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SVR, Mortality & cost burden- Study Reports SVR Normalizes Survival in Advanced Disease
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from Jules Levin, NATAP
There are numerous studies showing SVR "improves long-term outcomes by halting progression of fibrosis to cirrhosis and thereby preventing complications of cirrhosis including HCC", reduces if not eliminates HCC risk even after developing cirrhosis. Here is the latest data on this from a poster at AASLD. Below read increasing HCC/liver cancer & liver mortality rates from rent NHANES results, particularly among older folks, & older African-Americans & Latinos; below is a recent report from the VA reporting increases in cirrhosis, HCC & decompensated cirrhosis in the VA projecting new DAA IFN-free therapies will reduces deaths by 63%. Below is a report on the increases in the near future in the overall US population in advanced liver disease, HCC and in cost burden. And below is a study from the CDC CHeCS reporting HCV+ individuals die 15 years earlier & have increased rates of extra-hepatic diseases. Many studies have quantified the increased cost burden for all with HCV at various stages of disease and at the bottom of this report is a link to such a study: The average length of stay and total days of care by disease were obtained from these databases, which were used in calculating indirect costs. Direct cost associated with hepatitis C was estimated at $694-$1660 million per year, HCC (all causes) at $261-$978 million per year, HCC (hepatitis C only) at $140 million per year, and chronic liver diseases and cirrhosis at $1421 million per year; another study reports: "Adjusted all-cause costs were $20,961 per HCV patient, compared with $5451 per control......patients who achieved SVR incurred approximately half the HCV-related costs per month incurred by those who did not achieve SVR ($717 vs. $1436; P<0.0001)."
Adriaan van der Meer presented these data at AASLD 2013
"Comparison of the overall survival between patients with HCV-induced advanced hepatic fibrosis and the general population"
ABSTRACT-
INTRODUCTION Sustained virological response (SVR) is the primary efficacy measure for the treatment of chronic hepatitis C virus (HCV) infection, but randomized controlled trials showing a clinical benefit of antiviral therapy and validating SVR as surrogate endpoint are lacking. We compared the overall survival of patients with HCV-induced advanced fibrosis, with and without SVR, to that of the general population. METHODS Survival was assessed in an international cohort of consecutive patients with chronic HCV infection and advanced fibrosis (Ishak score 4-6) who started interferon-based therapy between 1990 and 2003. Per virological response group, the observed survival among patients was compared to the expected survival from matched age-, gender- and calendar time-specific death rates of the general Dutch population using the life table method and Wilcoxon (Gehan) test. RESULTS In total, 530 patients were followed for a median of 8.4 (IQR 6.4-11.4) years. Median age at baseline was 48 (IQR 42-56) years and 369 (70%) patients were male. SVR was attained by 192 (36%) patients. Cox regression analysis showed SVR (included as time-dependent variable) was independently associated with reduced mortality (adjusted HR 0.24, 95%CI 0.14-0.49, p<0.001). The cumulative 10-year survival was 74.0% (95%CI 71.6-79.8) among patients without SVR, which was significantly lower compared to the age- and gender-matched general population (p<0.001). Patients with SVR showed a cumulative 10-year survival of 91.1% (95%CI 85.5-96.7), which did not differ significantly from the standardized general population (p=0.571). CONCLUSION Despite established advanced fibrosis or cirrhosis, patients with chronic HCV infection who attained SVR show a comparable survival to that of a general population. This further supports SVR is a relevant surrogate endpoint of anti-HCV therapy.
There are numerous studies finding HCV can very often have a bad affect on quality-of-life and there are similarly many studies showing SVR improves quality of life, here is just one very recent study presented at DDW 10 days ago. I could swamp you with many studies but t keep it easy here are just a few recent select studies:
NHANES/2014 - Changing Hepatocellular Carcinoma Incidence and Liver Cancer Mortality Rates in the United States......http://www.natap.org/2014/HCV/050514_01.htm......."US liver cancer mortality rates increased with age in all racial/ethnic groups..... Among individuals aged 50-64 years, blacks had the highest mortality rate (18.6), followed by Hispanics (13.5), Asians/Pacific Islanders (13.0), and whites (7.7)."
In this recently (2014) published NHANES data (2007-2010) from the NIH National Cancer Institute they report increases in HCC and liver cancer mortality due to HCV with the greatest increases among African-Americans AND among the aging older HCV+ group AND in looking at Supplementary Table 1 you can see the Annual percent change (APC) in new HCC cases in greatest among African-Americans:......"the racial group most affected by HCC, and among men aged 35-49 years. Incidence rates only increased among blacks, Hispanics, and white men and women aged 50+ years......Across states, increases in liver cancer mortality rates were most often seen among individuals aged 50-64 years (baby-boomers).....HCC incidence (new cases): Among individuals aged 50-64 years, rates significantly increased by 9.6% per year from 2000 to 2006, then by 5.2% per year from 2006 to 2010. Among individuals aged 65+ years, rates increased 3.6% per year during 2000-2010.......Between 2006 and 2010, the US liver cancer mortality rates increased with age in all racial/ethnic groups......Among individuals aged 50-64 years, blacks had the highest mortality rate (18.6), followed by Hispanics (13.5), Asians/Pacific Islanders (13.0), and whites (7.7).....As shown in Figure 1b, overall liver cancer mortality rates significantly increased during 2000-2010 (APC=2.1%), with a less rapid increase among individuals aged 65+ years (APC=1.1%) than among individualss aged 50-64 years (APC=5.6%)"
DDW: Quality of Life, Productivity, and Activity Impairment Among US Survey Respondents With Hepatitis C: An Evaluation of HCV and Six Select Medical Conditions - (05/06/14)
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There are numerous studies finding HCV increases mortality/risk for death, here is a CDC CheCS Study and this recent study from the VA presented at DDW last week:
DAAs reduce deaths by 63%.....Projected Health and Economic Impact of Hepatitis C on the United States Veterans Administration Health System From 2014 To 2024.....http://www.natap.org/2014/DDW/DDW_13.htm......."the prevalence of cirrhosis among patients with HCV increased from 9.6% in 1996 to 18.5% in 2006. The prevalence of decompensated cirrhosis and hepatocellular carcinoma also increased dramatically over those years, from 5% to 11% and from 0.07% to 1.3% respectively"......With no treatment, we estimated 958 deaths from HCV in 2014, 1,490 in 2019 and 1,800 in 2024. If all patients were treated with Peg/Rbv, deaths would decrease by 7.1%, 8.0%, and 8.9% in 2014, 2019, and 2024, respectively. In 2014, 2019, and 2024, deaths would decrease by 10.9%, 12.3%, and 13.7% with protease triple therapy, and by 50.2%, 56.7%, and 63.1% with all oral IFN-free DAA therapy (AOR)."
