The U.S. Department of Health and Human Services has put together a set of guidelines to help health care providers and patients make decisions regarding when to start, when to stop, and when to change HIV medications. It also helps providers and patients choose among more than 25 approved HIV medications.

The guidelines were written and are revised regularly by a panel of HIV experts, including researchers, health care providers, and community activists. They were first published in 1998 and have been updated numerous times since then.

Some of the topics the guidelines cover are listed below.

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 doctor should consider the risks and benefits of starting treatment earlier or later.

• Benefits:
  • Earlier and easier reduction of viral load
  • Delay or prevent a weakened immune system
  • Stay healthier longer
  • 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.
• Risks:
  • It can be hard to take drugs everyday
  • Drug-related side effects
  • May reduce future treatment options
  • No one knows how long the drugs will keep working

• Benefits:
  • May avoid negative effects on quality of life for a longer period of time
  • Avoid drug-related side effects for a longer period of time
  • May have treatment options for the future
• Risks:
  • May have immune system damage that cannot be reversed or improved
  • May be harder to bring down viral load
  • May have a worse disease course than those who start treatment early

Once you have decided to start therapy, you need to choose what combination of drugs you are going to take. No HIV drug should be used by itself. There are about 29 drugs to choose from. When you and your doctor talk about a treatment regimen, think about what will fit into your lifestyle. Think about dose schedule, number of pills, side effects, and future treatment options.

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)
• Fusion inhibitors
• Multi-class combination products
• Entry inhibitors
• Integrase inhibitors

Your first treatment regimen will probably contain a PI or an NNRTI along with two NRTIs. This combination will attack HIV at different parts of its lifecycle to pack a strong punch against the virus. The following HIV drug combinations are recommended for first-time treatment regimens:

• Preferred NRTI combination:   Emtriva (emtricitabine) + Viread (tenofovir) or Truvada (contains both drugs)  [alternatives:  (1) Combivir,  (2) Epzicom, (3) Videx EC + Epivir, or (4) Videx EC + Emtriva 
• Preferred NNRTI:  Sustiva (efavirenz)  [alternative: Viramune (nevirapine)]
• Preferred PI combinations:
  • Reyataz (atazanavir) + Norvir (ritonavir) once daily
  • Prezista (darunavir) + Norvir once daily
  • Lexiva + Norvir twice a day
  • Kaletra (ritonavir + lopinavir) once or twice a day

Your first treatment regimen will probably contain one NNRTI + two NRTIs  OR  one PI combination + two NRTIs from the list above.  While these regimens are "preferred," they may not be the best choices for everyone. (For example, Sustiva is not recommended for use in women who are pregnant or may become pregnant.) Other PI-based regimens that may be considered along with 2 NRTIs for initial therapy include:

• • Reyataz (atazanavir) once daily
  • Lexiva (fosamprenavir) + Norvir once daily
  • Lexiva twice daily
  • Invirase (saquinavir) + Norvir twice daily

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

• Side effects – In some cases, your doctor can treat side effects without switching your HIV drugs. If the side effects cannot be controlled or are very serious, your doctor 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.
• Trouble with adherence (taking your medication exactly as prescribed) - 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 doctor about adherence. If you have problems sticking to your medication schedule, your doctor 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 to undetectable levels or starts increasing, it may be time for a change. In this case, the doctor will usually change two or three medications at once. [Note: a key goal of therapy is to get your viral load to undetectable levels within four to six months of starting treatment.]

Some people want to stop taking their HIV drugs altogether. Stopping or interrupting treatment typically causes a large increase in viral load and a large drop in CD4 cells. Once HIV treatment is begun, it should not be interrupted except for serious drug side effects or conditions that prevent one from swallowing pills, capsules, or liquids.

Drug resistance tests are available to determine if your virus has become resistant to any HIV medications. The guidelines offer the following recommendations on when to have a drug resistance test:

• Testing recommended if:
• • Your viral load goes up while you are on HIV medication. The information from the test helps your doctor choose drugs for your next combination that are most likely to help you.
  • You’ve recently started HIV drugs and the combination isn’t bringing down your viral load enough.
  • You were recently infected with HIV and are thinking of starting drug therapy. You may have been infected with a drug-resistant strain of HIV.
• Testing should be considered if:
• • You’ve been HIV-positive for a long time and haven’t started taking medications. However, testing is not always useful under these circumstances because you may not have enough drug-resistant virus in your body to get an accurate result.

Pregnant women with HIV should also have a resistance test prior to starting HIV treatment or if they have detectable virus in their blood while on HIV treatment. This can help women choose the drugs that will be most effective in decreasing their viral load and reducing the chances of passing HIV to their babies.

The guidelines include a long section on what to consider when you are already receiving HIV treatment but you may want or need to change your treatment.  Changing treatment is a complicated process and should be discussed with your doctor.

The guidelines offer 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 women with HIV, the guidelines also contain important information on pregnancy and women-specific treatment issues. 

The guidelines are a set of recommendations to help you and your doctor understand your treatment options. 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