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DAAs reduce mortality, cancer risk in HCV study.

DIRECT-ACTING ANTIVIRALS significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.

Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).

There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.

Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.

Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, C 46-0.93), and reduced risk of all-cause nortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.

"These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma," said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Universite, Institut National de la Sante et de la Recherche Medicale (INSERM), Paris.

Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.

In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data were available, they said.

There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.

"Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment," Dr. Carrat and colleagues said in a commentary on their results.

However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.

Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Generale de la Sante), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.




SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1.

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Title Annotation:CARDIOLOGY
Author:Bowser, Andrew D.
Publication:Family Practice News
Article Type:Clinical report
Date:Mar 1, 2019
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