advertisement

HIV/Aids

28 June 2007

New HIV med fast-tracked

US regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.

0
US regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.

The oral drug is the first in an HIV drug class called integrase inhibitors. It is generically known as raltegravir, and formerly known as MK-0518. The drug blocks the insertion of HIV's genetic material into human DNA and thereby prevents the virus from replicating. It should be taken twice daily, and can be taken with or without food.

The preliminary results of two phase III trials, presented earlier this year at the 14th Annual Retroviral Conference, showed that raltegravir is active against HIV in patients resistant to all three previously approved drug classes for HIV infection.

Used with standard HIV meds
Merck said the drug, if approved, will be used alongside standard oral HIV drugs by patients who are no longer adequately protected by their current treatments because of viral resistance.

The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.

With priority review status, the US Food and Drug Administration will make its decision on whether to approve the drug within 6 months, rather than the usual 10- to 12-month review period.

Merck tested Isentress in patients who continued to take a standard HIV drug regimen, although they were infected with strains of the virus that had become resistant to at least one drug in each drug class.

Merck added that it is also moving forward with marketing applications for the drug outside of the United States. – (ReutersHealth)

Read more:
HIV/Aids Centre

June 2007

 

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Ask the Expert

HIV/Aids expert

Dr Sindisiwe van Zyl qualified at the University of Pretoria in 2005. She is a patients' rights activist and loves using social media to teach about HIV. She is in private practice in Johannesburg.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules