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Journal Club

Journal Club. Alcohol, Other Drugs, and Health: Current Evidence March–April 2017. Featured Article. Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents Tsui JI, et al. Drug Alcohol Depend . 2016;169:101–109. Study Objective.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2017 www.aodhealth.org

  2. Featured Article Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents Tsui JI, et al. Drug Alcohol Depend. 2016;169:101–109. www.aodhealth.org

  3. Study Objective • To examine the association between direct-acting antiviral agent (DAA) HCV treatment outcomes (sustained virologic response [SVR]), and alcohol use. www.aodhealth.org

  4. Study Design • Observational study among 15,151 patients in the Veteran’s Administration health system who initiated HCV DAAs over 18 months (1/1/14–6/30/15) and had completed the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire* within one year prior to initiating therapy. * AUDIT-C scores were categorized as: abstinence (0), low-level drinking (1-3 for men, 1-2 for women), and unhealthy drinking (4-12 in men, 3-12 in women). www.aodhealth.org

  5. Assessing Validity of an Article about Prognosis • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org

  6. Are the Results Valid? • Was the sample representative? • Were the subjects sufficiently homogeneous with respect to prognostic risk? • Was follow-up sufficiently complete? • Were objective and unbiased outcome criteria used? www.aodhealth.org

  7. Was the sample representative? • Participants in the study (N=15,151) were patients in the Veterans Administration. • 52% white • Average age of 60 years • 96.7% male • 44% had alcohol use disorder • 37% had substance use disorder • 79.8% had HCV genotype 1 www.aodhealth.org

  8. Were the subjects sufficiently homogeneous with respect to prognostic risk? • Yes. www.aodhealth.org

  9. Was follow-up sufficiently complete? • “Data on SVR were missing in 1409 out of the 15,151 patients who received antiviral treatment (9.3%). The proportion of patients with missing SVR data was greater in the [people with unhealthy drinking] (12.9%) than in the [people with low-level drinking] (9.8%) and the abstinent group (8.7%).” www.aodhealth.org

  10. Were objective and unbiased outcome criteria used? • Yes. The primary outcome, acheivement of SVR, was objectively determined through the electronic medical record. www.aodhealth.org

  11. What Are the Results? • How likely are the outcomes over time? • How precise are the estimates of likelihood? www.aodhealth.org

  12. How likely are the outcomes over time? • There was no difference in SVR between those who were abstinent (92%), had low-level drinking (93%), or unhealthy drinking (91%). If everyone with missing SVR data was considered a treatment failure, the SVR rate for those with unhealthy drinking (79%) was lower than for those who were abstinent (84%), or had low-level drinking (84%). www.aodhealth.org

  13. How precise are the estimates of likelihood? • On multivariable analysis, there was no difference in SVR between the 3 drinking categories. • However, in a model with imputation of missing SVR data, when compared with those who were abstinent, those with unhealthy drinking were less likely to achieve SVR (adjusted odds ratio [aOR], 0.75, 95% CI 0.60–0.92), while those with lower-level drinking were not (aOR, 1.03, 95% CI 0.89–1.2). www.aodhealth.org

  14. How Can I Apply the Resultsto Patient Care? • Were the study patients and their management similar to those in my practice? • Was follow-up sufficiently long? • Can I use the results in the management of patients in my practice? www.aodhealth.org

  15. Were the study patients similar to those in my practice? • The study population was large, but consisted of patients who were mostly male with an average age around 60 years. www.aodhealth.org

  16. Was follow-up sufficiently long? • Yes. www.aodhealth.org

  17. Can I use the results in the management of patients in my practice? • Yes. This study adds to a growing body of evidence showing high success rates for treatment of HCV with DAAs, regardless of alcohol or other drug use. • Even if the success rates are somewhat lower among those with alcohol use disorder, this should not deter us from considering HCV treatment with DAAs. www.aodhealth.org

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