On October 27, results from the AMBER study for Janssen’s antiretroviral therapy (ART) single tablet regimen (SRT), Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]) was presented at the European AIDS Clinical Society (EACS) 16th European AIDS Conference in Milan, Italy.
The data, which compare the safety and efficacy of Symtuza versus a regimen of Prezcobix (darunavir/cobicistat) and Truvada (emtricitabine/tenofovir disoproxil fumarate [F/TDF]), demonstrated that Symtuza met its primary endpoint of non-inferiority with respect to efficacy, while resulting in less impairment in renal function and bone mineral density. If approved, Symtuza would be the first protease inhibitor (PI)-based STR, giving it a competitive advantage in patients who require a PI as part of their ART regimen.
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Although there is currently no cure for HIV, modern ART regimens are now efficacious enough to suppress the virus to the point where patients are able to lead a relatively normal life. In fact, the most recent clinical trial guidelines from the FDA recommend that the efficacy of new drugs should be determined by their ability to reduce the HIV viral load to the point of undetectability by diagnostic techniques, considered to be equivalent to <50 copies of viral RNA per millilitre of blood. Due to concerns over the development of resistance, normal practice is to administer a triple-cocktail of drugs to a patient, with many options now available as STRs for patient convenience.
Although the efficacy of modern drugs is very high, there remains room for improvement with respect to drug safety profiles, due to the need for patients to remain on ARTs for the remainder of their life. For example, drugs such as the widely used nucleotide reverse transcriptase inhibitor (NRTI), Viread (tenofivir [TDF]), are associated with renal and bone toxicity. Janssen’s Symtuza has been designed to include drugs associated with strong safety profiles. With the inclusion of darunavir and cobicistat, it is also the first STR to include a boosted PI.
The AMBER trial was designed to enroll 725 treatment-naïve patients with HIV, who were randomized into two arms. Patients in the study arm received Symtuza once-daily, while patients in the comparator arm received Prezcobix plus Truvada once-daily. The primary endpoint was defined as non-inferiority with respect to efficacy at 48 weeks, with safety included as a secondary endpoint. Symtuza was found to be non-inferior at 48 weeks, with an efficacy of 91.4% defined as the proportion of patients with undetectable levels of HIV RNA. In comparison, the Prezcobix with Truvada regimen was found to have an efficacy of 88.4% under the same criteria.
The safety results for Symtuza were also comparable with respect to the number of reported adverse events (AEs). In the study arm, 86.2% of patients reported AEs, and 5.2% reported serious AEs, compared to 84.6% and 6.1% respectively in the comparator arm. Symtuza was also shown to have less effect on renal function and bone mineral density than the comparator, with statistical significance observed in all counts measured.
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By GlobalDataJanssen have also reported positive safety and efficacy results from EMERALD, a second Phase III trial for Symtuza in July 2017, which supported their application to market the drug in Europe and was approved by the EMA in September 2017. The FDA is currently considering Symtuza for approval in the US, having received a new drug application (NDA) from Janssen in September 2017. These positive data announced from the AMBER trial will support data from the EMERALD trial, making it very likely that Janssen’s NDA will be successful and that the FDA will approve Symtuza in 2018.
