Serum albumin levels at 1 month of human albumin (HA) treatment may be a better threshold than baseline levels when making clinical decisions, according to a long-term, open-label study published in the Journal of Hepatology.
Investigators analyzed data from the Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis (ANSWER) study. This study was a randomized, parallel trial conducted at 33 hospitals between 2011 and 2015 in Italy. Researchers randomly assigned patients (N=431) with liver cirrhosis and persistent ascites despite diuretic treatment to receive standard treatment (n=213) or standard treatment with 40g of HA twice a week for 2 weeks followed by 40g/wk (n=218) for ≤18 months.
Baseline serum albumin levels did not differ (P =.86) between the standard (3.1±0.49 g/dL) or treatment (3.09±0.55 g/dL) groups nor did the proportion of patients with hypoalbuminemia (<3.5 g/dL: 75.6% vs 73.4%; P =.6), respectively.
For every decrease of 0.1 g/dL of baseline albumin level, the investigators observed a high associated risk for 18-month mortality (hazard ratio [HR] 4.42; 95% CI, 2.34-8.33; P <.001) among the standard treatment group. Among the treatment group, however, the same decrease of baseline albumin level had a lower risk for 18-month mortality (HR 1.85; 95% CI, 0.99-3.49; P =.055).
Among patients with available follow-up data, the average baseline serum level was 3.08±0.54 g/dL. At 1 month of treatment, the level rose to 3.83±0.6 g/dL (P <.001) and remained stable among 94.3% of patients thereafter.
Patients who achieved a 1-month treatment albumin level of ³4 g/dL had a reduction of 18-month mortality by 80% (HR 0.2; 95% CI, 0.08-0.52; P <.001) compared with patients not reaching this threshold.
This cut-off threshold (1-month treatment albumin ³4 g/dL) also stratified patient risk for refractory ascites, hepatic encephalopathy grades III and IV, hyponatremia, hyperkalemia, renal impairment, and bacterial infections.
Patients who received HA long-term had a significantly higher 18-month survival (61.3% vs 36.7%; P =.032) and a reduction of cirrhosis, hepatic encephalopathy grades III and IV, and hyponatremia. Long-term HA therapy incurred an average of €108.58/patient/year.
The limitations of this study included the low sample sizes and the absence of an independent validation cohort. An additional validation study is needed.
The conclusions drawn from these data were that serum albumin levels after 1 month of treatment (³4 g/dL) were indicative of a higher likelihood for survival and a lower likelihood for complications. Long-term HA therapy was observed to be well tolerated among patients. The time-course change of albumin level may be used by clinicians to guide treatment decisions for each patient individually.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Caraceni P, Tufoni M, Zaccherini G, et al. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites [published online August 24, 2020]. J Hepatol. doi: 10.1016/j.jhep.2020.08.021