Johnson & Johnson (JNJ), which develops medical devices, pharmaceutical and consumer packaged goods, said in a statement on Monday 16 March that it had no evidence its HIV drug, Prezista, had any effect on patients suffering from the disease caused by coronavirus.
Darunavir (DRV) is a protease inhibitor that goes under the brand name Prezista. It is used by HIV patients and is currently only approved for use with a “boosting” agent, and in combination use with other antiretrovirals, for the treatment of HIV-1.
Antiretrovirals are a class of drugs that inhibit the activity of retroviruses – these are any of a group of RNA viruses which insert a DNA copy of their genome into the host cell in order to replicate, such as HIV.
DRV is marketed by Janssen Pharmaceutica, a pharmaceutical company headquartered in Belgium and owned by Johnson & Johnson.
Johnson & Johnson said that there was “anecdotal” and “unsubstantiated reports” that claimed that DRV has an antiviral effect against against SARS-CoV-2, the virus that causes COVID-19.
Coronavirus has affected more than 156,000 people across the world and killed at least 5,833.
However, it made it clear that:
Janssen has no clinical nor pharmacological evidence to support the inclusion of DRV/cobicistat in treatment guidelines for 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.
There are no published in-vitro studies with DRV and coronavirus.
It added that 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.”
Johnson & Johnson shares are down over 5% in early trading:
“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,” said Johnson & Johnson in the statement.
“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.”