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Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents.

ABSTRACT: BACKGROUND:It is unclear whether alcohol use negatively impacts HCV treatment outcomes in the era of direct antiviral agents (DAAs). We aimed to evaluate the associations between current levels of drinking and treatment response among persons treated for HCV with DAAs in the national Veterans Affairs (VA) healthcare system. METHODS:We identified patients who initiated HCV DAAs over 18 months (1/1/14-6/30/15) and had documented alcohol screening with the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire within one year prior to initiating therapy. DAAs included: sofosbuvir (SOF), ledipasvir/sofosbuvir (LDV/SOF) or ombitasvir-paritaprevir-ritonavir, and dasabuvir (PrOD). AUDIT-C scores were categorized as 0 (abstinence), 1-3 (low-level drinking) and 4-12 (unhealthy drinking) in men or 0, 1-2 and 3-12 in women. RESULTS:Among 17,487 patients who initiated DAAs, 15,151 (87%) completed AUDIT-C screening: 10,387 (68.5%) were categorized as abstinent, 3422 (22.6%) as low-level drinking and 1342 (8.9%) as unhealthy drinking. There were no significant differences in sustained virologic response (SVR) rates between abstinent (SVR 91%; 95% CI: 91-92%), low-level drinking (SVR 93%; 95% CI 92-94%) or unhealthy drinking (SVR 91%; 95% 89-92) categories in univariable analysis or in multivariable logistic regression models. However, after imputing missing SVR data, unhealthy drinkers were less likely to achieve SVR in multivariable analysis (AOR 0.75, 95% CI 0.60-0.92). CONCLUSION:Absolute SVR rates were uniformly high among all persons regardless of alcohol use, with only minor differences in those who report unhealthy drinking, which supports clinical guidelines that do not recommend excluding persons with alcohol use.

SUBMITTER: Tsui JI

PROVIDER: S-EPMC6534140 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents.

Tsui Judith I JI Williams Emily C EC Green Pamela K PK Berry Kristin K Su Feng F Ioannou George N GN

Drug and alcohol dependence 20161022

<h4>Background</h4>It is unclear whether alcohol use negatively impacts HCV treatment outcomes in the era of direct antiviral agents (DAAs). We aimed to evaluate the associations between current levels of drinking and treatment response among persons treated for HCV with DAAs in the national Veterans Affairs (VA) healthcare system.<h4>Methods</h4>We identified patients who initiated HCV DAAs over 18 months (1/1/14-6/30/15) and had documented alcohol screening with the Alcohol Use Disorders Ident ...[more]

PMID: 27810652

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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.

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Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents.

Publications

Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents.

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