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    DAAs do not increase risk of hepatic decompensation in HCV patients

    Direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infections does not increase the risk of hepatic decompensation or lead to a decline in renal function, according to a new study.

    The incidence of hepatic decompensation in HCV-infected patients treated with Paritaprevir/ritonavir, Ombitasvir, Dasabuvir (PrOD) for up to 12 weeks after completion of treatment is comparable to those treated with a sofosbuvir/ledipasvir regimen, and is lower than among those treated with a sofosbuvir/simeprevir regimen, lead author Adeel A. Butt, MD, professor of medicine at Weill Cornell Medical College, told Medical Economics. The risk was predominantly observed in those with pre-treatment cirrhosis, he said.

    The researchers published their results in the January 2017 Alimentary Pharmacology & Therapeutics.

    In October 2015, the FDA had updated its guidance regarding the safety of the PrOD regimen and ombitasvir, paritaprevir and ritonavir regimen based on 26 worldwide cases of worsening liver injury, hepatic decompensation and liver failure. The guidance was focused on patients with pre-treatment advanced liver disease, specifically those with moderate to severe hepatic impairment (Child-Pugh B and C).

    “Those were self-reported cases and no large scale study was available to quantify these risks. Ours is the first national study with a large population to address this question,” said Butt.

    Next: Analysis summary

    Mark L. Fuerst
    Staff Correspondent


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