Dataset Information

Association of Direct-Acting Antiviral Treatment With Mortality Among Medicare Beneficiaries With Hepatitis C.

ABSTRACT: Importance: Direct-acting antiviral (DAA) drugs are highly effective in curing hepatitis C virus (HCV) infection. Previous simulations showed extended life as a key health advantage of DAA drugs, but real-world evidence on the association between DAA treatment and reduced mortality is limited.

Objectives: To examine the association of DAA treatment with mortality among Medicare beneficiaries with hepatitis C.

Design, setting, and participants: This cohort study used Medicare claims data of beneficiaries who sought hepatitis C care for the first time between January 1, 2014, and December 31, 2016, after at least a 1-year washout period. Medicare Part D files were used in identifying DAA therapy initiation and completion. Death dates, demographic data, and indicators of health risks were obtained from the Master Beneficiary Summary Files. Beneficiaries with hepatitis C were considered as patients with DAA treatment if they initiated DAA therapy during the study period. Beneficiaries with hepatitis C who did not initiate DAA therapy during the study period were considered as patients without DAA treatment. Patients without DAA treatment were selected using 1-to-1 propensity score matching. Data were analyzed between September 1, 2019, and March 31, 2020.

Exposures: Completion of DAA treatment.

Main outcomes and measures: Time to death from the index date of seeking hepatitis C care after at least a 1-year washout period. Cox proportional hazards regression models with time-varying exposure were used to compare mortality rates between propensity score-matched cohorts of patients with DAA treatment and those without DAA treatment. Separate analyses were performed for patients with or without cirrhosis. Heterogeneity in the association between DAA treatment and mortality by sex and dual-eligibility status was examined.

Results: A propensity score-matched sample of 51?478 Medicare beneficiaries with a mean (SD) age of 59.4 (11.1) years and 30 473 men (59.2%) was assessed. Of this total, 8240 patients (16.0%) had cirrhosis (5224 men [63.4%]; mean [SD] age, 62.3 [9.7] years) and 43?238 patients (84.0%) had no cirrhosis (25 249 men [58.4%]; mean [SD] age, 58.8 [11.3] years). The adjusted hazard ratio (HR) of dying between patients with DAA treatment and those without DAA treatment in the cirrhosis group was 0.51 (95% CI, 0.46-0.57). The association of DAA treatment with mortality did not differ by sex (women vs men: HR, 0.46 [95% CI, 0.38-0.56] vs HR, 0.53 [95% CI, 0.47-0.60]; P?=?.27) or dual-eligibility status (non-dual-eligible HR, 0.52 [95% CI, 0.43-0.63] vs dual-eligible HR, 0.50 [95% CI, 0.44-0.57]; P?=?.80) in the cirrhosis group. The adjusted HR of dying between patients with DAA treatment and those without DAA treatment among patients without cirrhosis was 0.54 (95% CI, 0.50-0.58). The association of DAA treatment with mortality did not differ by sex (women vs men: HR, 0.53 [95% CI, 0.46-0.60] vs HR, 0.55 [95% CI, 0.50-0.60]; P?=?.66) among patients without cirrhosis. However, the survival advantage associated with DAAs for non-dual-eligible beneficiaries was statistically significantly higher than for dual-eligible beneficiaries among patients without cirrhosis (HR, 0.47 [95% CI, 0.41-0.55] vs HR, 0.57 [95% CI, 0.52-0.62]; P?=?.02).

Conclusions and relevance: In this cohort study, DAA treatment appeared to be associated with a decrease in mortality among Medicare beneficiaries with or without cirrhosis. These findings suggest that increasing access to DAA drugs for all patients with HCV infection, regardless of disease progression, could improve population health.

SUBMITTER: Kalidindi Y

PROVIDER: S-EPMC7737657 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Association of Direct-Acting Antiviral Treatment With Mortality Among Medicare Beneficiaries With Hepatitis C.

Kalidindi Yamini Y Jung Jeah J Feldman Roger R Riley Thomas T

JAMA network open 20200701 7

<h4>Importance</h4>Direct-acting antiviral (DAA) drugs are highly effective in curing hepatitis C virus (HCV) infection. Previous simulations showed extended life as a key health advantage of DAA drugs, but real-world evidence on the association between DAA treatment and reduced mortality is limited.<h4>Objectives</h4>To examine the association of DAA treatment with mortality among Medicare beneficiaries with hepatitis C.<h4>Design, setting, and participants</h4>This cohort study used Medicare c ...[more]

