The Means for Curative Hepatitis C Care are Available, But Many Still Don’t Utilize

Hepatitis C has been called the silent killer because many people who have the disease often are not aware they have it, and it can quietly linger in the body for years and lead to serious consequences including liver disease, cancer, and death.

"Most of the time people don't even realize they have hepatitis C because they present asymptomatic,” said Tracy Gowan MSN, APRN, FNP-C, Hep C Center, University of Louisville Hospital. “So a lot of times this is found with the incidental finding on lab work, or perhaps an ER visit.”

“Before we had COVID, hepatitis C was the most deadly infectious disease that's reportable to the CDC,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.

However, in the last few years there has been a greater emphasis placed on hepatitis C including the Biden Administration’s Eliminate Hepatitis C plan and the CDC’s updated screening guidelines. These newer initiatives combined with the existing curative therapies make the timing right to gain inroads to bring down incidence rates and cure those who may be undiagnosed with the silent killer.

Here is a review of some of the newer strategic initiatives to reduce incidence rates, clinical information on therapies, and the existing challenges to getting people into the continuum of care.

It All Starts With Testing

There is an estimated 2.4 to 3 million people in the United States with HCV and 58 million people worldwide with the virus.¹And while millions are affected by HCV, many people go undiagnosed and therefore, untreated.

In recent years the Centers for Disease Control and Prevention (CDC) upgraded its testing guidelines and now recommends universal hepatitis C screening for all adults 18 years of age and older, all pregnant people during each pregnancy, and frequent testing for people in certain high-risk groups.²

According to the National Center for Biotechnology Information, annual HCV screening rates were 39.9% in 2019, 26.9% in 2020, and 48.6% in 2021. Investigators did acknowledge these screening rates during the COVID-19 pandemic were lower than before the pandemic. In 2021, screening rates during outreach and education months contributed to nearly 50% of annual screenings.³

Aside from people with HCV who are asymptomatic, another major reason people with HCV are not getting screened are those within marginalized populations such as people who inject drugs (PWID) or those using Medicaid. These marginalized groups may not be engaged or have limited interactions with health care. They can also be dealing with how the rest of the world perceives them.

“I think there's some stigma associated with people with hepatitis C,” Schmid said.

HCV testing has low rates overall, and another challenge has been the current CDC testing guidelines, which includes a 2-step process. Investigators looking at the current testing paradigm reported one-third of patients receive incomplete testing, which can lead to a gap between those who have hepatitis C and those who undergo testing for infection detection.⁴

Current Testing Paradigm

The testing process was developed in 2013 and was made up of 4 possible operational strategies (“steps”) used to diagnose hepatitis C infection:

Blood is submitted for testing if the sample collected is reactive for hepatitis C antibody during initial testing
2 specimens are collected in separate tubes from a single venipuncture. The first tube is used in hepatitis C antibody testing and the second is for hepatitis C RNA testing if the hepatitis C antibody test is reactive
If it is reactive, the same venipuncture sample blood used for hepatitis C antibody testing is reflexed for hepatitis C RNA testing without another blood draw
Another blood sample is submitted for hepatitis C RNA testing if the initial testing of antibody has used finger-stick blood

By reducing the number of tests and linking testing to care, you can get people on therapy sooner and close the continuum loop. “If you could do that in a one step process, you could get these patients, linked to care and get them moving forward,” Gowan said.

The Biden Administration is trying to build awareness around testing, and just this past Sunday, May 19, the president's proclamation about National Hepatitis Testing Day was an opportunity to discuss the challenges and opportunities to screen, prevent, and cure hepatitis C. “I encourage all Americans to join in activities that will increase awareness about viral hepatitis and what we can do to prevent and treat it,” Biden said in the proclamation.⁵

Advent of Direct Acting-Antivirals, Reducing Further Health Care Encounters

In 2011, a class of therapies called direct-acting antivirals (DAA) were developed, and they were considered a major advancement in the treatment of HCV. They were found to achieve a virological response exceeding 90% in most genotypes.⁶ Prior to DAA, Gowan remembers clinicians using interferon for HCV treatment, but that was a long, painstaking process to cure with a few challenges.

"Interferon was a weekly injection for 48 weeks,” Gowan said. “And, it was difficult for patients who it caused a lot of barriers with getting access to the clinic.” She said barriers to getting to the clinic on a weekly basis included things like transportation and childcare. In addition, she said the side effects made patients feel flu-like, and the cure rate was approximately 50-60%. With the addition of DAA, this made a cure a more likely outcome. And the DAA therapy regimen is a lot shorter and does not involve taking injections.Today, people take a single tablet daily for 8 to 12 weeks to be considered cured from the virus.

