Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis
Phase observationalN = 530
- Population
- Patients with chronic hepatitis C infection and advanced hepatic fibrosis or cirrhosis (Ishak score 4-6) who started interferon-based treatment between 1990 and 2003 (median follow-up 8.4 years).
- Design
- International multicentre long-term follow-up (cohort) study from 5 tertiary care hospitals in Europe and Canada. Patients started an interferon-based regimen between 1990 and 2003 after histological proof of advanced fibrosis or cirrhosis (Ishak 4-6); follow-up ran to January 2010 through October 2011. Observational: arm roles below label the SVR comparison, not randomised assignment.
- Primary endpoint
- All-cause mortality
- Arms
- SVR achieved (experimental, n = 192): Interferon-based treatment with sustained virological response
- No SVR (control): Interferon-based treatment without sustained virological response
- People
- van der Meer AJ
All-cause mortalityHR 0.26 (95% CI 0.14–0.49)Δ 120-month All-cause mortality−17.1 pointsΔ 120-month Incidence of hepatocellular carcinoma−16.7 points
Show the numbers
| Endpoint | Analysis | SVR achieved | No SVR | Effect |
|---|---|---|---|---|
| All-cause mortality530 patients who started interferon-based treatment (192 achieved SVR)Cumulative all-cause mortality at 10 years of follow-up, with SVR as a time-dependent covariate in the Cox model. | primarymedian follow-up 8.4 yearsvan 2012 | 8.9% at 10 y (3.3–14.5%) | 26% at 10 y (20.2–28.4%) | HR 0.26 (95% CI 0.14–0.49)P<.001Hazard ratio is from time-dependent multivariate Cox regression. Deaths: 13 with SVR and 100 without. The published 10-year interval for the no-SVR arm is printed as 20.2%-28.4% and is reproduced as published. Liver-related mortality or transplantation: hazard ratio 0.06 (95% CI 0.02-0.19; P<.001). |
| Incidence of hepatocellular carcinoma530 patients who started interferon-based treatment (192 achieved SVR)10-year cumulative incidence of hepatocellular carcinoma (a secondary outcome in the paper). | exploratorymedian follow-up 8.4 yearsvan 2012 | 5.1% at 10 y (1.3–8.9%) | 21.8% at 10 y (16.6–27.0%) | P<.001Hepatocellular carcinoma developed in 7 patients with SVR and 76 without. No hazard ratio for this outcome appears in the abstract. |
| Endpoint | Analysis | SVR achieved | No SVR | Effect |
|---|---|---|---|---|
| All-cause mortality530 patients who started interferon-based treatment (192 achieved SVR)Cumulative all-cause mortality at 10 years of follow-up, with SVR as a time-dependent covariate in the Cox model. | primarymedian follow-up 8.4 yearsvan 2012 | 8.9% at 10 y (3.3–14.5%) | 26% at 10 y (20.2–28.4%) | HR 0.26 (95% CI 0.14–0.49)P<.001Hazard ratio is from time-dependent multivariate Cox regression. Deaths: 13 with SVR and 100 without. The published 10-year interval for the no-SVR arm is printed as 20.2%-28.4% and is reproduced as published. Liver-related mortality or transplantation: hazard ratio 0.06 (95% CI 0.02-0.19; P<.001). |
| Incidence of hepatocellular carcinoma530 patients who started interferon-based treatment (192 achieved SVR)10-year cumulative incidence of hepatocellular carcinoma (a secondary outcome in the paper). | exploratorymedian follow-up 8.4 yearsvan 2012 | 5.1% at 10 y (1.3–8.9%) | 21.8% at 10 y (16.6–27.0%) | P<.001Hepatocellular carcinoma developed in 7 patients with SVR and 76 without. No hazard ratio for this outcome appears in the abstract. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| All-cause mortality | 0.26 | 0.14–0.49 |