2006: Revolution in HIV treatment. First EMA approval for single tablet regimen taken once a day

Nominated by: Gilead Sciences

Organisation in nomination: Gilead Sciences

Antiretroviral therapy (ART) has played an instrumental role in the treatment of HIV, increasing the life expectancy and quality of life of those affected. The first treatments for HIV infection required patients to adhere to complex regimens, consisting of up to 30 tablets per day, some taken every four hours.

In 2006, a new ART was approved by the European Medicines Agency (EMA) as the first treatment that provided a complete treatment regimen in one single tablet, to be taken once daily. This eliminated the possibility of taking partial medication, improved adherence and simplified the treatment regimen.

ART adherence is one of the key determinants of HIV disease progression, with incomplete adherence potentially compromising treatment effectiveness and leading to unsuppressed virus, with the potential for developing HIV drug resistance. By simplifying the treatment regimen, the single tablet ART has supported treatment adherence, helping to advance progress towards the UNAIDS’ goal[1] of viral suppression in 90% of HIV positive people receiving antiretroviral therapy[2].

The breakthrough was celebrated by Dr. Eschenbach, FDA Commissioner, as a “fundamental change to the treatment paradigm” and was approved via the FDA’s fast track scheme, also in 2006[3].

Research in HIV continues and since then treatment approaches have further progressed. However, the breakthrough achieved in 2006 was instrumental in paving the way for modern treatment options benefiting people living with HIV today.


[1] 90-90-90: An ambitious treatment target to help end the AIDS epidemic

[2]  Yiyun Chen, Barriers to HIV Medication Adherence as a Function of Regimen Simplification, 2018

[3] Quote by Dr Andrew von Eschenberg

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