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Gilead’s Biktarvy Receives EC’s Marketing Authorization for the Treatment of HIV in Pediatric Patients

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Gilead’s Biktarvy Receives EC’s Marketing Authorization for the Treatment of HIV in Pediatric Patients

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  • The EC has authorized the new low-dose of Biktarvy (bictegravir 30mg/ emtricitabine 120mg/ tenofovir alafenamide 15mg) for HIV inf. in virologically suppressed children aged 2yrs. The authorization was based on the open-label study of Biktarvy
  • The therapy was found to be effective & well-tolerated @24wks. In (Study 1474), treatment outcomes were evaluated in adolescents aged b/w 12-≤18yrs. (cohort 1), children b/w 6-≤12yrs. (cohort 2) & children aged 2yrs. (cohort 3)
  • 98% in cohorts 1 & 2 remained suppressed @48wks. after switching to Biktarvy, a similar result was observed in cohort 3 & 91% remained virologically suppressed @24wks. with no new adverse reactions in pediatric patients aged ≥2yrs. The EC’s marketing authorization will be valid in all 27 member states of the EU, Norway, Iceland & Liechtenstein

Ref: Gilead | Image: Gilead

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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