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Issue No. 35 | August 28, 2009

News and Features

MMWR Publishes Early Release of the Updated Guidelines for the Prevention and Treatment of Opportunistic Infection in HIV-Exposed and HIV-Infected Children

“New guidelines to assist health care workers in preventing and treating the secondary infections that can afflict U.S. children exposed to, or infected with, HIV, were published by the National Institutes of Health and the Centers for Disease Control and Prevention....

“Major changes in the pediatric guidelines include:

  • Emphasis on the importance of effective antiretroviral therapy to improve children’s immune function.…
  • Information on diagnosing and managing immune reconstitution inflammatory syndrome….
  • Information on the management of antiretroviral therapy in children with opportunistic infections, including potential drug-drug interactions.
  • New guidance on use of antibiotic drugs to prevent Pneumocystis jirovecii pneumonia in infants....
  • Updated immunization recommendations for HIV-exposed and -infected children, including hepatitis A, human papillomavirus, meningococcal, and rotavirus vaccines.
  • A new section outlining treatments for malaria, which may become an opportunistic infection in HIV-infected immigrant children or HIV-infected children who travel to countries with malaria.
  • New recommendations on when to discontinue medication for preventing opportunistic infections.…"

For more information on changes in the pediatric guidelines:

FDA and Tibotec Issue Updated Safety Warning for Etravirine

“Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, issued a Dear Healthcare Professional letter to relay important, updated prescribing information for Intelence (etravirine) which reflects an important safety update regarding severe skin and hypersensitivity reactions….

“Specifically, the existing Warning and Precaution regarding Severe Skin Reactions has been strengthened to reflect that there have been postmarketing reports of:

  • fatality due to toxic epidermal necrolysis
  • hypersensitivity reactions, sometimes accompanied by hepatic failure

"Additionally, Guidance has been added that INTELENCE should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop….

“Should you have any questions, require further information on product safety, or wish to report adverse patient experiences, please contact Tibotec Therapeutics Medical Information at 1-877-REACH TT (1-877-732-2488).

"Alternatively, adverse events may be reported to FDA’s MedWatch reporting system:

  • By phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178),
  • Online ( or
  • Mailed, using the MedWatch FDA 3500 postage paid form, to the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787"

For more information on the updated safety warning and facts on etravirine:

HVTN 505 HIV Vaccine Trial Begins Recruiting Participants

“The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has opened enrollment in HVTN 505, an exploratory HIV vaccine clinical study examining whether a two-part vaccine regimen can decrease viral load (the amount of HIV in the blood) in study participants who later become infected with HIV. Viral load is an important health indicator in people who are infected with HIV because typically those with less virus remain healthier longer. Further, HIV-infected individuals with reduced levels of virus may be less likely to transmit the virus to other people.

"Neither of the two vaccines contains HIV and neither vaccine can infect study participants with the virus. Both vaccines have been found safe when tested in animals and when used in hundreds of people in earlier clinical trials."

For more information on the HVTN 505 HIV vaccine study:

CDC Continues to Provide Guidance about H1N1 Flu in HIV-Infected Adults

“CDC, in coordination with state and local health departments and with WHO, is working aggressively to understand the epidemiology of this novel H1N1 flu and determine if it affects HIV-infected people and people with other immunocompromising conditions differently. As additional information about the situation become available, the CDC’s recommendations may change.  Please check the CDC H1N1 Flu website frequently.”

More information is available from the CDC: