J&J Says HIV Drug Darunavir Hasn’t Been Proven to be Effective for COVID-19 Treatment

As the COVID-19 epidemic continues, researchers and biopharma companies are evaluating the effectiveness of approved and experimental drugs to treat the disease caused by the novel coronavirus. For example, Gilead Sciences is running clinical trials in the U.S. and China on its investigational antiviral drug remdesivir, which was originally under development for SARS.

Johnson & Johnson announced today that, although there have been anecdotal and unsubstantiated reports that its darunavir marketed by its company Janssen as Prezista is being used in treatment, there is no evidence it has any effect against SARS-CoV-2, the virus responsible for COVID-19.

Darunavir is a protease inhibitor used to treat HIV, usually with a boosting agent or other antiviral drugs. The company says the drug is only approved for use with a boosting agent, such as ritonavir or cobicistat.

The company isn’t out-and-out saying the drug or any combination drugs with darunavir as a formula might not be effective, but they are saying it’s not based on testing at this time. The company had donated three darunavir compounds to be used in Chinese clinical trials and will continue evaluating the drug and other compounds in the laboratory as potential therapies for COVID-19.

J&J wrote, “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.”

They also added that there are no published in-vitro studies with DRV and coronavirus, and that based on early, unpublished data from some laboratory experiments, “it is not likely DRV will have significant activity against SARS-CoV-2 when administered at the approved safe and efficacious dose for the treatment of HIV-1 infection.”

J&J is working to screen compounds within the company and in collaboration with other companies to speed development of therapies against the virus, including a high-priority project to develop a vaccine using its AdVac and PER.C6 technologies.

At least some of this appears to come from a February report in China’s Changjiang Daily newspaper saying that a Zhejiang University researcher identified abidol and duranavir as possible treatments for COVID-19.

“This latest outbreak of a novel pathogen once again reinforces the importance of investing in preparedness, surveillance and response to ensure the world remains ahead of potential pandemic threats,” stated Paul Stoffels, vice chairman of the executive committee and chief scientific officer at J&J.

Another HIV drug being tested is AbbVie’s Kaletra/Aluvia (lopinavir/ritonavir). The company announced on March 9 that it was collaborating with health authorities and institutions globally to determine if the drug was effective and safe against COVID-19.

“We are committed to helping in any way we can to address the COVID-19 public health crisis, which is why we responded quickly to the Chinese authorities’ request for Aluvia in late January,” said Richard A. Gonzalez, chairman and chief executive officer of AbbVie. “We are working with global health authorities to meet the need of COVID-19 patients, conduct the appropriate clinical trials to evaluate its efficacy and ensure uninterrupted supply of the drug Kaletra/Aluvia for HIV patients around the world.”