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About the HIV Treatment Guidelines

What are the Federal HIV treatment guidelines?

The U.S. Department of Health and Human Services (DHHS) issues guidelines to help doctors treat people with HIV in the United States. Separate guidelines have been developed for:

• treatment of adults and adolescents

• treatment of children

• treatment of pregnant women and prevention of mother-to-child transmission of HIV

• prevention of opportunistic infections

The guidelines are written in sophisticated medical language and may be challenging for the general public to read and understand. "HIV and Its Treatment: What You Should Know" is a series of easy-to-read fact sheets based on the Federal guidelines. These fact sheets can help you understand the recommendations found in the guidelines.

Who writes the guidelines?

The guidelines are written, reviewed, and updated by panels of HIV experts from across the country. Panel members include physicians, pharmacists, researchers, and HIV treatment advocates.

What information is used in developing the guidelines?

The panels of HIV experts study drug information submitted to the U.S. Food and Drug Administration (FDA), as well as research findings presented at conferences and published in professional journals. Often new information comes from clinical trials testing the safety and effectiveness of different treatments. Members of the guidelines panels also use their own clinical experience to make the recommendations found in the treatment guidelines.

What information will I find in the guidelines?

Topics covered in the guidelines include:

• the goals of anti-HIV therapy

• when to start treatment

• monitoring of patient health

• medication side effects and their management

• anti-HIV medications for use during pregnancy

• diagnosis of HIV infection in infants

Much of the information is presented in tables and charts for quick reference.

Will the guidelines tell me what HIV medications I should take?

The guidelines list "preferred" and "alternative" HIV treatment regimens. You and your doctor will decide which medications are right for you; each HIV treatment regimen is tailored to the individual patient (see Recommended HIV Regimens Fact Sheet).

When are the guidelines updated and how can I access them?

Updates to the HIV treatment guidelines can occur at any time. Since the guidelines were first introduced in 1998, the period between updates has ranged from several weeks to several months or more. You can join the AIDSinfo E-News listserv to receive an e-mail notification when updated guidelines are released (http:// aidsinfo.nih.gov/Other/subscribe.aspx).

Current and past versions of the guidelines are available online at http://aidsinfo.nih.gov/Guidelines/ Default.aspx. The "HIV and Its Treatment: What You Should Know" fact sheet series is available online at http://aidsinfo.nih.gov/other/factsheet.aspx. Paper copies of the guidelines and fact sheets can be ordered online at http://aidsinfo.nih.gov/OrderPublication/ OrderPubsDefaultCenterPage.aspx or by calling 1– 800 – 448 – 0440.

For more information:

Contact your doctor or an AIDSinfo Health Information Specialist at 1– 800 – 448 – 0440 or http://aidsinfo.nih.gov.

Terms Used in This Fact Sheet:
Clinical trial: a scientifically designed study testing the safety and effectiveness of a medication or other treatment in human volunteers.

Opportunistic infections: infections that usually don't cause disease in people with normal immune systems, but can affect people with damaged immune systems, including people with HIV.

May 2005

A Service of the U.S. Department of Health and Human Services

Recommended HIV Treatment Regimens If you are pregnant or considering becoming pregnant, there are additional treatment considerations. The HIV During Pregnancy, Labor and Delivery, and After Birth Fact Sheet Series has more information on HIV treatment and pregnancy. What are some of the negative side effects of HAART? You may experience negative side effects (drug toxicity) when you take anti-HIV medications. Some of these side effects are serious, even life-threatening; you may have to change medications due to intolerable side effects (see Side Effects of Anti-HIV Medications Fact Sheet Series). You and your doctor or pharmacist should discuss the side effects of each medication. Possible side effects of HAART include: • liver problems – see Hepatotoxicity Fact Sheet • diabetes – see Hyperglycemia Fact Sheet • abnormal fat distribution (lipodystrophy syndrome) – see Lipodystrophy Fact Sheet • high cholesterol – see Hyperlipidemia Fact Sheet • decreased bone density – see Osteonecrosis, Osteopenia, and Osteoporosis Fact Sheet • skin rash – see Skin Rash Fact Sheet • pancreatitis (inflammation of the pancreas) • nerve problems • increased bleeding in patients with hemophilia Side effects that may seem minor, such as fever, nausea, and fatigue, can mean there are serious problems. Always discuss any side effects you are having with your doctor. For more information: Contact your doctor or an AIDSinfo Health Information Specialist at 1–800–448–0440 or http://aidsinfo.nih.gov. A Service of the U.S. Department of Health and Human Services This information is based on the U.S. Department of Health and Human Services' Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents (available at http://aidsinfo.nih.gov). HIV and Its Treatment — Recommended HIV Regimens Terms Used in This Fact Sheet: Antiretroviral: a medication that interferes with replication of retroviruses. HIV is a retrovirus. Drug toxicity: the harm a medication can do to your body. Viral load: the amount of HIV in a sample of blood. Reviewed August 2006 When I start treatment, what kinds of medications will I need to take? Anti-HIV medications are used to control the reproduction of the virus and to slow the progression of HIV disease. They are also called antiretroviral medications. There are four classes of FDA-approved antiretroviral medications: NRTIs, NNRTIs, PIs, and fusion inhibitors. The Available Anti-HIV Medications Fact Sheet lists the FDA-approved antiretroviral medications by class. How many medications will I need to take? The recommended treatment for HIV is a combination of three or more medications in a regimen called Highly Active Antiretroviral Therapy (HAART). How many pills you will need to take and how often you will take them will depend on what medications you and your doctor choose. Which medications should I take? Each HAART regimen is tailored to the individual patient – there is no one "best" regimen. You and your doctor will decide which medications are right for you. For people taking HAART for the first time, the recommended regimens are: Sustiva + Combivir (Retrovir and Epivir) Sustiva + Truvada (Emtriva and Viread) Atripla (Sustiva and Truvada) Kaletra + Combivir (Retrovir and Epivir) Kaletra + Truvada (Emtriva and Viread) Are there any other treatment regimens? Yes, there are several other regimens. Some people may benefit from a regimen other than those listed above. You and your doctor will select a regimen based on your particular needs (see Starting Anti-HIV Medications Fact Sheet). In general, taking only one or two drugs is not recommended because any decrease in viral load is almost always temporary without three or more drugs. The exception is the recommendation for pregnant women, who may take Retrovir alone or with other drugs to reduce the risk of passing HIV to their infants.

