12 research outputs found
Medical resource utilization and costs among Australian patients with genotype 1 chronic hepatitis C: results of a retrospective observational study
<p><b>Objective:</b> To evaluate medical resource utilization (MRU) and associated costs among Australian patients with genotype 1 chronic hepatitis C (GT1 CHC), including both untreated patients and those receiving treatment with first-generation protease inhibitor-based regimens (telaprevir, boceprevir with pegylated interferon and ribavirin).</p> <p><b>Methods:</b> Medical records were reviewed for a stratified random sample of GT1 CHC patients first attending two liver clinics between 2011–2013 (principal population; PP), supplemented by all GT1 CHC patients attending one transplant clinic in the same period (transplant population; TP). CHC-related MRU and associated costs are reported for the PP by treatment status (treated/not treated) stratified by baseline fibrosis grade; and for the TP for the pre-transplant, year of transplant and post-transplant periods.</p> <p><b>Results:</b> A total 1636 patients were screened and 590 patients (36.1%) were included. Comprehensive MRU data were collected for 276 PP patients (F0–1 <i>n</i> = 59, F2 <i>n</i> = 58, F3 <i>n</i> = 53, F4 <i>n</i> = 106; mean follow-up = 17.3 months). Thirty-eight (13.8%) were treatment-experienced prior to enrolment; 55 (19.9%) received triple therapy during the study. Data were collected for 112 TP patients (mean follow-up = 29.9 months), 33 (29.5%) received a transplant during the study, and 51 (45.5%) beforehand. The annual direct medical costs, excluding drug costs, were higher among treated PP vs untreated PP (AU1,954 vs : pre-transplant 155,138, post-transplant $7,358).</p> <p><b>Limitations:</b> To aid interpretation of results, note that only patients with GT1 CHC who are actively managed are included, and MRU data were collected specifically from liver outpatient clinics. That said, movement of patients between hospitals is rare, and any uncaptured MRU is expected to be minimal.</p> <p><b>Conclusions:</b> CHC-related MRU increases substantially with disease severity. These real-world MRU data for GT1 CHC will be valuable in assessing the impact of new hepatitis C treatments.</p
Patient demographic and clinical characteristics.
<p>†In month prior to engaging with community hepatitis service; OST opiate substitution therapy.</p><p>Patient demographic and clinical characteristics.</p
Unadjusted and adjusted analysis of factors associated with HCV treatment uptake (N = 279).
<p>†In month prior to engaging with service.</p><p>Unadjusted and adjusted analysis of factors associated with HCV treatment uptake (N = 279).</p
Covariates evaluated for association with SVR12 in univariate and multivariate analyses.
<p>Based on patients who completed therapy (excluding those who discontinued for reasons unrelated to efficacy). Ribavirin-containing arms are pooled. <i>ITPA</i>, inosine triphosphatase; GGT, gamma glutamyl transferase; Hb, hemoglobin; TID16W, faldaprevir 120 mg once daily, deleobuvir 600 mg three times daily, and ribavirin for 16 weeks; BID28W, faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and ribavirin for 28 weeks; TID40W, faldaprevir 120 mg once daily, deleobuvir 600 mg three times daily, and ribavirin for 40 weeks.</p><p>Covariates evaluated for association with SVR12 in univariate and multivariate analyses.</p
Hemoglobin levels over time.
<p>Mean hemoglobin by treatment group over time is shown. The mean reduction at the end of treatment for the pooled ribavirin-containing arms was approximately 2.5 g/dL. TID16W/TID28W/TID40W, faldaprevir 120 mg once daily, deleobuvir 600 mg three times daily, and ribavirin for 16, 28, and 40 weeks, respectively; BID28W, faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and ribavirin for 28 weeks; TID28W-NR, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily without ribavirin for 28 weeks.</p
Baseline demographics and disease characteristics.
<p><sup>a</sup>Fibrosis stage was determined by either METAVIR score or fibroscan result; if a METAVIR score was not available, then a fibroscan result was used (fibroscan <9.5 = ≤F2 and fibroscan ≥9.5 = ≥F3). TID16W/TID28W/TID40W, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily plus ribavirin for 16, 28, and 40 weeks, respectively; BID28W, faldaprevir 120 mg once daily and deleobuvir 600 mg twice daily plus ribavirin for 28 weeks; TID28W-NR, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily, without ribavirin, for 28 weeks.</p><p>Baseline demographics and disease characteristics.</p
Effect of <i>ITPA</i> SNPs on hemoglobin level, ribavirin dose, and erythropoietin use, pooled ribavirin-containing arms.
<p><sup>a</sup>Anemia as an adverse event defined by investigators (not a laboratory event).</p><p><i>ITPA</i>, inosine triphosphatase gene; SNP, single nucleotide polymorphism; Hb, hemoglobin.</p><p>Effect of <i>ITPA</i> SNPs on hemoglobin level, ribavirin dose, and erythropoietin use, pooled ribavirin-containing arms.</p
Probability of anemia over time.
<p>Among patients in the pooled ribavirin-containing arms with anemia, the median time to the first occurrence of anemia was 42 days.</p