FDA Move Aims to Diversify HCV Test Maker Market, Reduce Regulatory Burden

On November 19th, the Food and Drug Administration (FDA) released a pair of orders affecting Hepatitis C (HCV) antibody screening and diagnostic tools. The move was announced as a proposed order in April 2020 with a total of 13 comments on the proposed orders, including the National Association of State and Territorial AIDS Directors (NASTAD), Hawaii and Washington state Departments of Health, the National Hepatitis Roundtable, and one of the current leading device manufacturers, Abbott.

The final orders reclassify already existing screening and confirmatory blood and plasma testing while also changing the name of acknowledged name of the technology in use from “assay devices” to “tests”. The move is anticipated to reduce the burden in applying for regulatory approval of new tests but also require “special controls” to ensure the quality of testing technologies on the market continue to meet the high safety and accuracy standards they currently meet.

Of note, the FDA considered the impact the new final orders would have on public health initiatives, specifically the National Viral Hepatitis Strategic Plan.  Additionally, Abbott’s support comment was relatively brief and contained only the concern for possible product code labeling limitations for potential technologies; suggesting the FDA take a similar approach as taken to combination antibody and antigen testing with regard to HCV as with HIV testing. Abbott’s recommendation in the comment was to merely name the technologies “serological” tests rather than limiting application based on the mechanism of action in the test as both the proposed and final orders did.

NASTAD’s comment highlighted the difficulty in current surveillance efforts as confirming an acute or active HCV infection is a two-step process, of which, the organization claims few providers or patients follow through. NASTAD drew direct and natural and logical conclusions from the Centers for Disease Control and Prevention’s (CDC’s) Viral Hepatitis Surveillance Report, highlighting the public health risk HCV poses and the barriers to more effective surveillance efforts, including the cost and regulatory hurdles for new screening technologies to enter the market. The public health interests commenting requested the FDA consider expanding the final rule to include potential future technologies like over the counter (OTC) antibody tests or screening technologies based on body fluids other than blood and plasma or combination testing technologies targeting multiple types of viral hepatitis or HCV-HIV combination tests. The FDA’s response to comments in the final orders stated the new final order could not go beyond the scope of existing technologies and, as such, would not be able to change the approval pathway for new or emerging technologies.

While the orders represent an encouragement for manufacturers to enter the existing technologies market with regard to HCV screenings, diversifying the field, the announcement does not affect developing or new technologies and the pathways to approval those potential products will need to navigate.

HCV Screenings: An Evolving Blind Spot Amid Covid-19

A recent study in the Journal of Primary Care & Community Health highlighted the impact of COVID-19 on routinized Hepatitis C (HCV) screening in ambulatory care settings. (Press release and summary of study findings by the Boston Medical Center can be found here.)

Before we dig into the findings, some background:

On April 10, 2020, the Centers for Disease Control and Prevention issued expanded recommendations regarding Hepatitis C Virus screenings to include universal screening for adults aged 18 and over at least once in a lifetime and all pregnant persons – except in settings where HCV prevalence is less than 0.1%. The recommendations also calls for periodic screening among people who inject drugs (PWID).

Prior to this update, the previous recommendations (2012) for HCV screenings was primarily limited to an age cohort focused on Baby Boomers (adults born between 1945 and 1965, regardless of risk factors) and certain risk factors including potential for occupational exposure.

These recommendations came on the back of the CDC’s Viral Hepatitis Surveillance Report (2003-2018), indicating a rise in acute HCV infections among all age cohorts except those under the age of 19, with PWID representing the leading risk factor for new HCV infections (72%). However, data collection on both acute HCV infections and risk factors is sorely lacking. The 2018 surveillance report notes Alaska as having no statutory or regulatory reporting requirement, Hawaii did not report data to the CDC for any year of the report, and 6 other states merely indicated as “data unavailable” (most typically for all reporting years). Finally, no state reported a sero prevalence below 0.1%.

In a report entitled Beyond Baby Boomers, the CDC notes the surge in new HCV infections was dramatically impacted by the opioid crisis – a driving cause in new infections among younger cohorts.

Despite these recommendations, health care providers and traditional health care settings like primary care providers and hospitals routinely miss opportunities to identify PWID and offer HCV screening. This leaves emergency rooms and comprehensive syringe service providers as the most critical partners in identifying new HCV infections, with a priority in op-out screening as a means to increase surveillance, linkage to care, and stigma-reducing education.

All of this makes the Boston Medical Center study that much more alarming. The COVID-19 pandemic, while bringing much to us in the way of innovative health care access, has drastically decreased HCV screening in ambulatory care settings in part because of the leading innovation: telemedicine. Authors observed a hospital-wide reduction in HCV screenings by 50% and diagnoses of HCV by 60%. The finding was even more striking in primary care settings at 72% decrease in HCV screenings and a 63% decrease in new diagnoses. While HCV screenings are not the only preventative care to suffer, as noted by the authors, this is particularly concerning because of the nature of infectious disease impact on public health and because chronic HCV is the leading cause of hepatic illness in the United States.

The blind spot on the horizon is our less than proactive approach in directing resources and programing. Primarily, as many are learning thanks to COVID-19, data collection is historical in nature and offers a limited ability to predict where these necessary resources should be targeted, both geographically and demographically. Data collection efforts may need to consider other metrics in addition to screening and surveillance data in reviewing where resources and programs should focus as we move through the pandemic (i.e. fatal and non-fatal opioid overdose data). Given the CDC’s acknowledgement of the role the opioid crisis has had in driving new HCV infections, the agency’s December 2020 press release indicating an increase in overdose deaths associated with COVID-19 is all that more concerning.

Finally, advocates working at varying intersections of addiction, harm reduction, HCV, HIV, and overall health care could aim their efforts at state and federal policy influencers associated with the Centers for Medicare and Medicaid Services (CMS) to call for including HCV screening as a standard of care for all ambulatory care providers, either by incentive or penalty, as applied to approved Marketplace plans. Other avenues for this strategy should include other state insurance regulatory bodies.

We cannot afford to allow COVID-19 to detract from efforts to address existing syndemics.