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Table 4 Summary of clinical studies reporting the impact of SVR on liver-related complications

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 Outcomes assessed 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 Liver-related complications Overall 9-year incidence liver-related complication rate was 25% for untreated, 25% for non-response and 2% for SVR
Abergel et al. 2004 [73] France 163 Not stated Retrospective cohort study in patients with severe fibrosis treated with IFN alone (n = 64) or IFN plus ribavirin (n = 99) Progression of fibrosis Fibrosis progression rate decreased in both responders and non-responders to treatment. 33% SVR regressed from cirrhosis to severe fibrosis; corresponding figure for non-responders was 9% (p = 0.058)
Braks et al. 2007 [43] France 113 8.2 (3.1) years Retrospective cohort study in patients with compensated cirrhosis treated with IFN, IFN plus ribavirin or pegIFN plus ribavirin Liver-related complications Proportion of patients with ascites was 5.4% for SVR vs. 10.5% for non-SVR, rates of digestive hemorrhage were 2.7% vs. 5.3%, respectively
Poynard et al. 2013 [74] France 933 6.3 years Prospective cohort study in HCV patients, 62% genotype 1 Regression of fibrosis, progression to cirrhosis HR (95% CI) for regression of fibrosis at 10 years for SVR versus non-response = 4.94 (2.59–9.44) (p < 0.001)
HR (95% CI) for progression to cirrhosis = 0.185 (0.106–0.264) for SVR and 0.173 (0.123–0.224)
Roche et al. 2008 [75] France 113 31.4 monthsa Open label study in with liver transplant recipients treated with IFN plus ribavirin or pegIFN plus ribavirin, 75% genotype 1 Fibrosis stage For SVR mean (SD) necroinflammatory grade decreased from 1.9 (0.6) to 1.0 (0.6) post-therapy and improved in 71.5% and remained stable in 26% SVR patients; corresponding figures in non-SVR patients were 51.5% and 46%, respectively
Wiese et al. 2014 [76] Germany 718 35 years Prospective, community-based multicenter study in women with HCV genotype 1, SVR rate of 46% in treated patients Cirrhosis Incidence of cirrhosis at 35 years post-infection = 6.0% for SVR vs. 15.3% for non-SVR
Annicchiarico et al. 2012 [77] Italy 135 44.4 monthsa Prospective study in 135 HCV patients with cirrhosis Portal hypertension Development of portal hypertension was 10% for SVR versus 40% for non-SVR (p < 0.0005) progression of portal hypertension was 25% for SVR vs. 48% for non-SVR (p < 0.01)
Bruno et al. 2010 [78] Italy 218 11.4 yearsa Retrospective cohort study in patients with compensated cirrhosis (n = 149 patients treated with IFN or IFN plus ribavirin), but no esophageal varices Esophageal varices Esophageal varices developed in 32% untreated patients, 39% non-SVR patients and 0% SVR patients
D’ambrosio et al. 2011 [79] Italy 127 77 months Prospective cohort study in initially treatment-naïve patients with compensated cirrhosis, treated with IFN plus ribavirin Esophageal varices (development of and or progression in size/severity) Development/progression occurred in 5% SVR patients versus 15% non-SVR patients. 8-year cumulative probability of esophageal varices was 6% for SVR vs. 30% for non-SVR (p = 0.03)
Arase et al. 2009 [69] Japan 2,842 6.4 yearsa Retrospective cohort study in patients treated with IFN or pegIFN plus ribavirin, 6% patients had cirrhosis at baseline Onset of type 2 diabetes Adjusted HR (95% CI) for the development of diabetes for non-SVR vs. SVR was 2.73 (1.77–4.20) (p < 0.001)
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 Hepatic failure In the total population, annual incidence of hepatic failure was 0% for SVR and 0.5% for non-responders; corresponding figures for patients with cirrhosis were 0% and 1.0%, respectively
Uenishi et al. 2008 [64] Japan 209 4.1 yearsa Retrospective cohort study in patients who underwent curative surgery for early stage HCC (n = 139 had no antiviral treatment, remainder treated with pegIFN plus ribavirin) Tumor-free survival and recurrence of HCC Tumor-free survival rate at 5 years was 54% for SVR group vs. 23% for non-SVR/untreated group (p < 0.001)
Lee et al. 2013 [80] South Korea 315 45 monthsa Retrospective chart review, 86% patients treated, 15% with cirrhosis at baseline, SVR rate of 75% Cirrhosis Cumulative 5 year rate of cirrhosis was 27.6% for patients without SVR vs. 0% for patients with SVR (p < 0.01)
Canete et al. 2013 [81] Spain 105 9.3 years Retrospective study of paired biopsy data in HCV patients with mild-moderate fibrosis treated with IFN plus ribavirin Progression of fibrosis Progression of fibrosis was reported in 5.3% patients with SVR and 50% patients with non-response (p < 0.0001). Fibrosis improved in 30.5% patients with SVR and 14.6% patients with non-response
Simo et al. 2006 [70] Spain 234 5.7 years Retrospective cohort study in patients with HCV (without severe fibrosis) treated with IFN or IFN plus ribavirin, 79% genotype 1 Onset of type 2 diabetes HR (95% CI) for onset of diabetes for SVR vs. non-SVR was 0.48 (0.24–0.98) (p = 0.04)
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 Decompensated cirrhosis (ascites, variceal bleeding, encephalopathy) HR (95% CI) for hepatic decompensation for SVR vs. non SVR = 0.23 (0.08–0.53) (p = 0.002)
Innes et al. 2012 [56] United Kingdom 1,215 5.3 years Retrospective cohort study in previously naïve patients, 36% genotype 1, treated with IFN-based therapy, 14% patients with cirrhosis at baseline Liver-related inpatient hospital episodes Adjusted HRs (95% CI) for SVR versus non-SVR were 0.22 (0.15–0.34) for liver-related hospital episode (p < 0.01)
Cozen et al. 2013 [66] United States 358 10 years Retrospective database analysis in patients with HCV treated with IFN monotherapy or pegIFN plus ribavirin, 69% genotype 1 and 7.3% with cirrhosis at baseline Cirrhosis HR (95% CI) for development of cirrhosis vs. never treated = 0.68 (0.26–1.80) for SVR and 2.35 (1.18–4.69) for non-responders
Hyder et al. 2013 [72] United States 20,486 5 years Retrospective database analysis of US veterans with no history of diabetes treated between 1998–2007 Onset of type 2 diabetes HR (95% CI) for onset of type 2 diabetes for SVR versus non-response was 0.76 (0.70–0.82) (p < 0.0001)
Oni et al. 2011 [71] United States 8,687 >6 years Retrospective database analysis in patients treated with pegIFN-based treatment Onset of type 2 diabetes Rate of new onset of diabetes was 10.2% for SVR group vs. 15% for non-SVR group
  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.