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Olysio/Sovaldi combination yields high SVR12 in Child-Pugh A cirrhosis

In a new clinical study, researchers found that Olysio combined with Sovaldi with or without ribavirin had a higher efficacy rate and lower rate of adverse events among patients with Child-Pugh A cirrhosis vs. patients with Child-Pugh B/C cirrhosis.

Researchers, including Norah A. Terrault, MD, MPH, University of California San Francisco, conducted a multicenter study of 160 adults with HCV genotype 1 and cirrhosis treated with Olysio (simeprevir, Janssen Therapeutics) and Sovaldi (sofosbuvir, Gilead Sciences) with or without ribavirin (RBV) for 12 weeks. Of all the patients, 35% had Child-Pugh B/C cirrhosis and 64% had Child-Pugh A.

Norah A. Terrault

The median baseline MELD score was 9 (interquartile range, 8-11). Patients were matched with controls based on treatment center, age, Child-Pugh class, and MELD score.

Overall, 73% of patients with Child-Pugh B/C achieved sustained virologic response at week 12 (SVR12) compared with 91% of patients with Child-Pugh A cirrhosis (P < .01). More patients with Child-Pugh B/C discontinued treatment early compared with the Child-Pugh A patients (11% vs. 1%). Also, more patients in the Child-Pugh B/C group experienced adverse events requiring hospitalization compared with the Child-Pugh A group (22% vs. 2%), as well as more infections requiring antibiotics (20% vs. 1%) and hepatic decompensating events (20% vs. 3%; P < .01 for all).

Two patients died, one in the Child-Pugh B/C group due to liver-related causes and one patient in the Child-Pugh A group that was not liver-related.

Multivariate analysis showed that Child-Pugh B/C cirrhosis was an independent predictor for the absence of SVR12 (OR = 0.27; 95% CI, 0.08-0.92). Between the treated patients and controls, adverse events that required hospitalization (9% vs. 13%; P = .55), infections (8% vs. 6%; P = .47) and decompensated events (9% vs. 10%; P = .78) were similar.

“We present very limited data on [Child-Pugh C] cirrhosis, and those treated had a perceived critical need for treatment, given the absence of other [interferon]-free regimens at the time,” the researchers wrote. “Understanding the reasons for the reduced efficacy of current all-oral regimens in those with advanced cirrhosis, especially [Child-Pugh C cirrhosis], remains a top priority for the HCV treatment community.” – by Melinda Stevens

Disclosures: Terrault reports consulting for Janssen and receiving grants from Gilead Sciences. Please see the study for a full list of all other authors’ relevant financial disclosures.