Hepatic Encephalopathy

January 15, 2018

Delcath Systems issued results of a multicenter retrospective analysis of Delcath’s PHP Therapy. The study was conducted by researchers from Moffitt Cancer Center (Moffitt) in Tampa, FL, and the University Hospital Southampton (UHS) in the United Kingdom. Patients in the study were treated at the two centers between December 2008 and October 2016. Patients received up to four PHP treatments at UHS and up to six PHP treatments at Moffitt. All patients received at least one PHP treatment, the median number of treatments per patient was two and a total of 134 PHP treatments had been administered. Results showed that of the 51 treated patients, 22 (43.1 percent) showed a partial response, three (5.9 percent) showed a complete response and 17 (33.3 percent) had stable disease. The six-month overall and hepatic disease control rates were 64.7 percent and 70.6 percent, respectively. Survival analysis showed median overall survival of 15.3 months at the time of data cut off. One year overall survival was 64.6 percent. Safety analysis showed that 19 patients (37.5 percent) had Grade three or four non-hematologic toxicity. Cardiovascular toxicity was seen in 17.6 percent of patients, a rate comparable to the company’s prior Phase III study. The system has not been approved by the FDA, and is undergoing Phase III clinical testing in the U.S.

May 4, 2009

Salix reported positive results from a phase III trial of rifaximin for the treatment of hepatic encephalopathy (HE). This multinational, randomized, double-blind, placebo-controlled trial enrolled 299 subjects who received either rifaximin 550 mg twice daily or placebo. It was designed to assess the long-term (six months) efficacy, safety and tolerability of rifaximin in maintaining remission compared to placebo. The primary endpoint was time to first breakthrough HE episode. Rifaximin significantly reduced the risk of an HE breakthrough episode by 58% compared to placebo (p<0.0001). At six months, breakthrough HE episodes were experienced by 22% in the rifaximin group and 46% in the placebo group (p<0.0001). This reduction of the risk of HE breakthrough was maintained across all subgroups in the study, indicating a high degree of consistency in the intent-to-treat population. In addition, rifaximin, had a safety profile that was comparable to placebo after six months of treatment.