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

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).