PMID: 32692371

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Project description:ImportanceDirect-acting antiviral (DAA) therapy for hepatitis C is highly effective but expensive. Evidence is scarce on whether DAA therapy reduces downstream medical costs.ObjectiveTo examine the association of DAA therapy with posttreatment medical costs among Medicare beneficiaries.Design, setting, and participantsThis retrospective cohort study obtained data from various Medicare claims files for 2013 to 2017. The study population comprised patients with a hepatitis C diagnosis in 2014 who were enrolled in fee-for-service Medicare and Part D. Multivariate regression models were used to compare changes in medical costs over a 30-month posttreatment follow-up period between patients who used DAA therapy (treatment group) and a propensity score-matched cohort of patients who did not use DAA (control group). The model was estimated separately for patients with and those without cirrhosis. Data were analyzed between September 1, 2019, and March 31, 2020.ExposuresCompletion of DAA therapy.Main outcomes and measuresTwo outcomes were established: hepatitis C or liver disease-related costs and total medical costs. Costs were measured by Medicare-allowed payments, which included Medicare reimbursements, patient responsibilities, and third-party payments.ResultsA propensity score-matched cohort of 15 198 patients (9038 men [59.5%]; mean [SD] age, 60.2 [10.8] years) was analyzed. During the first 6 months after DAA therapy, hepatitis C or liver disease-related costs decreased by $2498 (95% CI, -$3356 to -$1640) in patients with cirrhosis and by $486 (95% CI, -$603 to -$369) in patients without cirrhosis compared with control or untreated patients. Cumulative reductions in hepatitis C or liver disease-related costs during 30 months after DAA treatment were $15 808 (95% CI, -$22 530 to -$9085) in patients with cirrhosis and $5372 (95% CI, -$6384 to -$4360) in patients without cirrhosis. Among those who used DAA therapy compared with control patients, total medical costs decreased by $2905 (95% CI, -$4832 to -$979) in patients with cirrhosis and by $1287 (95% CI, -$2393 to -$283) in patients without cirrhosis during the first 6 months after DAA therapy. No statistically significant association was found between DAA therapy and total medical cost reductions after 12 months of follow-up. Cumulative reductions in total costs during 30 months after DAA therapy were $7074 (95% CI, -$18 448 to $4298) in patients with cirrhosis and $7497 (95% CI, -$14 287 to -$709) in patients without cirrhosis.Conclusions and relevanceThis study reported that DAA therapy appeared to be associated with a decrease in hepatitis C or liver disease-related costs for 30 months after treatment and with reduction in total medical costs for only 12 months after treatment in patients with or without cirrhosis. Longer-term follow-up studies with diverse outcomes are necessary to assess the value of DAA therapy.

Project description:ImportanceDirect-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection is associated with lower mortality and is effective in individuals with alcohol use disorder (AUD). However, despite recommendations, patients with AUD may be less likely to receive DAAs.ObjectiveTo assess the association between alcohol use and receipt of DAA treatment among patients with HCV within the Veterans Health Administration (VHA).Design, setting, and participantsThis cohort study included 133 753 patients with HCV born from 1945 to 1965 who had completed the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and had at least 1 outpatient visit in the VHA from January 1, 2014, through May 31, 2017, with maximal follow-up of 3 years until May 31, 2020; DAA receipt; or death, whichever occurred first.ExposuresAlcohol use categories generated using responses to the AUDIT-C questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses: current AUD, abstinent with AUD history, at-risk drinking, lower-risk drinking, and abstinent without AUD history. Demographic, other clinical, and pharmacy data were also collected.Main outcomes and measuresAssociations between alcohol use categories and DAA receipt within 1 and 3 years estimated using Cox proportional hazards regression stratified by calendar year.ResultsOf 133 753 patients (130 103 men [97%]; mean [SD] age, 60.6 [4.5] years; and 73 493 White patients [55%]), 38% had current AUD, 12% were abstinent with a history of AUD, 6% reported at-risk drinking, 14% reported lower-risk drinking, and 30% were abstinent without a history of AUD. Receipt of DAA treatment within 1 year was 7%, 33%, 53%, and 56% for patients entering the cohort in 2014, 2015, 2016, and 2017, respectively. For patients entering in 2014, those with current AUD (hazard ratio [HR], 0.72 [95%, CI, 0.66-0.77]) or who were abstinent with an AUD history (HR, 0.91 [95% CI, 0.84-1.00]) were less likely to receive DAA treatment within 1 year compared with patients with lower-risk drinking. For those entering in 2015-2017, patients with current AUD (HR, 0.75 [95% CI, 0.70-0.81]) and those who were abstinent with an AUD history (HR, 0.76 [95% CI, 0.68-0.86]) were less likely to receive DAA treatment within 1 year compared with patients with lower-risk drinking.Conclusions and relevanceThis cohort study suggests that individuals with AUD, regardless of abstinence, were less likely to receive DAA treatment. Improved access to DAA treatment for persons with AUD is needed.

Project description:UnlabelledHepatitis C virus (HCV) is the most common cause of mixed cryoglobulinemia syndrome (MCS). The efficacy and safety of all-oral direct-acting antiviral (DAA) therapy in HCV-associated MCS (HCV-MCS) is largely unknown. The authors studied case series of patients with HCV-MCS who were treated with sofosbuvir-based regimens and historical controls treated with pegylated interferon and ribavirin in a single health care network. HCV-MCS was defined by circulating cryoglobulin associated with systemic vasculitis symptoms. Renal involvement (n = 7) was established by kidney biopsy (n = 5) or by two or more of the following clinical findings: reduced kidney function, proteinuria, or hematuria with other causes excluded (n = 2). Twelve patients received DAA therapy between December 2013 and September 2014. Median age was 61 years, 58% were male, and 50% had cirrhosis. Median baseline serum creatinine was 0.97 mg/dL (range 0.7-2.47). Four patients received rituximab concurrent with DAA therapy. Sustained virological response rate at 12 weeks (SVR12) was 83% overall. Patients with glomerulonephritis who achieved SVR12 experienced an improvement in serum creatinine and a reduction in proteinuria. Cryoglobulin levels decreased in 89% of patients, with median percent decreasing from 1.5% to 0.5% and completely disappearing in four of nine cases who had cryoglobulins measured after treatment. Serious adverse events were infrequent (17%). In contrast, the historical cohort treated with pegylated interferon and ribavirin experienced only 10% SVR12, with 100% experiencing at least one adverse event and 50% experiencing premature discontinuation due to adverse events.ConclusionSVR12 rates for sofosbuvir-based DAA regimens in HCV-MCS were 83%, significantly higher than historical controls treated with pegylated interferon and ribavirin; patients with glomerulonephritis experienced improvement in renal function, including those not concomitantly treated with immunosuppression.

Dataset Information

Association of Direct-Acting Antiviral Treatment With Mortality Among Medicare Beneficiaries With Hepatitis C.

Publications

Association of Direct-Acting Antiviral Treatment With Mortality Among Medicare Beneficiaries With Hepatitis C.

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