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DDW DIGESTIVE DISEASE WEEK 2012

M AY 1 8 – 2 1 S A N D I E G O UNITED STATES

Part 1

NEW EPIDEMIOLOGICAL AND THERAPEUTIC CONCEPTS I N H E PAT I T I S C

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Epidemic of Hepatitis C Virus (HCV) Over the last years, there has been a significant global increase in the prevalence of HCV infection, with 200 million of infected subjects worldwide and between three and four million of subjects being exposed to this virus annually. It should be stressed that HCV Genotype 1 is identified in 75% of the cases of infected subjects in United States. Estimates from the United States indicated that the prevalence of patients with anti-HCV antibodies in 2008 reached 3.6 million of affected subjects, with a population of 11 million people suffering from a chronic HCV infection and near 1.6 million of patients not yet diagnosed. As it is well known, chronic infection caused by this virus may lead to an advanced liver disease 2

(ALD), including cirrhosis, decompensated cirrhosis, and liver cancer, as well as the need of liver transplant. A study presented within the framework of the Digestive Disease Week 2012 (DDW 2012, San Diego, U.S.A.) by Zalesak and et al.1 assessed the mentioned circumstances in deep. The objective introduced by these researchers was to determine annual ALD progression rates in the HCV-infected population, by age cohort. In addition, they attempted to project expected prevalence in 2015 if patients were left untreated. As methodology, PharMetrics and Medicare databases were used to identify patients with HCV, with or without ALD,


applying the International Classification of Diseases (ICD-9 codes). Future ALD prevalence was projected from progression and mortality trends of these databases. The results informed that 1.1 million of chronically HCV-infected patients were tabulated in the following age groups: 1644 (16.1%), 45-54 (38.8%), 55-64 (36.4%) and older than 65 (8.6%). The proportion of patients diagnosed with ALD increased with age. In this way, ages between 16-44, 45-54 and 55-64 years had a 9.1%, 17.1% and 22.4% of patients with ALD, respectively. In the largest group (45-54 years), 4.4% of HCV-infected patients without ALD developed such complications annually, 11.5% of cirrhotic patients developed a decompensated cirrhosis, and 3.2% of patients developed liver cancer and/or required transplant.

the number of patients diagnosed with HCV and ALD will increase from 198.000 (2008) to near 304.000 (2015) patients. Finally, if similar progression rates are applied, it may be foresee that near 299.000 undiagnosed patients may develop ALD between 2008 and 2015, if left untreated. As conclusion, it was informed that most HCV-infected subjects in 2008 belonged to the age group of 45-65 years (called “baby boom generation�). It is expected that a significant proportion of these patients will annually develop an ALD, indicating the immediate need to diagnose and treat this pathology before the development of expensive and irreversible complications. It is thus expected that, without any specific treatment, the number of patients with ALD will be tripled between 2008 (198.000 patients) and 2015 (603.000 patients). See Table 1.

As regards data projection, it is assumed that, without treatment, Table 1

ession of erent Age Kevin rek Martyn1, yle Hvidsten2.

Projection of patients infected with HCV and advance liver disease at the time of diagnosis

d liver

Table 1

700

Without diagnosis before 2009 Diagnosed before 2009

600

Patients with advanced liver disease (in thousands)

500 400

159

300

58

201

239

271

299

111

200 100

220

240

258

274

286

297

304

193

2008

2009

2010

2011

2012

2013

2014

2015

0

Current and Future Disease Progression of HCV-Infected Patients Among Different Age Cohorts. Sa1084 | Martin Zalesak1, Kevin Francis1, Ann Kwong2, Hong Li1, Derek Martyn1, Leslie S. Orne1, Amanda Smith1, Kyle Hvidsten2.

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News in the treatment of HCV infection DDW Combined Clinical Session. New Therapies for HCV: Practitioners Delivering Specialty Care. 19 de mayo de 2012.

While successful results have been obtained using ribavirin and pegylated interferon (PEG-IFN), it is considered that treatments available for chronic HCV infection are effective in less than 50% of patients with HCV Genotype 1. In this sense, from its approval in the United States (May 23, 2011) by the FDA’s Antiviral Drugs Advisory Committee, protease inhibitors used in combination with the previously mentioned drugs (ribavirin and pegylated interferon) have been settled as the modern standard treatment of chronic HCV infection, due to their effectiveness in inhibiting hepatitis C virus replication. Thus, this combination of drugs is indicated in the treatment of HCV Genotype 1 in adult patients with compensated liver disease, including cirrhosis. For its approval, the safety and efficacy of one of the most important protease inhibitors – telaprevir – were assessed in three Phase 3 clinical trials in near 2.250 adult patients previously treated or who had received prior treatments. In patients previously untreated, 79% of those receiving telaprevir experienced a sustained viral response (SVR), compared with those treated with PEG-IFN alpha and ribavirin alone. SVR assessed in such trials and in the groups of patients treated with telaprevir was 20% and 45% higher than with the current standard treatment. The Protease Inhibition for Viral Evaluation 1 (PROVE1) study

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showed that adding telaprevir to the conventional treatment regime determined an improvement in the viral response to HCV2. In the first studies, a rapid reduction of HCV RNA levels was produced. However, patients receiving telaprevir had a higher treatment discontinuation rate (21%), compared to the placebo group (11%), due to adverse effects, mainly due to skin rash. More news… In DDW 2012, the Combined Clinical Session on New Therapies for HCV, under the title “Practitioners Delivering Specialty Care”, included the debate on modern therapies against this pathology with increasing prevalence. In addition, an important project was presented, called Project ECHO (Extension for Community Healthcare Outcomes), which is a new model for hepatitis C care designed with the objective of enhancing the access to these complex treatements3. In such Session, Norah A. Terrault, M.D. (Director of Viral Hepatitis Center at the University of San Francisco) highlighted the development achieved by including the protease inhibitor telaprevir in the treatment of HCV infection, in particular in those untreated cases (naïves) as well as those who had received a therapeutic regime without results or who had presented relapses. However, in this meeting, it was also informed that there


are groups still presenting suboptimal response rates. As commented, also within the framework of this Combined Session in DDW 2012, Professor Sanjeev Arora, Director of Project ECHO (University of New Mexico School of Medicine, Albuquerque), described the telemedicine and distance learning program designed to improve access to quality health care services for patients with hepatitis C living in New Mexico, in particular inhabitants of rural areas. It is calculated that there are near 28.000 patients with HCV in New Mexico, 2.300 being residents of state prisons. Project ECHO was successful in terms of promoting communication between health care providers in rural clinics, the Indian Health Service and prisons with specialists of the University of New Mexico. This communication was brought to life in weekly

contacts and meetings in which multiple cases of these pathologies were presented to the mentioned specialists. In addition, within the framework of this project, videoconference techniques were used to train primary healthcare system physicians on this complex disease. It should be mentioned that more than 50% of healthcare providers in the rural areas of New Mexico are clinicians and nurses. This experience has already been published in the prestigious journal New England Journal of Medicine in 2011, highlighting the benefits from the contact of university specialists of New Mexico with 21 Project ECHO locations of rural areas and prisons. This interaction determined a SVR comparable between the university environment and ECHO centers, where it reached a total of 57.5% and 58.2% of patients, respectively.

References: 1-

Current and Future Disease Progression of HCVInfected Patients Among Different Age Cohorts. Sa1084| Martin Zalesak1, Kevin Francis1, Ann Kwong2, Hong Li1, Derek Martyn1, Leslie S. Orne1, Amanda Smith1, Kyle Hvidsten2 Presentado en Viral Hepatitis: Epidemiology and Co-Morbidities. Poster Session: Saturday, 8:00AM - 5:00PM | P7015 | Location: San Diego Convention Center - Halls C-G.

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McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection.. N Engl J Med 2009;360:1827-38.

PRESS

B uenos A i res Argenti na

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New Therapies Against HCV: Practitioners Delivering Specialty Care. Combined Clinical Symposium. Saturday, 8:30AM - 10:00AM | L3005 | Location: San Diego Convention Center - 6a. Managing HCV - a Public Health Imperative; Screening and Linkage to Care 8:30 Sp168 | John Ward. Protease Inhibitors the First Year in Review 8:52 | Sp169 | Andrew J. Muir. Expanding Access to Care: Project ECHO 9:14 | Sp170 | Sanjeev Arora. The Future of HCV Therapy 9:36 | Sp171 | Norah A. Terrault.

The data and results presented herein were obtained from a conference on Medicine and the information summarized might be preliminary and subject to changes. This information is exclusively included for physician’s training and educational purposes only. Summary prepared by the Staff of Circle Press based on their attendance to the Symposium. Photo Database: Shutterstock

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