Darunavir (Prezista)

Darunavir (Prezista) is an antiretroviral drug from the class known as protease inhibitors. Protease inhibitors block the activity of the HIV protease enzyme that HIV uses to break up large viral proteins so that new HIV particles can be formed. Inhibiting this action slows HIV replication and delays damage to the immune system. For more information on how protease inhibitors work, see Protease inhibitors in the section Ways of attacking HIV.        

Darunavir (formerly TMC114) was developed by the Belgian company Tibotec and designed to be active against HIV resistant to then-current 'first-generation' protease inhibitors. It was originally licensed in 2006 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use and the US Food and Drug Administration for use in highly treatment-experienced people.

This recommendation was based on favourable results from the POWER study, a randomised comparison of darunavir/ritonavir with other ritonavir-boosted protease inhibitors in people with experience of all three classes of antiretroviral (ARV) drugs available at the time the study began. Participants in this study had relatively high levels of protease inhibitor resistance.

Following the results from the TITAN study in 2008, in which boosted darunavir showed a clear advantage in treatment-experienced people with less exposure to protease inhibitors, the EMA expanded its licence to include use by people with any prior ARV experience.

In 2008, the US approved darunavir’s use in ARV-naive individuals, based on data from the ARTEMIS study. Darunavir was approved for once-daily first-line use in Europe in February 2009.

Response to darunavir does not appear to vary according to previous protease inhibitors use. Analysis of resistance in clinical studies have indicated HIV would need to accumulate up to eleven different mutations in the protease enzyme to become resistant to darunavir.

Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.