HIV Treatment Guidelines

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Key Changes in the Revised February 2013 Guidelines (US)

Some of the important updates in the most recent version of the US Department of Health and Human Service's (DHHS) guidelines for the treatment of HIV in adults and adolescents are listed here:

  • The DHHS's panel of experts now recommends that all people living with HIV (HIV+) take HIV drugs, no matter what their CD4 count. They recommend this not only to prevent disease progression, but also to prevent HIV transmission since evidence now clearly shows that HIV+ people who take HIV drugs that control the growth of the HIV virus are much less likely to spread HIV to others.
  • In the HIV and Women section, there are new recommendations for HIV+ pregnant women. The first states that women who become pregnant while taking Sustiva (efavirenz) can continue to take Sustiva if it is effective in suppressing their viral load. The second says that women who have a viral load less than 400 can take oral HIV drugs and do not need to use intravenous (IV) Retrovir (zidovudine) during labor and delivery of their baby.
  • Drug-resistance testing: people for whom Isentress (raltegravir) does not work should now be given a drug-resistance test for integrase inhibitors to guide future treatment
  • New terminology: the term "early" will now be used to describe both the 'acute' phase of HIV infection that occurs immediately after infection as well as 'recent' infection (within the first six months)
  • Drug interactions: new tables listing interactions between HIV drugs and other medications commonly taken by those living with HIV (tables 14 – 16b); these include known and predicted interactions for Stribild (Elvitegravir + cobicistat + tenofovir + emtricitabine)

More information on updates to the treatment guidelines is included below.

What Are Treatment Guidelines?

US Guidelines

A branch of the US government, called the Department of Health and Human Services, (DHHS), has put together a set of HIV treatment guidelines. The guidelines provide a lot of useful information to help health care providers and people living with HIV make decisions about when to start, when to stop, and when to change HIV medications. It also helps providers and HIV+ people choose among the many available HIV drugs.

The guidelines are written and reviewed regularly by a group of HIV experts, including researchers, health care providers, and community activists. They were first published in 1998 and have been updated many times since then. The most recent guidelines were released in February 2013. The full version of the guidelines is available at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf.

Some of the topics the guidelines cover are listed below.

Global Guidelines

The World Health Organization (WHO) released new HIV treatment guidelines in June 2013 at the International AIDS conference in Malaysia. The WHO recommends that HIV drugs be offered to all those living with HIV whose CD4 count is less than 500. It also recommends that HIV drugs be offered to certain groups as soon as they test positive for HIV:

  • Women who are pregnant or breastfeeding
  • HIV+ people whose regular sexual partners are HIV-negative
  • Those with active tuberculosis (TB)
  • Those with hepatitis B and severe chronic (long-term) liver disease
  • Children younger than 5 years of age

The guidelines also recommend using viral load tests instead of CD4 counts to see how HIV drugs are working.

Treatment Goals

The guidelines describe the goals of HIV treatment. They are basically to keep you as healthy and as well as possible using the best care and treatment available today. The goals are the same for people just starting treatment and those who have been on treatment for a long time:

  • Preserve or improve the health of your immune system by increasing your CD4 cells
  • Get your viral load as low as possible for as long as possible
  • Improve your quality of life and reduce illness and death
  • Prevent HIV transmission

When to Start Treatment?

There has been a lot of discussion and debate about when to start treatment over the years. The guidelines have been changed a number of times. Some earlier versions recommended that people wait longer before starting HIV treatment. This was because of concerns about the HIV drugs, such as side effects and difficult dosing schedules. It was thought that HIV was not as harmful as possible drug side effects in people with higher CD4 counts.

There is now more proof that untreated HIV is bad for your health at all stages of disease. Several large studies have shown that people who begin treatment early have a better outcome than those who wait to start treatment until their HIV has progressed. Also, the drug combinations now available are easier to take and have fewer side effects than older regimens. For these reasons the newest guidelines recommend starting earlier.

The current US guidelines state:

  • HIV treatment is recommended for anyone who is HIV+, no matter what their CD4 count. This recommendation also includes the following:
    • HIV treatment can prevent both AIDS-related and non-AIDS-related illness in people living with HIV
    • HIV treatment can prevent transmission of HIV to others. Research has shown that taking HIV drugs as they are prescribed can reduce the amount of HIV in the blood and genital fluids. Therefore, HIV+ people on HIV treatment are less likely to spread the virus to others.
    • HIV treatment should only be started when people understand the risks and benefits of treatment and are willing and able to commit to taking HIV drugs as they are prescribed (this is known as adherence)
  • HIV treatment is also strongly recommended if you are in one or more of the following situations, no matter what your CD4 count:
    • You have or had symptoms of AIDS (such as opportunistic infections, also called OIs)
    • You are a pregnant woman
    • You have HIV-related kidney disease (HIVAN or HIV nephropathy)
    • You need treatment for hepatitis B and/or hepatitis C
  • The DHHS panel's recommendation to begin treatment with a CD4 count above 500 is a "moderately strong" recommendation based on expert opinion and not on data from clinical trials. The panel's recommendation to begin treatment with a CD4 count under 500 is based on the results of well-designed studies and is considered strong.

