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

• We describe a US FDA phase II clinical trial of ultraviolet blood irradiation (UVBI) in patients with hepatitis C virus (HCV) infection.
• The UVBI medical device showed significant HCV viral load and liver function test reductions used as a standalone therapy in a significant proportion of the patients in this trial.
• The therapy was shown to be safe in this US FDA clinical trial.
• Two patients in the trial who had concurrent psoriasis showed a clinical response to this therapy.
• This device has also demonstrated efficacy in as yet unpublished animal studies on influenza and simian immunodeficiency virus infection.

SummaryObjectivesPrior 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.MethodsNine 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.ResultsAt 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.ConclusionsIn 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).