Publications by authors named "Rehab Badawi"

33 Publications

Clinical study evaluating the efficacy of ivermectin in COVID-19 treatment: A randomized controlled study.

J Med Virol 2021 Oct 7;93(10):5833-5838. Epub 2021 Jun 7.

Department of Endemic Medicine, Kasr Alainy School of Medicine, Cairo University, Cairo, Egypt.

Researchers around the world are working at record speed to find the best ways to treat and prevent coronavirus disease 2019 (COVID-19). This study aimed to evaluate the efficacy of ivermectin for the treatment of hospitalized mild to moderate COVID-19 infected patients. This was a randomized open-label controlled study that included 164 patients with COVID-19. Patients were randomized into two groups where Group 1 (Ivermectin group) included patients who received ivermectin 12 mg once daily for 3 days with standard care and Group 2 (control group) included patients who received standard protocol of treatment alone for 14 days. The main outcomes were mortality, the length of hospital stay, and the need for mechanical ventilation. All patients were followed up for 1 month. Overall, 82 individuals were randomized to receive ivermectin plus standard of care and 82 to receive standard of care alone. Patients in the ivermectin group had a shorter length of hospital stay (8.82 ± 4.94 days) than the control group (10.97 ± 5.28 days), but this was not statistically significant (p = 0.085). Three patients (3.7%) in each group required mechanical ventilation (p = 1.00). The death rate was three patients in the ivermectin group (3.7%) versus four patients (4.9%) in the control group without any significant difference between the two groups (p = 1.00). Although there was no statistically significant difference in any endpoints by ivermectin doses (12 mg/day for 3 days); there was an observed trend to reducing hospital stay in the ivermectin-treated group.
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http://dx.doi.org/10.1002/jmv.27122DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242425PMC
October 2021

The Effect of HCV Eradication after Direct-Acting Antiviral Agents on Hepatic Steatosis: A Prospective Observational Study.

Endocr Metab Immune Disord Drug Targets 2022 ;22(1):100-107

Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background And Aim: Eradication of hepatitis C virus (HCV) by direct-acting-antiviral- agents (DAAs) was followed by fibrosis regression, but little is available about hepatic steatosis changes after DAAs. The aim of this work was to assess the prevalence of hepatic steatosis among HCV Egyptian patients and the long term changes occuring after viral eradication.

Methods: This prospective cohort study included 150 HCV patients with significant fibrosis. They were examined by Transient elastography to evaluate liver stiffness measurement (LSM) and hepatic steatosis before treatment, at SVR12 and 1 year after the end of therapy.

Results: LSM showed a significant positive correlation to pretreatment of hepatic steatosis. LSM significantly decreased and hepatic steatosis significantly increased both at SVR12 and one year after DAAs. Patients with steatosis showed significantly higher median LSM and controlled attenuation parameter (CAP) values at: baseline, SVR12, and one year after therapy. Also, the pretreatment steatosis and body mass index (BMI) had a significant negative correlation with fibrosis regression one year after therapy in all studied groups.

Conclusion: Hepatic steatosis is common in HCV Egyptian patients and increases after HCV eradication with DAAs. BMI and CAP values are negatively correlated to hepatic fibrosis regression and positively correlated to steatosis progression one year after DAAs. So, HCV patients with hepatic steatosis may need close follow up for atherosclerotic and HCC risk after DAAs, especially if they are overweight.
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http://dx.doi.org/10.2174/1871530321666210125125500DOI Listing
January 2022

Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study.

Arch Virol 2021 Mar 25;166(3):949-954. Epub 2021 Jan 25.

Department of Chest Diseases, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

No specific antiviral drugs have been approved for the treatment of COVID-19. This study aimed to evaluate the efficacy of favipiravir in treatment of COVID-19. This was a multicenter randomized controlled study including 96 patients with COVID- 19 who were randomly assigned into a chloroquine (CQ) group and a favipiravir group. None of the patients in the favipiravir group needed mechanical ventilation (p = 0.129). One patient (2.3%) in the favipiravir group and two patients (4.2%) in the CQ group died (p = 1.00). Favipiravir is a promising drug for COVID-19 that decreases the hospital stay and the need for mechanical ventilation.ClinicalTrials.gov Identifier NCT04351295.
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http://dx.doi.org/10.1007/s00705-021-04956-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7829645PMC
March 2021

The Correlation Between the Autotaxin Enzyme and Pruritus in Egyptian Patients Suffering from Chronic Liver Disease.

Antiinflamm Antiallergy Agents Med Chem 2021 ;20(3):302-307

Department of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background & Aims: Pruritus associated with liver diseases confines daily activities and causes sleep deprivation in patients with chronic liver diseases. Autotoxin enzyme (ATX) was found to be higher in sera of patients with intrahepatic cholestasis and it was found to be associated with the intensity of itching. The aim of this study was to assess the correlation between the autotaxin enzyme and pruritus in Egyptian patients suffering from chronic liver disease (CLD).

Methods: This cross-sectional study was carried on a total number of 80 patients with chronic liver disease divided into four groups: Group A and B included cirrhotic patients suffering from pruritis with and without cholestasis, while group C and D included patients without pruritis with or without cholestasis and group E included 17 healthy controls. They were subjected to measurement of serum autotoxin concentration by ELISA in addition to routine investigations including liver function tests: Total and direct bilirubin, ALT, AST, Alkaline phosphatase, Gama- glutamyl transferase, and serum albumin.

Results: There was a significant increase in autotaxin in the four groups included chronic liver disease patients (P-value <0.001*) compared to control group (group E). Autotoxin level was the only marker that had a significant increase in pruritus groups (groups A & B) compared to non-pruritus groups (groups C & D) with cut off value ≥ 32.

Conclusion: Serum autotaxin level was elevated in patients with chronic liver diseases with pruritus. Autotaxin enzyme may play a key role in the induction of hepatogenic pruritus. So, autotaxin enzyme inhibitors and lysophosphatidic acid (LPA) receptor blockers could be a future line of treatment of hepatogenic pruritus.
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http://dx.doi.org/10.2174/1871523020666210114092924DOI Listing
January 2021

Impact of laparoscopic cholecystectomy on the complexity of endoscopic retrograde cholangiopancreatography.

Eur J Gastroenterol Hepatol 2022 Feb;34(2):142-145

Tropical Medicine Department Tanta University, Tanta, Egypt.

Background And Objectives: A scarce number of researches discussed the impact of cholecystectomies on the anatomy of common bile duct (CBD) and intern if this will affect the difficulty of endoscopic retrograde cholangiopancreatography (ERCP). The objective of present study was to assess the impact of complicated cholecystectomy on the complexity and safety of the ERCP procedure.

Study Design: A total of 100 patients were enrolled after meeting the following inclusion criteria - study group (group A): 50 patients with previous history of complicated laparoscopic cholecystectomy and control group (group B): 50 patients with previous noncomplicated laparoscopic cholecystectomy. ERCP was performed and complexity was judged by a number of cannulation attempts, ERCP time, pancreatic cannulation and post-ERCP pancreatitis.

Results: The study revealed prolonged ERCP procedure duration in noncomplicated cholecystectomy (24.2 ± 8.5 min) and it was significantly more prolonged in complicated cholecystectomy (39.6 ± 10.7 min; P = 0.03). The trials of cannulation attempts were significantly higher in the study group with complicated cholecystectomy (P = 0.009). Pancreatic duct cannulation was frequently higher in the complicated cholecystectomy group (P = 0.03). Difficult or failed stone extraction was significantly prevalent in the complicated cholecystectomy group and the occurrence of post-ERCP pancreatitis (PEP) was significantly higher than the control group.

Conclusion: ERCP after complicated laparoscopic cholecystectomy is more complex with increased duration liability of complications.
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http://dx.doi.org/10.1097/MEG.0000000000002017DOI Listing
February 2022

Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience.

