Design and evaluation of a device for trapping hepatitis C viral particles at ultra low concentrations

Abstract

A new method to quantify hepatitis C (HCV) viral particles when present in ultra low concentrations is being developed. Hepatitis C is a viral infection that affects the liver. There are 3.2 million people in the United States with an active hepatitis C infection. Untreated HCV can lead to cirrhosis, liver failure and liver cancer. HCV treatments can be very costly and physically taxing for patients; the side-effects of treatment are comparable to persistent flu-like symptoms. Physicians are looking to shorten the duration of the standard treatment, typically 24 to 48 weeks, for patients who respond quickly. Physicians must have more sensitive testing equipment to truly know when a patient has been cured and be able to successfully shorten the length of treatment. Current diagnostic tests are insufficiently sensitive when the patient begins to positively respond to treatment and the amount of the virus present in his/her blood dramatically decreases. This limitation can be overcome by employing an in-vivo sampling technique, where a device is placed in a vein to trap HCV viral particles present in the blood. These particles are then subsequently quantified with a commercially available test. This technique allows at least 40,000 times more blood to be sampled in 30 minutes than with a traditional blood draw, greatly increasing the effective sensitivity of the test. The approach provides significant medical benefit to the patient being treated and a strong financial incentive to the entity paying for the treatment.