162 A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF OCR-002 IN HEALTHY VOLUNTEERS

Abstract

(22–79), follow up median 42 (2–78) months after biopsy. At biopsy 102 were compensated (no ascites, bleeding episodes, encephalopathy). Results: Median CPA value in compensated patients was 15.1 (2–43), in decompensated patients 27 (10–60) (p < 0.0001). Median time to first decompensation was 23 (2–75) months. CPA values were different for different categories: ALD 27% (9–60), HCV 15% (3–38), HBV 10% (4–22), AIH 18% (8.5–39), NASH 16.4% (5–35), PBC 16.5% (10–23), PSC 26% (11–41). CPA was correlated with decompensation status (p < 0.0001), Child–Pugh Score (p < 0.0001), MELD (p < 0.0001), MELD-Na (p < 0.0001). AUROC for CPA to decompensation within 24 months was 0.73 (95%CI: 0.56–0.90) and best cut off was 18.1 (68% sensitivity and 78% specificity). Decompensation within 48 months had an AUROC of 0.81 (95%CI: 0.70–0.93) and best cut off was 15.2 (85% sensitivity and 71% specificity). Cox regression for time to decompensation was evaluated using MELD, MELDNa, Child–Pugh Score and CPA. CPA was the only variable independently associated with future decompensation within 24 months (OR 1.091, 95%CI: 1.02–1.17; p = 0.008) and within 48 months (OR 1.105, 95%CI: 1.05–1.16; p < 0.000). Conclusion: CPA is worse in decompensated compared to compensated cirrhosis, and is strongly associated with future decompensation in compensated cirrhosis of different etiologies. CPA can be used to assess severity of cirrhosis histologically and it correlates with clinical outcome.