Category: Federal Forum Posters
Purpose: The primary objective of this study was to determine the impact of successful treatment of Hepatitis C with antiviral pharmacotherapy on the change in hemoglobin A1c (HbA1c) in patients with type 2 diabetes mellitus (T2DM). In addition, this study investigated the impact of therapy on microvascular complications (retinopathy, nephropathy, and neuropathy) and macrovascular complications (stroke, myocardial infarction, and death) of type 2 diabetes mellitus in the veteran population with Hepatitis C.
Methods: A retrospective cohort analysis was conducted through electronic chart review in patients with chronic Hepatitis C and T2DM. The local Hepatitis C clinical case registry was used to identify patients treated from January 1, 2005 to June 30, 2016 in the pharmacy liver clinic. Patients were included in the study if they completed antiviral Hepatitis C treatment at the Providence Veterans Affairs Medical Center and had a diagnosis of type 2 diabetes mellitus. Patients were excluded from the study if they did not complete antiviral therapy, were lost to follow-up, or died before sustained virologic response could be assessed, or were enrolled in hospice or palliative services at time of enrollment. Patients were characterized based upon achievement of sustained virologic response. The primary outcome was the change in mean HbA1c, which was analyzed for the 24-month period pre-treatment and post-treatment using a paired t-test. We estimated that a sample size of 90 patients would provide 80% power to detect a 0.37% difference in HbA1c pre- and post- treatment assuming a standard deviation of 1.2% and an alpha level of 0.05. As a secondary analysis, patients were followed from the index date to either death or the end of the study period and assessed for the incidence or progression of microvascular complications (retinopathy, nephropathy, neuropathy), and macrovascular complications (stroke, myocardial infarction, death).
Results: A total of 72 patients met inclusion and exclusion criteria and were evaluated in the study. For all patients, the average pre-treatment HbA1c was 7.29% ± 1.12 and the average post-treatment HbA1c was 6.91% ± 0.99; -0.39% ± 1.23% [95% CI -0.67 to -0.11], p-value < 0.01. The change in mean HbA1c was greater in patients who achieved a sustained virologic response as opposed to those who did not achieve viral suppression. In the group of patients who did not achieve SVR, the HbA1c actually rose on average by nearly 0.5%. However, this group of patients is too small (n = 6) to draw any meaningful conclusions. Patients with a higher baseline HbA1c of greater than or equal to 7.0% showed a greater reduction in mean HbA1c over the study period of nearly 1.0%. Patients enrolled in metabolic clinic, endocrinology clinic, or diabetes care team had a greater reduction in mean HbA1c. Macrovascular complications were numerically higher in the group of patients who did not achieve a sustained virologic response.
Conclusion: Treatment of Hepatitis C with antiviral therapy was associated with a minor but statistically significant reduction in HbA1c from the 24-month period pre-treatment to the 24-month period post-treatment. The reduction in HbA1c was greater among patients with a baseline HbA1c greater than or equal to 7.0%. Sustained virologic response was associated with a greater reduction in HbA1c, although the size of the population limits interpretation of this data. Enrollment in metabolic clinic, diabetes care team, or endocrinology clinic represents a potential confounding variable.
Amy St. Amand– PGY1 Pharmacy Practice Resident, Providence Veterans Affairs Medical Center, Coventry, RI