The researchers noted that their findings suggest clinicians and policy makers should encourage hepatitis C virus (HCV) treatment in those with unhealthy alcohol consumption or alcohol use disorder (AUD) rather than create barriers to it.
A patient's alcohol consumption or alcohol use disorder (AUD) does not lower their odds of achieving sustained virologic response (SVR) when receiving direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection, according to a study published in JAMA Network Open.
The researchers explained that clinicians previously treated HCV with interferon-based regimens, and patients who actively consumed alcohol in the previous year were more likely to discontinue treatment. As a result, many clinicians were reluctant to treat those with recent alcohol use despite these patients still achieving SVR.
Nowadays, clinicians treat HCV with DVV therapy. The current guidelines of the American Association for the Study of Liver Disease (AASLD), Infectious Diseases Society of America (IDSA), and the Department of Veteran Affairs (VA) do not advise clinicians to withhold DAA therapy from patients who drink, regardless of their intake levels. However, the researchers explained that some clinicians still withhold DAA therapy from those who consume alcohol, and some payers require alcohol abstinence for reimbursement. Because of this, they conducted a study to determine whether alcohol use prevents patients receiving DAA therapy for HCV from achieving SVR.
The researchers created a study population based on data from the VA Corporate Data Warehouse, which is collected from more than 1200 health care facilities. Their population consisted of patients from the 1945 to 1965 VA Birth Cohort, who initiated interferon-free DAA therapy between January 1, 2014, and June 30, 2018.
“This birth cohort was chosen because people born between 1945 and 1965 are known to have a 6-fold higher prevalence of HCV infection compared with all other age groups,” the authors wrote. “In addition, the CDC and the US Preventive Services Task Force recommended onetime HCV screening for these individuals during the time of study.”
The researchers included 69,229 patients in the primary analyses, the population having a mean (SD) age of 62.6 (4.5) years. The population consisted of 67,150 (97.0%) men, 34,655 (50.1%) non-Hispanic White patients, and 28,094 (40.6%) non-Hispanic Black patients.
They created alcohol use categories based on responses to the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) questionnaire and AUD diagnoses defined in both the International Classification of Diseases, Ninth Revision and the International Statistical Classification of Diseases, Tenth Revision.
Based on patient responses and diagnoses, the researchers classified them into 1 of the following categories: abstinent without history of AUD (AUDIT-C score of 0 and absence of AUD diagnosis), abstinent with history of AUD (AUDIT-C score of 0 and presence of AUD diagnosis), lower-risk consumption (AUDIT-C score of 1-3 and absence of AUD diagnosis), moderate-risk consumption (AUDIT-C score of 4-7 and absence of AUD diagnosis), or high-risk consumption or AUD (AUDIT-C score of >8 or presence of AUD diagnosis with nonzero AUDIT-C score).
The researchers found that 32,290 patients (46.6%) were abstinent without AUD, 13,415 (19.4%) had lower-risk consumption, 11,215 (16.2%) had high-risk consumption or AUD, 9192 (13.3%) were abstinent with AUD, and 3117 (4.5%) had moderate-risk consumption. Overall, 65,355 patients achieved SVR; the researchers noted that 58,651 did so 12 weeks to 6 months after DAA therapy completion, while 6704 did so 4 to 12 weeks after completion.
In an unadjusted model, the researchers explained that patients who were abstinent without AUD history (odds ratio [OR], 0.89; 95%CI, 0.81-0.97) and those who were abstinent with AUD history (OR,0.71; 95%CI, 0.64-0.80) had lower odds of achieving SVR compared with patients who reported lower-risk consumption. On the other hand, in the fully adjusted model, no alcohol category was significantly associated with decreased odds of SVR (abstinent without AUD history: OR, 1.09; 95% CI, 0.99-1.20; abstinent with AUD history: OR, 0.92; 95% CI, 0.82-1.04; moderate-risk consumption: OR, 0.96; 95% CI, 0.80-1.15; high-risk consumption or AUD: OR, 0.95; 95% CI, 0.85-1.07).
“Our findings suggest that clinicians and policy makers should encourage HCV treatment in those with unhealthy alcohol consumption or AUD, rather than creating barriers to HCV treatment,” the authors wrote. “Given the high rates of SVR across all alcohol use categories, there is no indication for payers to require alcohol abstinence before reimbursement of DAA therapy for HCV infection.”
The researchers acknowledged various limitations to their study, one being their use of data from patients born between 1945 and 1965, meaning their findings may not be generalizable to those born outside of this time frame. Additionally, these findings may not be generalizable to women as they only made up a small portion of the study population.
Despite these limitations, the researchers noted that their study has many strengths, including their access to detailed, diverse electronic health record data. Consequently, they are confident in their findings, noting that DAA therapy should be provided, and its costs reimbursed, regardless of a patient’s alcohol consumption or AUD history.
“Restricting access to DAA therapy according to alcohol consumption or AUD creates an unnecessary barrier to patients accessing DAA therapy and challenges HCV elimination goals,” the authors concluded.
Reference
Cartwright EJ, Pierret C, Minassian C, et al. Alcohol use and sustained virologic response to hepatitis C virus direct-acting antiviral therapy. JAMA Netw Open. 2023;6(9):e2335715. doi:10.1001/jamanetworkopen.2023.35715
Despite Record ACA Enrollment, Report Reveals Underinsured Americans are in Crisis
November 21st 2024Despite significant progress in expanding health insurance coverage since the Affordable Care Act (ACA) was enacted, millions of Americans still face critical gaps in access and affordability to health care.
Read More
New Study Finds Risk Groups, Outpatient Care Barriers in Chronic Liver Disease
November 20th 2024Patients with chronic liver disease who were unable to establish care were 85% more likely to require recurrent hospitalizations. This group included a disproportionate number of women and individuals with physical limitations affecting their health.
Read More
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
Listen
Why Right Heart Catheterization Confirming PAH Diagnosis May Be Underperformed
November 20th 2024Professional guidelines say that when pulmonary arterial hypertension (PAH) is diagnosed, right heart catheterization should be performed, but a quarter of the time, it isn’t—so investigators set out to discover why.
Read More
OS Better With Belantamab Mafodotin Triplet vs Daratumumab in R/R MM
November 19th 2024The key secondary end point of overall survival (OS) was met in the DREAMM-7 trial of belantamab mafodotin (Blenrep; GSK) for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM).
Read More