Real-life experience with first generation HCV protease inhibitor therapy in Germany: The prospective, non-interventional PAN cohort

Mauss, S; Böker, K. H. W.; Buggisch, Peter; Christensen, Stefan; Hofmann, Werner; Schott, Eckart; Pfeiffer-Vornkahl, H.; Alshüth, U.; Hüppe, D

doi:10.1055/s-0034-1399383

Cited by 11 publications

(14 citation statements)

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“…Basing SVR rates on clinical trials may overestimate the benefits of treatment in practice, although this issue may be of decreasing concern, as several recent studies have shown comparable efficacy between real-world and trial settings. [40][41][42][43][44] We explore the sensitivity of our results to variations in various parameter values in the online supplementary appendix; while the precise magnitudes of results vary, the overall conclusions do not: across a wide range of parameter values, model results demonstrate that increasing treatment capacity reduces the infected population and adds significant social value.…”

Section: Limitationsmentioning

confidence: 99%

Economic study of the value of expanding HCV treatment capacity in Germany

Sbarigia

Wirth

Nuys³

et al. 2017

BMJ Open Gastroenterol

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BackgroundToday's highly efficacious, low-toxicity interferon-free treatment regimens for chronic hepatitis C virus (HCV) can cure most patients with HCV in 12–24 weeks. The aim of this study was to understand how the introduction of shorter duration treatment regimens for HCV will impact the capacity for treatment and value to society.MethodsA Markov model of HCV transmission and progression was constructed, incorporating nationally representative data on HCV prevalence, incidence and progression; mortality, treatment costs, medical expenditures, employment probabilities and disability payments in Germany. The model was stratified by HCV genotype and exposure route (1-time healthcare exposure, injection drug use and sexual activity). Treatment scenarios were based on German treatment guidelines and projected treatment capacity. The impact of different treatment scenarios on disease transmission and prevalence, quality-adjusted life years (QALYs), treatment costs, medical expenditures, employment and disability expenditures was calculated.ResultsDepending on their adoption profile, new treatment regimens and protocols introduced over the next several years will increase HCV treatment capacity in Germany by 8–30%, reducing disease transmission and prevalence, increasing QALYs and adding €94–310 million in discounted social value (QALYs plus medical savings net of treatment costs) over a 30-year horizon. Additional social value in the form of higher employment and lower disability would also result.ConclusionsThe introduction of shorter HCV treatment regimens and the resulting increased treatment capacity in Germany would result in large gains to society by reducing disease transmission and prevalence, resulting in longer, healthier, more productive lives for current and future generations.

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Section: Limitationsmentioning

confidence: 99%

Economic study of the value of expanding HCV treatment capacity in Germany

Sbarigia

Wirth

Nuys³

et al. 2017

BMJ Open Gastroenterol

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“…The SVR24 rate from the Irish national HCV registry compared favourably with the outcomes from other international real world studies [46, 47]. Comparing key baseline demographics and HCV characteristics between the three studies demonstrated that our cohort was younger and had a higher proportion of males.…”

Section: Discussionmentioning

confidence: 60%

“…We directly compared the SVR24 rates from our cohort with outcomes reported in the US-based HCV-TARGET study and the German-based PAN study (Fig. 5) [46, 47]. In the TPV/PR cohorts, a statistically significant difference was observed in the SVR24 rates between this study and both the HCV-TARGET and PAN studies ( p < 0.05).…”

Section: Resultsmentioning

confidence: 82%

“…Comparing key baseline demographics and HCV characteristics between the three studies demonstrated that our cohort was younger and had a higher proportion of males. However, our Irish cohort did include a lower proportion of patients with previous treatment experience while the proportion of patients with cirrhosis was lower than in the HCV-TARGET study but higher than the proportion in the PAN study [46, 47]. These demographic details suggest that the cohorts in the HCV-TARGET and PAN studies would be considered more difficult-to-treat than the Irish cohort and therefore, is reflected in the lower SVR24 rates reported in these studies.…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness of triple therapy with direct-acting antivirals for hepatitis C genotype 1 infection: application of propensity score matching in a national HCV treatment registry

