Dataset Information

Association of the Extension for Community Healthcare Outcomes Project With Use of Direct-Acting Antiviral Treatment Among US Adults With Hepatitis C.

ABSTRACT:

Importance

Direct-acting antiviral (DAA) medications are highly effective in treating hepatitis C virus (HCV) infection. However, use of DAAs in rural and underserved areas is low owing to limited access to specialist physicians with experience in care of HCV infection. Project ECHO (Extension for Community Healthcare Outcomes) is a distance education model that trains primary care physicians to improve access to care for underserved populations with complex diseases such as HCV infection. Evidence on whether Project ECHO is associated with increased DAA use is limited.

Objective

To examine the association between Project ECHO and use of DAA treatment in patients with HCV infection.

Design, setting, and participants

This cohort study used data from Medicare beneficiaries who newly sought care for HCV infection between January 1, 2014, and December 31, 2017. Data were analyzed between September and December 2020.

Exposures

Project ECHO.

Main outcomes and measures

Use of DAA treatment. Discrete-time hazard models with state and year fixed effects were used to examine the association between Project ECHO and DAA use in rural areas and areas with low specialist density.

Results

A total of 267 908 patients (mean [SD] age, 60.7 [11.5] years; 57.9% male; 66.6% White patients) were included in the analysis. For every 100 clinicians attending a Project ECHO training, the odds of DAA treatment initiation among patients with HCV infection increased by 9% (adjusted odds ratio [OR], 1.09; 95% CI, 1.07-1.11; P < .001) in nonrural areas with specialist density equaling 0. The association between DAA use and Project ECHO was stronger in areas with lower vs higher specialist density. For every additional 100 Project ECHO participants, the odds of DAA use decreased by 1% as specialist density in the area increased (adjusted OR, 0.99; 95% CI, 0.98-1.00; P = .03). There was no association between Project ECHO and the odds of receiving DAAs among patients in rural vs urban areas (adjusted OR, 1.01; 95% CI, 0.99-1.02; P = .49).

Conclusions and relevance

In this cohort study, implementation of Project ECHO was associated with increased DAA use in areas with few specialist physicians, suggesting that Project ECHO may enhance access to DAA treatment through expanding the capacity of primary care physicians to treat HCV infection, especially in underserved areas.

SUBMITTER: Tran L

PROVIDER: S-EPMC8254131 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceRecent reports based on the US Food and Drug Administration's voluntary Adverse Events Reporting System raised questions about the safety of direct-acting antivirals (DAAs) for treatment of the hepatitis C virus (HCV).ObjectiveTo assess the rates of adverse events in patients with HCV infection exposed to DAAs compared with those not exposed.Design, setting, and participantsA retrospective cohort study calculated unadjusted adverse event rates for exposed vs unexposed time, using claims and clinical data from 3 health systems between January 1, 2012, and December 31, 2017. Of 82 419 eligible adults, a total of 33 808 who met eligibility criteria (age, 18-88 years; HCV quantitative result or genotype from 2012 or later; continuously enrolled; naive to DAA treatment at baseline) were included. Marginal structural modeling methods were used to adjust time-to-event analyses for characteristics that are associated with both outcomes and probability of treatment.Interventions or exposuresExposure to DAAs compared with no DAA exposure.Main outcomes and measuresDeath, multiple organ failure, liver cancer, hepatic decompensation, acute-on-chronic liver event, acute myocardial infarction, ischemic or hemorrhagic stroke, arrhythmia, acute kidney failure, nonliver cancer, hepatitis B reactivation, hospitalizations, and emergency department visits.ResultsOf the 33 808 patients who met all inclusion criteria, 20 899 (61.8%) were men; mean (SD) age was 57.2 (10.6) years. In unadjusted analyses, DAA exposure was associated with significantly lower rates of death (10.7 vs 33.7 events per 1000 person-years; rate ratio [RR], 0.32, 95% CI, 0.25-0.40). Seven other unadjusted adverse clinical events ratios were below 70% and statistically significant favoring the DAA group: multiple organ failure (RR, 0.56; 95% CI, 0.44-0.72), liver cancer (RR, 0.62; 95% CI, 0.48-0.80), hepatic decompensation (RR, 0.62; 95% CI, 0.52-0.73), acute-on-chronic liver event (RR, 0.68; 95% CI, 0.56-0.84), acute myocardial infarction (RR, 0.64; 95% CI, 0.42-0.97), ischemic stroke (RR, 0.63; 95% CI, 0.42-0.95), and hemorrhagic stroke (RR, 0.47; 95% CI, 0.25-0.89); none favored the non-DAA group. In the marginal structural modeling-adjusted analysis, DAA exposure was associated with statistically significant lower odds of adverse events than non-DAA exposure for death (adjusted odds ratio [aOR], 0.42; 95% CI, 0.30-0.59), multiple organ failure (aOR, 0.67; 95% CI, 0.49-0.90), hepatic decompensation (aOR, 0.61; 95% CI, 0.49-0.76), acute-on-chronic liver event (aOR, 0.71; 95% CI, 0.56-0.91), and arrhythmia (aOR, 0.47; 95% CI, 0.25-0.88).Conclusions and relevanceDirect-acting antiviral exposure may not be associated with higher rates of any serious adverse events, including those related to liver, kidney, and cardiovascular systems. Safety concerns based on previous reports did not appear to be supported in this study with more comprehensive data and rigorous statistical methods.