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Recommended HIV Treatment Regimens If you are pregnant or considering becoming pregnant, there are additional treatment considerations. The HIV During Pregnancy, Labor and Delivery, and After Birth Fact Sheet Series has more information on HIV treatment and pregnancy. What are some of the negative side effects of HAART? You may experience negative side effects (drug toxicity) when you take anti-HIV medications. Some of these side effects are serious, even life-threatening; you may have to change medications due to intolerable side effects (see Side Effects of Anti-HIV Medications Fact Sheet Series). You and your doctor or pharmacist should discuss the side effects of each medication. Possible side effects of HAART include: • liver problems – see Hepatotoxicity Fact Sheet • diabetes – see Hyperglycemia Fact Sheet • abnormal fat distribution (lipodystrophy syndrome) – see Lipodystrophy Fact Sheet • high cholesterol – see Hyperlipidemia Fact Sheet • decreased bone density – see Osteonecrosis, Osteopenia, and Osteoporosis Fact Sheet • skin rash – see Skin Rash Fact Sheet • pancreatitis (inflammation of the pancreas) • nerve problems • increased bleeding in patients with hemophilia Side effects that may seem minor, such as fever, nausea, and fatigue, can mean there are serious problems. Always discuss any side effects you are having with your doctor. For more information: Contact your doctor or an AIDSinfo Health Information Specialist at 1–800–448–0440 or http://aidsinfo.nih.gov. A Service of the U.S. Department of Health and Human Services This information is based on the U.S. Department of Health and Human Services' Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents (available at http://aidsinfo.nih.gov). HIV and Its Treatment — Recommended HIV Regimens Terms Used in This Fact Sheet: Antiretroviral: a medication that interferes with replication of retroviruses. HIV is a retrovirus. Drug toxicity: the harm a medication can do to your body. Viral load: the amount of HIV in a sample of blood. Reviewed August 2006 When I start treatment, what kinds of medications will I need to take? Anti-HIV medications are used to control the reproduction of the virus and to slow the progression of HIV disease. They are also called antiretroviral medications. There are four classes of FDA-approved antiretroviral medications: NRTIs, NNRTIs, PIs, and fusion inhibitors. The Available Anti-HIV Medications Fact Sheet lists the FDA-approved antiretroviral medications by class. How many medications will I need to take? The recommended treatment for HIV is a combination of three or more medications in a regimen called Highly Active Antiretroviral Therapy (HAART). How many pills you will need to take and how often you will take them will depend on what medications you and your doctor choose. Which medications should I take? Each HAART regimen is tailored to the individual patient – there is no one "best" regimen. You and your doctor will decide which medications are right for you. For people taking HAART for the first time, the recommended regimens are: Sustiva + Combivir (Retrovir and Epivir) Sustiva + Truvada (Emtriva and Viread) Atripla (Sustiva and Truvada) Kaletra + Combivir (Retrovir and Epivir) Kaletra + Truvada (Emtriva and Viread) Are there any other treatment regimens? Yes, there are several other regimens. Some people may benefit from a regimen other than those listed above. You and your doctor will select a regimen based on your particular needs (see Starting Anti-HIV Medications Fact Sheet). In general, taking only one or two drugs is not recommended because any decrease in viral load is almost always temporary without three or more drugs. The exception is the recommendation for pregnant women, who may take Retrovir alone or with other drugs to reduce the risk of passing HIV to their infants.

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