The US Food and Drug Administration (FDA) today approved the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen. The new test will enable HIV testing to expand to regions without traditional healthcare facilities and speed up treatment, according to the agency.
The Alere Determine HIV-1/2 Ag/Ab Combo test, manufactured by Orgenics of Yavne, Israel, can detect HIV antibodies and the HIV-1 p24 antigen in human serum, plasma, and venous or fingerstick whole-blood specimens. The HIV-1 antigen is an earlier tip-off to HIV-1 infection than HIV-1 antibodies by themselves. The new test can tell the difference between acute vs established HIV-1 infections when the blood specimen tests positive for the p24 antigen, but negative for HIV-1 and HIV-2 antibodies.
Most HIV infections worldwide stem from HIV-1. HIV-2 infections occur mostly in West Africa.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research in a news release. “Earlier diagnosis may also help to reduce additional HIV transmission.”
The Alere Determine HIV-1/2 Ag/Ab Combo test is not intended to screen blood donors.
Source: Medscape.com
;<�? n<� 0� http://www.medscape.com/viewarticle/779445″ target=”_blank”>priority review status to dolutegravir. Its approval comes 4 days after the FDA okayed the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen.
The FDA determined that dolutegravir is safe and effective on the basis of 4 clinical trials involving 2539 participants with HIV. Drug regimens for treating HIV that included dolutegravir proved effective in reducing viral loads, according to the agency. The pharmacokinetics, safety, and activity of the drug with regard to children defined in the pediatric indication were established in a fifth clinical trial.
Insomnia and headache were common adverse events observed in the clinical trials. Among the more serious adverse events were hypersensitivity reactions and abnormal liver functions among patients who also were infected with hepatitis B or C, or both. The drug’s label contains instructions on how to monitor patients for such serious adverse events.
Source: Medscape.com
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