Antiviral treatment for hepatitis C virus infection: Effectiveness at general population level in a highly endemic area

Mariano, Andrea; Caserta, Carmelo Antonio; Pendino, Gaspare Maria; Vacalebre, Carmelo; Surace, Pasquale; Fiorillo, Maria Teresa; Surace, Monica; Alicante, Saverio; Amante, Angela; Marra, Monica; Gutamo, G.; Amato, F.; Messineo, Antonio; Mele, Alfonso

doi:10.1016/j.dld.2008.11.011

Cited by 15 publications

(11 citation statements)

References 35 publications

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“…A retrospective study of 293 HCV-infected patients attending a referral liver unit in Cleveland, Ohio, and a prospective multicenter study of 4084 veterans referred for HCV treatment over a one year period at 24 Veterans Affairs (VA) Medical Centers showed that only 28.3% and 32.2% patients, respectively, were considered eligible for antiviral treatment [2,3]. Only 8 (9.5%) out of the 84 unselected HCV-RNA positive subjects detected by screening of the general population in a small Southern Italian town, seen in a single liver unit, received treatment [5].…”

Section: Discussionmentioning

confidence: 99%

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Current practice of hepatitis C treatment in Southern Italy

Stroffolini

Spadaro²,

Guadagnino

et al. 2010

Digestive and Liver Disease

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a b s t r a c tBackground: Only a small proportion of subjects referring to hospitals for hepatitis C virus (HCV) positivity receives antiviral therapy. Aim: To evaluate the rate of antiviral treatment and the causes for no treatment in HCV-RNA positive subjects seen in hospital settings. Patients and methods: A prospective study enrolling over a 6-month period (February-July 2009) all consecutive anti-HCV positive subjects initially referred (naïve patients) to 12 liver units in Southern Italy for HCV treatment. Results: Out of 608 subjects evaluated, 74 (12.2%) had no detectable HCV-RNA in the serum and thus were excluded. Of the remaining 534 HCV-RNA positive subjects, 357 (66.9%) were not treated for the following reasons: 49.9% were older than 65 years of age (75% of them >70 years), 14.3% had normal liver enzymes, 13.2% had compensated/decompensated cirrhosis, 10.4% refused treatment, 9.8% had ongoing substance or alcohol abuse. Multivariate analysis showed that females (O.R. 2.27; C.I. 95% 1.05-4.90) and subjects with low educational level (O.R. 4.38; C.I. 95% 1.27-15.11) were more likely to decline therapy. Conclusions: The majority of patients with HCV infection does not receive antiviral treatment. The effectiveness of the current standard therapy for HCV infection is low despite its good efficacy.

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Section: Discussionmentioning

confidence: 99%

“…Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.dld.2010.03.020 general population received treatment [5]. However, because the two Italian studies were both performed in a single Hepatology unit, results may have been affected by a potential bias due to centre effect.…”

Section: Introductionmentioning

confidence: 99%

Current practice of hepatitis C treatment in Southern Italy

Stroffolini

Spadaro²,

Guadagnino

et al. 2010

Digestive and Liver Disease

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“…The authors concluded that clinicians should not assume that results from registration trials are transferable to their own clinical practice. The lower SVR rate (37.5 %) of patients in "real life" treatment study and low eligibility to therapy at general population level in a highly endemic area was presented by Mariano et al (2009) and in nationwide retrospective treatment study in Hungary [54,55]. In our study overall sustained virological response in ITT/PP analysis was achieved in 39,4 % /43 % patients: in 47,2 % / 51.3 % of naive and 26.9 % / 28.1 % of treatment experienced patients, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Majority of RCT and community based studies found that high pretreatment viral load and presence of advanced fibrosis or cirrhosis are strong independent negative predictors of SVR in combined antiviral treatment [15,24,25,40,44,[45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Treatment With Pegylated Interferon and Ribavirin in Patients With Chronic HCV Infection “Under Real Life“ Conditions

