HIV Treatment Bulletin

US Stribild label updated: new indication to include patients age 12 and older

FDA Update

On 31 January 2017, the US label for the fixed dose combination Stribild was expanded to include paediatric patients aged 12 years and older who weigh at least 35 kg. [1]

Recommendations were based on 48-week results from Study GS-US-236-0112 showing that exposures (AUC) of elvitegravir and tenofovir in 14 paediatric subjects aged 12 to less than 18 years were increased by 30% and 37%, respectively, compared with exposures achieved in adults.

These differences were deemed acceptable based on the overall safety profile of these drugs and exposure-safety assessments. The other components of Stribild had similar exposures in adolescents compared with adults.

Other changes in the product label included:

  • The section on new onset or worsening renal impairment was updated to include serum creatinine and serum phosphorus as part of renal function testing prior to and during administration of Stribild.
  • The section on bone loss and mineralisation defects was updated with information about the effects of tenofovir DF on bone mineral density in paediatric and adolescent patients.
  • The warnings and precautions section was also revised to emphasise severe acute exacerbations of Hepatitis B in patients with HIV/HBV coinfection.

For full details please see the full US prescribing information.

Stribild is a fixed dose combination that contains elvitegravir, cobicistat, emtrictiabine and tenofovir disoproxil fumarate, manufactured by Gilead Sciences.

Reference:

Gilead Sciences. Drug label information of Stribild. (January 2017)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74ae2a93-b267-444c-8f0f-a2a6522260ee