Thursday, July 6, 2017

Changes in renal function indices in cirrhotic chronic hepatitis C patients treated with sofosbuvir-containing regimens

Changes in renal function indices in cirrhotic chronic hepatitis C patients treated with sofosbuvir-containing regimens
Jianhong Chen1, Xiaxia Zhang1, Hao Luo1, Chihong Wu1, Min Yu1, Dan Liu1, Hongli Xi1, Yihang Zhou1, Yaoyu An1 and Xiaoyuan Xu1

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doi: 10.18632/oncotarget.18701

Received: March 26, 2017
Accepted: June 04, 2017
Published: June 28, 2017

Hepatitis C virus (HCV) is an important pathogen affecting approximately 130–150 million people worldwide [1, 2]. Chronic hepatitis C (CHC) patients have enhanced risk of cirrhosis and hepatocellular carcinoma [3, 4]. The emergence of direct-acting antivirals (DAAs) has revolutionized the treatment of HCV with shorter treatment durations, higher sustained virological response (SVR) rates, fewer adverse events (AEs) and fewer contraindications than those of traditional peginterferon and ribavirin (PegIFN/RBV, PR) treatment regimens [58].

With the wide application of DAAs, challenging issues regarding the efficacy and safety of new DAAs regimens have arisen, e.g., resistance-associated variants, drug-drug interactions (DDIs), HBV (hepatitis B virus) reactivation, hepatotoxicity and nephrotoxicity [920]. In October 2016, the United States Food and Drug Administration issued a black box warning regarding the risk for HBV activation with 9 DAAs, citing 24 cases that included 3 reports of acute liver failure (

The Institute for Safe Medicine Practices followed up with a review of Adverse Event Reporting System data covering a 12-month span. The review uncovered 524 cases of liver failure associated with DAAs and that 31.5% of the patients had died at the time of the review (

Traditional PR treatment regimens and first-generation protease inhibitors are considered nephrotoxic [21, 22]. Although all-oral DAAs regimens were well tolerated in clinical trials, recent real-world studies demonstrated some cases with nephrotoxicity that were treated with sofosbuvir (SOF)-containing regimens [1820]. Some cases with hepatotoxicity and nephrotoxicity associated with DDIs were reported in CHC patients with concomitant diseases, HBV or HIV co-infections, and liver transplantations [11, 14, 16, 17].

Considering the increasing occurrence of cases with hepatotoxicity, nephrotoxicity, and DDIs, this study aimed to explore the changes of hepatic and renal function indices in CHC patients treated with DAAs.

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