One of the world’s most dangerous viruses
John Cunningham (JC) virus is usually harmless; the majority of people have been exposed in childhood or adolescence and will never develop any symptoms. However, this virus might provoke life-threatening brain injury.
JC virus is one of nine new viruses infecting humans that were discovered since 1971. Almost 90% of the world’s population carries a life long-dormant non-pathogenic JC virus. The virus puzzle is not entirely solved yet — for example, the latency of these recently recognized viruses, disease-causing potential, and causes for reactivation.
Chickenpox, for example, is a childhood infection caused by the varicella-zoster virus. Symptoms of chickenpox are hard to miss; rashes had been recognized and described since ancient civilizations. After an initial infection of chickenpox, the virus remains dormant in the human body for life. Occasionally this virus reactivates and causes shingles if the immune system of its host weakened due to age, immunosuppression, genetics, or certain medications. Although, painful condition, shingles usually are not life-threatening.
Another example is a fungus called Candida Auris that killed half of the patients infected according to the New York Times recent report. No antifungal drug exists to treat Candida Auris.
This virus is deadly and often overlooked
JC virus has been detected in the sewage system across the world, and it is unknown how the infection in humans occurs. No signs, symptoms, or diseases are associated with the primary infection. No known causes or life choices affect the incidence in the population. JC virus is a polyomavirus, and it closely related to the BK virus. Both viruses infected humans silently in childhood and were named after the initials of the first documented patient. Controversy about the origin of both BK and JC virus are abundant. There is even some evidence that the viruses can be transferred from mother to child through the placenta.
Progressive Multifocal Leukoencephalopathy (PML) is rare but almost always fatal and is begins when dormant JC virus travels and damages the white matter of the brain. Scientists have very few treatment options for patients affected by PML. In November 2019, an early study reported that 7 out of 12 people survived after being treated with experimental adoptive cellular immunotherapy. This encouraging results must be confirmed in further studies.
The progress in medicine is relentless. More patients survive severe diseases because of a new class of biologic drugs. In 2018, James P. Allison and Tasuku Honjo won the Nobel Prize in Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. That Nobel Prize was the latest of three Nobel Prizes that expedited invention and clinical use of monoclonal antibodies know as mAb or biologics. MAbs are used since 1986 for the treatment of cancer, autoimmune diseases, asthma, arthritis, dermatitis, and even osteoporosis. Over 60 different mAb biologics are used clinically today, and the market has reached hundreds of billions of dollars. Another 130 new mAbs are in development by dozens of biotech startups. Biologics are saving lives and helping to overcome severe and intractable diseases.
Black box warnings
Nevertheless, many mAb have so-called Black box warnings. Of the 222 drugs approved in 2001–2010, the FDA required 61 black box warnings. Sixty-nine percent of approved mAbs have the black box.
Black box warnings are the strictest label that the FDA use for prescription drugs. Treatment with monoclonal antibodies may reactivate dormant viruses inside you, including the JC virus. As black box warning states, “It may cause death.” JC virus can travel to the brain and destroy white matter. It happens if your immune system misfunction. A young woman with lupus developed progressive multifocal leukodystrophy (PML) after being treated for her autoimmune diseases. She is one of the unlucky patients treated with extensively used mAbs. The PML is a terrible neurological condition with no actual treatment and a very high mortality rate.
The evergrowing number of biologics (mAbs) prescribed nowadays to treat many diseases from eczema, osteoporosis, psoriasis to cancer, multiple sclerosis. A relevant, timely, and crucial question arises.
The urgent need to define and implement risk-reduction strategies to avoid JC virus reactivation and subsequent permanent brain destruction. Minimizing the risks of using new drugs is crucial. One of the solutions is to understand the importance of monitoring the outcomes of patients and defining clear post-approval strategies.