FDA Warning on Invirase

Call for Early Treatment for HIV Act to be Included in Health Care Reform

Cyndi Lauper, Lady Gaga Put Spotlight on Women and HIV

Global Health Advocates and UN Officials Meet in U.K., Urge World Leaders to Fulfill Promise of Universal Access to HIV Treatment

HIV Found to Hide in Bone Marrow


FDA Warning on Invirase

According to a February report from the U.S. Food and Drug Administration (FDA), the agency is reviewing study data on “a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir). The data suggest that together the two drugs may affect the electrical activity of the heart.”

Invirase, an HIV protease inhibitor drug, must be taken with a booster dose of Norvir to achieve adequate blood levels. The FDA cautions that “Patients should not stop taking their prescribed antiretroviral medications. Patients who are concerned about possible risks associated with using Invirase and Norvir should talk to their healthcare professional.”

The FDA does not yet know the extent of the potential side effect or its clinical implications (in other words, whether it will require medical care). The agency noted that some people may be at increased risk of developing an abnormal heart rhythm.

“The changes to the electrical activity of the heart possibly associated with these drugs, known as prolonged QT or PR intervals, can be seen on an electrocardiogram (EKG),” the report continued. “A prolonged QT interval can increase the risk for abnormal heart rhythms, including a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop; this is known as heart block and can affect how fast the heart is able to beat.”

The report noted that “The FDA's analysis of these data is ongoing. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) anti-arrhythmic drugs; or in patients with a history of QT interval prolongation.”

In addition, medical providers should not prescribe Invirase to patients with cardiomyopathy, ischemic heart disease, pre-existing conduction system disease, or underlying structural heart disease.—Enid Vázquez

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Call for Early Treatment for HIV Act to be Included in Health Care Reform

According to an action alert issued by Housing Works and the Campaign to End AIDS (C2EA), “the Early Treatment for HIV Act (ETHA) is an important step to improving health care for people with HIV—and would address the fact that, in many states, people with HIV can’t access Medicaid because they aren’t sick enough to receive it.” Also, “with the AIDS Drug Assistance Program (ADAP) in crisis, ETHA represents an important bridge to 2014, when the Medicaid expansion in health care reform goes into effect.”

New Yorkers can call the bill’s Senate sponsor, Senator Chuck Schumer (202-224-6542), and tell him to include ETHA in the final health care reform bill. Non-New Yorkers can tell President Barack Obama (202-456-1111) and House Speaker Nancy Pelosi (202-225-4965) to include the bill in health reform legislation.

Pelosi was an original cosponsor of the ETHA legislation, and President Obama is on record supporting ETHA. The bill was included in the original House version of the health care reform legislation, but wasn’t in the Senate bill. They know ETHA is the right thing to do—they just need to hear from those it would affect urging them to make it part of reform legislation.

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Cyndi Lauper, Lady Gaga Put Spotlight on Women and HIV

E.J. Mundell, writing for HealthDay News, reports that Cyndi Lauper and Lady Gaga have teamed up with the MAC AIDS Fund to promote HIV awareness and prevention among women.

"Fighting HIV/AIDS is not a one-woman job," Lauper told HealthDay. "Lady Gaga and I are using our voices as a call to action for women all over the world. I lost a lot of friends to AIDS before we even knew what it was. Today, across the world, women are more likely to become infected with HIV than men. Each one of us needs to do our part to fight for women impacted by HIV and AIDS."

And while Lauper, 56, got involved in the fight against AIDS early in the epidemic, Lady Gaga said she's on board for a new generation.

"Anything I can do to help raise money for HIV/AIDS awareness -- that's what I'm here for, and I'm very honored to be a part of this," the pop star, 23, said in a statement.

