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Article Publish Status: FREE
Abstract 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 Source:

Int J Infect Dis. 2015 Aug ;37:58-63. Epub 2015 Jun 17. PMID: 26092299

Abstract Author(s):

J Todd Kuenstner, Shanker Mukherjee, Stuart Weg, Trish Landry, Thomas Petrie

Article Affiliation:

J Todd Kuenstner

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).

Study Type : Human Study
Additional Links
Therapeutic Actions : Light Therapy : CK(154) : AC(0)
Additional Keywords : Ultraviolet Blood Irradiation

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Sayer Ji
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