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Home Industry News Janssen reports positive clinical data for new HIV regimen

Janssen reports positive clinical data for new HIV regimen

31st October 2017

Janssen has announced the findings of a new clinical study that demonstrates the potential benefits of a new HIV regimen.

Data from the phase III AMBER study has shown that an investigational single-tablet regimen, containing darunavir, cobicistat, emtricitabine and tenofovir alafenamide, achieved its primary endpoint in terms of virologic response rates.

The new regimen was able to demonstrate non-inferiority to darunavir/cobicistat plus emtricitabine and tenofovir disoproxil fumarate in previously untreated HIV-1-positive adults, while the safety performance of this treatment approach was also encouraging.

It is hoped that the findings of this study can be used to support US regulatory approval of this regimen.

Dr Rick Nettles, vice-president of medical affairs at Janssen's infectious diseases unit, said the results show how the therapy "could provide a complete and simplified regimen for treatment-naive patients who may struggle with adherence, and in turn face the risk of developing drug resistance".

The treatment was approved in Europe in September 2017 and is being marketed under the brand name Symtuza.

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