Tenofovir disoproxil fumarate (TDF) is a preferred NRTI among recommended regimens for treatment-naive HIV-infected adults and adolescents, but is associated with nephrotoxicity and reduced bone mineral density. Lifelong antiretroviral treatment and the increasing comorbidities being recognized and treated in HIV-infected patients creates an urgent need to improve the safety profile of regimens that most effectively suppress HIV replication.
Genvoya (E/C/F/TAF) was approved in adults and pediatric patients 12 years of age and older in the US and EU in 2016 and approved in 2017 for use in pediatric patients 6 to < 12 year of age weighing ≥ 25 kg. HIV-infected children ages ≥ 2 years of age will benefit from the availability of an age-appropriate formulation containing TAF, which has the potential for an improved renal and bone safety profile relative to TDF, an important consideration for a population in which peak bone mass has not yet been achieved and for whom HIV treatment is anticipated to be life-long.
The objective of this study was to characterize the pharmacokinetics (PK), and confirm the dose of E/C/F/TAF and to evaluate the safety, tolerability and antiviral activity of E/C/F/TAF as an STR in treatment-naive HIV-1 infected adolescents 12 to less than 18 years of age and in virologically suppressed HIV-1 infected children 2 to < 12 years of age.
Expected impact: Provide data on plasma exposures in the pediatric population that are comparable to those associated with safety (less effect on bone mineral density and renal function), and efficacy in adults.
