Kaletra Added To FDA Side Effects Watch List For Potential Safety Problems In Newborns – Kaletra (lopinavir/ritonavir) oral solution has been added to a U.S. Food and Drug Administration (FDA) drug safety watch list due to potentially serious side effects in newborns. Kaletra’s inclusion on the watch list indicates that the FDA is concerned about a potential safety issue but does not have definitive evidence that the drug is actually causing harm. The FDA will continue to monitor reported side effects for Kaletra in newborns. The FDA states that the drug’s inclusion on the watch list does not mean that patients should discontinue Kaletra, but they should contact their physicians if they have concerns. Side effects can be reported to the Adverse Event Reporting System. For more information, please see the FDA website.

Struggling Florida ADAP Receives Assistance From Pharmaceutical Companies – The Florida Department of Health announced last week that it will receive temporary assistance from pharmaceutical companies to keep its struggling AIDS Drug Assistance Program (ADAP) running. ADAPs provide HIV drugs to low-income people with HIV and AIDS. The companies will provide free HIV drugs to 6,500 people in Florida’s ADAP through April, when the program will receive additional federal funding. The assistance will be provided through Welvista, a non-profit organization that helps the uninsured. Florida announced last month that unless it received financial assistance it would stop providing HIV drugs this month to members of its ADAP (see related AIDS Beacon news). For more information, please see the Sun Sentinel.

Theratechnologies Announces Licensing Agreement For Egrifta In Europe And Asia – Theratechnologies announced last week that it has reached a licensing agreement with Spanish pharmaceutical company Ferrer Internacional S.A. to market Egrifta (tesamorelin) in Europe, Russia, South Korea, Taiwan, and some central Asian countries. Egrifta is the first drug to treat lipodystrophy, abnormal fat distribution that is a side effect of certain anti-HIV medications. Under the agreement, Ferrer will be responsible for marketing and regulatory approval; Theratechnologies will manufacture Egrifta and is responsible for any additional research and development. Theratechnologies and Ferrer have not yet specified when Egrifta might be available in these countries. For more information, please see the Theratechnologies press release.

In commemoration, Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, has released a statement addressing the importance of the day. He also details what has already been accomplished, and what obstacles still remain in the fight against HIV/AIDS.

National Black HIV/AIDS Awareness Day was founded in 2001 in collaboration between several national organizations to spur African American communities nationwide to take control of the disease.

National Black HIV/AIDS Awareness Day has four main goals. The first is to educate African Americans on HIV/AIDS, particularly within their community, where it directly affects them. Second, this day hopes to motivate African Americans to get tested on an annual or bi-annual basis. Ideally, the day itself can serve as an appointment date to get tested for HIV.

The last two components of this day lie in involvement and treatment. This day of awareness promotes the participation of the national African American population in HIV/AIDS efforts and programs throughout the country. In terms of treatment, the day also serves as a time to connect care and treatment options and facilities to those who need them.

The existence of National Black HIV/AIDS Awareness Day came about as a result of the immense toll taken on the national African American population by HIV/AIDS each year.

According to Fauci, “While black men and women made up 13 percent of the U.S. population in 2007, they accounted for more than half of all new HIV/AIDS diagnoses that year and nearly half of all Americans living with HIV/AIDS”.

The significance of the problem is only augmented by the fact that in 2006, HIV was the third most common cause of death among African American women aged 35-44.

Though in the media, Africa is hailed as the HIV/AIDS hotspot of the world, it is reported that 6.5 percent of black men living in Washington D.C. are HIV-positive. This statistic is higher than that of many African nations.

In his statement, Fauci uses these statistics to inspire the nation to band together to help the African American HIV/AIDS cause.

First and foremost, the country must work together to eliminate the stigmas currently associated with the disease and at-risk populations that are preventing people from seeking and accessing help. These stigmas include those surrounding homosexuality and injection drug use, as well as those regarding the HIV-positive condition.

Says Fauci, “Fostering acceptance…will help create a positive climate for HIV prevention and treatment services in black communities.”

Beyond this, the NIAID would like to dramatically increase the numbers of infected persons seeking treatment. At the current rate, the virus is being passed on more than it ought to be, given the level of medicine available in the United States. Those who test positive should seek treatment even before the onset of symptoms, and should be motivated to do so, if not in their personal interest, then in that of their partner’s.

There are many ongoing research projects to help the HIV/AIDS cause, including several major NIAID/HIV efforts. However, it ultimately will come down to a national cooperative effort.

“Through partnerships among the African-American, scientific and public health communities,” says Fauci, “We can expand the access of black men and women to HIV prevention, treatment and care, with the goal of ending the terrible scourge of HIV/AIDS.”

For assistance in creating a National Black HIV/AIDS Awareness Day event, to find an event near you, or to become a sponsor, information can be found at the day’s official Web site. Here you can also order the official t-shirt to support the day and all the planning that surrounds it.

Please consider scheduling your next test appointment on National Black HIV/AIDS Awareness Day.

Additional information on National Black HIV/AIDS Awareness Day can be found via Fauci’s NIAID statement.