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Table 2 Summary of clinical studies reporting the impact of SVR on HCC

From: Achieving sustained virologic response in hepatitis C: a systematic review of the clinical, economic and quality of life benefits

Study Setting Sample size Mean follow up Study details Key findings
Coverdale et al. 2004 [47] Australia 455 9 yearsa Retrospective cohort study including 384 treated with IFN alone, (n = 71 untreated) including patients with cirrhosis Overall 9-year incidence of HCC was 10% for untreated, 11% for non-response and 2% for SVR
Van der Meer et al. 2013 [20] Europe and Canada 248 8.3 yearsa Cohort of consecutive genotype 1 patients with advanced fibrosis, 24% with SVR HR (95% CI) for HCC for SVR versus non-SVR was 0.20 (0.06–0.69) (p = 0.011)
Van der Meer et al. 2012 [38] Europe and Canada 530 8.4 yearsa Retrospective cohort study in patients with advanced fibrosis/cirrhosis treated with IFN, IFN plus ribavirin or pegIFN plus ribavirin, median follow up 8.4 years, 68% genotype 1 Rate (per 100 patient years) for HCC were 0.55 (0.14–0.96) for SVR vs. 2.63 (1.83–3.82) without SVR (p < 0.001)
Braks et al. 2007 [43] France 113 8.2 (3.1) years Retrospective cohort study in patients with compensated cirrhosis treated with IFN or pegIFN-based treatment Proportion of patients with HCC was 2.7% for SVR versus 31.6% for non-SVR
Cardoso et al. 2010 [42] France 307 3.5 yearsa Retrospective analysis in patients with bridging fibrosis or cirrhosis treated with IFN, pegIFN or pegIFN plus ribavirin Adjusted HR (95% CI) for non-SVR versus SVR was 3.06 (1.12–8.39) (p = 0.029) for HCC
Bruno et al. 2007 [44] Italy 883 96.1 months Retrospective database analysis in patients treated with IFN monotherapy with no cirrhosis or decompensation, 73.5% genotype 1 Adjusted HR (95% CI) for non-SVR versus SVR was 2.59 (1.13–5.97) (p = 0.025) for HCC
Calvaruso et al. 2013 [23] Italy 444 69 monthsa (range 24–130 months) Prospective cohort study in PR-treated patients with compensated cirrhosis, 83% genotype 1, 24% with SVR HR (95% CI) for HCC for non SVR versus SVR = 4.44 (1.30–15.11) (p = 0.017)
Pellicelli et al. 2013 [27] Italy 172 5 yearsa Retrospective-prospective study in patients with HCV genotype 1 treated with pegIFN plus ribavirin, 34% with cirrhosis Multivariate OR (95% CI) for development of HCC for no SVR versus SVR = 3.58 (0.9–14.3) (p = 0.06)
Hara et al. 2014 [24] Japan 1,125 Not stated Retrospective cohort study in PR-treated (SVR and non SVR) and untreated patients HR (95% CI) for HCC for SVR versus non-SVR and untreated = 0.12 (0.03–0.48) (p = 0.003)
Ikeda et al. 2006 [35] Japan 2,166 15 years Retrospective cohort study in patients with HCV patients (n = 512 untreated, n = 1,654 treated with IFN-based therapy) Crude rate of HCC at 15 years was 13.9% for all treated patients, 23.9% for untreated and 7.5% for SVR
Imai et al. 2010 [28] Japan 568 11 years Retrospective cohort study in consecutive HCV patients treated with IFN monotherapy HR (95% CI) for HCC for SVR versus non-treated patients was 0.20 (0.08–0.50) (p < 0.001) for patients <60 years and 0.23 (0.08–0.64) (p = 0.005) for patients >60 years
Imazeki et al. 2005 [46] Japan 459 8.9 (3.2) years Retrospective cohort study in patients, inc patients with cirrhosis, treated with IFN alone (n = 355) or untreated (n = 104), n = 116 patients achieved SVR In the total population, annual incidence of HCC was 0.5% for SVR versus 2.6% for non-responders; corresponding figures for patients with cirrhosis were 9% and 34%, respectively
Kobayashi et al. 2007 [29] Japan 1,124 66 monthsa (range 12–197 months) Retrospective cohort study in HCV patients treated with IFN or IFN plus ribavirin (373 with SVR, 751 without SVR) HCC developed in 3.5% SVR patients versus 8.1% non-SVR patients. SVR HCC patients had a significantly more advanced stage of fibrosis (p < 0.001)
Maruoka et al. 2012 [40] Japan 721 9.9 (5.3) years Retrospective cohort study in patients treated with monotherapy (n = 577, of which n = 221 (38.3%) achieved SVR and n = 144 untreated patients Annual rate of HCC development was 2.71% for untreated patients, 2.31% for non-SVR and 0.24% for SVR (p < 0.0001)
