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

Int J Infect Dis. 2015 Aug;37:58-63. doi: 10.1016/j.ijid.2015.06.006. Epub 2015 Jun 17.

Abstract

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).

Keywords: FDA trial; Hepatitis C virus (HCV); Mycobacterium avium paratuberculosis (MAP); Psoriasis; Safety and efficacy; Ultraviolet blood irradiation (UVBI).

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Female
  • Hepacivirus / isolation & purification
  • Hepatitis C / diagnosis
  • Hepatitis C / therapy*
  • Hepatitis C / virology
  • Humans
  • Liver Function Tests
  • Male
  • Middle Aged
  • Prospective Studies
  • Ultraviolet Therapy* / adverse effects
  • Ultraviolet Therapy* / instrumentation
  • Viral Load
  • Young Adult