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HEALTH OUTCOMES IN PATIENTS WITH CHRONIC HEPATITIS C TREATED IN COMMUNITY VERSUS ACADEMIC CENTRES: WEEK 12 RESULTS OF THE APPROACH STUDY
RP Myers, PJ Marotta, F Anderson, R Lalonde, T Manchanda for the APPROACH Study Group
University of Calgary, University of Western Ontario, Liver and Intestinal Research Centre, Vancouver, McGill University, Hoffmann-La Roche Ltd
BACKGROUND: The impact of treatment at academic (AC) versus community centres (CC) on the outcome of anti-hepatitis C (HCV) therapy is poorly described. Our objective was to compare quality of life (QoL), resource utilization (RU), productivity, and clinical outcomes between AC and CC in the context of a multi-centre observational study (APPROACH) of peginterferon-alpha2a and ribavirin (PEG-IFN/RBV).
METHODS: The study includes 384 HCV-monoinfected patients treated with PEG-IFN/RBV; 95% have completed their W12 visit. This descriptive analysis compares patient characteristics, QoL (SF-36 scores), RU, productivity, and clinical outcomes between AC and CC at baseline and W12 using Fisher’s exact and Mann-Whitney tests.
RESULTS: In total, 16 AC and 29 CC enrolling 133 and 251 patients, respectively, were included. Nearly all sites (96%) have access to HCV nursing support. Overall, 66% of patients were male, mean age was 46±10 yrs, 55% were employed, and 91% were treatment-naïve. Among patients undergoing biopsy (38%), 10% had cirrhosis (AC 14% vs. CC 8%; P=0.38). Genotypes were 53% G1, 20% G2 and 24% G3, and 76% had viral load >400,000 IU/mL. There were no significant differences in baseline clinical characteristics, QoL, or productivity between groups. By W12, transformed SF-36 scores declined between 9% and 24% in all patients. Similar declines were observed among AC and CC except the Physical Functioning domain which fell more in AC patients (22% vs. 16%; P=0.03). At W12, patients from AC also reported more visits to specialists (P=0.04), but other aspects of RU did not differ between groups. Similarly, adverse events, dosage reductions/discontinuations, and the number of days lost or underproductive were not significantly different. By ITT analysis, EVR rates were lower in G1 patients treated in AC than CC (61% vs. 77%, P=0.02), however, EVR data is currently unavailable in 22% of patients (AC 27% vs. CC 19%; P=0.23).
CONCLUSION: This multi-centre Canadian study suggests that health outcomes are similar among patients treated with PEG-IFN/RBV at AC and CC up to W12. Additional data to the end of follow-up will be necessary to confirm these findings.
Study supported by Roche Canada