Though many global health-care organizations support more extensive hepatitis C screening, some researchers are calling for more research into the risks and benefits of more widespread screening for the disease.
In 2012, the CDC recommended that all patients born between 1945 and 1965 be screened for hepatitis C, with the U.S. Preventive Services Task Force (USPSTF), and World Health Organization (WHO) calling for an expansion of screening in 2013 and 2014, respectively.
The USPSTF, however, noted the absence of studies on “long-term harms associated with antiviral regimens” and “the outcomes of treatment in screen-detected patients.”’
Prior to the 2012 recommendation, screening was focused only on patients at high risk for developing the disease, such as intravenous drug users and those who received a transfusion prior to 1992.
“We have a limited window of opportunity to collect appropriate evidence on whether this [widespread screening] is a good idea,” wrote Kenneth W. Lin, MD, of Georgetown University School of Medicine, and colleagues in the BMJ.
Current drug trials have relied on surrogate markers such as sustained virological response (SVR), which does not indicate cure, the researchers pointed out, and newer treatment regimens carry a risk for serious adverse events including persistent disability, hospital admission, and death.
“We know current medications can result in the virus becoming undetectable in a high number of people after three to six months, but 80% of people with hepatitis C do fine with or without treatment,” Lin said in a press release. “We need to know if the treatments have any long-term impact on the remaining 20% who are destined to develop liver failure, liver cancer or die from the disease.”
A shift in clinical trial design away from categorizing patients with hepatitis C by SVR towards categorizing them by risk for who will, or will not, develop end-stage renal disease is needed, the researchers argued.
“Since most individuals with hepatitis C never develop symptoms and die with it not of it, exposing these individuals to the harms of treatment with no possible benefit might outweigh benefits for the minority destined to develop end-stage disease,” they wrote.
In the United States, more than 2.7 million patients have hepatitis C. Many patients with the disease do not have symptoms and are not aware they have it. An estimated 16,000 patients require a liver transplant or die from hepatitis C each year.