Gray

Pasta

Norris

et al. 2017

BMC Health Serv Res

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BackgroundObservational studies are used to measure the effectiveness of an intervention in non-experimental, real world scenarios at the population level and are recognised as an important component of the evidence pyramid. Such data can be accrued through prospective cohort studies and a patient registry is a proven method for this type of study. The national hepatitis C (HCV) registry was established in Ireland in 2012 with the aim of monitoring the clinical and economic outcomes from new, high cost regimens for the treatment of HCV infection. A sustained virological response (SVR) 24 weeks following completion of therapy with interferon-containing regimens is considered a cure. Non-randomisation in these studies can result in confounding or selection bias. Propensity score (PS) matching is one of a number of statistical tools that can be used to mitigate the effects of confounding in observational studies.MethodsWe analysed the data of 309 patients who underwent triple therapy treatment with telaprevir (TPV) in combination with pegylated-interferon and ribavirin (PR) or boceprevir (BOC)/PR between June 2012 and December 2014. The decision to initiate treatment and the selection of the treatment regimen was at the discretion of the physician. To adjust for confounding, three approaches to propensity score matching were assessed Adjusted sustained-virological response rates (SVR), odds ratios, p-values and 95% confidence intervals were calculated from the three PS matched dataset.ResultsPrior to matching, the unadjusted sustained virological response rates 24 weeks after treatment complete (SVR24) were 74% (n = 158/215) and 61% (n = 57/94) for telaprevir/PR and boceprevir/PR, respectively. After matching, adjusted SVR24 rates were between 73–74% and 60–61% for telaprevir/PR and boceprevir/PR, respectively.ConclusionEfficacy rates were comparable with those reported in pivotal clinical trials and real world studies. After adjusting for confounding, we conclude that there was no difference in treatment effect after PS matching. The small sample size limits the conclusions that can be made about the effect of PS matching. Propensity score adjustment remains a tool that can be applied to future analysis, however, we suggest, where possible, using a larger sample size in order to reduce the uncertainty around the outcomes.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-017-2188-1) contains supplementary material, which is available to authorized users.

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“…For example, in the German PAN cohort study [23], SVR12 rates of 55% (boceprevir) and 63% (telaprevir) were obtained in treatment-naïve patients and 51% (boceprevir) and 68% (telaprevir) in previously treated patients. The Kaiser Permanente Medical Care Program in Northern California reported SVR rates of 53% and 56% with boceprevir- and telaprevir-based triple therapy [21].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study

Mangia¹

2017

aog

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BackgroundThe aim of the study was to determine the efficacy and safety of triple therapy with a first-generation protease inhibitor (PI; boceprevir, telaprevir) plus peginterferon alfa-2a or -2b plus ribavirin, and dual therapy (peginterferon alfa-2a or -2b plus ribavirin) in patients with chronic hepatitis C (CHC) in routine clinical practice.MethodsPegBase was an international, prospective, observational study in which 4441 patients with CHC were enrolled in 27 countries. This analysis focuses on results in 4100 treatment-naïve and previously treated patients treated with PI-based triple therapy or dual therapy, according to the discretion of the investigator and local standards of practice. The primary efficacy outcome was sustained virological response after 12-week follow up (SVR12).ResultsSVR12 rates in treatment-naïve genotype (G) 1 patients were 56.6% and 62.9% for recipients of boceprevir plus peginterferon alfa-2a/ribavirin and boceprevir plus peginterferon alfa-2b/ribavirin, respectively, and 65.3% and 58.6% for recipients of telaprevir plus peginterferon alfa-2a/ribavirin and telaprevir plus peginterferon alfa-2b/ribavirin, respectively. In previously treated patients assigned to these four regimens, SVR12 rates were 43.6%, 48.3%, 60.3% and 56.1%, respectively. Among treatment-naïve patients assigned to peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin, respectively, SVR12 rates were 49.2% and 41.9% in G1 patients, 75.7% and 83.3% in G2 patients, 65.9% and 65.9% in G3 patients, and 49.7%, and 51.1% in G4 patients. The safety and tolerability of dual and triple therapy were consistent with previous reports.ConclusionThe efficacy and safety of first-generation PI-based triple-therapy and dual-therapy regimens in this real-world cohort were broadly comparable to those of previous studies.

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Real-life experience with first generation HCV protease inhibitor therapy in Germany: The prospective, non-interventional PAN cohort

Cited by 11 publications

References 10 publications

Economic study of the value of expanding HCV treatment capacity in Germany

Economic study of the value of expanding HCV treatment capacity in Germany

Effectiveness of triple therapy with direct-acting antivirals for hepatitis C genotype 1 infection: application of propensity score matching in a national HCV treatment registry

Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study

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