Medicine (Baltimore) 2020 Oct;99(42):e21972

Department of Tropical Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease was difficult in the past because of the use of interferon (IFN). It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN. This study aimed to evaluate the antiviral efficacy, safety, and tolerability of ombitasvir/paritaprevir/ritonavir/ribavirin in chronic kidney disease patients infected with chronic HCV.This observational, open-label prospective study was carried out on 103 patients infected chronic HCV with different grades of renal impairment. Paritaprevir/ritonavir and ombitasvir (75/50/12.5 mg) twice daily plus ribavirin were given to the patients for 12 weeks. Dose adjustment of ribavirin was done according to degree of renal impairment.Sustained virological response (12 weeks after the end of treatment) occurred in 101 patients (98.1%). Anemia occurred in 48 patients. No serious adverse events were observed in any patient.Paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks was considered to be safe and effective in the treatment of chronic HCV infected patients with varying degrees of renal impairment.
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http://dx.doi.org/10.1097/MD.0000000000021972DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572016PMC
October 2020

Treatment of Hepatitis C Cirrhotic Patients With Directly Acting Antivirals: A Multicenter Study.

Infect Disord Drug Targets 2021 ;21(5):e270421186971

Department of Tropical Medicine, Tanta Faculty of Medicine, Tanta University, Tanta, Egypt.

Background: With the introduction of sofosbuvir-based regimens, high cure rates and decreased duration has been achieved. Several studies showed variances in SVR rates between different genotypes, with lower rates of SVR among cirrhotic patients. The aim of our study was to assess the safety and effectiveness of sofosbuvir-based antiviral regimens for the treatment of HCVinfected Egyptian cirrhotic patients.

Methods: This was a retrospective, observational, and comparative study. A total of nine hundred and forty-six cirrhotic patients with chronic HCV genotype 4 infection, who were eligible for direct acting drugs (DAAs) therapy, were enrolled. The primary outcome measures were the number of patients with successful eradication of the virus evidenced by SVR at 12 weeks after discontinuation of therapy (SVR12), and the secondary outcome measures were the incidence of adverse effects associated with the tested HCV therapy.

Results: Among the 946 patients enrolled in the study, 527 patients (55.7%) were males and 419 patients (44.3%) were females with a mean age of 54.00±8.88 years. 20.2% were diabetics and 19.1% were hypertensive. Patients were classified according to Child-Pugh classifications; 818 patients (86.46%) were Child-Pugh class A cirrhosis, while 28 patients (13.53%) were Child-Pugh class B cirrhosis. The SVR12 rate was 96.93% (917 /946). Treatment response in the Child-Pugh class A cirrhosis was 794 (97%) after 12 weeks, while treatment response in the Child-Pugh class B cirrhosis was 123 (96%). Mild side effects were observed in 76 patients.

Conclusions: Sofosbuvir based regimens were effective and safe in the treatment of cirrhotic patients with chronic hepatitis C genotype 4.
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http://dx.doi.org/10.2174/1871526520666201019122205DOI Listing
October 2021

Platelet Count Improvement after Chronic Hepatitis C Treatment among Cirrhotic Patients Who Achieved Sustained Virological Response: Realworld Results from 2186 Patients in Egypt.

Endocr Metab Immune Disord Drug Targets 2021 ;21(7):1300-1305

Department of Tropical Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background And Aims: This study aimed to assess the changes in platelet counts of patients with liver cirrhosis due to chronic HCV, who achieved sustained virological response (SVR) after taking direct acting antivirals (DAAs) in a large cohort study in Egypt.

Methods: This multicenter observational retrospective study was carried out on 2500 chronic hepatitis C virus (HCV) infected patients who achieved (SVR) after treatment with direct acting antiviral drugs (DAA). HCV infection was confirmed by positive PCR for HCV RNA infection. SVR was defined as a negative PCR test for HCV-RNA 12 weeks after completion of DAA therapy. Platelets count was measured before therapy, during therapy, at the end of treatment, and 12 weeks after the end of the treatment.

