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 HIV+ people 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 were written and are 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.

Some of the topics the guidelines cover are listed below.

The guidelines describe the goals of HIV treatment. They are basically to keep you as healthy and 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

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 has a negative impact on 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 guidelines state:

• HIV treatment should be started in anyone with a CD4 count less than 350
• HIV treatment should also be started 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
  • You need treatment for hepatitis B (HBV)
• HIV treatment is recommended to be started in anyone with a CD4 cell count between 350 and 500
• Some members of the guidelines’ committee felt that treatment should be start even earlier – with a CD4 count above 500 and no symptoms
  Because starting medication is such an important decision, the guidelines suggest considering more than just your CD4 count and viral load. You should also 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.

• Keeping your CD4 cell count higher
• Preventing irreversible damage to your immune system
• Decreasing the risk of HIV and non-HIV health problems
• Reducing your risk of transmitting HIV to others

• 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

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)
• Entry inhibitors
• Integrase inhibitors
  

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 and acceptable.

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:

• NNRTI-based regimen
  • Atripla (efavirenz + tenofovir + emtricitabine)
• PI-based regimens
  • Prezista (darunavir) 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 and Combivir (zidovudine + lamivudine)

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) or Combivir
  • Viramune (nevirapine) and Combivir
• PI-based regimens
  • Invirase (saquinavir) and low-dose Norvir and Truvada
  • Kaletra once or twice daily and Epzicom or Combivir or Truvada
  • Lexiva (fosamprenavir) and low-dose Norvir (once or twice daily) and Epzicom or Combivir or Truvada
  • Reyataz and low-dose Norvir and Epzicom or Combivir

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

• NNRTI-based regimen
  • Sustiva and Videx EC (didanosine) and Emtriva (emtricitabine) or Epivir (lamivudine)
• PI-based regimen
  • Reyataz (without Norvir) and Epzicom or Combivir
    

While the preferred regimens are the best choices for HIV treatment, they may not be ideal for everyone. 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, and not following food requirements can all cause your drugs to be less effective or to stop working altogether.

For more information on individual drugs and starting treatment see The Well Project "HIV Drug Info" section on the Treatments and Trials page.

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 may be able to pick the drug in your regimen that is causing the problem and switch that drug for another similar drug. In other cases, especially if it is not clear which drug is causing the problem, the entire regimen may need to be changed.
• Simplifying the regimen – There may be new formulations or combinations 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.
• Viral load not being 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 usually change two or three medications at once.
  Some people want to stop taking their HIV drugs altogether, but stopping or skipping treatment can be very bad for your health. It typically 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.

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 taken HIV drugs and are starting to receive medical care, 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 are 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

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, 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's okay for you to individualize therapy to your specific situation. Use the guidelines as a resource to help you make well-informed treatment decisions that are right for you.

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The full version of the guidelines is available at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf