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

2. Tsui JI, et al. Drug Alcohol Depend.
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.

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

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).

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?
Based on the Users’ Guides to the Medical Literature; for more information, see the following:

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?

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

8. Were the subjects sufficiently homogeneous with respect to prognostic risk?
Yes.

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%).”

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

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

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%).

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).

14. How Can I Apply the Results to 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?

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.

16. Was follow-up sufficiently long?
Yes.

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.