CDC seeks more testing for ‘huge uptick’ in HCV incidence

Hepatitis C virus (HCV) infection is the largest ongoing infectious disease epidemic in the U.S., and incidence rates are rising, according to CDC research (unpublished at press time) presented in November at the American Public Health Association's annual meeting in Chicago.

Researchers identified 18,000 death certificates in 2014 that noted HCV infection as an underlying cause of death, although the actual death toll is higher because only 19% of HCV patients have the infection recorded anywhere on their death certificate, said Scott Holmberg, MD, MPH, chief of the Epidemiology and Surveillance Branch of the Division of Viral Hepatitis at the CDC.

“We looked at 60 other infectious diseases that are required to be reported to CDC and found that, by 2011 and 2012, hepatitis C was already accounting for more deaths than these 60 other infectious conditions put together,” he said. “Do not minimize this outbreak. It is causing an awful lot of deaths.”

By CDC estimates, more than 3.2 million U.S. residents are living with chronic HCV infection, and 30,000 new cases are acquired each year. Physicians, especially those trained prior to the 1989 discovery of HCV, need to be aware of the infection's destructive capabilities, Dr. Holmberg said.

“I think too many physicians still view this as a benign chronic condition when, as you see in the data, it isn't,” he said.

Two epidemics

Dr. Holmberg discussed 2 facets of the hepatitis C epidemic: chronic HCV and acute HCV. Chronic cases are exhibiting rapidly increasing mortality and morbidity, and about 75% of those with chronic HCV are baby boomers born between 1945 and 1965, he said. “The problem with chronic hepatitis C virus is ... it's 20 to 30 years of gradually deteriorating liver disease, which may not be evident to the patient or physician,” Dr. Holmberg said.

Meanwhile, acute HCV cases are proliferating, particularly among young persons who inject drugs, he said. Acute cases reported to the CDC had remained steady from 2004 to 2010, running at about 800 to 1,000 annual cases, he said. “Remember, this is the tip of the iceberg,” Dr. Holmberg said. “These are the people who get symptomatic and get worked up. It's only a tiny fraction of people acutely infected who get reported to us.”

But in recent years, reported acute cases have increased to more than 2,000 each year, and this “huge uptick” has occurred mainly in nonminority white young persons located in rural areas east of the Mississippi River, he said. “We're in the midst of an emerging epidemic of acute HCV in young, nonurban persons who transition from prescription oral opioids to injecting heroin, often in their teens,” Dr. Holmberg said.

Most of these newly infected injection-drug users are 20 to 29 years old, with some also in the 30-to-39 range, Dr. Holmberg said. They are mainly nonurban, white, nonminority, and, unlike in previous years in which men predominated, they are almost as likely to be female, he said. “This worrisome, dreadful increase in rural and suburban areas is occurring in tandem, in conjunct, with an increase in urban areas, as well,” Dr. Holmberg said.

Screening and prevention

The CDC wants more people to get tested for HCV because it is the “paramount first step to getting them into care,” Dr. Holmberg said. The agency estimates that, as of 2013, 50% of people with HCV have been tested, 35% have been referred to an appropriate clinician, 12% to 23% have been evaluated for their stage of liver disease and treatment, 7% to 11% have been treated, and 5% to 6% have been cured.

“That means that half of our patients with hepatitis C are out there, showing up in our emergency rooms and hospitals, seriously ill at a time when it becomes much more difficult to treat them,” said Dr. Holmberg.

When Corinna Dan, RN, MPH, first started studying HCV in 2001, she said she wondered when the country would start taking it seriously—perhaps when more effective treatments or better screening recommendations became available, or when more people started dying, she thought. “That time is now. We have all of those things coming together, and I think that we have a real opportunity with hepatitis C here in the United States today,” said Ms. Dan, viral hepatitis policy advisor for the Office of HIV/AIDS and Infectious Disease Policy at the HHS.

Whereas prior screening recommendations by the CDC and the U.S. Preventive Services Task Force did not align, current guidelines are more consistent, she said. “We have agreement that we want to screen everyone born from 1945 to 1965 at least once for hepatitis C, and we will be able, just by doing that 1 thing, to diagnose 75% of people who are living with chronic hepatitis C,” Ms. Dan said.

Risk-based screening recommendations suggest addressing the amount of people who are injecting drugs and getting newly infected with hepatitis C. “You've got both [groups of] people: older individuals who need to be screened, but, as well, there's this huge prevention [and] early intervention opportunity that we need to seize now,” Ms. Dan said. Clinicians should identify patients who use drugs and are at risk for HCV and refer them to treatment, perhaps at opioid substitution treatment centers, Dr. Holmberg said.

HCV testing is a 2-step process that first requires an HCV antibody test and, if that test is positive, detection of the virus itself through a sensitive HCV-RNA test. With hepatitis C, 15% to 25% of people who become infected resolve the infection naturally, Ms. Dan said. “So some people who test positive for the antibody for hepatitis C are actually virus-free, even though that antibody persists, and so we really need to go that next step. ... Only about half of people who have had an antibody test actually have confirmed infection,” she said.

Barriers to treatment

The much-reported exorbitant cost of new, very effective oral HCV medications is 1 barrier to treatment. Although the sticker price for a complete treatment was initially $84,000, most insurers have negotiated total treatment cost to be under $50,000, which happens to be about what it cost for previous therapies, Dr. Holmberg said.

Given the millions of HCV patients, this may seem like too much money to bear as a society. But Chinese researchers recently combined these medications in new and effective ways, successfully curing 18 of 18 patients after 3 weeks of therapy, Dr. Holmberg noted. “This is huge news because that reduces the cost of these therapies down to a point where, frankly, we can start treating everybody,” he said.

Those with HCV who have the highest priority for treatment are those with advanced fibrosis or cirrhosis of the liver, and the next highest are those who have moderate fibrosis or cirrhosis, according to joint guidelines set by the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, and the International AIDS Society-USA.

“We all agree that we can start treating the sickest people first,” Dr. Holmberg said. “Drug prices have come down and ... will come down even more. And it was a cost-effectiveness analysis we did that indicates if we can get prices below $30,000, it would make public health sense to treat everyone.”