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Terlipressin promising in hepatorenal syndrome with concomitant alcoholic hepatitis

Presented By
Dr Kevin Korenblat, Washington University School of Medicine, MO, USA
DDW 2023
Phase 3, CONFIRM

Terlipressin, a synthetic long-acting vasopressin analogue, was approved in the US in September 2022 for the treatment of hepatorenal syndrome (HRS). Its efficacy was demonstrated, which has now been further explored in a subgroup analysis to assess its effect on participants with HRS and concomitant alcoholic hepatitis.

In the phase 3 CONFIRM trial (NCT02770716), 300 participants with type 1 HRS and cirrhosis, demonstrating rapid progressive renal failure, were randomised to receive either terlipressin or placebo [1]. Notably, the study included those with suspected or confirmed alcoholic hepatitis, a condition that exacerbates the already high mortality risk of HRS.

Alcoholic hepatitis was identified in around 40% of the study participants at baseline in both the terlipressin and placebo groups. Among this population subgroup, terlipressin proved significantly superior in achieving the primary endpoint of the trial, the verified reversal of HRS. Terlipressin showed a success rate of HRS reversal of 30.9% compared with 7.7% for placebo (P=0.005). Rates of renal replacement therapy by day 30 were slightly lower in the terlipressin group (21%) compared with the placebo group (25.6%), albeit not statistically significant (P=0.568).

While rates of intensive care unit (ICU) admission were similar between the subgroups, the terlipressin-treated participants had a shorter average ICU length of stay (6.9 days vs 12.4 days; P=0.514). Transplant-free survival was also numerically higher in the terlipressin group, with a median of 28 days versus 15 days in the placebo group, although the difference was not statistically significant (P=0.207).

In summary, these findings suggest that terlipressin treatment is associated with higher rates of verified HRS reversal in participants with concomitant alcoholic hepatitis, with a trend towards lower rates of renal replacement therapy and shorter ICU stays. “This data strongly supports a role for terlipressin for those with type 1 HRS and alcohol-associated hepatitis,” Dr Kevin Korenblat (Washington University School of Medicine, MO, USA) said. Despite the promising results, further research is needed to definitively establish the potential benefits of terlipressin in this patient subgroup.

  1. Korenblat K, et al. Clinical responses to terlipressin in the subgroup of patients with hepatorenal syndrome further compounded by alcoholic hepatitis: analysis of the confirm phase III study. Lecture 651, DDW 2023, 6–9 May, Chicago, IL, USA.

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