Abstract and Introduction
Abstract
Despite the release of a growing number of direct-acting antivirals and evolving policy landscape, many of those diagnosed with hepatitis C virus (HCV) have not received treatment. Those from vulnerable populations are at particular risk of being unable to access treatment, threatening World Health Organization (WHO) HCV elimination goals. The aim of this study was to understand the association between direct-acting antivirals approvals, HCV-related policy changes and access to HCV virus treatment in Indiana, and to explore access to treatment by race, birth cohort and insurance type. We performed a retrospective cohort study of adults with HCV from 05/2011-03/2021, using statewide electronic health data. Nine policy and treatment changes were defined a priori. A Lowess curve evaluated treatment trends over time. Monthly screening and treatment rates were examined. Multivariable logistic regression explored predictors of treatment. The population (N = 10,336) was 13.4% Black, 51.8% was born after 1965 and 44.7% was Medicaid recipients. Inflections in the Lowess curve defined four periods: (1) Interferon + DAA, (2) early direct-acting antivirals, (3) Medicaid expansion/optimization and (4) Medicaid restrictions (fibrosis/prescriber) removed. The largest increase in monthly treatment rates was during period 4, when Medicaid prescriber and fibrosis restrictions were removed (2.4 persons per month [PPM] in period 1 to 72.3 PPM in period 4, p < 0.001; 78.0% change in slope). Multivariable logistic regression analysis showed being born after 1965 (vs. before 1945; OR 0.69; 95% 0.49–0.98) and having Medicaid (vs. private insurance; OR 0.47; 95% CI 0.42–0.53), but not race was associated with lower odds of being treated. In conclusion, DAAs had limited impact on HCV treatment rates until Medicaid restrictions were removed. Additional policies may be needed to address HCV treatment-related age and insurance disparities.
Introduction
There are estimated to be over 70 million people globally and 2.4 million persons in the United States (US) living with hepatitis C virus (HCV).[1] The burden of disease is particularly high amongst vulnerable populations including younger people who inject drugs and racial and ethnic minorities.[1,2] Chronic HCV infection is characterized by progressive fibrosis, leading to cirrhosis and the potential development of hepatocellular carcinoma (HCC) and need for liver transplantation.[3]
By 2030, the World Health Organization global elimination targets for HCV are 80% of those eligible treated, 90% reduction in incidence of new infections and 65% reduction in liver-related mortality.[4] Recent medical advances, including the development of the more tolerable and effective direct-acting antiviral agents (DAAs), make achieving these goals possible.[5,6] However, accessing DAAs remain an issue, particularly for vulnerable populations; Black and Hispanic populations, and those insured with Medicaid are less likely to be treated than White and privately insured patients respectively.[7,8]
Policy changes have been made to reduce barriers to accessing care and receiving HCV treatment. In 2014, the Affordable Care Act (ACA) sought to expand insurance coverage through an optional state-level expansion of Medicaid.[9,10] In February of 2015, Indiana adopted a state-specific version of Medicaid expansion.[11] Locally, policies to improve access to treatment have been initiated and include Indiana Medicaid's negotiation of supplemental pharmaceutical rebate agreements, adoption of the HCV Extension of Community Healthcare Outcomes (ECHO) programme, and Medicaid's removal of the specialist provider and advanced fibrosis restriction requirements for treatment.[12–14]
There is ongoing interest in the impact of policy changes on access to care and treatment. Research on healthcare utilization by race, ethnicity and gender before and after implementation of the ACA showed non-Hispanic White patients had the greatest improvements, and Black men and women fared the worst with respect to changes in healthcare access.[15] With regard to HCV specifically, we previously showed that following the expansion of Medicaid, fewer Black patients with HCV were waitlisted for liver transplant in states that expanded the programme compared with states that did not. We hypothesized that this trend is related to increased access to treatment in states with expanded programmes leading to lower burdens of decompensated liver disease necessitating waitlisting of Black HCV patients.[16]
Advances in HCV treatment and policy changes facilitating access to treatment have the potential to substantially change the chronic liver disease landscape for all patients, including those from vulnerable populations and help us achieve the WHO HCV elimination goals. However, it is unclear which, if any, of these policies have translated into increases in HCV treatment rates. Understanding the impact of policies on treatment trends can inform public health HCV elimination efforts. Therefore, our study aims were to: (1) examine the association between policy changes and DAA approval on HCV treatment trends in Indiana, and (2) identify factors associated with receiving treatment for HCV infection to better understand what, if any, disparities exist in the receipt of HCV treatment in Indiana.
J Viral Hepat. 2022;29(5):366-374. © 2022 Blackwell Publishing
