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Issue No. 5 | February 5, 2010

News and Features

Join AIDSinfo in Observing National Black HIV/AIDS Awareness Day

February 7 is National Black HIV/AIDS Awareness Day (NBHAAD), a day on which we remember the impact of HIV on the African-American community and renew our resolve to fight this epidemic.   

HIV/AIDS disproportionately impacts blacks in the United States. According to the latest surveillance data from the Centers for Disease Control and Prevention (CDC), blacks represent only 13% of the U.S. population but accounted for 51% of the people diagnosed with HIV/AIDS in 2007. That year, rates of diagnosed cases of AIDS, the most advanced stage of HIV infection, were also higher in blacks than among any other race/ethnicity in the United States.

The theme of the 2010 NBHAAD is “HIV/AIDS Prevention – A Choice and a Lifestyle!” On this day, black communities and organizations across the country will be hosting programs to combat HIV/AIDS. AIDSinfo is proud to take part in this day by presenting a specialty page with information and resources for those interested in learning about and getting involved in NBHAAD.

More information is available:

Darunavir Product Label Updated to Add 96-Week Study Results

“On January 27, 2010, FDA approved revisions to the Prezista (darunavir) product labeling to include the 96 week data from two trials; one trial in treatment-experienced patients (TMC114-C214) and one trial in treatment-naïve patients (TMC114-C211).”

The complete revised labeling will be available at the FDA Web site.

More information is available:

Rare, But Serious Liver Complication Seen in People Taking Didanosine

“The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection. Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx.

“Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged esophageal veins (varices) in the gastrointestinal system. Because esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins, esophageal varices can break open. This can result in serious bleeding and, in some cases, death.

“FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.”

The complete revised labeling will be available at the FDA Web site.

More information is available:

Kaletra (Lopinavir/Ritonavir) Product Label Updated to Revise Drug-Drug Interactions

“On January 29, 2009, FDA approved revisions to the Kaletra (lopinavir/ritonavir) package insert to include drug-drug interaction information for concurrent Kaletra administration with inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio).

“Specifically, sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension is listed under Contraindications … because a safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erections and syncope. …

“Concurrent administration of salmeterol and Kaletra is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.”

The complete revised labeling will be available at the FDA Web site.

More information is available: