Predictive Factors for Sustained Virological Response after Treatment with Pegylated Interferon α-2a and Ribavirin in Patients Infected with HCV Genotypes 2 and 3

Niederau, Claus; Mauss, Stefan; Schober, Andreas; Stoehr, Albrecht; Zimmermann, Tim; Waizmann, Michael; Moog, Gero; Pape, S.; Weber, Bernd; Isernhagen, Konrad; Sandow, Petra; Bokemeyer, Bernd; Alshüth, U.; Steffens, H; Hüppe, D

doi:10.1371/journal.pone.0107592

Cited by 17 publications

(18 citation statements)

References 48 publications

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“…On the other hand, Niederau et al . did not find this factor to be a positive predictor of SVR in univariate logistic analysis; these results supported our findings [21]. Of note, our data about no link between baseline HCV viral load and SVR rate are also confirmed by the results of a study performed by Cheetham et al .…”

Section: Discussionsupporting

confidence: 91%

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Predictors of sustained virological response in patients with hepatitis C virus genotype 3 infection

Zarębska-Michaluk

Lebensztejn

Chrapek

et al. 2016

ceh

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Aim of the studyTo assess predictors of sustained virological response (SVR) in patients with chronic hepatitis C virus (HCV) genotype 3 treated with standard therapy.Material and methodsWe retrospectively investigated data of 116 consecutive treatment-naïve patients chronically infected with HCV genotype 3, treated with pegylated interferon alpha (PegIFNα) and ribavirin (RBV) for 24 weeks. HCV RNA at week 4 (rapid virological response – RVR) and week 12 (early virological response – EVR) were measured in 85 and 105 patients respectively. Liver biopsy data were available for 103 patients. The variables were compared between patients with an SVR and those without.ResultsOverall 70.7% of patients achieved an SVR. Pretreatment factors including younger age, mild liver fibrosis as well as normal values of gamma-glutamyl transferase (GGT) and platelet count were significantly associated with higher SVR rate in univariate analysis. In the multivariate analysis only baseline platelet count > 140 000/µl and normal GGT activity were correlated with higher SVR rate. At weeks 4 and 12 HCV RNA was undetectable in 34.1% and 84.8% of patients respectively. The SVR rate was significantly higher in patients with an RVR compared to those without (p = 0.002). Only 2 patients with a rapid and early virological response did not achieve an SVR; both had negative pretreatment prognostic factors.ConclusionsIn treatment-naïve patients with genotype 3 HCV infection, low baseline platelet count and elevated GGT activity were significantly associated with poor response to PegIFNα and RBV. Achieving a rapid and early virological response was associated with higher likelihood of an SVR.

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Section: Discussionsupporting

confidence: 91%

“…The efficacy of 24 weeks of treatment was comparable to most other reports from clinical trials and real-life studies, where the SVR rate was estimated to be between 60 and 90% [4, 6, 7, 12–21]. The lower SVR rate was documented by Niederau et al .…”

Section: Discussionsupporting

confidence: 81%

Predictors of sustained virological response in patients with hepatitis C virus genotype 3 infection

Zarębska-Michaluk

Lebensztejn

Chrapek

et al. 2016

ceh

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“…The authors were independent from the funding company in data analysis, data interpretation, report writing and publication. Up to now, data from this trial has been used in different publications giving detailed information on epidemiological data, treatment practice and outcomes in different genotypes as well as factors influencing treatment outcomes .…”

Section: Methodsmentioning

confidence: 99%

Costs and outcomes of treating chronic hepatitis C patients in routine care – results from a nationwide multicenter trial

Stahmeyer

Krauth

Bert

et al. 2015

Journal of Viral Hepatitis

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Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly.

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“…Fatigue and depression at the beginning of treatment are predictors for failure to attain SVR possibly due to treatment regimen non‐adherence …”

Section: Application Of Pro Assessment In Ch‐cmentioning

confidence: 99%

Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

Younossi

Henry

2015

Aliment Pharmacol Ther

164

189

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Summary Background Treatment for chronic hepatitis C (CH‐C) is rapidly changing and moving away from an interferon and ribavirin‐based therapy to interferon‐free ribavirin‐free all oral regimens. These regimens are simpler and shorter to administer with very high efficacy rates and better side effect profiles. As advances in the treatment of CH‐C occur, it is imperative to capture both clinical outcomes (efficacy and safety) as well as patient‐reported outcomes (PROs). In fact, PROs assesses and quantifies the impact of these regimens on patient experience. PROs assess patients' health‐related quality of life (HRQOL) especially in the realms of fatigue and neuropsychiatric issues such as depression which can affect treatment adherence and work productivity. Aim To review the literature related to PRO's in HCV patients and summarise the impact of CH‐C and its treatment on PROs. Methods Databases Ovid MEDLINE and PubMed were searched from 1990 to October 2014 using a combination of MEsh, thesaurus terms and relevant text words: hepatitis C, CH‐C, treatment, quality of life, health‐related quality of life, fatigue, work productivity, adherence, patient‐reported outcomes, direct acting anti‐viral agents and second generation direct acting anti‐viral agents. Each manuscript was assessed for pertinence to the issue of PROs in CH‐C as well as the quality of study design and publications. Results From the literature, it is evident that CH‐C patients have baseline PRO impairment. Furthermore, treatment with interferon with or without ribavirin and first generation DAAs causes additional PRO burden which can negatively impact treatment adherence and indirectly, treatment efficacy and work productivity. The new treatment regimens with interferon‐ and ribavirin‐free regimens not only have very high efficacy, but also result in the improvement of PRO scores as early as 2 weeks into treatment as well as possibly better adherence to treatment regimens. Conclusions CH‐C and its treatment have been associated with patient‐reported outcome impairment. The new IF‐free and RBV‐free regimens are associated with high efficacy and substantial improvement of patient‐reported outcomes in clinical trial setting. Although very encouraging, more data are needed to assess patient‐reported outcomes, adherence and work productivity of CH‐C patients in the real world setting of clinical practice.

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Predictive Factors for Sustained Virological Response after Treatment with Pegylated Interferon α-2a and Ribavirin in Patients Infected with HCV Genotypes 2 and 3

Cited by 17 publications

References 48 publications

Predictors of sustained virological response in patients with hepatitis C virus genotype 3 infection

Predictors of sustained virological response in patients with hepatitis C virus genotype 3 infection

Costs and outcomes of treating chronic hepatitis C patients in routine care – results from a nationwide multicenter trial

Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

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