People with hepatitis C who start direct-acting antiviral treatment when and where they are diagnosed had a high likelihood of achieving a cure, according to study results presented at the 2021 AASLD Liver Meeting. By eliminating the need to navigate the medical system, this model could be a good option for marginalized populations, including people experiencing homelessness and people who inject drugs.
Meghan Morris, MD, MPH, and colleagues at the University of California at San Francisco conducted the No One Waits study to assess the feasibility and effectiveness of delivering hepatitis C virus (HCV) treatment at the point where people receive a positive HCV RNA test result and are told of their diagnosis.
One of the major barriers to hepatitis C treatment, particularly for marginalized groups, is linking diagnosed people to care that requires them to follow up elsewhere. Prompt treatment leads to faster improvement of symptoms, lowers the risk of liver disease progression and prevents onward transmission of HCV. Eliminating the linkage step could lessen the likelihood that people will be lost to follow-up and fall out of care.
Study participants were recruited via street outreach in San Francisco targeting people experiencing homelessness and people who inject drugs. They first received a rapid HCV antibody test; if that was positive, it was followed with an HCV RNA test to determine whether they had a detectable HCV viral load, indicating active infection.
Those who tested HCV RNA positive were given a two-week starter pack of Epclusa (sofosbuvir/velpatasvir) when they received their diagnosis. Those who had health insurance received a prescription for the remainder of the 12-week treatment course and help obtaining payment assistance. Uninsured people continued to receive two-week supplies until they were insured.
Between July 2020 and September 2021—in the midst of the COVID-19 pandemic—414 individuals were initially screened for hepatitis C. Nearly half tested HCV antibody positive, including 113 people (27%) who were also HCV RNA positive and therefore eligible for treatment. Seventy-five of the 113 individuals (66%) returned for their HCV RNA test results, and all but two of these started treatment when given their diagnosis.
In the group of 73 treated participants, 70% were men, and the median age was 47 years. About 60% were white, 27% were Black and 11% were Latino. A majority were unhoused (61%), currently injected drugs (72%) and had an income below the federal poverty level (84%). However, just over half had a primary health care provider (53%).
At the time of the analysis, 47 treated participants (84%) had completed the 12-week course of therapy, while seven were lost to follow-up because they moved, and two were taken off treatment due to low adherence. Of the 47 who completed treatment, 42 (89%) had undetectable HCV RNA at the end of therapy. Among the 27 people who returned for follow-up testing 12 weeks after completing treatment, 26 (96%) achieved a sustained virological response (SVR-12), which is considered a cure.
“Preliminary results from our ongoing trial of people experiencing homelessness and currently injecting drugs indicate that point-of-diagnosis HCV treatment initiation is acceptable, feasible and results in high treatment completion and SVR,” the researchers concluded. They added that community engagement, participant rapport, financial reimbursement or provision of medication and wraparound services were “important factors for sustained clinical engagement.”
A limitation of this study is that participants did not have access to rapid HCV RNA testing and were required to come back to receive their diagnosis. A third did not do so, suggesting that on-the-spot diagnosis could further increase treatment initiation and cure rates.
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