MedicalResearch.com Interview with:
Dr. J. Todd Kuenstner MD
Charleston Area Medical Center, Charleston, Virginia
West Virginia School of Medicine, Charleston, West Virginia
Medical Research: What is the background for this study? What are the main findings?
Dr. Kuenstner: Prior to the advent of recent antiviral therapies with sustained virologic response rates (SVR) of 94%, ultraviolet blood irradiation (UVBI) was proposed as a method to improve the outcome of treatment with interferon and ribavirin which had an virologic response rates of 50%. This therapy was invented by Dr. Emmett Knott in 1928 and used to treat viral and bacterial infectious disease in the 1930s through the 1950s and an estimated 60,000 treatments were conducted in the United States by 1948. The AVIcure hemo-irradiator is a modification of the Knott Hemo-irradiator and meets contemporary safety standards.
This study describes the FDA phase II controlled clinical trial that was conducted before the advent of sofosbuvir and ledipasvir with the AVIcure hemo-irradiator using ultraviolet blood irradiation (UVBI) for the treatment of 10 patients infected with the hepatitis C virus (HCV). This study is significant because of the potential of this device for treating other infectious diseases with few treatment options. This therapy was safe and beneficial in the 10 patients that were studied. At the nadir of the viral load, the mean reduction of hepatitis C viral load was 45% (p=0.0048) or 0.35 log viral load (p=0.015). Three of the patients in the group achieved a greater than 0.5 log viral load reduction at some point in the trial. The phase I controlled clinical trial of UVBI in patients with HCV infection on 10 patients (submitted for publication) showed that 7 of 10 patients had a greater than 0.5 log reduction in viral load and a mean viral load reduction of 56% and a mean log viral load reduction of 0.60 (p=0.039).
In the phase II clinical trial, 8 of 10 patients also showed a concurrent reduction in their serum transaminase levels, mean reduction in AST of 15% (p=0.0069) and mean reduction in ALT of 19% (p=0.0031). The above phase II trial results were achieved in spite of two therapeutic “holidays” of 7 weeks duration during the trial and during these therapeutic “holidays” the patients did not receive any treatments.
Medical Research: What should clinicians and patients take away from your report?
Dr. Kuenstner: This controlled clinical trial in a viral infection, combined with two controlled trial reports in the Russian medical literature on the use of combination UVBI and antibiotics for more rapid resolution of tuberculosis and the extensive United States medical literature on the Knott Hemo-irradiator from 1930 through 1950 indicate that this therapy is useful for the treatment of infectious diseases. In recent years, increasing resistance to existing antimicrobial agents indicates the need for alternative strategies in combating infectious diseases.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Kuenstner: This device should be evaluated for the treatment of infectious diseases with few or no treatment options. Such diseases include multidrug resistant Mycobacterium tuberculosis, multidrug resistant Salmonella typhi, Mycobacterium avium complex, and dengue, chikungunya, Ebola, Marburg, West Nile and influenza viruses. Studies of patients who have failed existing therapies for other infections including malaria, human immunodeficiency virus and hepatitis B virus are also indicated.
We also believe that this device will be very useful in the treatment of Crohn’s disease and other diseases traditionally considered “autoimmune” but in our view caused by Mycobacterium avium paratuberculosis (MAP). We recently published a series of case reports describing the resolution of Crohn’s disease and complex regional pain syndrome in two patients who were treated with combination UVBI and antibiotics following demonstration of MAP positive blood cultures. Controlled clinical trials of UVBI are planned in these diseases.
The treatment of infectious disease with a medical device: results of a clinical trial of ultraviolet blood irradiation (UVBI) in patients with hepatitis C infection
J. Todd Kuenstnera, b, , ,Shanker Mukherjeec,Stuart Wegd,Trish Landrye,
International Journal of Infectious Diseases
Volume 37, August 2015, Pages 58–63
Dr. J. Todd Kuenstner MD (2015). Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious Disease