Real Life Experience in the Management of HCV Related Decompensated Cirrhosis With Direct Antiviral Agents

An observational case-control study which was conducted from June 2015 till the first of January 2018 in the Hepatology clinic - Zagazig University hospital-Egypt which is a tertiary referral center.

Out of 422 patients presented with decompensated cirrhosis due to HCV, 342 patients were excluded due to Hepatocellular carcinoma (n=61), cirrhotic cardiomyopathy (n=21), renal impairment (n=34), ischemic heart disease (n=37), active gastrointestinal bleeding (n=42), avoided treatment with DAAs and preferred conservative therapy (n=147); finally 80 patients with decompensated cirrhosis who were willing to be treated and showed frequent hepatic encephalopathy (HE) or difficult to treat ascites were selected to receive DAAs and included if they had chronic HCV proved by the positivity of HCV RNA and elevated transaminases. Their CTP score was >9, MELD score was <29 Patients were excluded if they had compensated cirrhosis or HCV without cirrhosis; exposure to previous antiviral therapy; hepatocellular carcinoma; other causes of liver diseases or mixed causes as excessive alcohol consumption, autoimmune liver disease; previous liver transplantation; patients with risk factors of myocardial dysfunction as abnormal T wave in electrocardiogram, ejection fraction (EF) less than 50%, left ventricular ejection fraction (LVEF) less than 50%.

The control group included 80 patients; they sought medical care at the Hepatology outpatient clinic-Zagazig University hospital. They had decompensated liver disease and preferred to be managed conservatively; they desired to avoid treatment by DAAs by themselves (n=43) or by their relatives (n=37) as they were concerned about the potential risk of liver cancer after direct antiviral agents. They were age, sex, CTP and MELD scores matched with the same inclusion and exclusion criteria and had been chosen from the patients who refused the treatment with DAAs (n=147) after their consent to participate in the study, while the remaining patients refused to be enrolled (n=67).

B-Baseline laboratory investigation

• Investigations preliminary to antiviral therapy as liver function tests, Prothrombin time, Prothrombin concentration (%), kidney function tests, complete Blood Count, fasting blood sugar, HBA1c if diabetes was present and serum AFP. For each patient, CTP and MELD scores were calculated.
• Quantitative assessment of HCV load in the serum by real-time Quantitative PCR (COBAS Ampliprep/Taqman HCV monitor version 2.0, with a detection limit of 15 IU/ml; Roche Diagnostic Systems, just before the study in both groups and after the first month, at the end of treatment and 3 months post-treatment to detect SVR 12th in DAAs treated group
• Genotyping for HCV using INNO-LiPA II, based on genotype-specific oligonucleotides from the 5' UTR that are immobilized on a nitrocellulose strip. The probe reactivity patterns were interpreted according to the manufacturer instructions.