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• W2085889621 abstract "Chronic hepatitis C is often depicted by the media as the “silent killer”. This definition is appropriate for a disease that is symptomless for years or even decades, during which it can be identified only by detecting anti-hepatitis C virus (HCV) antibodies in plasma and then confirmed by detecting HCV RNA. When the disease becomes clinically evident, the progression to cirrhosis or cancer has already occurred in many cases. At this stage, therapeutic opportunities are restricted, management is costly and life expectancy is low [[1]Hoofnagle J.H. Seeff L.B. Peginterferon and ribavirin for chronic hepatitis C.N Engl J Med. 2006; 355: 2444-2451Crossref PubMed Scopus (412) Google Scholar]. The present standard of care, Peg-interferon plus ribavirin, is able to eradicate HCV in 45% of cases infected with the difficult-to-treat genotypes 1 or 4, and in more than 80% of those carrying genotype 2 or 3. Eradicating the virus avoids disease progression in patients with less advanced stages of the liver disease and reduces, but does not eliminate, complications in patients with cirrhosis [[2]Bruno S. Stroffolini T. Colombo M. et al.Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study.Hepatology. 2007; 45: 579-587Crossref PubMed Scopus (550) Google Scholar], who also show a lower response rate to treatment. Thus, the optimal benefit of anti-HCV therapy derives from the early identification and treatment of the patients with chronic HCV infection. Barriers to treatment include difficulties in identifying patients with chronic hepatitis C due to the silent nature of the disease and the lack of awareness among healthcare providers and policy makers [[3]Mitchell A.E. Colvin H.M. Palmer Beasley R. Institute of Medicine recommendations for the prevention and control of hepatitis B and C.Hepatology. 2010; 51: 729-733Crossref PubMed Scopus (154) Google Scholar]; once identified, many patients are not treated due to contraindications of the current treatments, the presence of comorbidities or refusal [4Falk-Ytter Y. Kale H. Mullen K.D. et al.Surprisingly small effect of antiviral treatment in patients with hepatitis C.Ann Intern Med. 2002; 136: 288-292Crossref PubMed Scopus (285) Google Scholar, 5Allen S.A. Spaulding A.C. Osei A.M. et al.Treatment of chronic hepatitis C in a state correctional facility.Ann Intern Med. 2003; 138: 187-190Crossref PubMed Scopus (115) Google Scholar]. In this issue of Digestive and Liver Disease, Rein et al. present a forecast of the morbidity and mortality due to hepatitis C in the next 50 years in the United States in the absence of enhanced medical intervention, to evaluate the potential impact of improving identification of patients and of enabling more persons to receive antiviral treatment [[6]Rein D.B. Wittenborn J.S. Weinbaum C.S. et al.Forecasting the morbidity and mortality associated with prevalent cases of pre-cirrhotic chronic hepatitis C in the United States.Dig Liver Dis. 2011; 43: 66-72Abstract Full Text Full Text PDF PubMed Scopus (173) Google Scholar]. The model was based on the current low rate of incident cases recorded in the U.S. and the prevalence of hepatitis C, which is around 1% and peaks in relatively young persons. They forecast an increasing rate of HCV-related complications with a peak of morbidity and mortality between the years 2030 and 2035 that would originate in the year 2030 more than 36,000 deaths, 38,000 new cases of end-stage liver disease and 3200 referrals for transplant. Taking into account the entire period, about one third of the subjects infected with HCV in the year 2005 will have died from hepatitis C by the year 2060. Based on the data, the Authors solicit public intervention to improve the identification of the patients and consequently increase access to treatment. The desire to forecast the future originated with human civilization. The oracles exerted considerable influence on personal and public events. In ancient times men covered long distances and offered rich sacrifices to consult the oracles before major undertakings, such as wars, personal affairs and so forth. In the Greek world the oracle of Delphi, known as the Pythia, and in the Roman world the oracle of Cumae, the Sibyl, often gave ambiguous responses that needed to be interpreted. Today, predictions come from sophisticated mathematical modelling. Curiously, the questions underlying the need for forecasts have remained the same over time: are we prepared to face the events? Can we change their course? Both assume that forecasts are close to 100% reliable. All previsions are aggravated by some degree of uncertainty, which translates into a more or less wide range of possible outcomes. Rein et al. estimate that about one third of the HCV-infected persons will die due to the consequences of HCV in the next 50 years. However, the Monte Carlo simulation estimated a very wide range of possible values for the main outcomes; for example, in the year 2030 the range of deaths varies from a low 13,900 to a high 51,900, although with a narrow interquartile range. Today, in a time of limited resources in most western developed countries, will these figures be convincing enough for the decision-making authorities? As the Authors acknowledge, the rate of screening for HCV is low and would require greater public effort to cover a significant proportion of the undiagnosed population. In addition, we should consider that any screening program will generate a number of false negative or false positive results, which translate into additional costs. The identification of the target population with a high risk of harbouring HCV will limit false results; this is feasible where, as in United States, the main risk of acquiring HCV was intravenous drug use, but is difficult to achieve where, as in Italy, HCV was acquired in the past mainly from exposure to medical procedures or the use of glass syringes, i.e. where the number of exposed subjects is huge [[7]Stroffolini T. Mariano A. Iantosca G. Reported risk factors are useless in detecting HCV-positive subjects in the general population.Dig Liver Dis. 2004; 36: 547-550Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar]. In general, mass screening policies for hepatitis C are not considered cost-effective even in the presence of a higher prevalence of HCV carriers. For instance, in Italy the prevalence of HCV-infected individuals is around 3% in the general population; however, this overall prevalence derives from a very high prevalence among persons older than 65 years, with a high rate of comorbidities and for most of whom treatment is not applicable. Interestingly, one study showed that only a minority of the patients identified as having chronic HCV infection in a population-based study were eligible for treatment and even fewer were actually treated, leading to a negligible overall effectiveness in eradicating HCV in the whole population [[8]Mariano A. Caserta C. Pendino G.M. et al.Antiviral treatment for hepatitis C virus infection: effectiveness at general population level in a highly endemic area.Dig Liver Dis. 2009; 41: 509-515Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar]. This study extended to an open population the concept of the limited effect of antiviral therapy in HCV-infected patients seen at medical institutions [4Falk-Ytter Y. Kale H. Mullen K.D. et al.Surprisingly small effect of antiviral treatment in patients with hepatitis C.Ann Intern Med. 2002; 136: 288-292Crossref PubMed Scopus (285) Google Scholar, 5Allen S.A. Spaulding A.C. Osei A.M. et al.Treatment of chronic hepatitis C in a state correctional facility.Ann Intern Med. 2003; 138: 187-190Crossref PubMed Scopus (115) Google Scholar] and gave evidence against the effectiveness of population-based screening programs. Again, the question is whether identifying infected subjects can give access to therapies to the majority of them to reach an effectiveness of therapy adequate to the screening efforts. The advent of the new HCV NS3 protease or forthcoming NS5b polymerase inhibitors raised high expectations in terms of efficacy, particularly for genotype 1 HCV, as derived from phase 2 or 3 trials. However, they need to be administered in triple association with Peg-interferon and ribavirin, which causes an increase in adverse events [9Hézode C. Forestier N. Dusheiko Gn et al.Telaprevir and peginterferon with or without ribavirin for chronic HCV infection.N Engl J Med. 2009; 360: 1839-1850Crossref PubMed Scopus (967) Google Scholar, 10Kwo P.Y. Lawitz E.J. McCone J. et al.Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial.Lancet. 2010; ([Epub. ahead of print])PubMed Google Scholar]. Large-scale use of these drugs is needed to define their indications and effectiveness in the complex setting of clinical practice. One must also presume that further limitations to treatment will include the coverage of costs by insurance companies or public health assistance. Epidemiological scenarios for HCV may vary in different geographical areas, urban or non-urban population, risk exposure groups, etc. [[11]Shepard C.W. Finelli L. Alter M.J. Global epidemiology of hepatitis C virus infection.Lancet Infect Dis. 2005; 5: 558-567Abstract Full Text Full Text PDF PubMed Scopus (2213) Google Scholar]. Thus, the data from the simulation by Rein et al. cannot be generalized, but their strength resides in the accuracy of the model, which could be applied to different situations. An external validation was provided with an analysis of retroactive data. As the Authors acknowledge, the influence of additional factors that contribute to liver disease progression, such as obesity or liver steatosis, would be crucial in extending the validity of the results. Despite the limitations, we have to look ahead in the fight against HCV. The first objective is a thorough monitoring of the present epidemiological trends of HCV and of factors influencing disease progression, in order to provide forecasting models with reliable data for a given area. In this respect, the paper by Rein et al. is a nice example of how a forecasting methodology can be a tool for public health decisions. None to declare." @default.
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• W2085889621 title "The art of forecasting and the impact of forecasts: The case of chronic hepatitis C" @default.
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