AASLD 2016: Article: Direct Acting Anti-Viral (DAA) Therapy for Chronic Hepatitis C Virus (HCV) Infection Is Associated with Regression of Liver Fibrosis, Assessed by Serial Transient Elastography (Fibroscan)
Author/Source: Tapper EB, Castera L, Afdhal NH. Clin Gastroenterol Hepatol 2015;13:27-36.
Updated Abstract Information:
The total enrollment was 127 HCV-infected patients of whom 78 completed treatment and were included in the current analysis. The average age was ~60yo; 52% were male; 67% White; 83.3% had genotype 1; 61.5% had severe fibrosis or 26.9% cirrhosis. The primary endpoint was to assess an improvement of liver fibrosis by 30% as measured by Fibroscan.
A total of 73 (93.6%) people achieved a SVR/cure—and 5 (6.4%) people relapsed. Thirty-seven (47.4%) had at least a 30% improvement in fibrosis scores measured by Fibroscan measurements.
The authors noted that the higher the fibrosis score the more likely that people would achieve a 30% reduction in fibrosis score. Additionally, they mentioned that larger trials and long term data is needed.
Editorial comments: This is a small study. The results after such a short period of time after being cured are very hopeful especially for people who have significant liver fibrosis. I will track this study (and other similar studies) and follow-up with our audience. It will be very important that all of the patients in the study are followed long-term to see if the liver health improves in those who were cured and for those who were not cured and had progressed to end-stage liver disease or liver cancer.
ABSTRACT FINAL ID: 803
TITLE: Direct Acting Anti-Viral (DAA) Therapy for Chronic Hepatitis C Virus (HCV) Infection Is Associated with Regression of Liver Fibrosis, Assessed by Serial Transient Elastography (Fibroscan)
Background: Liver fibrosis stage determines clinical outcomes from chronic HCV infection. Those who achieved sustained virologic response (SVR) with interferon-based therapies had regression of fibrosis over time. This study aimed to assess the effect of HCV DAA therapy on changes in liver fibrosis, using transient elastography (Fibroscan).
Methods: Patients being treated with DAA therapy for chronic HCV were enrolled in this prospective cohort study. We performed pre-treatment baseline Fibroscans, then repeat scans at end of treatment (EOT) and 12 months post-treatment. The primary outcome was significant improvement in liver fibrosis (>30% decrease in Fibroscan score 12 months after treatment), relative to baseline. Multivariable logistic regression analysis was used to control for confounding. Signed rank test was used to assess change in liver stiffness measurement (LSM) between time points.
Results: Of the 47 patients who have completed the protocol, 27 (57.4%) had significant baseline liver fibrosis (LSM >7.3 kPa), and 27 (57.4%) were treatment-experienced. SVR rate was 95.7%. The primary outcome of >30% improvement in LSM was met in 24 (51.1%) patients. The 2 relapsers did not reach this outcome. Of those with baseline Metavir stage ≥F3 (LSM >8.5 kPa), 9/23 (39.1%) improved to 7.3 kPa was associated with reaching the primary outcome, and remained significant after controlling for BMI and elevated ALT (OR=8.8; 95% CI 1.9-37.2). In this subgroup (baseline LSM >7.3 kPa), median intra-patient change in LSM between pre-treatment and 12 months post-treatment was -4.5 kPa (IQR -7.1, -2.0; P<0.0001).
Conclusions: Treatment of chronic HCV with DAAs leads to clinically relevant reduction in liver fibrosis over the first year post-treatment, measured by Fibroscan, even after controlling for BMI and elevated ALT. This outcome was more likely in those with baseline significant liver fibrosis, with some experiencing improved Metavir fibrosis stage.
1. Tapper EB, Castera L, Afdhal NH. Clin Gastroenterol Hepatol 2015;13:27-36.