Dilemmas in Treatment of Hepatitis C in 2015

Abstract

Introduction: Hepatitis C virus (HCV) affects about 3 million people in United States today. After almost a decade we have a new line of drugs available for the management of this disease. They hold the promise of unprecedented treatment outcomes with few side effects. However, prior to their indiscriminate prescription, an assessment of significant side effects and interactions is warranted. The paucity of data regarding these novel agents presents a risk of unknown medication side effects and drug-drug interactions. Methods: This was an IRB approved, retrospective review of patients with HCV treated at our Veterans Hospital. Choice of therapy was based upon evidence based literature. Patients received either ledipasvir/sofosbuvir or Ombitasvir/Paritaprevir/Ritonavir/Dasbuvir therapy with or without ribavarin and peginterferon. Per our study design, patients were initially seen by a mid-level practitioner under the supervision of a physician. Patients who met criteria for treatment underwent a meeting with a pharmacist to discuss drug usage, side effects and interactions. Prior to a patient receiving their medication, the prescription was reviewed one final time by a gastroenterologist. Results: Of the 54 patients were included in the study (96% males; age range: 34-71 years, average BMI 30), 50% were HCV genotype 1a, 40% 1b and 10% others. In 28% patients, previous treatment was unsuccessful. Sustained virologic response, 12 weeks after treatment was achieved in 47 of 54 patients (87%). In 12 patients (25.5%) of the ledipasvir/sofosbuvir cohort there were drug interactions, as compared to 57% of patients in the Ombitasvir group. Our compliance in this group of patients at this VA was excellent at over 90%. Conclusion: In the present study the treatment response was 89%. However, a significant proportion of patients were not approved by the pharmacist after review of drug interactions. In 3 patients drug interactions were noted by the gastroenterologist in the final step. Common drugs which required dose adjustment or changes included omeprazole, trazodone, amlodipine, sildenafil, and tamsulosin. Hence, as demonstrated in this study, novel interferon free therapies have significant drug interactions and side effects. Nationwide in the VA health system alone, over 700 patients begin treatment with these drugs weekly. Prior to initiation of therapy, careful review of medications and prescriber familiarity drug interactions and side effect profile is critical to ensure optimal patient outcomes.Figure 1Figure 2