Collaborative HCV Care with Pharmacists Could Address System-Level Treatment Barriers

New research is shedding light on the importance of collaborative care for facilitating community-based point-of-diagnosis hepatitis C virus (HCV) treatment initiation among high-risk, marginalized patient populations.1

In the No One Waits (NOW) trial, a longitudinal partnership with a specialized, integrated pharmacy team helped facilitate same-day treatment at the point of HCV diagnosis and quickly transition study participants to insurance-covered direct-acting antiviral (DAA) treatment while overcoming system-level barriers to care.1

“DAA uptake among PWID and people experiencing homelessness is relatively low in the US, due to numerous individual-, practitioner-, and system-level barriers,” Meghan Morris, PhD, MPH, an associate professor of epidemiology and biostatistics at the University of California San Francisco, and colleagues wrote.1 “Interventions to improve HCV treatment uptake must contend with the complex landscape of prescription drug access barriers faced by marginalized communities.”

According to the World Health Organization, globally, an estimated 50 million people have chronic HCV infection, with about 1 million new infections occurring each year. People at higher risk include those who inject drugs, men who have sex with men, and those living with HIV. While DAAs can cure more than 95% of persons with hepatitis C infection, access to diagnosis and treatment is low, especially among marginalized populations.2

NOW was a non-randomized, single-arm, open-label phase 4 study evaluating the feasibility, acceptability, and safety of a point-of-diagnosis HCV treatment initiation model conducted from July 2020 to October 2021. Leveraging a sustained partnership with a specialty pharmacy team, investigators targeted individuals in San Francisco, California, who were experiencing homelessness, injecting drugs, and eligible for simplified HCV treatment.1,3

The study was conducted at a fixed non-clinical community building located in a neighborhood close to public transit and social service organizations and an area where PWID frequently congregate as well as a mobile medical van parked in the neighborhood with the highest percentage of African American and Black people in San Francisco with few city-supported social or medical service organizations. Individuals recruited via street outreach underwent testing for HIV and HCV antibodies.1,3

At the time of disclosure of HCV viremia, eligible individuals who provided voluntary consent were enrolled in the study and provided a 2-week starter pack of 400 mg of sofosbuvir and 100 mg of velpatasvir. Participants were transitioned to insurance-provided sofosbuvir-velpatasvir (SOF/VEL) when feasible to complete a 12-week treatment course.1,3

Of note, the study partnered with a pharmacy staff, including pharmacists and pharmacy technicians, at the University of California San Francisco specialty pharmacy, who worked with NOW study clinicians to create a collaborative workflow to facilitate SOF/VEL insurance authorization and dispensation to study participants.1

Of 492 people who underwent anti-HCV testing, 111 tested positive by anti-HCV antibody and confirmatory HCV RNA test. Of these eligible individuals, 89 (80%) returned for HCV RNA results disclosure and 87 (98%) accepted and initiated treatment at the point of diagnosis. Among the cohort, the majority of participants were male (71%), were currently injecting drugs (80%), unhoused (61%), and had an annual income below the 2020 US federal poverty line (97%).1

After initiating HCV treatment using a study-provided 14-day starter pack of medication, 75% of participants transitioned to insurance-covered SOF/VEL within 2 weeks. Overall, 90 % transitioned to insurance-covered SOF/VEL prior to completing the 12-week treatment course, with pharmacy members assisting participants in navigating insurance authorization, medication transport, and financial assistance.1

Investigators noted the remaining 10% never transitioned to insurance-covered medication because they were uninsured at trial enrollment (5%), had private managed care or VA insurance (5%), or voluntarily disenrolled from the trial prior to insurance verification (1%).1

“Collaborative care with an integrated pharmacy team was essential to the success of the NOW model. System-level barriers to accessing DAA HCV treatment, which disproportionately affects these marginalized populations, were mitigated by the NOW pharmacy team. The pharmacy team facilitated DAA access by assisting participants in navigating complex insurance and prescription drug-related barriers, including prior authorizations, medication costs, and medication delivery,” investigators concluded.1 “A similar approach could be used in other community-based HCV test-to-treat models.”

References

1. McGourty CA, Ung D, Clark M, et al. Facilitating access to direct-acting antivirals in a community-based point-of-diagnosis model for hepatitis C treatment: The role of the pharmacy team in the no one waits (NOW) study. International Journal of Drug Policy. https://doi.org/10.1016/j.drugpo.2025.104768

2. World Health Organization. Hepatitis C. April 9, 2024. Accessed March 17, 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

3. Morris MD, McDonell C, Luetkemeyer AF, et al. Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial. JAMA Netw Open.doi:10.1001/jamanetworkopen.2023.38792