Hepatitis C Virus Treatment in the ‘Real-World’: How Well Do ‘Real’ Patients Respond?

Abstract

Background: Published clinical trials of the treatment of HCV are largely multicentre prospective pharmaceutical trials. Patients in clinical trials tend to have more favorable outcomes than patients in the 'real-world', due to strict patient selection and differences in treatment conditions and available resources. Objectives: To assess the outcomes of Hepatitis C infected patients treated at the Barwon Health Liver Clinic with combination Pegylated interferon (PEG-IFN) and Ribavirin (RBV) therapy and to determine factors associated with a treatment response. Methods: Retrospective review of patients who received treatment for Hepatitis C at our institution's Liver Clinic from January 2001-September 2011. Patient demographics, comorbidities, treatment-related parameters and side effects were extracted from medical records and analyzed. Results: A total of 190 patients (120 male, 70 female) with a mean age of 42.8 years (range 20-68 years) commenced treatment. The most common genotype was genotype 3 (48.9%), followed by genotype 1 (42.6%). 150 of 190 patients (78.9%) completed treatment and had end of treatment data available. 107 of 182 patients, (58.8%) for whom sustained virologic response (SVR) rate data was available achieved an SVR. Overall response rates were; 46.9%, 68.8% and 62.4% in genotypes 1, 2 and 3 respectively. The response rate was significantly lower in 29 patients with documented cirrhosis (20.7%). Age, diabetes and alcohol abuse did not predict treatment response in our cohort. Side effects reported in 81.6% of patients included general malaise, hematological disturbance and psychiatric issues, and necessitated cessation of therapy in 16 patients (8.4%) and dose reduction in 26 patients (13.7%). Conclusions: Response rates to combination PEG-IFN and RBV therapy at our institution are comparable to other 'real-world' and pharmaceutical registration trials. Side effects of combination therapy were prominent but resulted in fewer discontinuations of therapy compared to pharmaceutical trials. ( J CLIN EXP HEPATOL 2014;4:214-220)

Use of the PRECIS-II instrument to categorize reports along the efficacy-effectiveness spectrum in an hepatitis C virus care continuum systematic review and meta-analysis

“…With regard to hepatitis C virus, gaps between the efficacy and effectiveness of hepatitis C virus treatment are substantial; treatment efficacy rates generally exceed 90%, while numerous reports find net effectiveness often under 20%. [40, 41]…”

Conceptual framework for outcomes research studies of hepatitis C: an analytical review

“… 50 s Presented as intravenous drug use mode of acquisition. 25 Abbreviations: ALT, alanine aminotransferase; BMI, body mass index; CAD, coronary artery disease; GI, gastrointestinal; HAART, highly active antiretroviral therapy; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PCP, primary care provider; PTSD, posttraumatic stress disorder; RNA, ribonucleic acid; STD, sexually transmitted disease; SVR, sustained viral response. …”

“…These new regimens have been tested in controlled trials, where patients tend to have relatively more favorable outcomes. 25 The effectiveness of these regimens in clinical practice must be determined. Outcomes research studies have shown that patient outcomes are affected by multiple factors, including the health care processes that are recommended in guidelines for the management of HCV infection.…”