Results: There were 2186 patients enrolled in the study; 1866 (85.4%) were treatment naïve. There were 1006 (46%) males and 1180 (54%) females. Mean age was 50.82± 11.66 years, 2142 (98%.0) patients achieved SVR, 2118 (96.9%) patients had Child -Pugh class A cirrhosis, and 68 (3.1%) had Child -Pugh class B liver cirrhosis. A significant increase in the platelets count was detected at the end of treatment in comparison to the pretreatment levels (P<0.001), and after achieving SVR (P <0.001) when compared to the pretreatment values.

Conclusion: Improvement of platelets count occurs after HCV therapy with DAAS in patients with liver cirrhosis. These results suggested that HCV eradication may have a role in the improvement of platelet count.
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http://dx.doi.org/10.2174/1871530320666200917113650DOI Listing
January 2021

Quadruple Therapy Offers High SVR Rates in Patients with HCV Genotype 4 with Previous Treatment Failure.

Adv Virol 2020 24;2020:9075905. Epub 2020 Jul 24.

Tropical Medicine Department, Tanta University, Tanta, Egypt.

Background And Aims: Direct-acting antivirals (DAAs) have made a revolution in hepatitis C virus (HCV) treatment with promising reduction of HCV infection and disease morbidities. However, unfortunately, treatment failure still occurs in about 5-15% of patients treated with DAA-based combination regimens. The primary aim of the study was to assess the efficacy and safety of a quadruple regimen of (sofosbuvir, daclatasvir, and simeprevir with a weight-based ribavirin) in chronic HCV DAAs-experienced patients.

Methods: This observational, open-label prospective study was carried out on 103 genotype 4 hepatitis C virus-infected patients who failed to achieve SVR12 after sofosbuvir-daclatasvir with or without ribavirin. Patients were treated for three months with sofosbuvir (400 mg), daclatasvir (60 mg), and simeprevir (150 mg) with a weight-based ribavirin dosage (1000-1200 mg/d). Response to treatment was determined by quantitative PCR for HCV at 3 months after the end of treatment (SVR12), and adverse events during the treatment were recorded.

Results: SVR was achieved in 100 patients (97.1%) at week 12 after treatment. No dangerous or life-threatening adverse events were recorded.

Conclusions: Retreatment of HCV genotype 4 patients with quadruple therapy is a good therapeutic option and achieves high response rates with minimal side effects.
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http://dx.doi.org/10.1155/2020/9075905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396033PMC
July 2020

Orphenadrine in treatment of muscle cramps in cirrhotic patients: a randomized study.

Eur J Gastroenterol Hepatol 2020 08;32(8):1042-1045

Department of Tropical medicine, Faculty of Medicine, Tanta University.

Objective: Many patients of liver cirrhosis are complaining of muscle cramps, which are annoying to them. There is no effective treatment for muscle cramps in cirrhotic patients till now. This study purposed to evaluate efficacy and safety of orphenadrine in the treatment of muscle cramps in cirrhotic patients.

Methods: One hundred and twenty four patients who had muscle cramps three or more times weekly were included. They were divided into two arms: 62 patients administrated orphenadrine and 62 administrated placebo. They were followed up till 2 weeks after the end of therapy. Muscle cramps were evaluated using questionnaire as regards severity, duration, and frequency. Also, side effects of orphenadrine were recorded.

Results: Frequency, duration of muscle cramps, and pain score improved significantly after 1 month of orphenadrine therapy in comparison to placebo. Few side effects were recorded in the form of dry mouth, drowsiness, and nausea.

Conclusion: Orphenadrine is considered as promising safe drug for treatment of muscle cramps associated with liver cirrhosis.
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http://dx.doi.org/10.1097/MEG.0000000000001622DOI Listing
August 2020

Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test for HBV Infection in Rheumatic Disease Patients Before Starting Immunosuppressive Therapies? A Cross-sectional Study.

