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Do directly acting antiviral agents for HCV increase the risk of hepatic decompensation and decline in renal function? Results from ERCHIVES
Author(s) -
Butt A. A.,
Ren Y.,
Marks K.,
Shaikh O. S.,
Sherman K. E.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13837
Subject(s) - sofosbuvir , ledipasvir , medicine , dasabuvir , simeprevir , ombitasvir , paritaprevir , gastroenterology , daclatasvir , cirrhosis , hepatitis c , decompensation , hepatitis c virus , virology , ribavirin , virus
Summary Background Directly acting antiviral agents ( DAA ) have been associated with hepatic decompensation, especially in patients with pre‐treatment cirrhosis, but this risk is not well defined. Aim To determine the incidence of hepatic decompensation, liver transplantation, death and worsening renal function in patients treated with a Paritaprevir/ritonavir, Ombitasvir, Dasabuvir (Pr OD ), sofosbuvir/simeprevir or sofosbuvir/ledipasvir regimen. Methods We followed ERCHIVES participants treated with the above regimens for up to 12 weeks post‐treatment. We excluded those with HIV , HB sAg+ and pre‐existing diagnosis of hepatic decompensation and hepatocellular carcinoma. Results Of 3728 persons on Pr OD , 1578 on sofosbuvir/simeprevir and 10 440 on sofosbuvir/ledipasvir, incidence rates (95% CI ) of hepatic decompensation/1000 patient‐years were 10.6 (5.89–17.36) for the Pr OD , 32.4 (20.74–48.16) for the sofosbuvir/simeprevir and 13.0 (9.74–17.10) for the sofosbuvir/ledipasvir. Among those with baseline cirrhosis, these rates were 36.9 (19.1–64.5), 61.8 (38.2–94.5) and 41.1 (29.9–55.2) respectively, while among those without cirrhosis at baseline, these rates were 2.7 (0.6–8.0), 7.5 (1.5–21.8) and 2.7 (1.2–5.4). Advanced fibrosis was associated with increased risk of hepatic decompensation in all groups [ HR (95% CI ) per 0.5 unit increase in FIB ‐4 score: Pr OD 1.11 (1.07–1.16); sofosbuvir/simeprevir 1.03 (1.01–1.05); sofosbuvir/ledipasvir 1.02 (1.01–1.03)]. There were no deaths. Proportion of persons with eGFR decrease >30 ml/min/1.73 m 2 was higher among the Pr OD group, but presence of cirrhosis did not appear to affect this. Conclusions The incidence of hepatic decompensation in persons treated with Pr OD , up to 12 weeks after completion of treatment, was comparable to those treated with sofosbuvir/ledipasvir regimen, and was lower than among those treated with a sofosbuvir/simeprevir regimen. Such risk was predominantly observed in those with pre‐treatment cirrhosis.