AMSTERDAM — Norfloxacin yielded improved 6-month survival compared with placebo in a cohort of HCV patients with Child-Pugh C cirrhosis, according to data presented at the International Liver Congress.
“In this trial involving patients with Child-Pugh C cirrhosis without recent history of fluoroquinolone therapy, 6-month mortality was significantly lower among patients who received norfloxacin than among those who received placebo,” Richard Moreau, MD, of APHP, DHU UNITY, Service d'Hépatologie, Hôpital Beaujon, Centre de Recherche sur l’Inflammation in Paris, said during a press conference. “Norfloxacin also reduced the risk of infections, but not that of [spontaneous bacterial peritonitis], and had no effect on the incidence of any other liver-related complication.”
Moreau and colleagues investigated the impact of norfloxacin therapy in a cohort of 291 patients. The multicenter, phase 3, randomized, double blind, placebo-controlled trial included 144 patients treated with 400 mg norfloxacin daily and 147 patients assigned placebo. Patients were treated for 6 months, with 6 months of follow-up after that.
Mortality served as the primary outcome in the intention-to-treat analysis. Transplantation or development of liver complications were the secondary endpoints.
The primary outcome was significantly lower in the study drug arm (P = .045), according to the results. This trend continued in the adjusted analysis (aHR = 0.575; 95% CI, 0.338-0.979).
Secondary endpoint results showed that spontaneous bacterial peritonitis (SBP) occurred in 7.9% of patients treated with norfloxacin and 14.3% of those assigned placebo (P = .15), which Moreau noted was not a significant difference. Infections rates were 23.9% for norfloxacin and 35% for placebo (P = .04). “There was no difference between the two groups in terms of septic shock,” he said. “Interestingly, we didn’t find any emergence of multi-resistant bacteria. We were nervous about the development of these bacteria but it didn’t occur.”
Transplantation rates were also similar, at around 13% in each group.
Baseline demographics were similar between the two arms. “There were high Child-Pugh and MELD scores in the cohort,” Moreau said. Just under 90% of patients in each group had ascites.
The discontinuation rate was 46% overall, with 42 patients discontinuing in the norfloxacin group and 50 patients discontinuing in the placebo group. “Most patients discontinued due to death,” Moreau said. Patient decision accounted for about 12% of discontinuations in each group. – by Rob Volansky
Reference: Moreau R, et al. Abstract #GS-001. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: Moreau reports no relevant financial disclosures.