New HIV Drug Etravine Wins FDA Approval

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: HIV / AIDS
Article Date: 22 Jan 2008 - 0:00 PDT

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The US Food and Drug Administration (FDA) gave approval last Friday, 18th January, for etravine to be used as an adjunct anti-HIV therapy for adults who have failed to respond to other antiretroviral treatments. The drug's brand name is Intelence and is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products of New Jersey.

Etravine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), a family of drugs that prevents the viral DNA from being copied and integrated with host cell DNA by blocking an enzyme. This stops the virus from multiplying. Other NNRTI drugs exist, but the virus has developed new mutant strains that have become resistant to them.

The FDA conducted a priority review of the drug, which has been approved for use only in combination with other anti-HIV treatments.

Director of the FDA's Division of Antiviral Products, Dr Debra B Birnkrant, said in a prepared statement that:

"This is another significant new product for many HIV-infected patients who are NNRTI resistant and whose infections are not responding to currently available medications."

When taken as prescribed, in conjunction with other anti-HIV drugs, etravine has two beneficial effects. First, it reduces the amount of HIV in the blood, and second it increases the number of CD4 white blood cells which helps the patient to resist and fight off other infections. This in turn reduces the risk of death or infection from having a weakened immune system.

It was the results of two randomized, double blind, placebo controlled trials called DUET-1 and DUET-2 on around 600 adults that provided the evidence to convince the FDA to approve the drug.

After 24 trial weeks, patients on etravine and background therapy had a higher drop in blood levels of HIV than those who only had the placebo plus background therapy. All the participants had had extensive treatment and developed resistance to an average of 12 other antiretrovirals.

DUET-1 was conducted in Argentina, Brazil, Chile, France, Mexico, Panama, Puerto Rico, Thailand, and the US. DUET-2 was the same trial in other countries: Australia, Canada, again the US, and several European countries.

Rash and nausea were the most common side effects reported on the trials. Also, in the overall development of the drug, there have been rare cases of serious skin conditions such as Stevens-Johnson syndrome and erythema multiforme.

The FDA suggests that patients who develop a rash while on etravine should go back and tell their doctor. Also, to prevent other side effects that might occur from the drug in combination with other medications, patients should tell their doctor about all other medications they have been taking before starting on etravine.

Patients on etravine may get infections, for example opportunistic infections and other infections that are usually observed in HIV patients.

The agency stressed that it is too early to assess the long term effects of etravine, and it has not been tested in pregnant women or in children aged 16 and under.

The FDA advises women who get pregnant while on anti-HIV drugs talk to their doctor about the use of etravirine during pregnancy and the possibility of registering with the Antiviral Pregnancy Registry.

Click here to read more about DUET-1 and DUET-2 (hivguidelines.org).

Sources: FDA announcement, wikipedia, New York State Department of Health (hivguidelines.org).

Written by: Catharine Paddock


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