[Note: Because the panel's expert opinion is not based on results from randomized controlled trials, which are often considered the 'gold standard' for providing evidence, there is some debate about the DHHS panel's recommendation to begin treatment with a CD4 count above 500. In other words, while some experts agree that the current level and quality of evidence supports treatment above 500, other experts do not.]

  • The guidelines also point to several conditions that increase the need for treatment, such as rapidly declining CD4 count (more than 100 cells per year) or higher viral load (more than 100,000 copies)
  • HIV drugs should be offered to people who are at risk of spreading HIV to their sexual partners
    Because starting medication is such an important decision, the guidelines suggest considering more than just your CD4 count and viral load. It is important to think about whether you are ready to start and able to take your medications as prescribed. You and your health care provider should consider the risks and benefits of starting treatment earlier or later.

Potential Benefits of Starting Therapy Early

  • Keeping your CD4 count higher
  • Lowering the risk of HIV-related problems that occur even when your CD4 count is high (such as tuberculosis and certain types of cancer)
  • Lowering the risk of heart, liver, and kidney disease that occur more often in HIV+ people
  • Reducing your risk of transmitting HIV to others

Potential Risks of Starting Therapy Early

  • Experiencing drug-related side effects, including possible long-term side effects not yet known
  • Developing drug resistance (when an HIV drug is no longer able to fight HIV effectively, we say that HIV has become "resistant" to that drug); drug resistance can reduce future treatment options

What to Start With?

Once you have decided to start treatment, you and your health care provider need to choose what combination of drugs you are going to take. No HIV drug should be used by itself. There are many drugs to choose from. The HIV drugs work in different ways to stop the virus at different points in its lifecycle. The drugs are divided into classes as follows:

  • Nucleoside/nucleotide reverse transcriptase inhibitors ("nukes" or NRTIs)
  • Non-nucleoside reverse transcriptase inhibitors ("non-nukes" or NNRTIs)
  • Protease inhibitors (PIs)
  • Integrase inhibitors
  • Entry inhibitors (which includes fusion inhibitors and chemokine receptor 5 (CCR5) antagonists)

Your first treatment regimen will probably contain:

  • An NNRTI plus 2 NRTIs or
  • An integrase inhibitor plus 2 NRTIs or
  • A PI plus 2 NRTIs [the PI should be combined, or "boosted," with a small dose of a second PI called Norvir (ritonavir); this makes the first PI work better.

These combinations will attack HIV at different parts of its lifecycle to pack a strong punch against the virus.

The guidelines rank specific drug combinations as preferred, alternative, acceptable, and acceptable with caution (see below). While the preferred regimens are the best choices for HIV treatment, they may not be ideal for everyone. Because everyone's situation is different, there may be cases in which alternative treatments are actually better for you. You and your health care provider should choose drugs based on your specific needs. Think about what will fit into your lifestyle, including dose schedule, number of pills, and side effects. Also consider what other medications you are taking, any other medical conditions you have, and the results of resistance testing (see below).

Whatever regimen you choose to take, you need to take your drugs on schedule. This is called adherence. In order to get the most benefit from HIV treatment, good adherence is required. This is because HIV drugs need to be kept at a certain level in your body to fight the virus. If the drug level falls, HIV may have a chance to fight back and develop resistance. Skipping doses, not taking the drugs on time, or not following food requirements can cause your drugs to be less effective or stop working altogether.

For more information on the different classes of HIV drugs and how they work, see The Well Project's article HIV Drugs and the HIV Lifecycle. For more information on individual drugs sorted by class see The Well Project's HIV Drug Chart. Please note: for the regimens listed below, the brand name of an HIV drug is listed first and capitalized, with the generic name lower-cased and in parentheses. For example: Truvada (emtricitabine + tenofovir).

Preferred Regimens

Study results of these combinations showed they were powerful and long-lasting, did not have a lot of side effects, and were easy to use. Preferred regimens included:

  • Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen
    • Atripla (efavirenz + tenofovir + emtricitabine)
  • Protease Inhibitor (PI)-based regimens
    • Prezista (darunavir) once daily and low-dose Norvir and Truvada (tenofovir + emtricitabine)
    • Reyataz (atazanavir) and low-dose Norvir and Truvada
  • Integrase inhibitor-based regimen
    • Isentress (raltegravir) and Truvada
  • Preferred regimen for pregnant women
    • Kaletra (lopinavir/ritonavir) twice-daily
    • Reyataz (atazanavir) and low-dose Norvir and Combivir (zidovudine + lamivudine)

The WHO guidelines suggest that first-line HIV therapy be a combination of an NNRTI plus 2 NRTIs. Specifically, they recommend either: (1) Atripla (efavirenz + tenofovir + emtricitabine) or (2) Sustiva (efavirenz ) + Viread (tenofovir) + Epivir (lamivudine). These two regimens are also those recommended for women who are pregnant or breastfeeding.

