New HIV Drug Approved By FDA

WASHINGTON -- The Food and Drug Administration said Friday it approved a new HIV drug from Johnson & Johnson for patients who have not been treated with other medications for the virus.

The once-a-day pill Edurant works by blocking the virus from reproducing. It is designed for use as part of a drug cocktail that reduce levels of HIV in the blood.

"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Dr. Edward Cox, FDA's director of antimicrobial products.

The FDA approved the drug based on a study of 1,368 patients showing it was as effective as Sustiva, an older HIV drug already on the market. After 48 weeks of study, 83 percent of patients taking Edurant had undetectable viral levels, compared with 80 percent of patients taking Sustiva.

The most common side effects with Edurant included depression, trouble sleeping, headache and rash.

Edurant is manufactured by Tibotec Therapeutics, a division of Johnson & Johnson's Ortho Biotech Inc.

Comments

[casfl]

08:53 AM on 05/21/2011

Aethlon Medical is developing a hemopurifier filter that greatly reduces viral load in the blood on its own.

[brianopnmndd]

07:46 AM on 05/21/2011

You would think with the addition of other options, the COSTS would come down on these drugs across the board..... NOT!!! The GOUGING shall continue!!!

[headedsouth]

07:18 AM on 05/21/2011

The "cure" is getting everyone tested, getting those that are HIV positive on treatment so that they are virtually non-transmittable and eventually the spread of new disease will stop. The chances of ridding a body of a virus is extremely remote.

[ejr5478]

03:03 AM on 05/21/2011

There's no profit in a cure.

[whoawhat]

12:56 AM on 05/21/2011

I'm not up to date on my HIV facts but how does this affect transmitting of the disease? If someone wants a new partner to get tested as a precaution and the results come back negative because the drug has reduced the virus to "undetectable" levels can the virus still be spread through sexual contact?

[Cowboy9156]

04:47 AM on 05/21/2011

This is a very good question and the FDA and the Medical Professionals need to answer it soon!

[MagCA68]

11:08 PM on 05/22/2011

undetectable levels do not transmit the virus.

[froidytoidy]

02:18 PM on 05/21/2011

whoawhat - very interesting question - here is some info that might help you.

http://www.health.state.ny.us/diseases/aids/facts/questions/transmission.htm

A person infected with HIV can pass the virus to others during these activities. This is true even if the person:

has no symptoms of HIV;
has not been diagnosed with HIV/AIDS;
is taking HIV medicine; or
has an undetectable viral load

[defelicep]

11:50 PM on 05/20/2011

The problem with the FDA is they're basically owned by the drug companies so we always have to take these new break thru's with grain of salt. Remember, more people every year die from FDA APPROVED drugs than 3 times that of the Vietnam war.

[hornet32j]

10:53 PM on 05/20/2011

Like they say theres always hope , its also said that everything is revelent .

[onionboy]

01:44 PM on 05/20/2011

Although it's easy to see this as a "me too" drug, for people who are taking antiretrovirals long term, treatment variety is important because improved viral resistance to specific compounds can occur with compounds over time. So, having an option, even just an equivalent option, can save their life.

[Skydave]

12:56 AM on 05/21/2011

For goodness sake, this is the United States, surely we can find a cure for this virus. I don't understand what is taking so long, I know they have prolonged life, but one would think a cure could be found. I don't know a lot about HIV, but I know that it still seems to be spreading. I have heard of people getting it through tranfusions, and I also read where a person was getting a kidney transplant and the donor was positive and the virus transfered to the recipient. How sad. I feel really bad for the people that get infected and especially the children.

[onionboy]

01:42 AM on 05/21/2011

Actually, there are cures for very few viruses; and not one yet for any retrovirus. HIV's at the top of the list, but a vaccine will likely come before cure. Anti-retrovirals are about as close to a cure as there is. In some people they reduce the viral load down to undetectable levels...but only so long as you stay on them.