Lack of evidence to support use of darunavir-based treatments for SARS-CoV-2

There has been increasing discussion recently among the medical / scientific community regarding the consideration of HIV protease inhibitors as therapeutic options for COVID-19 and we wanted to take the opportunity to address this directly.

At Janssen, patients are our priority and given the large public health and humanitarian implications of COVID-19, we are committed to global efforts to care for those affected, contain the current outbreak and develop measures to tackle future outbreaks.

We support broad access to information, and we strongly believe that the development of evidence-based intervention guidelines for COVID-19 is critical. That said, our view is that the consideration of HIV protease inhibitors, like darunavir, as therapeutic options for COVID-19 is based on limited, unpublished virologic and clinical data in the treatment of patients infected with severe acute respiratory syndrome (SARS-CoV-2) which is the cause of COVID-19.

Our first commitment is to the HIV patients who rely on darunavir, a protease inhibitor marketed by Janssen. It is currently only approved for use with a “boosting” agent, and in combination use with other antiretrovirals, for the treatment of HIV-1. Of note, darunavir should not be administered without a boosting agent (ritonavir or cobicistat) as previous studies of unboosted darunavir resulted in subtherapeutic drug levels and was associated with a higher rate of adverse events.

  • Janssen has no clinical or pharmacological evidence to support the inclusion of darunavir/cobicistat in treatment guidelines for COVID-19, nor is there published data on the safety and efficacy profile of darunavir/cobicistat in treatment of COVID-19.
  • There are no published clinical studies that have evaluated the efficacy and safety of darunavir, darunavir/cobicistat or darunavir/cobicistat/emtricitabine/tenofovir alafenamide for the treatment of novel coronavirus.
  • In addition, there are no published in-vitro studies with darunavir and coronavirus. Based on preliminary, unpublished results from a previously reported in-vitro experiment, it is not likely darunavir will have significant activity against SARS-CoV-2 when administered at the approved safe and efficacious dose for the treatment of HIV-1 infection.*
  • Additionally, structural analyses show very few interactions of darunavir with the active site of the SARS-CoV-2 protease.*

We remain open to collaborating with governments, healthcare professionals and others to ensure rigorous collection and transparency of data that will allow evidence generation to guide the use of effective medicines and support the best outcomes for patients affected by COVID-19.

Several Janssen compounds, including darunavir, are in the process of being evaluated in-vitro for potential antiviral activity against SARS-CoV-2. As soon as this data becomes available, we will provide an update.

There is no higher priority than patient health for Johnson & Johnson. Since January, we have been deeply engaged in a multipronged response to the SARS-CoV-2 outbreak.

Janssen is leading collaborative efforts to screen compounds in discovery and development within our organisation and across the broader pharmaceutical industry to accelerate the development of therapies. We have also initiated a high priority project to develop a SARS-CoV-2 vaccine candidate leveraging our AdVac and PER.C6 technologies.

For questions regarding darunavir or other protease inhibitors, please contact our Medical Information Team on 01494 567 444 or by e-mail at: [email protected].

If your enquiry is related to an adverse event associated with a Janssen product, please contact our Drug Safety Department on 01494 567447 or by e-mail at: [email protected].

The Janssen UK team

*Janssen Medical Information Factsheet

Date of preparation: March 2020
Item Code: CP-145102