Clinical Education Center
Hepatitis C: How Broad Screening and New Therapies Can Transform the Disease Burden
Approximately 3.2 million people in the United States have chronic hepatitis C virus (HCV) infection, with infection most prevalent among those born during 1945–1965. Less than half of those with HCV have been diagnosed.1-3 To address the impact of this epidemic, the Centers for Disease Control and Prevention and the United States Preventive Services Task Force have issued recommendations for HCV cohort-screening of adults born between 1945-1965, in addition to screening those at high risk of infection.4-5
Dr. Bruce Bacon, James F. King MD Endowed Chair in Gastroenterology, Saint Louis University School of Medicine, discusses why the advent of new, effective therapies, combined with more comprehensive screening, promise to transform the management of HCV and radically reduce the burden of the disease in the U.S.
The First Challenge – Identifying Those Infected
“The first challenge in HCV management is identifying infected patients who have not yet been diagnosed,” notes Dr. Bacon. The undiagnosed represent the majority of those who are chronically infected with the disease, but, despite the recommendations for cohort screening, there has not been sufficient incentive for physicians to change the approach to screening.
“Clearly, cohort screening is a good way to identify a large number of patients who have been infected but are unaware because they’re asymptomatic,” continues Dr. Bacon. “However, it’s been hard to justify large-scale screening when all we could offer these patients was a toxic therapy lasting up to a year with cure rates of 40% -50%. But things have changed dramatically. Now that we can cure more than 90% of patients with 12 weeks of a therapy that’s very safe and well tolerated, there’s every reason we should be identifying as many of those infected as possible. We have so much more to offer them now.”
Identifying patients infected with HCV is particularly important given that 60% to 70% go on to develop chronic liver disease, with up to 25% of these eventually developing cirrhosis.6 Early identification and intervention can limit the impact of the disease and halt its potentially fatal progression. Dr. Bacon stresses that while adopting cohort screening, it is equally important to continue screening for other risk factors such as a history of blood transfusion, history of injection drug use and incarceration. The various types of non-birth cohort screening used in the past, aren’t eliminated, rather they’re done in addition to birth-cohort screening.
The initial screening test is an antibody test, which indicates exposure, so a reactive result could indicate current HCV infection, past HCV infection that has resolved, or false positivity. A reactive result therefore needs to be followed up with further testing to confirm whether the patient has cleared the disease or whether there is active infection. This is achieved by nucleic acid testing (NAT) to identify HCV RNA in blood, which can be ordered, together with genotype testing, by the primary care physician before referring the patient to a specialist. An HCV antibody with reflex to quantitative testing to confirm infectivity may be ordered to eliminate the need for a separate follow-up test.7-8
The quantitative RNA test also provides the clinician with a viral load to serve as a baseline for monitoring response to therapy. (A qualitative RNA test only determines presence or absence of viremia.) 7-8 Testing to determine response is performed during treatment, at the end of treatment and at an interval after treatment.
New Therapeutic Options – Safer, More Effective, Shorter Duration
The need for specialist experience and expertise is becoming all the more important with the introduction of several new therapeutic options. “Things are going to get more complicated in the next couple of months,” notes Dr. Bacon. “We’re going to have at least three, maybe four, new regimens available to use, all of which will be successful, and all of which will have their own niches.”
Dr. Bacon anticipates FDA approval before the end of 2014 for several newdirect-acting antiviral agents with significantly higher response and cure rates than traditional therapy:“There is an even greater rationale now for identifying patients, as they can take advantage of the wealth of new treatments we’re going to have available within a couple of months. The advantage they should offer over traditional treatment is not only their superior efficacy – over 95% for certain regimens - but also fewer side effects and a shorter duration – 12 weeks for standard treatment compared with 24 weeks upwards.”
On a Path to Eradicating Hepatitis C
With the availability of new therapies and additional treatments in the pipeline, Dr. Bacon is optimistic about the future of HCV management. “If we find the patients and treat them appropriately, we could essentially eradicate Hepatitis C. In fact, a study was published in August 2014 suggesting that by 2036 Hepatitis C could be a rare disease in the U.S., and I think that may well be an accurate assessment.”9
- Armstrong GL, Wasley AM, Simard EP, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006;144:705–14.
- Smith BD, Morgan RL, Beckett GA et al. Hepatitis C Virus Testing of Persons Born During 1945–1965:Recommendations From the Centers for Disease Control and Prevention. Ann Intern Med. 2012;157:817-822.
- Rein DB, Smith BD, Wittenborn JS, et al. The Cost-Effectiveness of Birth-Cohort Screening for Hepatitis C Antibody in U.S. Primary Care Settings FREE. Ann Intern Med. 2012;156(4):263-270. doi:10.7326/0003-4819-156-4-201202210-00378
- Centers for Disease Control and Prevention. Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945–1965. MMWR. Vol. 61 / No. 4 August 17, 2012.
- U.S. Preventive Services Task Force Recommendation Statement. Screening for Hepatitis C Virus Infection in Adults http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm#copyright Accessed September 8, 2014
- Hepatitis C Information for Health Professional. Centers for Disease Control and Prevention. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm . Accessed September 8, 2014
- Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945–1965. LaboratoriansMMWR / Aug 17, 2012 /61/4. Centers for Disease Control and Prevention. http://www.cdc.gov/mmwr/pdf/rr/rr6104.pdf Accessed Sept. 10, 2014
- Testing for HCV Infection: An Update of Guidance for Clinicians and LaboratoriansMMWR / May 7, 2013 / Vol. 62. Centers for Disease Control and Prevention.
- Kabiri M, Jazwinski AB, Roberts MS, Schaefer AJ, Chhatwal J. The Changing Burden of Hepatitis C Virus Infection in the United States: Model-Based Predictions. Ann Intern Med. 2014;161:170-180. doi:10.7326/M14-0095