Infect Disord Drug Targets 2020 ;20(6):878-883

Department Tropical Medicine, Tanta University, Tanta, Egypt.

Background & Objectives: Prevalence of hepatitis B virus in patients with rheumatic diseases has been reported differently among studies. The loss of immune control in these patients may result in the reactivation of HBV replication within hepatocytes. Considering the lifelong use of multiple anti-rheumatic drugs, screening for HBV is recommended before starting immunosuppressive or immunomodulatory therapy. The aim of this study was to select the best and simplest test for screening of HBV in rheumatic patients.

Methods: This study was carried out in 102 patients with different rheumatic diseases. Screening to all patients for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and human immune deficiency virus antibodies (HIV) was done. HBV core antibodies and real time PCR to detect HBV DNA were done.

Results: The mean age of the patients was 37.18 ± 12.37 years, 3.9% of them were males and 96.1% were females. HBsAg had 100% Sensitivity, 100% Specificity, 100% PPV, 100% NPV and 99.0% accuracy. While, anti-HBc had 100% Sensitivity, 78% Specificity, 8% PPV, 100% NPV and 78% accuracy in the screening of HBV.

Conclusions: HBs Ag was found to be superior to antiHBc for screening for HBV infection in rheumatic patients.
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http://dx.doi.org/10.2174/1871526519666191212094141DOI Listing
September 2021

Predictors for Fibrosis Regression in Chronic HCV Patients after the Treatment with DAAS: Results of a Real-world Cohort Study.

Endocr Metab Immune Disord Drug Targets 2020 ;20(1):104-111

Department of Tropical Medicine, Tanta University, Tanta, Egypt.

Introduction: The goal of treatment of chronic hepatitis C (HCV) is viral eradication. However, obtaining histological regression is even more important, because it will reduce the overall morbidity and mortality related to cirrhosis. Introduction of direct-acting antivirals (DAAs) in HCV improves rates of sustained virologic response (SVR). However, fibrosis regression has not been extensively assessed. The aim of this study was to detect the factors affecting fibrosis regression in chronic HCV patients treated with interferon containing regimens versus interferon-free DAA regimens.

Methods: This prospective observational cohort study was conducted at the Tropical Medicine and Infectious Diseases Department, Tanta University, Egypt, between October 2015 and December 2017. Transient elastography (FibroScan®) examination was performed before therapy, at SVR12, 6 months and 1 year after completing therapy for cured patients.

Results: Reduction in fibrosis was reported in; 46.7% and 49.3% of patients with moderate fibrosis, and 89% and 78.7% of patients with advanced fibrosis after one year of interferon containing and interferon free DAAs regimens respectively. Using multiple regression analysis; it was found that BMI, degrees of hepatic stiffness and steatosis were related to regression of hepatic fibrosis after therapy.

Conclusion: DAAs with or without interferon resulted in a significant reduction of liver fibrosis. BMI, steatosis and liver stiffness were independent factors for fibrosis regression in chronic HCV patients treated with DAAs. Further studies are needed to explore the mechanism by which steatosis affects HCV related fibrosis regression after treatment with DAAs.
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http://dx.doi.org/10.2174/1871530319666190826150344DOI Listing
November 2020

Comparative Evaluation of Colon Cancer Specific Antigen-2 Test and Chromocolonoscopy for Early Detection of Egyptian Patients with Colorectal Cancer.

Antiinflamm Antiallergy Agents Med Chem 2020 ;19(3):302-312

Tropical Medicine Department, Tanta University, Tanta, Egypt.

Background: Effective screening of colorectal cancer (CRC) in early stage could reduce the advancement of CRC and therefore mortality. Effective screening is based on either stool dependent tests or colon dependent examination.

Aims: The aim of the study was a comparative evaluation of chromocolonoscopy and Colon Cancer-Specific Antigen-2 test for early detection of colorectal cancer in Egyptian patients.

