title: 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.
abstract: OBJECTIVE
  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).
authors.affiliation: Clinical Laboratories, Charleston Area Medical Center, Charleston, Virginia, USA; West Virginia School of Medicine, Charleston, West Virginia, USA. Electronic address: jtodd.kuenstner@camc.org.
authors.forename: J Todd
authors.initials: JT
authors.lastname: Kuenstner
authors.affiliation: Twin Rivers Gastroenterology Center, Easton, Pennsylvania, USA.
authors.forename: Shanker
authors.initials: S
authors.lastname: Mukherjee
authors.affiliation: Franklin Lakes, New Jersey, USA.
authors.forename: Stuart
authors.initials: S
authors.lastname: Weg
authors.affiliation: M Squared Associates, Washington DC, USA.
authors.forename: Trish
authors.initials: T
authors.lastname: Landry
authors.affiliation: AVIcure Bioscience LLC, Superior Quartz Products, Inc., Bethlehem, Pennsylvania, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Petrie
mesh_terms: D000328:Adult; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis / Q000628:therapy* / Q000821:virology; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014467:Ultraviolet Therapy / Q000009:adverse effects / Q000295:instrumentation; D019562:Viral Load; D055815:Young Adult
keywords: FDA trial; Hepatitis C virus (HCV); Mycobacterium avium paratuberculosis (MAP); Psoriasis; Safety and efficacy; Ultraviolet blood irradiation (UVBI)