Recently, Johnson & Johnson’s (JNJ) Intelence (etravirine) received full approval from the US Food and Drug Administration (FDA) for the treatment of HIV patients who are no longer responding to other treatments. Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks the enzyme HIV needs to multiply. The drug has been already approved for use in 50 countries around the world.

In January 2008, the drug received preliminary approval under the FDA’s accelerated approval program. Following this, J&J was allowed to market the drug. However, accelerated approval comes with the requirement of further follow-up data to prove the drug’s effectiveness. In January 2009, an application for final approval was submitted to the FDA, which included 48-week data from DUET-1 and DUET-2.

The DUET studies were conducted in many countries across the world. It examined the use of Intelence in combination with other antiretroviral agents in adult treatment-experienced HIV patients who are resistant to NNRTIs and protease inhibitors (PIs). Participants in the study were randomized to receive either Intelence (200 mg twice daily) or placebo. Patients were already being treated with darunavir/ritonavir and at least two investigator-selected antiretroviral drugs (NNRTIs with or without enfuvirtide).

Data from these studies revealed impressive results — 60% of patients taking Intelence for 48 weeks had undetectable levels of HIV in their blood compared with 38% of patients taking a placebo.

In August 2009, J&J received a setback with the FDA’s decision to strengthen the warning regarding a deadly skin reaction caused by Intelence. The increased warning followed the reported death of a patient from a skin reaction known as toxic epidermal necrolysis. Additionally, another case of liver failure was reported in a patient who recovered subsequently.

Since the launch of Intelence in January 2008, the product has included a warning about the risk of severe skin reactions, though the rate of serious allergic reactions had been quite low in the clinical trials (less than 0.1%).

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