September 4, 2015
Table of Contents
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 people living with HIV (HIV+) choose among the many available HIV drugs.
The US DHHS provides several different treatment guidelines related to HIV care. These include the Perinatal Guidelines, the Treatment of Opportunistic Infections Guidelines, and the Pediatric Antiretroviral Treatment Guidelines. This article discusses only the recommendations contained within the Guidelines for Antiretroviral Treatment in Adults and Adolescents.
The DHHS 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 April 2015. The full version of the guidelines is available at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Some of the important updates in the most recent version of the DHHS guidelines for the treatment of HIV in adults and adolescents are listed below.
The World Health Organization (WHO) released new HIV treatment guidelines in June 2013 at the International AIDS conference in Malaysia. Based on the results of recent studies, however, the WHO is expected to issue new HIV treatment guidelines late in 2015 that recommend HIV treatment for all people living with HIV, regardless of their CD4 count. Researchers have shown that people living with HIV who start treatment earlier, while their CD4 counts are still high, have a much lower risk of illness and death.
The June 2013 WHO guidelines recommend 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. These include:
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:
Some of the important updates in the most recent version of DHHS guidelines for the treatment of HIV in adults and adolescents are listed here:
More information on what the guidelines recommend is included below.
There has been a lot of discussion and debate about when to start treatment over the years, especially for people living with HIV who are relatively healthy (have high CD4 counts and no signs of ill health). 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. We now understand that this is not true.
The results of a recent study (the START trial) have definitively shown that people living with HIV who start treatment earlier, while their CD4 counts are still high, have a much lower risk of illness and death. This includes people living with HIV who may have no outward signs of ill health. The study showed that taking HIV drugs earlier reduced the likelihood of developing not only AIDS-related illnesses, but also non-AIDS related illnesses.
With the results of the START trial, it appears clear that the benefits of starting treatment early outweigh any potential risks. Consequently, scientific experts and policy makers came together in July 2015 and issued a consensus statement declaring that all people living with HIV should have access to HIV treatment as soon as they are diagnosed. This statement was supported by agencies such as the International AIDS Society, the US President's Emergency Plan for AIDS Relief (PEPFAR), and UNAIDS, among others.
Also, newer drug combinations now available are easier to take and have fewer side effects than older regimens. For all these reasons the newest guidelines recommend starting HIV treatment as soon as someone is diagnosed.
The current US guidelines state:
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.
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 ever 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:
Your first treatment regimen will probably contain:
These combinations will attack HIV at different parts of its lifecycle to pack a strong punch against the virus.
In the US, the DHHS guidelines rank specific drug combinations as recommended or alternative (see below). While the recommended 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).
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. Recommended regimens include:
Integrase inhibitor-based regimens:
Boosted PI-based regimen:
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.
These combinations have been proven effective and tolerable in clinical trials, but may have disadvantages compared to recommended regimens. Alternative regimens include:
After starting HIV treatment, you may need to make some changes in your regimen. The DHHS panel of experts suggests that the primary focus when changing or switching drug regimens should be the maintenance of viral suppression without reducing future treatment options.
Reasons for switching or changing your HIV drug regimen include:
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 US DHHS guidelines' recommendations on when to have a drug resistance test:
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 lot 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 for people who have used and are resistant to many HIV drugs, and treatment when you have HIV and other infections, including tuberculosis, hepatitis B, or hepatitis C. For women living with HIV, 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.