title: The number needed to treat to prevent mortality and cirrhosis-related complications among patients with cirrhosis and HCV genotype 1 infection.
abstract: Cirrhotic patients with chronic hepatitis C virus (HCV) infection remain at risk for complications following sustained virological response (SVR). Therefore, we aimed to evaluate treatment efficacy with the number needed to treat (NNT) to prevent clinical endpoints. Mortality and cirrhosis-related morbidity were assessed in an international multicentre cohort of consecutively treated patients with HCV genotype 1 infection and cirrhosis. The NNT to prevent death or clinical disease progression (any cirrhosis-related event or death) in one patient was determined with the adjusted (event-free) survival among patients without SVR and adjusted hazard ratio of SVR. Overall, 248 patients were followed for a median of 8.3 (IQR 6.2-11.1) years. Fifty-nine (24%) patients attained SVR. Among patients without SVR, the adjusted 5-year survival and event-free survival were 94.4% and 80.0%, respectively. SVR was associated with reduced all-cause mortality (HR 0.15, 95% CI 0.05-0.48, P = 0.002) and clinical disease progression (HR 0.16, 95% CI 0.07-0.36, P < 0.001). The NNT to prevent one death in 5 years declined from 1052 (95% CI 937-1755) at 2% SVR (interferon monotherapy) to 61 (95% CI 54-101) at 35% SVR (peginterferon and ribavirin). At 50% SVR, which might be expected with triple therapy, the estimated NNT was 43 (95% CI 38-71). The NNT to prevent clinical disease progression in one patient in 5 years was 302 (95% CI 271-407), 18 (95% CI 16-24) and 13 (95% CI 11-17) at 2%, 35% and 50% SVR, respectively. In conclusion, the NNT to prevent clinical endpoints among cirrhotic patients with HCV genotype 1 has declined enormously with the improvement of antiviral therapy.
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.
authors.forename: A J
authors.initials: AJ
authors.lastname: van der Meer
authors.forename: B J
authors.initials: BJ
authors.lastname: Veldt
authors.forename: J J
authors.initials: JJ
authors.lastname: Feld
authors.forename: H
authors.initials: H
authors.lastname: Wedemeyer
authors.forename: J-F
authors.initials: JF
authors.lastname: Dufour
authors.forename: F
authors.initials: F
authors.lastname: Lammert
authors.forename: A
authors.initials: A
authors.lastname: Duarte-Rojo
authors.forename: M P
authors.initials: MP
authors.lastname: Manns
authors.forename: S
authors.initials: S
authors.lastname: Zeuzem
authors.forename: W P
authors.initials: WP
authors.lastname: Hofmann
authors.forename: R J
authors.initials: RJ
authors.lastname: de Knegt
authors.forename: B E
authors.initials: BE
authors.lastname: Hansen
authors.forename: H L A
authors.initials: HL
authors.lastname: Janssen
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007391:International Cooperation; D008103:Liver Cirrhosis / Q000150:complications* / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
chemical_list: D000998:Antiviral Agents
keywords: chronic hepatitis C; cirrhosis; genotype 1; mortality; number needed to treat