Janssen’s SYMTUZA shows ‘positive outcome’ in AMBER study

Janssen’s (JNJ) new once-daily, single tablet combination therapy SYMTUZA alafenamide has shown to be both highly effective and well-tolerated in treating antiretroviral-naive HIV-1 patients through 48 weeks in the pivotal phase 3 AMBER study.1

The results of this study will be presented on 27 October 2017 at the 16th European AIDS Conference in Milan, Italy.

Findings from the study demonstrated that the single tablet regimen D/C/F/TAF provided effective and durable viral suppression, meaning most patients achieved an undetectable viral load, whilst offering the high genetic barrier to resistance of darunavir, for ART-naive HIV-1-infected patients. AMBER is a Phase 3 randomised double-blind non-inferiority international study designed to assess the efficacy and safety of D/C/F/TAF versus the control in HIV-1 positive treatment-naive adult patients over 48 weeks.

The control comprised two separate medications – a tablet of darunavir/ cobicistat plus a tablet of emtricitabine/ tenofovir disoproxil fumarate.

The primary endpoint was non-inferiority of the STR versus the control regarding the proportion of patients with a viral load of less than 50 copies per mL at 48 weeks. Reducing their viral load to an undetectable level is a key treatment goal for HIV patients, enabling their immune system to strengthen and leading to improved quality of life.

The single tablet D/C/F/TAF demonstrated durable non-inferiority versus the control group over 48 weeks and also produced low virologic failure rates.

The high efficacy results were consistent across different subgroups of patients. No treatment-emergent mutations related to darunavir, primary protease inhibitors or tenofovir were observed.

The STR showed improved bone and renal safety laboratory parameters, along with similar safety versus control through 48 weeks, in terms of rates of discontinuations due to adverse events , of Grade 3-4 AEs and of serious AEs.

D/C/F/TAF also demonstrated a similar total cholesterol/HDL cholesterol ratio, with limited lipid changes. D/C/F/TAF safety and efficacy were also demonstrated in the open label Phase 3 48-week EMERALD study, a switch trial amongst virologically suppressed ART experienced patients.

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