Alternative Regimens

These combinations have been proven useful in clinical trials, but may have disadvantages, such as less effectiveness or more side effects. Alternative regimens include:

  • NNRTI-based regimens
    • Sustiva (efavirenz) and Epzicom (abacavir + lamivudine)
    • Complera (emtricitabine + rilpivirine + tenofovir)
    • Edurant (rilpivarine) and Epzicom
  • PI-based regimens
    • Kaletra and low-dose Norvir once or twice daily and Epzicom or Truvada
    • Lexiva (fosamprenavir) and low-dose Norvir (once or twice daily) and Epzicom or Truvada
    • Reyataz and low-dose Norvir and Epzicom
    • Prezista and low-dose Norvir and Epzicom
  • Integrase inhibitor-based regimen
    • Stribild (Elvitegravir + cobicistat + tenofovir + emtricitabine)
    • Isentress and Epzicom

Acceptable Regimens

These combinations can be used in certain circumstances, but are not as good as preferred or alternative regimens. Acceptable regimens include:

  • NNRTI-based regimens
    • Efavirenz and Combivir
    • Viramune and Truvada or Combivir or Epzicom
    • Edurant and Combivir
  • PI-based regimens
    • Reyataz (without Norvir) and Epzicom or Combivir
    • Reyataz with low-dose Norvir and Combivir
    • Prezista (darunavir) and low-dose Norvir and Combivir
    • Lexiva and low-dose Norvir and Combivir
    • Kaletra and low-dose Norvir and Combivir
  • Integrase inhibitor-based regimen
    • Isentress and Combivir
  • Entry inhibitor-based regimens
    • Selzentry (maraviroc) and Combivir
    • Selzentry and Truvada or Epzicom

Acceptable with Caution Regimens

These combinations have been shown to be effective, but may have some safety or resistance concerns. Regimens that may acceptable when used with caution include:

  • PI-based regimens
    • Invirase (saquinavir) and low-dose Norvir and Truvada or Epzicom or Combivir

Changing or Stopping Treatment

After starting HIV treatment, you may need to make some changes in your regimen. Reasons for this include:

  • Side effects – In some cases, your health care provider can treat side effects without switching your HIV drugs. If the side effects cannot be controlled or are very serious, your health care provider may be able to find the drug in your regimen that is causing the problem and switch that drug for another drug. In other cases, especially if it is not clear which drug is causing the problem, the entire regimen may need to be changed.
  • Viral load not controlled – If your viral load does not come down or starts increasing, it may be time for a change. In this case, your health care provider will check for drug resistance and may change two or three medications at once.
  • Simplifying the regimen – There may be new formulations or combination pills you can take so you have fewer pills or fewer doses.
  • Trouble with adherence - If you miss doses of your medications, you can develop resistance to the drugs and they will stop working. Before changing to new medications, talk with your health care provider about adherence. If you have problems sticking to your medication schedule, your health care provider can help you figure out ways to stay on track or find an easier regimen for you to take.
  • Some people want to stop taking their HIV drugs altogether, but stopping or skipping treatment can be very bad for your health. It usually causes an increase in viral load and a drop in CD4 cells. Once HIV treatment is begun, it should not be stopped without speaking to your health care provider.

Resistance Testing

Drug resistance tests can tell if your virus is resistant to any HIV medications. This will help you and your health care provider choose the most effective drugs for you to take. The following are the guidelines' recommendations on when to have a drug resistance test:

  • Testing is recommended for
    • People who have just become infected with HIV, whether or not they are going to take HIV drugs right away
    • People who have never been on HIV drugs and are planning to start
    • People who are on HIV drugs and see their viral load go up
    • People who have recently started HIV drugs and their viral load is not coming down enough
    • HIV+ pregnant women
  • Testing is not usually recommended for
    • People who have stopped HIV drugs for four weeks or more
  • The February 2013 guidelines now recommend that people whose viral loads are not well controlled using an Integrase-based drug combination should receive a genotypic tropism test for Integrase resistance. This will help determine if any other drugs from the Integrase class should be included in future drug combinations.

Taking Care of Yourself

There is much more information in the guidelines, including other possible drug regimens, what drugs not to take, and what types of resistance tests to use. There is also a wealth of information on other aspects of HIV care and treatment, including adherence, drug side effects and interactions, special considerations for people with liver or kidney problems, treatment when you have HIV and either tuberculosis or HBV, and salvage therapy (treatment for people who have used and are resistant to many HIV drugs). For HIV+ women, the guidelines contain important information on pregnancy and women-specific treatment issues.

The guidelines are a set of recommendations to help you and your health care provider understand your treatment choices. They are based on the most up-to-date information from studies and clinical trials. But, remember, they are only general suggestions. It is okay for you to choose therapies for your specific situation. Use the guidelines as a resource to help you make well-informed treatment decisions that are right for you.

Additional Resources

Select the links below for additional material related to treatment guidelines.

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