Appendix Table A Frequency of end-stage liver disease in inception cohort. Reference Exposure followup Frequency ESLD (%) Seeff-1 PTH 24 23/568 (4%) 7
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1 Published as supplied by the author Appendix Table A Frequency of end-stage liver disease in inception cohort studies Route of Years Reference Exposure followup Frequency ESLD (%) Locasciulli PTH /48 (0%) 2 Vogt PTH /37 (0%) 4 Barrett 5 IG 22 0/87 (0%) 6 Seeff-1 PTH 24 23/568 (4%) 7 Lai 8 PTH 26 0/29 (0%) 9 Casiraghi PTH /16 (0%) Weise 11 IG 35 < 28/197 (< 14%) 12 Seeff-2 Unknown /17 (12%) ESLD = End-stage liver disease (decompensated cirrhosis or hepatocellular carcinoma); PTH = Post-transfusion hepatitis; IG = Hepatitis C contaminated immunoglobulin 1 Pediatric patients with leukemia who were cured but infected during treatment 2 There were an additional 18 patients who cleared the infection 3 Pediatric patients (mean age 3 years) who were transfused for cardiac surgery 4 An additional 30 initially infected patients were HCV-RNA negative when tested 20 years later 5 Pregnant Irish women receiving contaminated immunoglobulin for rh incompatability
2 6 These 87 women were positive for HCV-RNA; an additional 58 were not and presumably had undergone spontaneous viral clearance 7 This is the only denominator in this table that includes individuals who may not all have developed chronic hepatitis C 8 Previously transfusion naïve children with thalassemia major 9 Originally 73 cases of PTH due to hepatitis C were prospectively identified; 21 lost to follow-up (cardiac death, bone marrow transplantation, transfer to another unit); 23 of the remaining 52 cleared the virus so data only for the 29 with chronic hepatitis C 10 Neonatal mini-transfusions from hepatitis C positive donor (43 total were transfused, but 10 not found, 2 declined to participate, and 1 died of non-hepatic causes at age 4 months; 18 were anti-hcv positive and the 16 noted in the table were the 16 who were also HCV-RNA positive) 11 Subgroup of German women infected when given contaminated immunoglobulin during pregnancy for rh incompatibility who were followed, developed chronic hepatitis C, and were never treated 12 The 28 women in the numerator are the total number of individuals with signs of cirrhosis; not all of these individuals necessarily developed ESLD. 13 Korean War recruits in US Army who volunteered for serologic study; serum samples found decades later and 17 found to be seropositive (antibody only) for hepatitis C References: Locasciulli Locassiulli A et al, Blood 1997; 90: Vogt Vogt M et al, N Engl J Med 1999; 341: Barrett Barrett S et al, Gut 2001; 49:
3 Seeff-1 Seeff LB et al, Hepatology 2001; 33: Lai Lai ME et al, Eur J Haematol 2013; 90:501-7 Casiraghi Casiraghi MA al, Hepatology 2004; 39:90-6 Weise Wiese M et al, Hepatology 2014; 59:49-57 Seeff-2 Seeff LB et al, Ann Intern Med 2000; 132:105-11
4 Appendix Table B. How assumptions made in hepatitis C treatment models bias the model for treatment Assumption The natural history of hepatitis C Influence of biased assumption The incidence of ESLD is overestimated disease progression is estimated from data from tertiary referral centers Spontaneous viral clearance is not allowed, even though such events do occasionally happen Would occur more often in controls (since such responses in treated arm would be viewed as result of therapy) so fewer controls would progress than calculated in model Life expectancies of the infected individuals are assumed to be equivalent to the general population (other than for the risk of liver disease), Lower life expectancies in both groups result in less time for the controls to develop ESLD and fewer good years in portion of treated group that have SVRs (than are calculated in the model) even though infected patients are known to have reduced life expectancies, perhaps because of factors associated with the initial infection (e.g., intravenous drug use, blood transfusions for underlying diseases) SVR is considered a cure Model assumes that treated patients never progress to ESLD Those not developing SVRs are assumed to have subsequent courses comparable to untreated patients Those failing to develop SVRs have poorer prognostic factors, so average life/liver expectancy would be worse than average life/liver expectancy
5 in group containing some people who would develop SVR The percentage of SVRs translates into an equivalent percentage drop in the incidence of ESLD Those achieving SVRs are at lower risk of progression, so percentage developing SVRs is higher than the percentage of treated patients spared from developing ESLD Quality adjustments are made by Surrogate outcomes overvalued by hepatologists physicians, typically hepatologists ESLD = End-stage liver disease (decompensated cirrhosis and/or hepatocellular carcinoma); SVR = Sustained virological response
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