Virginia Health Clinic Provides Blueprint for Treating Local HCV Patients with Substance History

A community-based hepatitis C virus (HCV) treatment program was able to successfully cure a small cohort of patients with a history of drug use who received care from a nurse practitioner at a Federally Qualified Health Clinic (FQHC) over 12 weeks.¹

The findings from a group of Lynchburg, VA-based investigators provide a blueprint for implementation of community-level health care options for patients with HCV who may not be eligible for critical direct-acting antiviral (DAA) prescription at infectious disease clinics due to their drug addiction status. What’s more, the data come at a time when research indicates the US has only cured HCV in approximately one-third of patients due to limited care access and treatment follow-through.²

Susan B. Clapp, ANP, and Christopher B. Johnson, of the Community Access Network clinic in Lynchburg, reported outcomes from their FQHC’s quality improvement project designed to bridge gaps in care for local patients with HCV and a history of substance abuse. They noted that a local infectious disease specialty clinic denies treatment for patients with HCV who submit a positive urine drug screen—instead referring such patients “over an hour away to a university infectious disease specialty clinic.”

“The population of people who inject drugs has been identified as the largest group of those with HCV infections,” Clapp and Johnson wrote. “Challenges exist with HCV education, treatment, and management of this high-risk population, especially in vulnerable and underserved communities.”

They analyzed a quality improvement plan from their clinic that removed barriers including access to HCV medication, transportation issues, housing and food insecurity, addiction and mental health disorders. “Specifically targeting the subpopulation of positive HCV individuals who use drugs can greatly decrease the spread of HCV in this community as well as provide multidisciplinary, holistic services to people who inject drugs,” they wrote.

Their initial cohort was comprised of 25 adult participants >18 years old at baseline; eligible patients had tested positive for active HCV as well as on their urine drug screen. Patients were offered an 8-week regimen of DAA glecaprevir/pibrentasvir (Mavyret) to treat their HCV, initiated at the FQHC. The team sought a primary outcome of HCV viral load at 12 weeks post-treatment indicating hepatitis curation per sustained viral response (SVR).

Among the 25 initial participants, 2 were lost due to incarceration, 2 were lost in follow-up, and 1 entered a drug rehabilitation center prior to initiating DAA therapy. Of the remaining 20, mean patient age was 48 years old; 71% were male, 65% were White, and 35% were African American.

Between initial appointments and 12-week post-treatment lab appointment, patients received a complete examination, education on their disease, an overview of their treatment, and baseline lab work. Patients with mental health disorders were referred for behavioral health interventions. At the start of DAA treatment, patients received adherence education and a check-in call midway through the regimen from a nurse practitioner.

In instances when patients experienced issues with food or housing insecurity, or required basic resources like a phone, transportation or adequate clothing, care givers referred them to clinic community health workers. Patients were also directed to Medically Assisted Treatment (MAT) programs for substance abuse upon their own request.

At 12 weeks post-treatment, 3 patients were lost to follow-up and unable to be included in lab assessments. All 17 of the remaining patients who completed the regimen reported 100% undetectable disease, indicating cure of HCV. The finding surpassed the team’s expectation of >90% successful cure among treated patients.

“Furthermore, this outcome was not influenced by demographics such as age, ethnicity, or continued drug use while undergoing treatment,” they wrote. “The outcome of this study is consistent with previous research that demonstrates nurse practitioners can safely and effectively treat HCV in people who inject drugs in a community clinic setting without the need for infectious disease specialists administering the DAA.”

Clapp and Johnson advocated for more innovative and community-centric strategies to improve opportunities for management of, or even cure from, HCV.

“Our country is now in a position where DAA treatment for HCV is simplified for providers and patients can achieve a SVR with few side effects,” they concluded. “This study demonstrates that a non-specialist can treat HCV in vulnerable, low-income patients who continue to use illegal substances. They can be cured of their HCV and may return for additional services, even referral to addiction services when they are ready.”

References

1. ^{Clapp SB, Johnson CB. Providing Hepatitis C Treatment Locally for Substance-Using Patients. J Prim Care Community Health. 2023;14:21501319231186355. doi:10.1177/21501319231186355}
2. ^{Kunzmann K. Two-Thirds of Americans with Hepatitis C Have not Cleared Disease. HCPLive. Published July 7, 2023. https://www.hcplive.com/view/two-thirds-americans-hepatitis-c-cleared-disease}