PGI3 Treatment of Chronic Hepatitis C Genotype 1 in Poland – Real-Life Data

Abstract

shortcut though impairs the analysis in many different ways, limiting our full understanding of the phenomenon being modelled and ultimately our ability to accurately assess 'value for money' beyond the simple 'average'. This paper explores the value of access to individual patient data for cost-effectiveness modelling, structuring the discussion of the topic around three interrelated questions. First, what benefits can access to IPD bring to cost-effectiveness modelling? Second, what are the challenges for the simultaneous statistically synthesis of AD plus IPD to derive input parameters for a cost-effectiveness model? Third, what is the value of access to IPD compared to AD for cost-effectiveness modelling? Using two different case studies, the above questions will be addressed and discussed in the context of the debate around CEA of individualised treatment decisions. OBJECTIVES:When comparing combined therapy with peginterferon alpha-2a or alpha-2b and ribavirin to treat chronic hepatitis C (CHC), the results of clinical trials, observational studies, and meta-analyses have been inconsistent. Their effectiveness and tolerability were investigated using the nationwide database of chronic hepatitis patients who received interferon therapy in Japan. METHODS:The proportion with a sustained virologic response (SVR) and the dropout rate due to adverse events (AEs) were compared between alpha-2a and alpha-2b. All patients also received ribavirin. Multivariate logistic regression was conducted with adjustment for age, sex, platelet counts, ALT, viral load, genotype, and whether the patient was treatment-naïve, which are associated with effectiveness and tolerability. RESULTS: By December 2011, the database included 7820 patients. CHC patients treated with either alpha-2a (nϭ1737) or alpha-2b (nϭ4495) were analyzed. The mean (SD) age was 58.1 (10.4) years, and 3131 (50.2%) were female. In total, 2503 (41.0%) patients had a platelet count Ͻ150x103, 2503 (40.5%) had ALT Ͼ 60 IU/L, and 5765 (93.2%) had a high viral load. The numbers with genotype 1, 2, and 3 were 4291 (69.2%), 1838 (29.6%), and 76 (1.2%), respectively. Overall, 4434 (71.2%) patients were treatment-naïve. SVR was achieved in 53.5% (95% CI: 51.1-55.9%) with alpha-2a and 61.6% (95% CI: 60.2-63.1%) with alpha-2b (pϽ0.001). The dropout rate due to any AEs was 10.3% (95%CI: 8.9-11.8%) and 9.3% (95%CI: 8.5-10.2%) for alpha-2a and alpha-2b, respectively (pϭ0.226). After adjustment for possible confounders, no differences in effectiveness or tolerability were observed between the therapies, and the odds ratio of alpha-2a for SVR was 0.97 (95% CI: 0.86-1.10), and its odds ratio for dropout due to any AEs was 0.96 (95% CI: 0.79-1.17). There was no significant interaction of genotype and therapy. CONCLUSIONS: Alpha-2a and alpha-2b in combination with ribavirin showed comparable effectiveness and tolerability in clinical settings.