New Phase 3 AMBER study data continues to demonstrate high rates of virologic suppression at 96 weeks in ART-naïve adults with HIV-1 when treated with D/C/F/TAF.
The Janssen Pharmaceutical Companies of Johnson & Johnson today unveiled 96-week results from the pivotal Phase 3 AMBER study of SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF)) at HIV Glasgow in Scotland. D/C/F/TAF is a once-daily darunavir-based single-tablet regimen (STR), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. Genotypic testing should guide the use of D/C/F/TAF.
Results from the AMBER study demonstrated that a high proportion of antiretroviral treatment (ART)-naïve adults with HIV-1 (85%, 308/362) maintained virologic suppression (viral load <50c/mL; FDA-snapshot) at 96 weeks when treated with D/C/F/TAF. No darunavir, primary protease inhibitor, or tenofovir resistance-associated mutations emerged in any patient. As previously reported, only one patient receiving D/C/F/TAF developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation (M184V) through week 48. In the current analysis through 96 weeks, only one additional patient receiving D/C/F/TAF developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation to emtricitabine (M184V).
These 96-week data, which follow on from the earlier 48-week results, reinforce the long-term efficacy, high genetic barrier and safety of D/C/F/TAF as a treatment for ART-naïve adults with HIV-1.1 The control arm of the study consisted of 512 patient years exposure to darunavir (D)+ cobicistat (C)+ emtricitabine (F)/ tenofovir disoproxil fumarate (TDF) and 109 patient years exposure to D/C/F/TAF.
“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. The regimen adds to the choices for patients who start and receive life-long HIV therapy,” said Professor Chloe Orkin, Lead for HIV research at Barts Health NHS Trust.
D/C/F/TAF was generally well-tolerated with 3% (10/362) adverse event (AE)-related discontinuations over 96 weeks and 3% (11/362) of people experiencing a grade 3 or 4 study-drug related AE, compared with 1% (3/295) in the comparator arm. Bone, renal and lipid safety were consistent with known tenofovir alafenamide and cobicistat profiles. Efficacy and safety results were consistent with the 48-week results in the D/C/F/TAF group.
“These results mark another important milestone in ensuring that individualised treatment options are available to those living with HIV-1,” said Kimberley Brown, PharmD, AAHIVE, Study Responsible Scientist, Janssen Research & Development, LLC. “At Janssen, we are building on our 25-year heritage in HIV and remain committed to ongoing research and development of innovative solutions with the aim to make HIV history.”
On September 26, 2017, D/C/F/TAF was approved for the treatment of HIV-1 infection by the European Commission, based on results from a bioequivalence study that compared D/C/F/TAF with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. US FDA approval was granted on July 17, 2018 based on the results from the two pivotal Phase 3 studies, EMERALD and AMBER.
96-week results from the Phase 3 EMERALD trial in treatment-experienced virologically suppressed adults with HIV-1 were recently presented at IDWeek 2018, in San Francisco, CA.
D/C/F/TAF does not cure or prevent HIV-1 or AIDS.