The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide; Janssen) for the treatment of HIV-1 infection in pediatric patients weighing at least 40kg who are treatment-naive or virologically suppressed (<50 copies/mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. Previously, Symtuza was only indicated for the treatment of HIV-1 in adults.
Symtuza is a 4-drug combination of darunavir, an HIV-1 protease inhibitor; cobicistat, a CYP3A inhibitor; and emtricitabine and tenofovir alafenamide, both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs). The approval was based on data from 2 multicenter, open-label, phase 2/3 trials (GS-US-216-0128 and GS-US-292-0106) that evaluated the safety and antiviral activity of the components of Symtuza in pediatric patients with HIV-1 aged 12 to less than 18 years.
The GS-US-216-0128 trial assessed darunavir 800mg and cobicistat 150mg once daily with 2 NRTIs in 7 virologically suppressed patients aged 12 to less than 18 years and weighing ≥40kg. Results at week 48 showed that 86% of patients maintained HIV-1 RNA <50 copies/mL, and the median change in CD4+ cell count from baseline was -342 cells/mm3 (range -1389 to 210 cells/mm3).
Moreover, the GS-US-292-0106 trial evaluated cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg, as part of a fixed-dose combination regimen together with elvitegravir 150mg, in 50 treatment-naïve pediatric patients with HIV-1 aged 12 to less than 18 years and weighing ≥35 kg. At week 48, findings showed that 92% of patients maintained HIV-1 RNA <50 copies/mL, and the median increase in CD4+ cell count from baseline was 220 cells/mm3.
With regard to safety, there were no new concerns observed in pediatric patients compared with adults. The most common adverse reactions related to therapy include diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, and flatulence.
The product is available as 800mg/150mg/200mg/10mg strength tablets in 30-count bottles. For patients who are unable to swallow the whole tablet, Symtuza may be split into 2 pieces using a tablet-cutter, and the entire dose should be consumed immediately after splitting.
For more information visit symtuza.com.