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Issue No. 8 | April 11, 2014

News and Features

FDA Updates Raltegravir (Isentress) Labeling

“On April 8, 2014 FDA approved updates to the Isentress (raltegravir) label to include information regarding co-adminsitration of raltegravir with boceprevir or telaprevir.

“In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of telaprevir or boceprevir. No dose adjustment is required for Isentress or boceprevir or telaprevir.”

The revised label is available at the FDA website.

More information is available:

FDA Updates Darunavir (Prezista) Labeling

“On April 7, 2014, FDA approved new changes to the Prezista (darunavir) label to update the following sections:

  • “WARNING AND PRECAUTIONS, Severe Skin Reactions,  ADVERSE REACTIONS, Postmarketing Experience, and PATIENT COUNSELING INFORMATION sections of the labeling were updated with information regarding rash with eosinophilia and systemic symptoms.
  • “DRUG INTERACTIONS, Established and Other Potentially Significant Drug Interaction and CLINICAL PHARMACOLOGY, Table 15 subsections of the labeling were updated with information regarding dolutegravir. …
  • “CLINICAL PHARMACOLOGY, Microbiology subsection of labeling was updated to rilipivirine to the list of drugs that did not show antagonism with darunavir. 
  • “Prezista 400 mg tablets were removed from the HOW SUPPLIED/STORAGE AND HANDLING section because this dosage strength is no longer marketed in the US.”

The revised label is available at the FDA website.

More information is available:

Recent HIV/AIDS News from NIAID

  • April 3, 2014: Future HIV Vaccine Research Must Consider Both Protective Immune Responses and Those That Might Increase Susceptibility to Infection

    “Last year, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, held a scientific meeting to examine why certain investigational HIV vaccines may have increased susceptibility to HIV infection. In a new perspectives article appearing in the journal Science, HIV research leaders from NIAID (Anthony S. Fauci, M.D., and Carl W. Dieffenbach, Ph.D.) and its grantees at Emory University (Eric Hunter, Ph.D.) and the University of California, San Francisco (Susan Buchbinder, M.D.), summarize the findings and considerations for future HIV vaccine research.”

  • March 31, 2014: HIV-Infected Men at Increased Risk for Heart Disease, Large Study Finds

    “The buildup of soft plaque in arteries that nourish the heart is more common and extensive in HIV-infected men than HIV-uninfected men, independent of established cardiovascular disease risk factors, according to a new study by National Institutes of Health grantees. The findings suggest that HIV-infected men are at greater risk for a heart attack than their HIV-uninfected peers, the researchers write in Annals of Internal Medicine.”