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

• Main Authors: J. Todd Kuenstner, Shanker Mukherjee, Stuart Weg, Trish Landry, Thomas Petrie
• Format: Article
• Language: English
• Published: Elsevier 2015-08-01
• Series: International Journal of Infectious Diseases
• Subjects: Ultraviolet blood irradiation (UVBI); Hepatitis C virus (HCV); FDA trial; Safety and efficacy; Psoriasis; Mycobacterium avium paratuberculosis (MAP)
• Online Access: http://www.sciencedirect.com/science/article/pii/S120197121500140X

Objectives: Prior to the advent of therapies with sustained virological response rates of 94%, this study was conducted for the US Food and Drug Administration (FDA) to assess the safety and efficacy of ultraviolet blood irradiation (UVBI) for the treatment of hepatitis C virus (HCV) infection. Methods: Nine patients received 15 UVBI treatments over the course of 22 weeks with the AVIcure Hemo-modulator, which was modified from the original Knott Hemo-irradiator. The patients’ viral loads and liver function tests were obtained periodically during the study and analyzed during the course of the trial. Results: At the end of the study, the overall mean reduction in HCV viral load was 21.5% (p = 0.023); on day 140, direct bilirubin declined by 41.1% (p = 0.0059), aspartate aminotransferase declined by 15.2% (p = 0.0069), and alanine aminotransferase declined by 19.3% (p = 0.0031). The nadir of the mean and median viral load occurred on day 259, and it corresponded to a mean viral load reduction of 44.9% (p = 0.0048). During the course of the study, three patients had a greater than 0.5 log reduction in viral load (patient 1, 0.56 log reduction on day 259; patient 4, 0.69 log reduction at the end of the study; patient 11, 0.91 log reduction on day 259). Two patients showed marked improvement in their concurrent psoriasis at the conclusion of the trial. Conclusions: In this study, UVBI was safe and had a beneficial effect in the treatment of HCV. This device should be studied for use in psoriasis and in infectious diseases that have few treatment options. This article describes a prospective, controlled, phase II clinical trial submitted to the FDA of this device used for the treatment of HCV infection (Investigational Device Exemption (IDE) #G030242).