CLINICAL OUTCOMES OF ACUTE VIRAL HEPATITIS WITH AND WITHOUT URSODEOXYCHOLIC ACID THERAPY

Abstract

Objective:

To assess the efficacy of Ursodeoxycholic Acid (UDCA) as adjuvant therapy to fasten the resolution of hepatic inflammation and cholestasis in patients presenting with Acute viral hepatitis (AVH).

Study Design: 

Parallel group, randomized open label controlled trial.

Place and Duration of Study: 

The study was conducted at gastroenterology departments, for a period of 28 days for each individual participant.

Methodology: 

One hundred and fifty adult patients with an average age of 18-65 years with diagnosis of AVH (ALT >5x ULN) within 14 days of the onset of symptoms were collected. Participants were randomized in a 1:1 ratio to the UDCA group who received UDCA (13-15mg/kg/day plus standard supportive care) in the form of iv fluids anti ematics and control group (standard supportive care only). The primary outcome measured was the mean decrease in serum ALT level on Day 14. Subsequent effects of treatments Time to resolution of jaundice, and pruritus were secondary outcomes.

Results: 

A total of 150 participants were analyzed, 75 were in each group. The baseline characteristics were similar between groups. By Day 14 significant reduction in ALT level (185+-40 unit/L) was also shown in the UDCA group compared with the control (310+- 60 U/L; p < 0.001). The mean time for resolution of jaundice was shorter in the UDCA arm (mean 14.2 days compared to the control arm, mean 21.5 days). Mild diarrhea was reported in 5.3 of the UDCA group and no serious adverse events reported.

Conclusion: 

UDCA is a safe and effective adjunctive therapy which significantly improves biochemical recovery and clinical resolution of jaundice in patients with acute viral hepatitis.