Single-pill PI-based combination submitted to EMA

Simon Collins, HIV i-Base

On 12 September 2016, a press statement from Janssen reported that the company have submitted an application to the European Medicine Agency (EMA) for a single pill PI-based combination.

This formulation includes darunavir (800 mg), cobicistat (150mg), emtricitabine (200 mg) and tenofovir alafenamide (10 mg). Tenofovir alafenamide (TAF) is the new version of tenofovir- DF.

The indication is for treatment of adults and adolescents (aged 12 years and older with body weight of at least 40 kg).


The potential benefits of this new formulation will depend on it being priced comparable to a combination with the NRTI component being similar to generic alternatives.


Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency. (12 September 2016).

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