Kelsey Rife, Alessandra Lyman, and Kristina Pascuzzi are Clinical Pharmacy Specialists; Corinna Falck-Ytter is the Section Chief of Primary Care, Christopher J. Burant is a Statistician in the Geriatric Research, Education, and Clinical Center; and Yngve Falck-Ytter is the Section Chief of Gastroenterology and Hepatology; all at the VA Northeast Ohio Healthcare System in Cleveland. Sheena LeClerc-Kamieniecki is a Clinical Pharmacy Specialist at the Chillicothe Veterans Affairs Medical Center in Ohio. Corinna Falck-Ytter is an Associate Professor of Medicine, Christopher Burant is an Associate Professor of Nursing, and Yngve Falck-Ytter is a Professor of Medicine, all at Case Western Reserve University in Cleveland, Ohio. Correspondence: Kelsey Rife (kelsey.rife@ va.gov)
Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
Finally, hemoglobin was not collected to account for any impact ribavirin-associated anemia may have had on the immediate posttreatment HbA1c values. Phase 3 DAA trials have demonstrated that between 7% and 9% of patients on ribavirin-containing DAA regimens are expected to have a hemoglobin < 10 g/dL during the HCV treatment course.33-36 Ribavirin-containing regimens may minimally impact the immediate posttreatment HbA1c result, but not necessarily the 12- or 18-month posttreatment HbA1c levels due to the reversible nature of this adverse effect (AE) following discontinuation of ribavirin.
Future studies may be strengthened by controlling for possible confounders such as concomitant ribavirin, adherence to antihyperglycemic medications, comorbidities, years since initial DM diagnosis, and lifestyle modifications, including a decrease of alcohol consumption. A prospective study also may include data on hypoglycemic events and further determine the sustained response by including an 18- or 24-month posttreatment HbA1c in the protocol.
Conclusion
The findings of this study validate the significant HbA1c changes post-HCV treatment described in the recent veteran database study.32 However, the current study’s validated patient chart data provide a better understanding of the changes made to antihyperglycemic regimens. This also is the first study describing this phenomenon of improved insulin resistance to only be observed in approximately 80% of patients infected with HCV and comorbid T2DM. Furthermore, the variable magnitude of HbA1c impact reliant on baseline HbA1c is informative for individual patient management. In addition to the direct benefits for the liver on hepatitis C viral eradication, improvements in HbA1c and the de-escalation of antihyperglycemic regimens may be a benefit of receiving HCV treatment.
The improved DM control achieved with hepatitis C viral eradication may represent an opportunity to prevent progressive DM and cardiovascular AEs. Additionally, HCV treatment may be able to prevent the onset of T2DM in patients at risk. Arguably HCV treatment has significant benefits in terms of health outcomes, quality of life, and long-term cost avoidance to patients beyond the well-described value of decreasing liver-related morbidity and mortality. This may be an incentive for payers to improve access to HCV DAAs by expanding eligibility criteria beyond those with advanced fibrotic liver disease.
Acknowledgments This material is the result of work supported with the resources and the use of facilities at the VA Northeast Ohio Healthcare System.