There does seem to be a need for better awareness if the results of a new MAC AIDS Fund-sponsored poll of 1,000 American women is any indication. Among the survey's findings:

  • Nearly three-quarters (73 percent) of women surveyed do not know their current HIV status.
  • Most (78 percent) say they've had unprotected sex, and 72 percent of those who had sex without a condom said they did so because they believed they were in an exclusive relationship.
  • Over half (55 percent) of women say they have never had an HIV test, and about four in every 10 women who were tested can't remember when their last test took place.
  • Nearly six in 10 women (58 percent) say they don't get tested because they believe they are in a monogamous relationship.
  • One in every five women said there was nothing that would convince them now to get an HIV test, even if they had already had one in the past.

"The number of women living with HIV in the country has tripled since 1985 and it's the leading cause of death for black women ages 18 to 35," noted Nancy Mahon, executive director of the MAC AIDS Fund, which has earmarked more than $2.5 million to projects aimed at fighting HIV/AIDS.

As part of the campaign, Lauper and Lady Gaga have each lent their names to a shade of VIVA GLAM lipstick, with 100% of the proceeds going to the MAC AIDS Fund.

As Lady Gaga noted, women need only take a few simple steps to shield themselves from HIV. "Use protection, and be selective and strong about those you love," she said. "Your body is sacred, and it's OK to say no. Make your partners get tested, go together: it will only make your relationship stronger and healthier."

Lauper agreed. "Be smart, be careful, protect yourself," she said in a statement. "And look out for your sisters to make sure they are doing the same."

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Global Health Advocates and UN Officials Meet in U.K., Urge World Leaders to Fulfill Promise of Universal Access to HIV Treatment

In a joint press release issued by the International AIDS Society (IAS) and the U.K.'s Stop AIDS Campaign, it was noted that in 2005, at the G8 summit, “Britain led the way in pledging to achieve universal access to HIV prevention, treatment, and care by 2010. Significant progress has been made in some areas, but, as the universal access pledge comes due, only one-third of people in need of HIV treatment worldwide receive it, while more than 10 million more people in urgent need of life-saving treatment wait. Most people living with HIV are still unaware of their status. And fewer than half of pregnant women living with HIV receive the drug regimen that can extend their own lives and save their children from infection.”

"This is a commitment we cannot break and a fight we cannot lose. We are still far from reaching the level of care promised for 2010," said singer and AIDS campaigner Annie Lennox. "It is unacceptable that half of the pregnant women who need drugs to protect their own health and their babies cannot get them; that 10 million people in immediate need of treatment have no access. Governments such as the U.K. that have taken significant action to achieve the universal access pledge must take a strong stand to encourage those that lag behind to keep their promises on AIDS."

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HIV Found to Hide in Bone Marrow

In an article published in the online journal HealthDay on March 8, it was reported that researchers have found that the human immunodeficiency virus (HIV) “lurks in certain bone marrow cells and ‘reawakens’ only under certain circumstances.”

While antiretroviral drugs can now slow down or pause the replication of viral cells, HIV still has the ability avoid being killed off completely by medications. Drugs may prevent the virus from infecting new cells, "but they don't get rid of cells that contain the virus and have potential to make new viral particles," said Dr. Kathleen Collins of the University of Michigan, co-author of the study, said.

This helps explain why there is no cure for HIV. "A patient cannot be cured of HIV until all sources of infection are eliminated," said Jerome A. Zack, director of the UCLA Center for AIDS Research in Los Angeles.

In the new study, published in the March 7 online edition of Nature Medicine, researchers examined bits of HIV and cells from infected people in the laboratory. The investigators found that the virus can infect certain kinds of bone marrow cells that are the “parents” (progenitors) of blood cells, Collins said.

So it seems reasonable to use a medication to kill all those parent cells, thereby perhaps ridding the body of HIV. Unfortunately, though it sounds simple, killing all of those blood-producing marrow cells would be lethal to humans, said Collins. However, "maybe we could find ways of targeting only the latently infected bone marrow cells," she added.

Zack said the study findings are convincing, but "we as yet do not have easy ways to eliminate these dormant sources of virus. The challenge to the field is to find all sources of virus ─ this study identifies one ─ and identify ways to eliminate them. Only by developing strategies to eliminate all the different sources can we purge HIV from the body."

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