In many cases, the latest treatments for hepatitis C virus (HCV) infection are at least 90% effective at curing the infection; however, there still remains a subset of patients who don’t respond to the new medications. Led by researchers in Germany, a study was conducted to see how ribonucleic acid (RNA) assessment can be used to predict outcomes before the end of treatment.
Therapy options for hepatitis C now include sofosbuvir (SOF), ribavirin (RBV), pegylated-interferon-alfa (PegIFN), simeprevir (SMV), and daclatasvir (DCV). The research team studied 298 patients with hepatitis C, genotypes 1 to 5, treated with the following medication combinations:
99 patients: SOF/RBV for 12 or 24 weeks
79 patients: SOF/DCV with or without RBV for 12 or 24 weeks
69 patients: SOF/SMV with or without RBV for 12 weeks
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Freiman: There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia.
In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT.
MADISON, N.J., December 4, 2015 – In its commitment to provide diagnostic insights that enhance patient care and outcomes, Quest Diagnostics (NYSE: DGX) will automatically perform molecular testing on all patient specimens whose antibody screening results indicate hepatitis C virus infection, and remove standalone positive antibody screening as a test option. The change to the company’s service menu eliminates the prospect a patient may receive a positive screening result but fail to undergo additional molecular testing, as recommended by medical guidelines, to help confirm a diagnosis of active hepatitis C infection, the cause of chronic hepatitis C.
Conventional laboratory and medical practice for hepatitis C virus infection involves referring a patient for a second office visit and blood draw if the initial antibody screening test produces a positive result. As many as 60% of people who receive a positive antibody screening test for hepatitis C in the United States do not undergo guideline-recommended molecular testing to help identify active infection.
“This change to Quest’s test offerings is medically responsible and appropriate. It closes a gap in current hepatitis C care by reducing the possibility a patient will undergo multiple office visits and blood draws or be inappropriately referred to specialists based on incomplete testing,” said Rick L. Pesano, MD, PhD, vice president, development, science and innovation, Quest Diagnostics. “With this change to our offering, we will help more people receive insights they can use to access effective treatment and ultimately lead healthier lives.”