Methods: This case control study was carried out on 55 patients classified into 3 groups: Group I consisted of twenty patients with precancerous lesions detected by colonoscopy, Group II consisted of twenty patients diagnosed with colorectal cancer and Group III consisted of fifteen individuals (who underwent colonoscopy for other indications) as a control group. All the subjects were subjected to measure occult blood in the stool, measurement of Colon Cancer-Specific Antigen-2 level in serum and tissue and chromo colonoscopy using Indigo Carmine stain.

Results: In group II, there was a statistically significant increase in CCSA2 in serum as compared to the other 2 groups. Cutoff >11.3 CCSA2 in serum showed 65% sensitivity, 85% specificity, 81.2% PPV, 70.8% NPV and 70.3% accuracy in the differentiation of group II with cancer colon from group I with premalignant colonic lesions. A cutoff > 9.1 CCSA2 in serum showed 95% sensitivity, 46.67% specificity, 70.4% PPV, 87.5% NPV and 73.5% accuracy in differentiating group II with cancer colon from normal controls (group III).

Conclusion: CCSA-2 level in serum was significantly higher in cancer colon. Chromoendoscopy has a role in the detection of polyps, both neoplastic and non-neoplastic.
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http://dx.doi.org/10.2174/1871523018666190625164100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499350PMC
August 2021

Amyloid A in Serum and Ascitic Fluid as a Novel Diagnostic Marker of Spontaneous Bacterial Peritonitis.

Antiinflamm Antiallergy Agents Med Chem 2020 ;19(2):140-148

Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background: Diagnosis of Spontaneous Bacterial Peritonitis (SBP) depends mainly on ascetic fluid culture which may be negative in spite of the clinical suggestion of SBP and high ascetic fluid neutrophilic count.

Aims: This study aimed to evaluate the biological importance of amyloid A biomarker in both serum and ascetic fluid to diagnose SBP as early as possible and to compare it to other markers (C-reactive protein (CRP), and the neutrophil-to-lymphocyte ratio (NLR)).

Methods: This study included 37 patients with hepatic ascites; twenty-two of them had SBP, and 15 patients did not have SBP. Serum and ascetic fluid amyloid A, ascetic fluid neutrophil, C-reactive protein, and neutrophil-to-lymphocyte ratio were measured in all subjects before the start of antimicrobial chemotherapy to the infected ones.

Results: Both the serum and ascetic fluid amyloid and also, CRP were significantly higher in patients infected with ascetic fluid than others. The cut-off point of serum amyloid A for early detection of SBP was 9.25ug/ml with the high sensitivity and specificity. For ascetic amyloid A, the sensitivity and specificity were 90.09% and 60% at cut-off point 2.85ug/ml, respectively.

Conclusion: Amyloid A in serum and ascitic fluid can be considered as a good biomarker for early diagnosis of SBP.
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http://dx.doi.org/10.2174/1871523018666190401154447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475799PMC
January 2021

Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients with Chronic Hepatitis C: Real-world Results from 1716 Patients in Egypt.

Endocr Metab Immune Disord Drug Targets 2019 ;19(7):1005-1011

Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.

Background & Aims: Direct Antiretroviral Agents (DAAs), sofosbuvir-based therapies, have opened a new era in the treatment of chronic HCV infection. The aim of the study was to investigate the potential use of baseline and in serial serum, AFP levels as a predictor for response to DAAs in patients with Chronic Hepatitis C.

Methods: This multicenter observational study was carried out on 1716 chronic hepatitis C virusinfected patients who received direct anti-viral drugs for 12 weeks. The primary end point was sustained virological response at 12 weeks after the end of treatment determined by quantitative PCR for HCV RNA. Serum AFP was quantitatively assessed at baseline then after 12week after stoppage of treatment (SVR12).

