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G-CSF/darbopoietin increases survival in patients with cirrhosis

Granulocyte colony-stimulating factor with darbopoietin alpha was effective in extending survival in patients with decompensated cirrhosis, according to study data.

“This is the first double-blind randomized controlled study showing clinical benefit and an overall improved survival using a combination of [granulocyte colony-stimulating factor] and [erythropoietin] in patients with decompensated liver disease,” the researchers wrote. “This is also the first human study using [erythropoietin] in decompensated liver cirrhosis, demonstrating its potential in hepatic regeneration.”

Researchers from the Institute of Liver and Biliary Sciences in New Delhi, India, randomly assigned 29 patients to a dose of 5 µg/kg of granulocyte colony-stimulating factor (G-CSF) per day for 5 days and then an additional 12 doses spread out over every third day, with 40 mcg of subcutaneous darbopoietin alpha (DPO) for 4 weeks. These patients were compared with 26 patients in a control group that were given placebo. All patients had decompensated cirrhosis and were seen at the Institute of Liver and Biliary Sciences between May 2011 and June 2012.

All patients were followed for 12 months and the primary end point was survival at 12 months.

Overall, more patients in the G-CSF/DPO group survived through 12 months compared with the controls (68.6% vs 26.9%; P = .003). Also, patients in the G-CSF/DPO group had a greater reduction in Child-Turcotte Pugh scores (48.6% vs. 39.1%; P = .001) and greater reduction in MELD scores (40.4% vs. 33%; P = .03), respectively, compared with the controls.

More patients in the control group developed septic shock during follow-up compared with the G-CSF/DPO groups (38.5% vs. 6.9%; P = .005).

Treatment was well-tolerated by both groups of patients and no treatment discontinuations or major adverse events were observed in either group.

“The results of the present study would need to be confirmed in larger cohort of patients with decompensated liver disease,” the researchers concluded. – by Melinda Stevens

Disclosures: The researchers report no relevant financial disclosures.