Monday, February 12, 2018

Mortality Benefit of Successful Anti-HCV DAA Therapy in Patients Without Advanced Liver Disease

NEJM Journal Watch
February 9, 2018
Mortality Benefit of Successful Anti-HCV DAA Therapy in Patients Without Advanced Liver Disease 
Atif Zaman, MD, MPH reviewing Backus LI et al. Hepatology 2018 Jan 29.

Compelling evidence supports elimination of insurers' restrictions on providing direct-acting antiviral therapy to these patients.

Although direct-acting antiviral (DAA) regimens are effective in eradicating hepatitis C virus (HCV), their effect on long-term survival is unclear. Early studies in the interferon-based treatment era noted improved survival among HCV patients with advanced fibrosis, but studies in those with milder fibrosis are lacking.

In an observational cohort analysis, researchers assessed mortality in over 40,000 patients of Veterans Affairs facilities who received all-oral DAA therapy for genotype 1, 2, or 3 HCV infection and did not have advanced liver disease (FIB-4 score ≤3.25 and no evidence of overt compensated or decompensated cirrhosis or hepatocellular carcinoma).

In patients who achieved sustained virologic response (SVR; rate, 97%), the mortality rate (1.2 deaths/100 patient-years) was significantly lower compared with nonresponders (2.8) and some 60,000 untreated patients (3.8). In subgroup analyses by FIB-4 score, responders with a FIB-4 score <1.45 had mortality reductions of 46% and 67% compared with nonresponders and untreated patients, respectively, and those with a FIB-4 score of 1.45 to <3.25 had mortality reductions of 63% and 71% compared with those respective groups. In multivariate analysis, SVR was independently associated with reduced risk for death.

This is the most direct and compelling evidence showing that DAA treatment in HCV-infected patients who have early fibrosis/nonadvanced liver disease improves overall survival. Strengths of this study include a large sample size, a well-defined population, and the fact that all patients were offered HCV treatment. These results should be enough evidence to lift restrictions imposed by public and private payers who base treatment candidacy on degree of liver fibrosis.

Backus LI et al. Direct-acting antiviral sustained virologic response: Impact on mortality in patients without advanced liver disease. Hepatology 2018 Jan 29; [e-pub]. (

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