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