Although generally well tolerated in clinical trials, since the approval of etravirine, two types of severe reaction to the drug have been reported: toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS).

Reported cases of these reactions developed between three and six weeks after treatment with the drug was started. In most cases, they disappeared when treatment with etravirine was stopped and therapy with corticosteroids was provided. Symptoms include rash, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and high concentrations of a type of blood cell calls eosinophils.

In August 2009, the US Food and Drug Administration inserted a new warning to the package insert for etravirine (Intelence). It stated that severe cases of rash occurred in around 1.3% of people in phase 3 studies of the drug and 2% of people had to stop taking the drug due to serious rash, usually occurring in the first six weeks of treatment. In the most serious cases, people taking etravirine developed Stevens-Johnson syndrome or other severe skin reactions in which regions of the skin blister and peel away. It is expected that a similar warning will be added to European package inserts by the European Medicines Agency.

People who develop a severe rash while taking etravirine were advised to seek immediate medical advice. If a hypersensitivity reaction to the drug is diagnosed, treatment with it should be stopped immediately. People who have stopped treatment due to hypersensitivity reactions should not restart therapy. 

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 It may have been superseded by more recent developments.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.