Janssen’s darunavir-based single tablet regimen (STR) Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) showed a positive outcome in the treatment of HIV patients, putting the treatment on the right track for US approval.
The drug – which was approved for use in the EU earlier this year – treats antiretroviral-naive HIV-1 patients, but it only has an investigational drug status in the US to date.
That could change soon however, as the results from AMBER, a phase III randomised, double blind study, demonstrated that the STR provided ‘effective’ and ‘durable’ viral suppression.
Chloe Orkin, chair of the British HIV Association, said: “The AMBER study results show that the boosted darunavir-based STR was a highly effective regimen with favourable kidney and bone safety laboratory parameters compared to F/TDF (emtricitabine/tenofovir disproxil fumarate).
“It was very well-tolerated, and doses in a single daily tablet.”
The study – set out over 48 weeks – was designed to assess the efficacy and safety of Symtuza versus a control group on two separate medications – darunavir/cobicistat (D/C) and F/TDF – in HIV-1 positive treatment-naïve adult patients.
Findings showed durable non-inferiority verses the control group (91.4% versus 88.4%) and also produced low virologic failure rates (4.4% versus 3.3%).
According to Janssen, the STR – which comes with the high genetic barrier to viral resistance – was developed to provide HIV patients with a convenient once-daily single tablet that provides highly effective viral suppression.
Brian Woodfall, global head of late development, infectious diseases and vaccines, said: “Janssen’s mission in HIV is the delivery of transformational innovations to meet the diverse needs of the HIV community and to offer simple yet effective solutions to reduce the burden on those affected by this disease.”