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Low hepatic function increases risk for decompensation when on Sovaldi-based regimens for HCV

High levels of bilirubin at baseline and low albumin levels were risk factors for the development of liver decompensation and/or serious adverse events among patients with hepatitis C virus infection treated with Sovaldi-based regimens.

To determine the safety and efficacy of new HCV treatments in real-world clinical practice, Ponni V. Perumalswami, MD, assistant professor of medicine, division of liver diseases, Icahn School of Medicine at Mount Sinai, New York, and colleagues evaluated data of 511 patients with HCV who initiated treatment with Sovaldi- (sofosbuvir, Gilead Sciences) based regimens at Mount Sinai Medical Center between December 2013 and June 2014. The researchers assessed the data by two methods: clinicians created lists of all patients who began treatment and experienced hepatic decompensation or a serious adverse event within 1-month post-treatment, and patients on treatment were queried from the Mount Sinai Data Warehouse medical records database.

Ponni V. Perumalswami

Of the 511 patients, 499 had no history of hepatic decompensation during the previous 12 months, therefore were included in a nested case–control study to identify predictors of decompensation and/or serious adverse events. Cases and controls were matched 1:5 based on treatment regimen and duration.

Overall, the cumulative incidence of decompensation and/or serious adverse events was 6.4% for the entire cohort. Among the 499 previously stable patients, the incidence of decompensation and/or serious adverse events was 4.5%, with a mortality rate of 0.6%.

Of the 499 patients, 16 experienced one or more serious adverse events that were deemed potentially treatment-related. The sustained virological response rate was 44% for these patients (7/16).

Two of the 16 cases had complications consistent with autoimmune events and one experienced a flare of autoimmune hepatitis. Both underwent treatment with sofosbuvir and Olysio (simeprevir, Janssen). Compared with controls, the 16 cases had higher baseline median MELD scores (14 vs. 8; P < .01). Decompensation and/or serious adverse events were independently associated with lower baseline albumin and higher total bilirubin (P = .01 for both).

The researchers concluded: “Among HCV mono-infected patients, decreased hepatic reserve appears to be a risk factor for decompensation and [serious adverse events] on HCV treatment with [sofosbuvir]-containing regimens. These patients may benefit from more intensive monitoring during and for several months after discontinuing treatment.” – by Melinda Stevens

Disclosure: Perumalswami reports receiving research funding from Boehringer Ingelheim, Gilead Foundation, Gilead Sciences and the Merck Foundation. Please see the full study for a list of all other researchers’ relevant financial disclosures.