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IDSA/2013: CDC Figures Annual US Mortality in People With HCV Could Top 80,000: HCV Mortality Under-reported, Mortality Rate 12 Times Higher than General Population, HCV+ Die 15 Years Younger than General Population
"Our data suggests that the national mortality rate of those with HCV could be as high as 75,000 persons per year, with over 60% of current deaths in our HCV-infected cohort directly attributable to liver disease. Whether ascribed to liver-related causes or not, mortality in HCV-infected persons was 15 years younger compared with the national average in non-HCV infected persons." and HCV" had higher rates of death due to extra-hepatic diseases besides HCV
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CHRONIC HEPATITIS C VIRUS (HCV) DISEASE BURDEN AND COST IN THE UNITED STATES......http://www.natap.org/2013/HCV/010713_01.htm (Hepatology Dec 22 2012)......
in this study you can see in these graphs & tables the very significant increases in burden of HCV expected in the future in terms of diseases to patients - projected increases in advancing HCV disease to cirrhosis, HCC/liver cancer, decompensated cirrhosis AND the increased cost burden to private & public payers including hospital systems, the Federal, State & City governments, the VA and public city hospital systems like that in NYC which has a very large public hospital system with 15 public hospitals throughout NYC including Bellevue Hospital.
....... "incidence of more advanced liver diseases will continue to increase, with incidence of decompensated cirrhosis and HCC peaking in 2016-2017......by 2030, compensated cirrhosis cases will account for 37% of all prevalent cases. The HCV compensated cirrhotic population is projected to peak in 2015, while the decompensated cirrhotic population will peak in 2019"
......."The effects of new therapies were excluded from our model. However, if the number of treated patients is doubled and kept constant at 126,000 per year in 2012-2030 and the average SVR is increased to 70%, the 2030 prevalent population is projected to be less than 100,000 cases. This illustrates that it is possible to substantially reduce HCV infection in the US through active management."
........The prevalent population with compensated cirrhosis is projected to peak in 2015 at 626,500 cases, while the population with decompensated cirrhosis will peak in 2019 with 107,400 cases. The number of individuals with HCC, caused by HCV infection, will increase to 23,800 cases in 2018 before starting to decline.
In 2011, the total healthcare cost associated with HCV infection was $6.5 ($4.3-$8.2) billion.......Total cost is expected to peak in 2024 at $9.1 billion ($6.4-$13.3 billion), as shown in Figure 3. The majority of peak cost will be attributable to more advanced liver diseases-decompensated cirrhosis (46%), compensated cirrhosis (20%), and hepatocellular carcinoma (16%). The maximum cost associated with mild to moderate fibrosis (F0-F3) occurred in 2007 at nearly $780 million. The cost associated with compensated cirrhosis is expected to peak in 2022 at $1.9 billion, while the peak cost for decompensated cirrhosis and HCC is predicted to occur in 2025, with annual costs in excess of $4.2 billion and $1.4 billion respectively."
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Direct Economic Burden of Chronic Hepatitis C Virus in a United States Managed Care Population: 'HCV costs 4 times control group, SVR reduced costs'
http://www.natap.org/2013/HCV/040513_01.htm
"Adjusted all-cause costs were $20,961 per HCV patient, compared with $5451 per control......patients who achieved SVR incurred approximately half the HCV-related costs per month incurred by those who did not achieve SVR ($717 vs. $1436; P<0.0001)."....Our findings also confirm that the annual per patient cost burden to payers for chronic HCV exceeds that of other more common conditions such as cardiovascular disease ($18,953)27 and type 2 diabetes ($9677)"
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Economic burden of hepatitis C-associated diseases in the United States
Journal of Viral Hepatitis March 2012......http://www.natap.org/2012/HCV/040412_02.htm
"Our analysis highlights the need for more updated cost studies....HCC cases doubled between 1985 and 1998....Direct cost associated with hepatitis C was estimated at $694-$1660 million per year, HCC (all causes) at $261-$978 million per year, HCC (hepatitis C only) at $140 million per year, and chronic liver diseases and cirrhosis at $1421 million per year. These cost estimates were in different years, as shown in Table 1, making direct comparison difficult....
...The indirect costs, defined as the cost of forgone earnings or production because of hospitalization, ambulatory care, premature death, and work loss because of acute or chronic infection, were often higher than the direct costs. In a 2010 study, the indirect cost associated with hepatitis C was estimated at $490 per year per diagnosed individual [24]. In the 2008 report by the National Institute of Health (NIH) [19], the indirect cost ($1.78 billion in 2004) for hepatitis C was 67% higher than estimated direct costs ($1.1 billion in 2004)."
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