FDA approves Rukobia (Fostemsavir) for multidrug resistant H
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U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults patients with multidrug-resistant HIV infection.

• The safety and efficacy of Rukobia, were evaluated in a clinical trial of heavily treatment-experienced adult participants who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs.

• Participants received either Rukobia or a placebo twice daily for eight days, in addition to their failing antiretroviral regimen.

• After 24 weeks of Rukobia plus other antiretroviral drugs, 53 per cent of participants achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable. After 96 weeks, 60 per cent of participants continued to have HIV RNA suppression.

• The most common adverse reaction to Rukobia was nausea. Severe adverse reactions included elevations in liver enzymes among participants also infected with hepatitis B or C virus and changes in the immune system.

• The FDA granted approval of Rukobia to ViiV Healthcare.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-limited-treatment-options
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Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
Interesting read !
Jul 5, 2020Like1