HIV medicines are taken in a variety of ways:
- In one or more daily pills
- With or without meals
- Once daily or more frequently

It is important to let your healthcare provider know if you have any other health conditions or if you are currently taking any other medicines. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider will be able to prescribe an option that is right for you.

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Important Safety Information

What is the most important information I should know about TEMIXYS?

TEMIXYS can cause serious side effects, including:

Worsening of hepatitis B infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking TEMIXYS. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with TEMIXYS.

  • It is not known if TEMIXYS is safe and effective in people who have both HIV-1 and HBV infection.
  • Do not run out of TEMIXYS. Refill your prescription or talk to your healthcare provider before your TEMIXYS is all gone.
  • Do not stop taking TEMIXYS without first talking to your healthcare provider. If you stop taking TEMIXYS, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.

Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with HIV-1 and hepatitis C virus who were taking antiretroviral medicines for HIV-1 and were also being treated for hepatitis C with interferon alfa with or without ribavirin. If you are taking TEMIXYS and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.

What are the possible side effects of TEMIXYS?

TEMIXYS may cause serious side effects, including:

Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with TEMIXYS if they: o have taken nucleoside analogue medicines in the past o have a history of pancreatitis o have other risk factors for pancreatitis Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving TEMIXYS to your child if their symptoms and blood test results show that your child may have pancreatitis.

New or worse kidney problems, including kidney failure.Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with TEMIXYS. Tell your healthcare provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.

Bone problems can happen in some people who take TEMIXYS. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones. Tell your healthcare provider if you have any bone pain, pain in your hands or feet, or muscle pain or weakness during treatment with TEMIXYS.

The most common side effects of TEMIXYS include:
rash / headache / pain / diarrhea / depression

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TEMIXYS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you take TEMIXYS, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems, including hepatitis B or C virus infection.

have kidney problems, including end-stage renal disease (ESRD) that requires dialysis.

have bone problems, including a history of bone fractures.

are pregnant or plan to become pregnant. It is not known if TEMIXYS may harm your unborn baby.
Pregnancy Registry. There is a pregnancy registry for women who take TEMIXYS during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take TEMIXYS.

  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • Talk with your healthcare provider about the best way to feed your baby.

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 TEMIXYS. TEMIXYS may affect the way other medicines work, and other medicines may affect how TEMIXYS works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with TEMIXYS.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TEMIXYS with other medicines.

You should not take TEMIXYS if you also take:

adefovir (HEPSERA™)