Outcomes from the Kentucky viral hepatitis treatment (key treat) trial: a model of care for the treatment of the Hepatitis C virus in a rural Appalachian county in the U.S.


Author: Havens JR, Schaninger T, Lofwall MR, Young AM, Fraser H, Vickerman P, and Walsh SL.

Theme: Models of Care Year: 2024

Background: Multiple models of care will need to be employed to achieve elimination of the hepatitis C virus (HCV) in the United States. Implemented in 2019, KeY Treat sought to remove barriers to accessing HCV care in a rural county in the U.S. severely impacted by the opioid/HCV syndemic.

Methods: The Xpert HCV VL Fingerstick assay was utilized to streamline enrollment for those age>18 with detectable HCV RNA. Most (85%) participants were initiated on sofosbuvir/velpatasvir (SOF/VEL) at the first visit. The analytic sample includes 380 participants who were eligible and consented to study enrollment and per-protocol (PP) and intent-to-treat (ITT) sustained virologic response (SVR-12) rates are reported. A generalized linear model was used to estimate the relative risk (RR) of PP SVR-12.

Results: The majority of participants were male (58.5%), White (96.6%), and the median age was 41.8 years (IQR: 35.4, 48.7) One-third of participants injected drugs (mostly methamphetamine [92.3%)] in the past 30 days. Approximately 15% of participants were lost to follow-up. Per protocol SVR-12 rates were 92.7% and intent-to-treat SVR-12 78.1%. The RR of SVR-12 was significantly greater among females and older participants. Those reporting recent drug injection were 11% less likely to achieve SVR-12 versus those without recent injection (adjusted RR: 0.89, 95% Confidence Interval [CI]: 0.83, 0.97).

Conclusions: Results suggest that KeY Treat is a viable model of care, especially in those rural areas impacted by the opioid/HCV syndemic. SVR-12 was achievable for most participants. Even though people injecting drugs were less likely to achieve SVR, cure rate were still upwards of 85% in this population. Efforts to optimize outcomes among those who are actively injecting drugs should be a priority to facilitate elimination efforts. This, however, may be particularly challenging in rural regions of the U.S. with little to no access to harm reduction.

Download abstract Download slides Watch video