Moriyama et al. 2005 [31] Japan 269 >6 years Retrospective study in patients with cirrhosis treated with IFN-based treatment Mean annual incidence of HCC was 0.78% for SVR versus 0.17% for non-responders with ALT <80 IU and 4.68% for ALT >80 IU
Ogawa et al. 2013 [25] Japan 1,013 3.6 yearsa Prospective multicenter study in patients treated with pegIFN plus ribavirin, 70.1% had HCV genotype 1 and 14.8% had cirrhosis at baseline HR (95% CI) for HCC relative to SVR = 1.50 (0.65–3.44) (p = 0.34) for relapse and breakthrough and 3.72 (1.69–8.18) (p = 0.001) for non-response
Ogawa et al. 2012 [37] Japan 1,015 3.8 years (2–6 years) Prospective multicenter study in patients treated with pegIFN plus ribavirin (n = 712 genotype 1, n = 303 genotype 2) 6-year cumulative incidence of HCC was 3.4% for SVR versus 21.2% for non-response group (p < 0.0001) and 6.4% for transient response (ns)
Sasaki et al. 2014 [22] Japan 916 Not stated Retrospective study of IFN-treated patients Incidence of HCC was 3.6% in patients who achieved SVR vs. 21.2% in non-SVR patients
Sasaki et al. 2011 [34] Japan 236 50 monthsa N = 236 patients with IFN-based treatment, median follow up 50 months No significant difference in incidence of HCC for SVR versus non-SVR
Watanabe et al. 2011 [32] Japan 1,865 4.25 yearsa Retrospective cohort study in patients treated with pegIFN plus ribavirin, n = 999 (54%) with SVR 5 year cumulative incidence of HCC was 1.1% in patients with SVR and 7.1% in non-SVR patients (p < 0.001)
Yoshida et al. 2004 [36] Japan 2,787 >6.5 yearsa Retrospective database analysis in HCV patients (n = 395 untreated, n = 836 SVR, and n = 1,556 non-SVR) HR (95% CI) for HCC for non-SVR versus no treatment was 0.835 (0.625–1.125) (p = ns).
Annual incidence of HCC in SVR was 0.05–0.40% for F0–F1 and 0.15–3.20% for F4. For non-SVR annual incidence was 0.05–1.03% for F0–F1 and 0.29–12.5% for F4 (depending on age and gender)
Velosa et al. 2011 [39] Portugal 130 6.4 (4.0) years Retrospective cohort study in patients with cirrhosis treated with IFN, IFN plus ribavirin or pegIFN plus ribavirin HR (95% CI) for HCC for SVR versus non-SVR was 0.09 (0.01–0.77) (p = 0.024)
Aleman et al. 2013 [26] Sweden 351 5.3 years Prospective multicenter study in patients with HCV-related cirrhosis treated with pegIFN plus ribavirin, 50% genotype 1 HR (95% CI) for HCC for SVR versus non-SVR = 0.38 (0.14–0.88) (p = 0.04)
Hung et al. 2006 [30] Taiwan 132 37 monthsa (12–63 months) Retrospective cohort study in HCV patients with cirrhosis , inc. patients with HBV or HIV coinfection, 56% genotype 1b, treated with pegIFN plus ribavirin 4 year cumulative incidence of HCC was 28% in non-SVR versus 8% in SVR group (p = 0.0178)
Shih et al. 2012 [48] Taiwan 3,988 34.6 monthsa Retrospective analysis of patients with HCV monoinfection, (n = 344 patients treated with IFN-based treatment, n = 216 with SVR) Adjusted HR (95%CI) for SVR versus untreated was 0.23 (0.06–0.94) (p = 0.041) for HCC
Wang et al. 2011 [33] Taiwan 164 8 years Retrospective cohort study in patients treated with pegIFN plus ribavirin Incidence of HCC was 8.8% for patients with an SVR versus 14.3% for untreated patients (p = 0.352)
Yu et al. 2006 [45] Taiwan 1,619 5.2 years Prospective study in patients with or without cirrhosis (n = 562 untreated and n = 1,057 treated with IFN or IFN plus ribavirin) RR (95% CI) for HCC versus untreated was 0.245 (0.13–0.46) (p < 0.0001) for SVR and 0.990 (0.635–1.541) (p = 0.963) for non-SVR
Morgan et al. 2010 [41] United States 140 78.6 (15.9) months Prospective analysis from the HALT-C trial in patients with advanced fibrosis treated with pegIFN plus ribavirin and achieving SVR HR (95% CI) for SVR versus non response was 0.19 (0.04–0.80) for HCC
Wang et al. 2013 [21] Not stated 138 8 years Patients (mean age 56 years) treated with PR, 80% achieved SVR 8-year incidence of HCC was 13.5% for SVR patients, 23.5% for relapsers and 20% for non-responders (p = 0.518)
  1. aMedian follow up.
  2. ALT, alanine aminotransferase; CI, confidence interval; HCC, hepatocellular carcinoma; HR, hazard ratio; IFN, interferon; ns, not significant; SVR, sustained virologic response.