Noninvasive biomarkers predict improvement in liver fibrosis after successful generic DAAs based therapy of chronic hepatitis C in Egypt

Abstract

Background: The scale of HCV problem in Egypt prioritized the development of a national control strategy that employs the use of locally manufactured generic direct-acting antivirals (DAAs). Achieving sustained virologic response in chronic HCV patients is the key for preventing fibrosis progression and ultimately its resolution. Objective(s): To evaluate impact of generic DAAs on liver fibrosis in chronic HCV patients using some noninvasive biomarkers (NIBMs). Methods: A total of 280 chronic HCV patients (18 treatment experienced and 262 naive) were enrolled and received the standard of care. All patients were clinically evaluated before starting treatment and at 4, 12 and 24 weeks of treatment. Results: The sensitivity and the specificity of the tested NIBMs for predicting cirrhosis versus liver ultrasound ranged between 75.0-79.6% and 59.4-67.2% respectively. All NIBMs showed significant linear decline during the treatment and follow up periods among responders but tended to fluctuate in values toward an increase among non-responders. In cox regression analysis, normal baseline ALT, AST, total serum cholesterol, serum albumin, WBCS, prothrombin activity and early stages of liver fibrosis predicted improvement in liver fibrosis by 1.5-2 folds. The mean probability of recovery at 1, 3, 6 months varied between the different scores and ranged from 0.059 to 0.637, 0.125-0.741, 0.538-0.951 respectively. Conclusion:The results provide prognostic data on the improvement in liver fibrosis over the treatment course and follow up periods without the need for a liver biopsy. Early detection and management of HCV infection should be emphasized to maximize the benefits of the treatment. Recently many noninvasive biomarkers (NIBMs) for assessing liver fibrosis have been developed, and are frequently used in clinical

Impact of sustained virologic response in regression of portal hypertension in Egyptian patients with hepatitis C virus-associated cirrhosis and portal hypertension

“…Our finding was roughly close to Abd El-Wahab et al [ 12 ], who showed that males were 50.7% and females were 49.3%, whereas in our study, males represent 40% and 30% in group A and group B, and females represent 60% and 70% of groups A and B, respectively. Disparately, Mehrez et al [ 13 ] studied 50 Egyptian patients with HCV genotype 4 infection and showed that 54% were males and 46% were females.…”

Effectiveness of hepatitis B vaccination in chronic HCV patients after successful generic direct acting antiviral therapy: significance of isolated hepatitis B core antibodies

“… Diagnosis of chronic HCV infection was based on positive polymerase chain reaction assay (PCR) [HCV RNA above limits of detection (LOD) 15 mIU/ml)] [3, 4]. A positive HBsAb test was defined as having a titre of 10 mIU/ml or above. Vaccine non‐responders were defined as patients who did not develop HBsAb after the three vaccine doses. Vaccine non‐responders are those who developed a positive HBsAb test after at least one dose of HBV vaccine. Serological responses to the HBV vaccine were categorised as: non‐responders (anti‐HBsAb < 10 mUI/ml), seroconversion (anti‐HBsAb = 10–99 mUI/ml) and seroprotection (anti‐HBsAb > 100 mUI/ml). Staging of liver fibrosis was based on FIB‐4 index and radiographic morphology of the liver on ultrasound [5]. Definition of a case of cirrhosis was based on having a persistent International normalised ratio (INR) level >1.2, persistent high levels of total bilirubin (>1.2 mg/dl), low platelet count (<150 × 10 9 /l) and a cirrhotic liver morphology on imaging (usually by ultrasounds or CT scan) [29, 30].…”

“…Patients were enrolled after completing a 12-week regimen of DAAs (SOF + DAC or SOF + DAC + RBV) and successfully achieving SVR. Patient selection and the standard of care for HCV treatment according to the national protocol Ministry of Health and Population [19] is described elsewhere [3][4][5]. The study was conducted over a period of 9 months between January and September 2020.…”

“…• Staging of liver fibrosis was based on FIB-4 index and radiographic morphology of the liver on ultrasound [5].…”

“…Novel direct acting antivirals (DAAs) have effectively turned hepatitis C virus (HCV) infection into a curable disease with a realistic potential of HCV elimination [1]. Over 90% of HCV infected patients in all genotypes achieve sustained virological response (SVR) [1][2][3][4][5]. However, many HCV-treated patients continue to exhibit high-risk behaviour, putting them at lifetime risk for reinfection [1].…”