FDA approves etravirine tablets for HIV

The U.S. Food and Drug Administration has approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA.

Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains.

"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," said Debra B. Birnkrant, M.D., director of the FDA's Division of Antiviral Products.

When used with other active anti-HIV medicines and when taken as prescribed, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.

The FDA's approval of etravirine is based primarily on data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.

The most common adverse events reported were rash and nausea. Patients developing a rash while taking etravirine should contact their doctor. To avoid drug interactions, patients starting etravirine treatment should tell their prescribers and pharmacists about all the medications they take. Information about drug interactions is contained in the etravirine package insert.

In the overall development program for etravirine, rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported. Patients taking etravirine may develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV infection. The long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 years and younger has not been studied.

Etravirine also has not been studied in pregnant women. Women who are taking HIV medications when they become pregnant are advised to consult their physician or other health care professional about use of etravirine during pregnancy and about registering with the Antiviral Pregnancy Registry.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Innovative HIV vaccine approaches yield potential for broad protection against viral strains