Regulatory Decision Summary for Biktarvy

The safety and efficacy of Biktarvy in geriatric patients are supported by the results from study 4449. In this open-label single arm study, 86 virologically suppressed (HIV-1 RNA less than 50 copies per mL) HIV-1 infected adults aged ≥ 65 years were switched from a stable antiretroviral regimen to Biktarvy. Patients treated with Biktarvy had a mean age of 70 years (range: 65 to 80). Ninety-eight percent (84/86) and 91% (78/86) of patients remained virologically suppressed (HIV-1 RNA < 50 copies/mL) at Week 24 and Week 48, respectively. Two and 8 patients did not have virologic data due to discontinuation or missing data at the Week 24 and Week 48 time points, respectively. The safety profile of Biktarvy in virologically suppressed patients aged ≥ 65 years in study 4449 was similar to adult patients < 65 years of age.

The safety and efficacy of Biktarvy in patients with ESRD (estimated CrCl of less than 15 mL/min) on chronic hemodialysis are supported by the results from study 1825. In this open-label single arm study, 55 virologically suppressed adults with ESRD on chronic hemodialysis were treated with emtricitabine (FTC) and tenofovir alafenamide (TAF), the components of Biktarvy, for 96 weeks. In an extension phase, 10 virologically suppressed patients switched to Biktarvy and all patients remained virologically suppressed (HIV-1 RNA < 50 copies/mL) for 48 weeks. The safety profile of Biktarvy in study 1825 was similar to patients with normal renal function. The pharmacokinetic analysis in study 1825 revealed lower trough concentrations of bictegravir (BIC) in patients with ESRD on chronic hemodialysis compared with those in patients with normal renal function or mild to moderate renal impairment; however, considering that virologic suppression was maintained through Week 48 of the study, lower BIC trough concentrations were not considered clinically relevant. The pharmacokinetic analysis also showed that the exposures of FTC and tenofovir, the active metabolite of TAF, in patients with ESRD on chronic hemodialysis were significantly higher than in patients with normal renal function. However, considering that the safety profile of FTC plus TAF in patients with ESRD on chronic hemodialysis was similar to that in patients with normal renal function, higher FTC and tenofovir exposures were not considered clinically relevant.

Based on the review of above evidence, the benefit-harm balance of Biktarvy in patients ≥ 65 years of age or patients with ESRD on chronic hemodialysis is considered to be positive when used as described in the Biktarvy Product Monograph at this time.