News (Updated July 12, 2009)

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Merck HIV drug Isentress gets full US approval

On Thursday July 9, 2009, 6:37 pm EDT

WASHINGTON (AP) -- The Food and Drug Administration said Thursday it has approved expanded use of a Merck & Co. HIV drug, Isentress.

Known chemically as raltegravir, it is now approved for treating new and existing patients with the virus that causes AIDS, in combination with other types of HIV drugs.

The drug got an accelerated approval from FDA in October 2007, limiting it to use in patients who had drug-resistant strains or were failing on other therapies, also in combination with other HIV drugs. Now it can be used in all adult patients.

The recommended dose for new adult patients is 400 milligrams twice daily, with or without food, FDA said. The ruling was made Wednesday but announced late Thursday.

The approval was based on a 48-week study comparing patients who took Isentress with patients who took another HIV drug, Sustiva. Both groups also took two other HIV drugs.

Isentress is an integrase inhibitor, meaning it works by blocking the enzyme integrase, one of three types of enzymes the AIDS virus uses to reproduce and infect cells.

 

Appeals court rules for Abbott in AIDS drug case

Tue Jul 7, 7:27 pm ET

SAN FRANCISCO – A federal appeals court has rejected a lawsuit accusing Abbott Laboratories of antitrust violations over a sudden 400-percent price hike of a popular AIDS drug.

Advocacy groups and drug benefit providers sued Abbott in 2004. They alleged the North Chicago , Ill. , drugmaker raised the price of the HIV-fighting Norvir to stifle competition and boost sales of its own alternative, Kaletra.

The company paid $10 million to settle the lawsuit and agreed to let the 9th U.S. Circuit Court of Appeals still determine if the price hike was an illegal business practice.

The court ruled in Abbott's favor Tuesday. If it had lost, Abbott would have had to pay an additional $17.5 million.

A lawyer for the advocacy groups says they're weighing whether to appeal the decision.

 

Sexual barriers may up HIV risk in black gay men

Mon Jul 6, 2009 1:24pm EDT

By Megan Rauscher

NEW YORK (Reuters Health) - New research hints that the social and sexual networks of black gay men, constrained by the preferences and attitudes of non-black gay men, may explain the risk of more rapid spread of HIV, the virus that causes AIDS, and higher sustained prevalence of HIV infection in black gay men.

While black Americans are disproportionately affected by HIV/AIDS, most studies have found that black gay men don't engage in higher risk sexual activity any more frequently than other gay men, H. Fisher Raymond and Willi McFarland of the San Francisco Department of Public Health point out in a report in the journal AIDS and Behavior.

To study the influence of social and sexual mixing between racial and ethnic groups of gay men in San Francisco , Raymond and McFarland interviewed 1,142 gay men. Fifty-six percent were white, 22% Latino, 14% Asian and 9% black. The men reported on a total of 3,532 sexual partnerships.

They found that black gay men were three times more likely to have sexual partners that were also black, than would be expected by chance alone.

In addition, black gay men were the least preferred of sexual partners by other races and were believed to be riskier to have sex with, which can lead to men of other races avoiding black men as sexual partners.

Black gay men were also counted less often among friends and were perceived as less welcome at the common venues that cater to gay men in San Francisco by other gay men.

These influences, Raymond told Reuters Health, push black gay men closer together in smaller social and sexual networks - "networks that are already at higher risk for HIV infection merely because the background prevalence of HIV is higher than in other groups."

"Social and sexual networks are directly related to how much risk we expose ourselves to (and) it seems clear that these networks are influenced by both forces an individual can control and those that one can't," Raymond said.

"Of our findings, social networks and access to community spaces may be the areas most amenable to action," Raymond said. "Acting on personal preferences in sexual partners may not be, however raising awareness that personal preferences may be shaped by underlying negative racial stereotypes or history isn't without merit," he added.

"The racial disparity in HIV observed for more than a decade," Raymond and McFarland conclude in their report, "will not disappear until the challenges posed by a legacy of racism toward blacks in the U.S. are addressed."

SOURCE: AIDS and Behavior, June 2009.


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