In the White House’s new budget they have put aside several billion dollars towards establishing a hepatitis C (HCV) program. In addition, an HCV vaccine is expected to go into phase 1 clinical trials this year, and a pharmaceutical company is working with states to gain better therapeutic access.
In its latest budget, the Biden administration has earmarked over $11 billion dollars for HCV care funding over the next 5 years.
A hallmark of the plan is to establish the National Hepatitis C Elimination Program, which the administration has said it wants to dedicate $6.1 billion to set up and a total of $11.3 billion to address the program’s costs.
This ambitious program will expand testing, screening, prevention, and treatment of HCV, and will focus on the marginalized populations that are the greatest at risk. These populations including people who use drugs, the uninsured, Blacks, American Indians, and Alaskan indigenous peoples who may not be in the continuum of care currently.
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 last week 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.
They point out, for example, that HCV infection can present asymptomatically, and an estimated 40% of those who have hepatitis C are not even aware they are infected.1
Fleurence and Collins also detail the current screening and treatment 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.”
It has been pointed out in past studies that people who are limited socioeconomically may have difficulties making it to these multiple appointments because of transportation issues and taking time off from work. Not to mention, these same populations may be under or uninsured, making subsequent treatment difficult.
There are multiple benefits for getting more HCV patients the necessary care needed including potentially curing them of HCV and preventing cancer. “Hepatitis C is the most common cause of liver cancer today, so this initiative is an important contribution to President Biden’s Cancer Moonshot,” Fleurence and Collins added.
Another ancillary benefit is avoiding downstream health care costs for those who might need hospitalization for HCV-related comorbidities.
The coauthors point to the success of the patchwork of groups who have been already working on HCV care access including individual states, the Cherokee nation, Federal Bureau of Prisons, and the Veterans Administration.
“The Veterans Health Administration has treated more than 92,000 veterans with hepatitis C virus since 2014, with cure rates exceeding 90%,” they write.
HCV Vaccine in Development
It took Michael Houghton, PhD, and his fellow researchers over 7 years to discover the hepatitis C virus. Houghton who is Li ka Shing professor and holder of the Canada Excellence in Research chair (CERC) in Virology within the Li Ka Shing Institute of Virology at the University of Alberta, codiscovered the hepatitis C virus along with Qui-Lim Choo, PhD, George Kuo, PhD, and Daniel W. Bradley, PhD. For the HCV discovery, Houghton was awarded the 2020 Nobel Prize in Physiology or Medicine and shared the honor with Harvey J. Alter, MD, and Charles M. Rice, PhD. Houghton is also a board member of the Liver Health Initiative.
Houghton and his colleagues have applied that same perseverance in in developing a prophylactic HCV vaccine. The path from virus discovery to vaccine development was not any easier. For the vaccine, they encountered a number of issues including the lack of animal models, the challenge of growing cell cultures, and limited interest from biopharmaceutical companies.
Despite these challenges and shortcomings, Houghton and colleagues pushed on. After more than 10 years, he and his team at the University of Alberta developed what he calls a second-generation vaccine. “We know it can elicit cross-neutralizing antibodies across most of the strains seen around the world…And then we have also dialed in cellular immune responses rather like the COVID-19 vaccines that do both—antibodies and cellular T-cell responses,” Houghton said in an interview with Contagion.
They performed vaccine studies in chimpanzees years ago, which showed efficacy, and that no other HCV investigational vaccine has done testing in animal models.
Houghton and his coinvestigators are planning for a summer 2023 phase 1 clinical trial application, and in speaking with him last week, he says this timeline is still holding up. They are conducting preclinical toxicology studies aimed at showing their purification methods remove any adventitious viruses.
Overall, Houghton remains optimistic about the chances of their investigational vaccine getting approved. “I’m very encouraged that we can make a vaccine to the Hep C virus.”
Getting Therapy Access at the State Level
Uptake for therapy remains challenging, and there have been restrictions preventing access. Three of the most significant prior authorization restrictions to treatment are liver damage, sobriety, and prescriber limitations. Since 2017, 33 states have either eliminated or reduced their fibrosis restrictions, 29 have loosened their sobriety restrictions, and 28 have scaled back their prescriber restrictions. Additionally, there are now 11 states that have removed prior authorization for most patients entirely: Washington, Louisiana, New York, California, Indiana, Wisconsin, Michigan, Rhode Island, Missouri, Alaska, and Virginia.
Biopharmaceutical company, AbbVie, has been working with stakeholders in individual states to help remove barriers. Their HCV therapy, glecaprevir /pibrentasvir (Mavyret), is FDA approved and indicated to treat adults and children 3 years of age and older with chronic HCV. When the therapy was approved nearly four years ago, the FDA acknowledged that it could cure the virus.
“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in their announcement. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”
AbbVie recently partnered with the Texas Health and Human Services Commission (HHSC) in working towards reducing chronic HCV in Medicaid patients. This collaborative initiative aims to increase awareness, screening, diagnosis, and treatment for Texas Medicaid recipients. In January, HHSC removed all restrictions to Mavyret to reach Medicaid patients and their prescribers.
HHSC has selected Mavyret as the primary preferred therapy option for treating HCV in Medicaid patients, and it is the only direct-acting antiviral medication available to Texas Medicaid patients without prior authorization.
“We are excited for this partnership with AbbVie to reach more people with this disease in Medicaid so they can receive curative treatment,” Priscilla Parrilla, director of the Vendor Drug Program, said in a statement.
“AbbVie is looking forward to partnering with HHSC to provide education on this important initiative to patients and health care professionals in the state of Texas and advance our shared goal of Hepatitis C reduction,” Horia Ijacu, vice president, U.S. Medical Affairs, Specialty, AbbVie, said in a statement.
In addition, the AbbVie Health Economics and Outcomes Research (HEOR) team has created a website, mappinghepC.com, to improve awareness of HCV epidemiology in the United States. The information is based on data from 2 large national laboratory companies representing a very large proportion of US patients who were screened for HCV antibody and/or tested for HCV RNA from January 1, 2015 through December 31, 2019.
The website shows the prevalence of HCV across the US and extrapolates it to determine if states will reach the World Health Organization’s (WHO) 2030 HCV elimination goals. WHO updated recommendations for its goals last year and called for "radical simplification" of care pathways and increased point of care (PoC) testing, if its Global Health Sector Strategy goals of 90% testing and 80% treatment are to be attained by 2030.
Adding the weight of the federal government can be a huge improvement in working towards greatly diminishing this serious, public health problem. Ultimately, the budget request made by the Biden administration will need to get passed through Congress, and with a new republican-majority house, it remains to be seen how this budget will shake out and how much will be allocated for the HCV elimination program.
However, no matter what may or may not happen in the federal budget and the fate of the HCV elimination program, separately, a hepatitis C vaccine is moving towards clinical trials, and therapy access continues to improve—getting more patients into the continuum of care.
1. US Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970-975. doi:10.1001/jama.2020.1123