Virological Efficacy of New, Oral, Direct-Acting Antivirals in Hepatitis C Patients With Mixed Cryoglobulinemia

Abstract

Introduction: Mixed cryoglobulinemia (MC), is strongly associated with hepatitis C virus (HCV) infection. Historically, HCV-MC patients are difficult-to-treat. 30-40% patients fail to achieve end of treatment or sustained virological response to combination treatments using pegylated interferon, ribavirin and first generation direct acting antivirals (DAA's). Data on the efficacy of new oral DAA's in this special population is limited. Our study aim was to evaluate the virological efficacy of new oral DAA's in HCV patients with MC. Methods: Retrospective cohort study in an integrated health care system with 3.8 million members in Southern California. Regional hepatitis C registry was accessed to identify chronic HCV patients treated with new DAA's. ICD code for cryoglobulinemic vasculitis and CPT codes for cryoglobulin were applied followed by manual chart review to identify HCV patients with MC. Demographic information, HCV genotype, viral load, prior HCV treatment, liver cirrhosis, MC clinical manifestations and other laboratory data were obtained through chart review. The primary endpoint was sustained virological response (SVR) at week 4. Results: 18 HCV-MC patients treated with new oral DAA's were identified (Image 1). The mean age was 63 years, 11 (61%) females, and 11 (61%) white. 10 (55%) patients were cirrhotic and 11 (61%) HCV treatment naïve. 9 patients received sofosbuvir/ribavirin, 4 sofosbuvir/ribavirin/peg interferon, 4 ledipasvir/sofosbuvir and 1 sofosbuvir/ simeprevir. All patients achieved end of treatment response (ETR). 16 out of 18 (88.88%) attained sustained virological response (SVR) at week 4; of these 16 patients, 12 have achieved SVR12 and 8 have SVR24 till date. The longest known SVR duration till date is 50 weeks. 80% of cirrhotics had SVR4. Conclusion: New DAA's are superior to past regimens in achieving SVR in this difficult to treat population.Figure 1