| Summary: | The FDA Phase I controlled clinical trial results of ultraviolet blood irradiation (UVBI) to treat patients with hepatitis C Virus (HCV) infection are described in this report. This study was conducted prior to the availability of other highly effective therapies, e.g., the combination of ledipasvir and sofosbuvir (Gilead Sciences, Inc.). Five UVBI treatments were administered to 10 patients in 3 weeks. Viral loads and markers of hepatic inflammation were assessed before and after treatment. The patients were treated with a modified Knott Hemo-Irradiator (AVIcure Bioscience, LLC). After five treatments in nine of the patients, the mean percentage change in viral load was −56.0% and the mean change in log viral load was −0.60 (p = 0.017). During the study, seven of 10 patients demonstrated a > 0.49 log reduction in viral load. There were no significant adverse events. UVBI was safe in all patients and effective for the treatment of HCV infection in a majority of patients (IDE #G030242). This device should be studied for the treatment of other infectious diseases for which there are few treatment options.
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