Efficacy and safety of sofosbuvir–ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection

Abstract

Background and aimsTreatment of hepatitis C virus (HCV) infection has significantly changed during the last few years. The combination of ledipasvir and sofosbuvir has been shown to treat high proportions of patients with HCV genotype 1 with remarkable tolerability. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ledipasvir in treating treatment-naïve Egyptian patients with genotype 4 HCV infection.Patients and methodsIn this open-label randomized study, 200 treatment-naive patients who were HCV antibody positive and HCV RNA positive by polymerase chain reaction, aged >18 years, were enrolled. The patients were classified into two groups: group I included 100 patients who received single therapy with sofosbuvir plus ledipasvir for 12 weeks and group II included 100 patients who received sofosbuvir plus oral weight-based ribavirin for 24 weeks. The primary end point was a sustained virological response at 12 weeks (SVR12) after the end of treatment, determined by quantitative polymerase chain reaction for HCV RNA.ResultsGroup I patients showed statistically significant (p<0.05) higher SVR12 compared with group II patients (99% vs. 80%). There was no statistical difference (p>0.05%) between the studied groups regarding the frequencies of the side effects (26% vs. 29%). The most common adverse effects were headache, fatigue, myalgia, and cough.ConclusionSofosbuvir and ledipasvir treatment for 12 weeks was well tolerated by patients with HCV genotype 4 and resulted in 99% SVR for all patients who received 12 weeks of the study drugs. ClinicalTrials.gov Identifier: NCT02992457.

Copeptin as a novel marker predicting prognosis of liver cirrhosis and its major complications

“…Importantly, hyponatremia in cirrhosis is a frequent event well reflecting the severity of portal hypertension and independently associated with poor quality of life and mortality. 5 , 28 …”

“…Cirrhosis is usually the final histological pathway whatever the underlying cause of liver diseases. 1 There are many factors that can lead to liver cirrhosis and portal hypertension, which include viral hepatitis, 2 – 5 alcohol abuse, sclerosing cholangitis, and common inborn errors of metabolism that include Wilson disease, hemochromatosis, and alpha-1 antitrypsin deficiency. 6…”

IL-1&alpha; correlates with severity of hepatitis C virus-related liver diseases

“…HCV genotype 4 is the most prevalent genotype accounting about 90% among Egyptian patients with chronic HCV infection. 4 – 9 …”

Hepatitis C virus genotype 4-infection and interferon-free treatment in Egypt

“…Interferon-a was associated with the development of thyroid autoimmunity and/or thyroid dysfunction in 5-12% of patients with chronic hepatitis C, usually by unmasking subclinical abnormalities [12]. Pretreatment TSH did not affect SVR rates after DAA treatment including SOF/DCV with or without ribavirin [6,13]. Moreover, thyroid dysfunction was improved in 80% of HCV GT4 patients with thyroid dysfunction who were being treated with DAAs [13].…”

“…The estimated rates of HCV infection in Egypt is around 14.7%, and the predominant HCV GT is GT4, where GT4a, GT4b, GT1 and GT3 represent 63, 30, 6 and 1% of cases, respectively [1]. Recently, the results of treatment with combinations of direct-acting antivirals (DAAs) for HCV GT4 Egyptian patients have been reported [2][3][4][5][6]. Almost all of these regimens could lead to more than 95% or more than 90% SVR rates, respectively, in the following patients: ''easy-to-treat'' patients who were treatment-naïve and did not have cirrhosis but had compensated liver biochemical parameters or ''difficult-to-treat'' patients who had previously failed interferon therapy with or without DAAs or an interferon-free combination, regardless of fibrosis stage, and had cirrhosis.…”