“Thank goodness for the direct acting agents, because they were a big game changer for treating and curing hepatitis C,” Gowan said. In addition to higher cure rates, Gowan said there are minimum side effects and even less clinical encounters. “We may start patients on medication and not even bring them back until we check them for a cure. And most of the time when patients come back to clinic, they tell me they can't even tell they're on these medicines. They're like taking a vitamin."

Another aspect of a curative approach as opposed to chronic care is the idea that you eliminate the long-term treatment for these patients by not having to continue to see specialists, be on a life-long therapy regimen, or get comprehensive tests or procedures.

“If we treat people, we will not have all these downstream costs, like liver failure, transplants, and cancer. We will save money,” Schmid said.

Older Treatment vs DAA

Before the advent of Direct-acting antivirals (DAA), the HCV cure rate using interferon was 50-60%. Since the widespread use of DAA, these therapies can cure more than 95% of people with HCV.

Eliminate Hepatitis C Initiative

Last year, the Biden administration decided to earmark $11 billion dollars for HCV care funding over 5 years. A hallmark of the plan is to establish the National Hepatitis C Elimination Program, which the administration wants to dedicate $6.1 billion to set up and a total of $11.3 billion to address the program’s costs.⁷

This program aims to expand testing, screening, prevention, and treatment of HCV, and will focus on the marginalized populations that are the greatest at risk. In addition to PWID and the uninsured, Blacks, American Indians, and Alaskan indigenous peoples are at increased risk and may not be in the continuum of care.⁷

One of the architects of the plan, is former NIH Director Francis Collins, MD, PhD, who is serving as a scientific advisor to the Biden Administration. In a commentary published in JAMA and cowritten with Rachael Fleurence, MSc, PhD, they discussed the genesis of this program, some of the shortfalls of the current medical paradigm for care, and strategies to improve it.

Fleurence and Collins detailed the aforementioned screening challenges. “One major limitation is that testing for hepatitis C now requires 2 steps: initiating treatment starts with an antibody test to detect prior infection, followed by an RNA test to determine whether infection is active,” Fleurence and Collins write. “Return of those test results can take days or weeks, and then a third visit is needed to initiate treatment.”

One person with commitment accomplishes more than a thousand with an opinion. —author, Orrin Woodward

Help at the Community Level

This quote from Schmid encompasses the type of grassroots movement that individual, committed clinicians and smaller community health centers are doing every day: “One of the things I'm really pleased about is working with the community health centers, because they are on the front lines. There are a lot of people who are uninsured, or who have been in jail, and they go to community health centers.”

One example of working at the community level is the Cherokee Nation Health Services program in Oklahoma. They have been working towards increasing hepatitis C screening, and getting people who are infected with the virus, into treatment.⁸

Whitney Essex, MSN, FNP-BC is a family nurse practitioner for Cherokee Nation Health Services (CNHS) and works in the infectious diseases department where she is the coordinator for the Cherokee Nation Hepatitis C Elimination program.⁸

She has been involved in the program since its inception in 2015, and was an investigator in 2 studies—one looking at nearly the first 2 years of the program and then studying 5 years of the program.⁸

“First-time HCV screening coverage increased from 20.9% to 38.2%, and identification of current HCV infection and treatment in newly screened individuals increased from a mean (SD) of 170 (40) per year to 244 (4) per year and a mean of 95 (133) per year to 215 (9) per year, respectively,” the investigators wrote in the first study.

“We started universal screening for hepatitis C in Cherokee Nation several years before the CDC made it a recommendation,” Essex said in a previous interview with Contagion. “And so I think that is where successes really started. We're finding patients and knowing that they had hepatitis C. Because it is so silent, many patients don't know they're infected. And, so the universal screening was a big turning point where we were able to track these patients down, and let them know about the hepatitis C diagnosis and get them treated.”

In addition, the program set out goals to get patients into care and document cures.

“During the implementation period, of the 793 individuals with current HCV infection accessing the CNHS, 664 were evaluated (83.7%), 394 (59.3%) initiated treatment, and 335 (85.0%) had documented cure. In less than 2 years, the 85% 3-year goal was reached for cure (85.0%), and the goal for linkage to care was nearly reached (83.7%), whereas screening (44.1%) and treatment initiation (59.3%) required more time and resources,” the authors wrote in their first study.

Where Do We Go From Here?

There are solutions available to make inroads to reducing and curing HCV; however, challenges like low testing rates, barriers to care, and inertia by Congress all lead to less than optimal outcomes and weigh down best efforts. Nonetheless, initiatives done at community health centers and national advocacy organizations can certainly help patients at the ground level. And the hope is that the Biden Administration's plan will get passed by Congress, and it will lead to a larger national movement to move the needle in the right direction.