Janssen has unveiled new late-stage data on Symtuza showing positive long-term efficacy and safety in antiretroviral treatment-naïve adults with HIV.
After 96 weeks’ treatment with Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]) 85% of ART-naïve adults with HIV-1 maintained virologic suppression.
Also of note, no darunavir, primary protease inhibitor, or tenofovir resistance-associated mutations emerged in any patient, the firm said, although there was another case of a patient developing a nucleoside reverse transcriptase inhibitor resistance-associated mutation to emtricitabine.
D/C/F/TAF was generally well-tolerated with 3% adverse event (AE)-related discontinuations over the period and 3% of people experiencing a grade 3 or 4 study-drug related AE, compared with 1% in the comparator arm. Bone, renal and lipid safety were consistent with known tenofovir alafenamide and cobicistat profiles, Janssen said.
“The 96-week results from the AMBER study demonstrate that the darunavir-based single-tablet regimen has a good safety profile and efficacy and a high genetic barrier beyond the first year of treatment,” commented Professor Chloe Orkin, Lead for HIV research at Barts Health NHS Trust.
“The regimen adds to the choices for patients who start and receive life-long HIV therapy.”
Symtuza is already approved to treat HIV on both sides of the Atlantic.