Results: SVR12 rate was 97.8%. Elevated serum AFP was significantly higher in non -SVR group p value (<0.001). There was a significantly marked decrease in AFP after treatment in comparison to pretreatment values. The multivariate logistic regression analysis on the resulting significant variable from the univariate analysis revealed that only AFP was significantly related to the response to direct antiviral therapy in patients with chronic hepatitis C with p <0.001, OR 1.10 (95% CI 1.07:1.12). Other sociodemographic (e.g. Age, gender, BMI, ..) or laboratory factors (Hb, ANC, WBCs, …) did not show any significant association with the patients' response to treatment.

Conclusions: Serum AFP levels were a predictor for response in patients with chronic HCV with the administration of direct antiviral drugs.
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http://dx.doi.org/10.2174/1871530319666190204154830DOI Listing
March 2020

Outcomes of Treatment and Predictors of Response to Sofosbuvir Plus Simeprevir in Hepatitis C Virus with Genotype-4 Infection.

Infect Disord Drug Targets 2020 ;20(3):389-395

Department of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background & Aims: Treatment plan of chronic HCV infection has dramatically improved after the introduction of different groups of Direct-Acting Antiviral (DAA) drugs. These drugs have been found to be safe and effective. Sofosbuvir (SOF) plus simeprevir (SMV) regimen has been shown to be tolerable and effective in treatment of patients with HCV genotype 1. The aim of the study was to evaluate the safety and the efficacy of combined sofosbuvir plus simeprevir treatment in genotype 4 chronic HCV patients.

Methods: This open-label multicenter prospective study was carried out on 381 Egyptian patients with chronic hepatitis C virus- infection. Treatment experienced and treatment-naive patients were included. Subjects administrated a regimen of sofosbuvir (400 mg/ day) plus semiprevir (150 mg /day) for twelve weeks. Sustained Virological Response (SVR) was confirmed by undetectable HCV RNA by quantitative PCR 3 months after the end of the treatment.

Results: 97.6% (372 /381) of patients had SVR. None of the studied clinical and demographic characteristics were associated with the SVR status. However, patients who failed to achieve SVR showed low albumin level and high total leucocyte. The most common side effects of the studied regimen were headache, fatigue, itching, photosensitivity, and cough.

Conclusions: Twelve weeks' regimen of sofosbuvir plus simeprevir was considered to be safe and tolerable in the treatment of HCV genotype 4; also it was associated with high SVR (97.6%).
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http://dx.doi.org/10.2174/1871526519666181218104600DOI Listing
April 2021

Metformin ameliorated methotrexate-induced hepatorenal toxicity in rats in addition to its antitumor activity: two birds with one stone.

J Inflamm Res 2018 8;11:421-429. Epub 2018 Nov 8.

Department of Tropical, Faculty of Medicine, Tanta University, Tanta, Egypt,

Methotrexate (MTX) is a drug used in treatment of various malignancies. Unfortunately, it leads to life-threatening complications including hepatorenal toxicity. Previous studies revealed the protective effects of metformin (MET) on hepatorenal toxicity in other models in addition to its anticancer effects. The current study investigates the effect of MET on MTX-induced hepatorenal toxicity and the possible mechanisms involved in this toxicity which can be overwhelmed by MET. Thirty male rats were divided into 3 groups: normal control, MTX treated and MET/MTX treated. After 7 days, MTX induced hepatorenal toxicity as proved by histological examinations and biochemical analysis of liver and kidney functions. Also, it led to significant increase in hepatic and renal malondialdehyde levels, significant decrease in hepatic and renal total antioxidant capacity levels and Na+/K+-ATPase activities and significant up regulation of mRNA expressions of nuclear factor kappa-light-chain-enhancer of activated B cells, cyclooxygenase-2 and caspase 3 compared with the control group. While, MET could significantly reduce hepatorenal toxicity and counteract the effects of MTX on all measured parameters. In conclusion, MET can be an effective adjuvant to MTX chemotherapy that could ameliorate its hepatorenal toxicity through antioxidant, anti-inflammatory and anti-apoptotic mechanisms.
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http://dx.doi.org/10.2147/JIR.S178767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6233475PMC
November 2018

Randomized-controlled trial of methocarbamol as a novel treatment for muscle cramps in cirrhotic patients.

