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Issue No. 22  | August 16, 2013
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FDA Approves Dolutegravir, a New Drug to Treat HIV-1 Infection

“The U.S. Food and Drug Administration today [August 12, 2013] approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
 
“Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.
 
“Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. …
 
“Tivicay’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads.
 
“A fifth trial established the pharmacokinetics, safety and activity of Tivicay as part of treatment regimens for HIV-infected children ages 12 years and older weighing at least 40 kg who have not previously taken integrase strand transfer inhibitors.”

 

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U.S. Public Health Service Updates Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis

The U.S. Public Health Service (USPHS) recently updated recommendations for the management of health care personnel who experience occupational exposures to blood and/or other body fluids that might contain HIV and recommendations for HIV postexposure prophylaxis (PEP). For a summary of the recommendations, read the PubMed abstract. A link to the entire guideline is available below the abstract.


NIH-Funded Study Suggests Current Antiretroviral Drug Regimens May Protect Against Puberty Delays in HIV-Infected Children

“For children who have been HIV-infected since birth, current anti-HIV drug regimens may protect against the delays in puberty that had been seen in HIV-infected children taking older regimens, according to researchers funded by the National Institutes of Health.

“HIV appears to delay puberty. Among children born before 1990, more than 10 percent of HIV-positive girls and boys had not entered puberty by 12 and 13 years of age, respectively. However, a study published in the journal AIDS has found that puberty was delayed for less than 1 percent of children born since 1997, when more effective anti-HIV drug therapies became widely available. Combination antiretroviral treatments — three or more drugs from two or more different anti-HIV drug classes — are now the standard therapy.

“Presumably, improved health resulting from the more effective therapy allows the children to enter puberty on a more age appropriate timetable, said study author Rohan Hazra, M.D., of the Maternal and Pediatric Infectious Disease Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

“Based on information collected over 12 years from more than 2,000 HIV-infected boys and girls, the researchers found that for each year of combination antiretroviral treatment a child received, puberty started about a month earlier when compared to children with HIV who took other drug therapies or no drugs at all. …

“The researchers also confirmed that the youth with the most severe symptoms of HIV infection tended to have the greatest delays in puberty.”

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ISSN 1558-3228