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

Apr 08, 2020
United States

Anecdotal, unsubstantiated reports claim that darunavir has antiviral effect against COVID-19

Johnson & Johnson has no evidence that darunavir has any effect against SARS-CoV-2, the virus that causes COVID-19

Johnson & Johnson is screening its antiviral compounds, including darunavir, to determine potential in vitro effect against SARS-CoV-2

We are partnering with multiple organizations to support the development of research programs and fast-track solutions for COVID-19

 

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

Considering the large public health and humanitarian implications, 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. HIV protease inhibitors are being considered as therapeutic options for COVID-19. We believe this use is based on limited, unpublished virologic and clinical data in the treatment of patients infected with severe acute respiratory syndrome (SARS) coronavirus.

Our first commitment is to the HIV patients who rely on darunavir. Darunavir (DRV) is 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, DRV should not be administered without a boosting agent (ritonavir or cobicistat) as previous studies of unboosted DRV resulted in subtherapeutic drug levels and was associated with a higher rate of adverse events.

  • Janssen has no clinical nor pharmacological evidence to support the inclusion of DRV/cobicistat in treatment guidelines for COVID-19, nor are there published data on the safety and efficacy profile of DRV/cobicistat in treatment of COVID-19.

     
  • There are no published clinical studies that have evaluated the efficacy and safety of DRV, DRV/cobicistat or DRV/cobicistat/emtricitabine/tenofovir alafenamide for the treatment of novel coronavirus.

     
  • Results from a single center, open label, randomized, and controlled trial conducted at Shanghai Public Health Clinical Center (SPHCC) of darunavir and cobicistat (DRV/c) in treating laboratory-confirmed 30 COVID-19 patients showed that DRV/c was not effective.

     
  • Many Janssen compounds, including darunavir, are in the process of being evaluated in-vitro for potential antiviral activity against SARS-CoV-2. The in-vitro antiviral activity of DRV against SARS-CoV-2 was assessed. DRV showed no activity against SARS-CoV-2 at clinically relevant concentrations (EC50 >100 μM). These data do not support the use of DRV for treatment of COVID-19.

     
  • Additionally, structural analyses show very few interactions of DRV 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 transparent 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.

Janssen has also provided DVR-based medicines to support three clinical studies in China. We have received unpublished results from one clinical study (listed above). These results show that five days of darunavir and cobicistat was not effective in treating COVID-19. As soon as this data is published and further preclinical and / or clinical data become available, we will update this information.

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 organization 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.

We are partnering with multiple organizations to support the development of collaborative research programs and fast-track the development solutions for COVID-19.

*Janssen Medical Information Factsheet

Cautions Concerning Forward-Looking Statements

This letter contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding darunavir/cobicistat and development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.