Welcome, Guest. Please login or register.
November 17, 2017, 08:11:18 PM

Login with username, password and session length

  • Total Posts: 722383
  • Total Topics: 58698
  • Online Today: 331
  • Online Ever: 1421
  • (August 13, 2016, 05:18:44 AM)
Users Online
Users: 6
Guests: 254
Total: 260


Welcome to the POZ Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: Great News  (Read 2367 times)

0 Members and 1 Guest are viewing this topic.

Offline ubotts

  • Member
  • Posts: 347
Great News
« on: October 15, 2007, 10:34:18 AM »

San Francisco Chronicle

FDA approves important new AIDS drug Isentress

- Sabin Russell,
Chronicle Medical Writer
Saturday, October 13, 2007

Pharmaceutical giant Merck & Co. won Food and Drug Administration approval Friday for Isentress, an HIV suppressor that has performed well in clinical trials and has been hailed as the most important new AIDS drug in a decade.

The Merck drug has been closely watched since human testing began in 2005 because it was the first AIDS medicine to block an enzyme, called integrase, that is crucial in the process HIV uses to replicate.

The new medication, also known by its generic name, raltegravir, is the first of what is expected to be a new class of AIDS drugs known as integrase inhibitors.

Two other enzymes, reverse transcriptase and protease, are the targets of almost all other major AIDS drugs. These drugs work better in combination than by themselves. Now, doctors have a pill that attacks the third in this trio of critical enzymes, and clinical trials have shown Isentress to be particularly beneficial in these drug combinations.

"This is fantastic news," said UCSF Professor Dr. Warner Greene, director of the Gladstone Institute of Virology and Immunology. "This drug looks more potent than virtually anything we have ever seen."

First to benefit from the new medication are thousands of people who have been infected for years and have grown resistant to so many AIDS drugs that they are running out of options.

This is the group that was used to test the new drug in clinical trials. More than 80 percent of those who took Isentress saw the level of virus in their blood drop to barely detectable levels - a sign that the disease is under control.

"We are at a watershed period for these patients. For many years, they have had a limited number of options," said Dr. Robin Isaacs, leader of Merck's HIV treatment and vaccine efforts.

Patients who are prescribed the drug will take two 400 mg tablets a day, in combination with other AIDS medicines chosen by their physicians.

Isentress is the latest of several AIDS drugs to be approved this year that, in combination, could bolster the immune systems of veteran patients who have built resistance to earlier generation of drugs.

"This is a really exciting time for patients," Isaacs said.

But Isentress won't be cheap. Immediately after receiving FDA approval to market the drug, Merck disclosed that it plans to sell Isentress for $27 a day, or $9,850 per year - making it one of the costlier pills on the market.

A new drug by Pfizer Inc., Selzentry, sells for at least $10,600 a year. The Pfizer pill, which received FDA approval in August, also represents a new class of AIDS drug. This one blocks a structure on the surface of blood cells called CCR5, which the AIDS virus uses to wedge its way into cells.

Martin Delaney, founder of San Francisco's Project Inform - a leading AIDS drug advocacy organization - and an activist in a group called the Fair Pricing Coalition, said Merck is not charging as much as he had feared.

"It falls in the middle of the high end for AIDS drugs. For us, that is a victory," he said.

Although tests have shown that Isentress does not cause common HIV drug side effects such as driving up levels of fat cells in the blood, early animal studies showed that the drug might cause cancer in rats. Human trials have shown a 20 percent higher risk of cancer in patients, compared with those who took a placebo.

But Merck scientists said the elevated risk appears to be the result of chance - cancer rates in the placebo group were lower than is typical among AIDS patients, and as testing has continued, the small number of cancers in both groups has been balancing out.

Gladstone AIDS researcher Greene also said he believes the new integrase inhibitor will prove safe because there are no known biological reasons why the drug might cause cancer. Greene said he has no economic ties to Merck.

Pharmaceutical researchers are fond of targeting enzymes because these catalysts play powerful roles in biological processes. Block an enzyme, and an entire chain of molecular events that promote disease might be broken. Enzymes are also vulnerable to molecules that can be made small enough to be taken in pill form and be carried by the blood throughout the body.

The first generations of AIDS drugs targeted reverse transcriptase, an enzyme that HIV uses to convert its genes into the DNA code used by human cells. The second generation of AIDS drugs attacked HIV protease, an enzyme that helps newly formed viruses escape the cells where they have been replicating.

Friday's FDA approval is the culmination of 14 years of research by Merck to find an integrase inhibitor. It turned out to be a daunting challenge that frustrated other drug companies for years. Another integrase inhibitor by Gilead Sciences Inc. of Foster City is undergoing large-scale clinical trials.

Robert Rode, a Merck marketing vice president, said the new pills should be available in pharmacies in as few as two weeks. The company has been providing Isentress free to 6,000 patients worldwide, including 3,400 in the United States, while the company awaited FDA marketing approval.

He said a program is in place at Merck to "make this product available globally." The company has provided steep discounts for its AIDS drugs overseas, but the high cost of branded antiviral drugs remains a hurdle for international control of the epidemic.

E-mail Sabin Russell at srussell@sfchronicle.com


More info @ AIDSmeds.com:

Live Love Laugh and dance like no ones watching.
Laughter is the best medicine, so try to have a laugh everyday..Even if your not feeling your best, think about something that was funny at one time in your life and work with it..   :o)

Offline aztecan

  • Member
  • Posts: 5,517
  • 32 years positive, 60 years a pain in the butt
Re: Great News
« Reply #1 on: October 15, 2007, 11:48:09 PM »
I've seen a couple of things about this. Sounds exciting doesn't it!


"May your life preach more loudly than your lips."
~ William Ellery Channing (Unitarian Minister)


Terms of Membership for these forums

© 2017 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.