When should I start treatment?
Australian Society for HIV Medicine (ASHM) is the peak body that sets out the Clinical Treatment Guidelines for Australia1 – providing commentary in the Australian context upon the US Department of Health & Human Services (DHHS) Treatment Guidelines2. As new evidence and new treatments arise, the guidelines are amended to reflect the Australian context. The clinical guidelines can be complex so we have produced the following brief summaries and support guides below.
Results for two pivotal randomized controlled trials (START3 and TEMPRANO4) were recently published, both demonstrating that the clinical benefits of antiretroviral therapy (ART) are greater when ART is started early, with pre-treatment CD4 counts >500 cells, than when initiated at a lower CD4 cell count threshold. This offers important evidence on the optimal time to start treatment – thus the guidelines now recommend treatment for all PLHIV regardless of CD4 count, to reduce the risk of disease progression and the inflammatory effects of HIV on the body.
Until the results of these two studies (above) became available, the guidelines previously recommended starting ART when CD4 cell counts were between 350 to 500 CD4 cells (strong evidence) and >500 CD4 cells (moderate evidence). This was primarily based on data from observational cohort studies and expert opinion. The above new studies now provide A1 (strong) evidence for starting treatment above 500 CD4 cells, as they are large randomised controlled trial (RCT) evidence.
The guidelines also emphasise a more rapid start to treatment, in the following situations:
- Opportunistic Infections or AIDS-defining illness (including dementia).
- Rapidly declining CD4 count (e.g. above >100 CD4 cell loss over a year)
- Very low CD4 counts below < 200.
- HIV associated kidney disease (called “HIVAN”).
- Hepatitis B or Hepatitis C coinfection.
- Acute/Recent HIV diagnosis (within the last 6 months).
- High Viral Load >100,000 copies.
HIV treatment is also recommended for the prevention of transmission of HIV, but this is a more personal – less clinical – choice. Please see our Prevention: Transforming HIV section of the website.
Starting treatment is always an individual decision between you and your doctor. It is important to discuss all the benefits (pros) and risks (cons) to starting treatment, and your personal readiness to start treatment, with your doctor.
- ASHM Antiretroviral Guidelines: US DHHS Guidelines with Australian Commentary. http://arv.ashm.org.au/
- US DHHS https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-treatment-guidelines/0
- INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. Jul 20 2015. Available at http://www.ncbi.nlm.nih.gov/pubmed/26192873
- Temprano ANRS 12136 Study Group. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med. Jul 20 2015. Available at http://www.ncbi.nlm.nih.gov/pubmed/26193126
WHAT TREATMENTS SHOULD I START WITH?
The Australian Treatment Guidelines follow US Department of Health & Human Services (DHHS) which currently recommend nine (9) possible three (3) drug combinations as the recommended treatment to start with. They are mostly either 1 or 2 pills, taken once a day. Your doctor will discuss the recommended choices with you, but if you are unsure about making a decision which combination to choose seek more information or discussion. Some of these treatment combinations include the new (recently approved) tenofovir alafenamide (TAF), which is a lower dose than the older (but still effective) tenofovir disoproxil fumerate (TDF). The combinations to choose from are:
- Kivexa & Tivicay (abacavir / lamivudine + dolutegravir)
- now in a 3 drug combined single pill called Triumeq
- Truvada & Tivicay (tenofovir DF / emtricitabine + dolutegravir)
- Descovy & Tivicay (tenofovir AF / emtricitabine + dolutegravir)
- Stribild (tenofovir DF / emtricitabine / elvitegravir / cobicistat*)
- a 3 drug combined single pill (with cobicistat as a booster*)
- Genvoya (tenofovir AF / emtricitabine / elvitegravir / cobicistat*)
- a 3 drug combined single pill (with cobicistat as a booster*)
- Truvada & Isentress (tenofovir DF / emtricitabine + raltegravir)
- Descovy & Isentress (tenofovir AF / emtricitabine + raltegravir)
- Truvada & Prezista (tenofovir DF / emtricitabine + darunavir / ritonavir*)
- Descovy & Prezista (tenofovir AF / emtricitabine + darunavir /ritonavir*)
* Ritonavir and Cobicistat are called “booster drugs” as they keep the other drug levels (in that combination) up high enough in the bloodstream to stop HIV replicating. Ritonavir and Cobicistat boosters are not active drugs against HIV, but they are required to make the other active drugs (in those combinations) work properly. Cobicistat is always combined in the same pill as the active drug it is boosting, but ritonavir is always taken as a separate pill.
Note: Darunavir (Prezista) which is recommended for first line use in the US guidelines is not licenced for first-line treatment in Australia – your doctor can advise which treatments you can’t take first, as some are only for changing treatment (if your first regimen becomes unsuitable for you).
In addition to the above regimens, alternative/other regimens are available which may be the preferred regimen for some patients, due to unique clinical and personal needs. The preferred regimens (above) are usually offered because they are the easiest to take and tolerate, are less complicated, and have the greatest and strongest evidence for first-line use.
The selection of a treatment regimen should be individualised on the basis of efficacy, toxicity (side effects), number of pills, dosing frequency, drug interactions (with any other treatments), resistance test results, and other health conditions you might have. These can all affect the decisions about which treatments to take.
Your complete individual clinical and personal circumstances are important considerations in order to make a joint decision with your doctor about what treatment will be best for you.
WHERE TREATMENTS WORK IN THE HIV LIFECYCLE
What are the current treatments available?
Below is a visual list description of all the current HIV antiretroviral (ARV) treatments available in Australia:
WANT MORE INFORMATION?
iPlanPLUS! is a resource designed to help you talk with your doctor/s about your HIV treatments to ensure that your antiretroviral drug combination:
- effectively controls HIV and
- protects other aspects of your health and wellbeing, and
- reduces the likelihood of treatment-related side effects in the long-term.
iPlanPLUS! was developed by NAPWHA through an unrestricted educational grant from ViiV Healtcare
You may view the resource on the NAPWHA website here http://napwha.org.au/publications/iplanplus