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Abstract The course of hepatitis C infection varies. The best indicator of disease progression is the degree of liver fibrosis. The noninvasive tests aim to accurately identify liver fibrosis, and thus, reduce the use of liver biopsy in indeterminate cases. Standardization studies are required before the tests are implemented, although they appear to be a suitable alternative to liver biopsy. This study aims to evaluate post-treatment improvement in liver fibrosis in chronic HCV patients using some non-invasive markers. The present study included 280 patients admitted at the liver center of El-Qubbary hospital in Alexandria for receiving Sofosbuvir plus Daclatasvir combination therapy for treatment of chronic HCV infection according to the international guidelines. The main findings of the present study were as follows: The majority of the enrolled chronic HCV patients (66.1%) were in the age group 50- 75 with an overall mean±SD of age equal to 50±73 years. The percentage of males was comparable to that of the females (50.7% vs 49.3% respectively). Almost two thirds (60.4%) were rural residents and about 40.0% were occupying urban residences. Regarding the marital status, the majority of the HCV patients were married (82.1%) while only 4.6% were single. High literacy was the predominate feature among the enrolled patients where 46.1% had secondary education and almost one fourth (26.1%) were university graduates. As regards the participants‟ occupations, 29.3% worked as housewives, 22.1% as employee, 15.4 as clerks, 14.3% as farmers, 3.2% as health care workers, 1.1% as student while 11.4% were not working. In total, 28.6% of the studied patients were smokers, none was alcoholic and a negligible number (0.4%) was abusing drugs. The BMI measurements revealed that the majority of the HCV patients (71.8%) were obese and about one fourth (24.6%) were overweight. Almost one half (53.5%) were free of co-morbidities, while 30.0% were diabetic, 14.3% were hypertensive, 5.7% had renal diseases and 5.4% had portal hypertension. The most frequently reported symptoms during the treatment course were fatigue (88.2%), flu like symptoms (60.7%), gastrointestinal upsets (19.3%), infections (13.2%) and skin rash (6.8%). The past history of INF therapy was reported by 6.4% of the enrolled HCV patients under treatment. Liver ultrasound of the enrolled HCV patient revealed liver cirrhosis (64.6%), abnormal echo pattern (25.2%), splenomegaly (9.6%), fatty fibrosis (8.9%) and coarse bright liver. Liver cirrhosis or fibrosis among HCV patients under treatment was present in 77.1% The overall sustained virologic response rate among the HCV patients who received the standard DAA regimen was 98.6%. There was improvement in all the hematological, biochemical and virological laboratory findings over the treatment course and during the fellow up periods among the responders comparing fluctuating values among the non responders. Regarding the diagnostic accuracies of noninvasive indices for predicting cirrhosis versus liver ultrasound. The sensitivity and the specificity of the evaluated liver Summary & Conclusions 89 fibrosis scores ranged between 75.0-79.6% and 59.4-67.2% respectively. Comparing to liver ultrasound, the inter-Rater reliability as measured by Cohen‟s Kappa test for all the calculated liver fibrosis scores was fair (Kappa values ranged between 0.261- 0.355. Apart from the AAR, all non invasive liver fibrosis scores showed significant linear decline during treatment and follow up periods among responders (p<0.05). On the other hand, the majority of these scores tended fluctuate in values toward an increase in a non linear pattern among non responders (p>0.05) In the employed cox regression analysis, normal baseline ALT, AST, TSC, serum albumin, WBCS, prothrombin activity and early stages of liver fibrosis as revealed by liver fibrosis scoring (FIB-4, Forns, and CDS) predicted improvement in liver fibrosis by 1.5-2 folds The probability of recovery at 1, 3, 6 months varied between the different scores and ranged from 0.059-0.637, 0.125-0.741, 0.538-0.951 respectively. In conclusion Rapid improvements in HCV therapies will greatly enhance the likelihood of SVR among all patient groups with HCV infection, including those traditionally considered „hard to treat‟. Sofosbuvir-based therapy causes a clinically significant improvement in hepatic fibrosis measures using non invasive liver fibrosis biomarkers even in cirrhotic patients. Our results indicate that non-invasive fibrosis scores were fairly accurate noninvasive blood tests to predict the presence or absence of significant fibrosis. This enabled us to providing prognostic data regarding the improvement in liver fibrosis over the treatment course and follow up periods without the need for a liver biopsy. |