Speičienė

Kotovienė

Mickevičius

et al. 2014

Medicinos Teorija Ir Praktika

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Objective. To investigate the outcomes of combined therapy of hepatitis C (HCV) patients with peginterferon and ribavirin in ”real life” practice, to compare them with data obtained in randomized clinical trials (RCT) and to evaluate possible predictors of sustained virological response (SVR). Material and methods. The retrospective study of HCV patients routinely examined and treated in the Vilnius University Hospital Santariskiu Klinikos (2003−2009 yrs) was carried out. They had undergone the treatment with combination of peginterferon alfa and ribavirin according to the Lithuanian guide. Overall 203 patients were enrolled. SVR was evaluated in 179 patients. Results. The overall rate of SVR was 43 %: in 51,3 % of naives (genotype 1 − 38,8 %, genotype 2 – 100 %, genotype 3 − 82,6 % cases) and in 28,1 % of experienced patients (genotype 1 – 17 %, and genotype 3 – 64,3 % cases). Significant relations of SVR and HCV genotype was observed: 68,9 % having genotype1 were non-responders, whereas 80 % and 75,7 % ones with genotype 2 and 3 achieved SVR (p 0.005 and p = 0.01, respectively). The inverse relation with the age (p 0.01), degree of fibrosis (p = 0.039) and previous unsuccessful treatment was confirmed by multivariate analysis. Conclusions. Data of SVR obtained „on real life“ conditions are non unambiguous: SVR of naive and experienced patients overall and those with genotype 1 were similar or slightly lower, while for patients with genotype 3 significantly higher than results presented in clinical trials. Genotype 1, previous unsuccessful antiviral treatment, older age, and advanced fibrosis were strongest negative predictors for SVR.

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“…Based on published data, it was assumed that in Italy, only 8% of chronic HCV patients are currently treated in clinical centers,19 and among these diagnosed patients, only 20% are treated with dual or triple therapy 20. Finally, patients were divided by genotypes according to national epidemiological data21,22 where a prevalence of 56%, 30%, 10%, and 5% in terms of genotypes 1, 2, 3, and 4, respectively, was estimated.…”

Section: Epidemiological Datamentioning

confidence: 99%

Health policy model: long-term predictive results associated with the management of hepatitis C virus-induced diseases in Italy

Mennini

Marcellusi²,

Andreoni³

et al. 2014

CEOR

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BackgroundAt present, there are no specific nationwide epidemiological studies representing the whole Italian population. This study is aimed at describing the epidemiological and economic burden that HCV will generate in the next few years in Italy. Furthermore, the impact that future anti-HCV treatments may have on the burden of disease was considered. This analysis was developed for the period 2012–2030 from the perspective of the Italian National Health Service (NHS).MethodsA published system dynamic model was adapted for Italy in order to quantify the HCV-infected population in terms of disease progression and the associated costs from 1950 to 2030. The model structure was based on transition probabilities reflecting the natural history of the disease. In order to estimate the efficacy of current anti-HCV treatment strategies for genotypes 1 and 4, the sustained virological response (SVR) rate in registration clinical trials for both boceprevir and telaprevir was estimated. It was assumed that the efficacy for patients treated with peginterferon + ribavirin was equal to the placebo arm of a randomized clinical trial (RCT) relating to boceprevir and telaprevir. For genotypes 2/3 patients it was assumed that treatment efficacy with dual therapy was equal to a SVR rate from the literature. According to the aim of this study, only direct health care costs (hospital admissions, drugs, treatment, and care of patients) incurred by the Italian NHS have been included in the model. Costs have been extrapolated using the published scientific literature available in Italy and actualized with the 2012 ISTAT (Istituto Nazionale di Statistica) Price Index system for monetary revaluation. Three different scenarios were assumed in order to evaluate the impact of future anti-HCV treatments on the burden of disease.ResultsOverall, in Italy, 1.2 million infected subjects were estimated in 2012. Of these, about 211,000 patients were diagnosed, while only about 11,800 subjects were actually being treated with anti-HCV drugs. A reduction of health care costs is associated with a prevalence decrease. Indeed, once the spending peak is reached during this decade (about €527 million), the model predicts a cost reduction in the following 18 years. In 2030, based on the more effective treatments currently available, the direct health care cost associated with the management of HCV patients may reach €346 million (−34.3% compared to 2012). The first scenario (new treatment in 2015 with SVR =90% and same number of treated patients) was associated with a significant reduction in HCV-induced clinical consequences (prevalence =−3%) and a decrease in direct health care expenses, corresponding to €11.1 million. The second scenario (increase in treated patients to 12,790) produced an incremental cost reduction of €7.3 million, reaching a net decrease equal to €18.4 million. In the third scenario (treated patients =16,770), a higher net direct health care cost decrease versus the base-case (€44.0 million) was estimated.ConclusionOur model showed...

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Antiviral treatment for hepatitis C virus infection: Effectiveness at general population level in a highly endemic area

Cited by 15 publications

References 35 publications

Current practice of hepatitis C treatment in Southern Italy

Current practice of hepatitis C treatment in Southern Italy

Efficacy of Treatment With Pegylated Interferon and Ribavirin in Patients With Chronic HCV Infection “Under Real Life“ Conditions

Health policy model: long-term predictive results associated with the management of hepatitis C virus-induced diseases in Italy

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