Point-of-diagnosis HCV treatment model yields 95% SVR at 12 weeks among marginalized group
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Key takeaways:
- Of those who completed treatment, 92% had undetectable hepatitis C virus RNA at completion and 95% attained sustained virologic response at week 12.
- No adverse events or deaths were reported.
A test-and-treat model for hepatitis C virus infection among injection drug users and people experiencing homelessness resulted in high levels of treatment initiation, completion and cure, and may expand care access to marginalized groups.
“Marginalized populations, including people experiencing homelessness or housing instability, people in marginalized racial and ethnic groups, people with current or prior justice system involvement and, particularly, people who inject drugs (PWID), are disproportionately affected by HCV,” Meghan D. Morris, MPH, PhD, of the department of epidemiology and biostatistics at the University of California, San Francisco, and colleagues wrote in JAMA Network Open. “Providing HCV treatment in a trusted community setting at the time of diagnosis could facilitate improved treatment uptake and reduce loss to follow-up for difficult-to-link populations.”
In a single arm, nonrandomized controlled trial, researchers investigated the feasibility, acceptability and safety of the test-and-treat No One Waits model of care by recruiting individuals experiencing homelessness or PWID at a nonmedical community site in San Francisco.
The model provided participants a 2-week starter pack of sofosbuvir 400 mg and velpatasvir 100 mg at the time of HCV RNA test disclosure, followed by a 12-week insurance-provided course of treatment. The primary studied endpoint was sustained virologic response at week 12 (SVR12).
Between July 2020 and October 2021, the outreach team enrolled 492 people (median age, 48 years; 71% men), of whom 111 (23%) tested positive for HCV RNA and were eligible for treatment. Of those, 80% returned for confirmatory results, 98% initiated treatment and 79% completed 12 weeks of treatment with sofosbuvir-velpatasvir.
Researchers noted that 97% of participants had income below the poverty line, 94% had lifetime injection drug use, 80% reported current injection drug use and 61% experienced homelessness in the past year.
Of 66 individuals who completed treatment, 92% had undetectable HCV RNA at treatment completion and 95% attained SVR12, which corresponded with a treatment response of 67% (95% CI, 56-76) in the intention-to-treat population and 84% (95% CI, 73-92) in the per-protocol group.
Researchers noted that a “significantly greater number” of those who experienced homelessness in the past 12 months did not attain SVR12 compared with individuals who did not experience homelessness (83% vs. 17%).
There were no adverse events, late exclusions or deaths reported within the study population.
“Point-of-diagnosis HCV treatment initiation among PWID and people experiencing homelessness was feasible and acceptable and yielded high SVR12 rates,” Morris and colleagues concluded. “Our trial was conducted in a nonclinical community space with procedures specifically designed to reflect the environment and services needed to provide HCV testing, disclosure and treatment to a socially marginalized population.”
They continued: “A similar approach could be used in other nonclinical settings and same-day HCV test-and-treat models.”
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