The label for Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate; Gilead) has been updated to include use in pediatric patients aged ≥12 years weighing ≥35kg. Also, updates to the Warnings and Precautions section and Use in Specific Populations were made.
This expanded pediatric approval was based on Week 48 data from the Study GS-US-236-0112. The new indication now states that Stribild is a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients ≥12 years of age weighing ≥35kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Stribild.
The recommended dosage of Stribild is 1 tablet taken orally once daily with food in adults and pediatric patients ≥12 years of age with a body weight ≥35kg (≥77lbs) and creatinine clearance ≥70mL/min.
The New Onset or Worsening Renal Impairment subsection now includes serum creatinine and serum phosphorous as part of renal function testing before and during administration of Stribild. No data are available to make dose recommendations for pediatric patients with renal impairment.
The Bone Loss and Mineralization Defects subsection now includes information about the effects of tenofovir disoproxil fumarate on bone mineral density in pediatric and adolescent patients. Clinical data showed HIV-1 infected patients aged 2–<18 years showed similar bone effects to those seen in adults, suggesting increased bone turnover. Total body bone mineral density gain was less in the tenofovir disoproxil fumarate-treated HIV-1 patients vs. control groups.
The overall Warnings and Precautions section was modified to emphasize severe acute exacerbations of hepatitis B in co-infected patients. It states that severe acute exacerbations of hepatitis B (eg, liver decompensation and liver failure) have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir disoproxil fumarate. Co-infected patients should be closely monitored with follow-up for at least several months after stopping treatment with Stribild. Anti-hepatitis B therapy may be warranted especially in patients with advanced liver disease or cirrhosis.
Stribild is available as 150mg/150mg/200mg/300mg strength fixed-dose tablets in 30-count bottles.
For more information call (800) 445-3235 or visit Stribild.com.