Eur J Gastroenterol Hepatol 2019 04;31(4):499-502

Department of Tropical Medicine, Tanta University, Tanta.

Background: Muscle cramps occur in 29-88% of patients with liver cirrhosis. They adversely affect quality of life. This study aimed to evaluate the efficacy and safety of methocarbamol as a novel therapy in controlling muscle cramps in cirrhotic patients.

Patients And Methods: This study was carried on 100 patients with liver cirrhosis in addition to chronic hepatitis C who presented with frequent muscle cramps (≥three cramps per week). Half of these patients received methocarbamol and the other half received placebo. This was done through equal randomization. Questionnaires on muscle cramp were answered. Patients were evaluated before, after 1 month of treatment, and 2 weeks after washout of treatment in terms of severity, duration, and frequency of cramps. Liver, renal functions, and electrolytes were analyzed. Also, any side effect was detected.

Results: Patients who were treated with methocarbamol showed a significant decrease in the frequency and duration of cramps. Also, the pain score improved significantly. However, no significant changes were observed in the placebo group. Few side effects of methocarbamol were recorded, including dry mouth and drowsiness.

Conclusion: Methocarbamol seems to be a promising safe and well-tolerated medication, and plays a role in the treatment of muscle cramps in patients with liver cirrhosis.
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http://dx.doi.org/10.1097/MEG.0000000000001310DOI Listing
April 2019

Sofosbuvir, Pegylated Interferon and Ribavirin in the Treatment of an Egyptian Cohort with Hepatitis C Virus Infection in Real-Life Clinical Practice.

Infect Disord Drug Targets 2019 ;19(2):179-184

Tanta University, Department of Tropical Medicine, Tanta, Egypt.

Background & Aims: Hepatitis C virus infection is a major public health problem in Egypt with a risk for morbidity and mortality due to chronic liver disease complications. Worldwide, Egypt has the highest prevalence of HCV infection with the overall prevalence of about 14.7%. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus Pegylated Interferon (Peg- IFNa) and Ribavirin (RBV) in Egyptian patients with chronic hepatitis C virus (HCV) infection.

Methods: This study was carried out in 1200 patients with chronic hepatitis C virus infection who were eligible for interferon therapy. They were treated with the triple therapy of sofosbuvir 400 mg once daily, Peg-INF subcutaneous injection weekly for 12 weeks in combination with oral weight-based ribavirin. The primary outcome measures were the number of patients with successful eradication of the virus evidenced by the sustained virologic response (SVR) at 12 Weeks. After discontinuation of Therapy (SVR12), the secondary outcome measures were the incidence of adverse effects associated with the tested HCV therapy.

Result: The mean age of the patients was 49.32 ± 6.97 years. 45.9% of them were males and 54.1% were females.70 patients (5.8%) had a history of previous HCV treatment. ''1077 (89.8%)'' of patients achieved successful eradication of virus while ''106 (8.8%)'' were resistant to treatment and ''17 (1.4%)'' stopped treatment. Good predictors of response to the triple therapy were female gender, treatment naive and non-cirrhotic patients.

Conclusion: The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus and is associated with real-life SVR12 rates of 89.8%.
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http://dx.doi.org/10.2174/1871526518666180912121835DOI Listing
October 2019

Predicting Esophageal Varices in Cirrhotic Hepatitis C Virus Patients Using Noninvasive Measurement of Insulin Resistance Variables.

Endocr Metab Immune Disord Drug Targets 2018 ;18(6):573-580

Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background & Aims: Esophageal varices (EV) are a major complication of portal hypertension in cirrhotic patients. Screening is essential for all patients with cirrhosis. Performing non-invasive methods for screening is a cost-effective and time-saving measure. The aim of this work is to evaluate whether insulin resistance (IR) assessed by HOMA-IR score can predict the presence of EV or not.

Methods: This cross-sectional study was carried out on sixty Egyptian cirrhotic HCV patients divided into 3 groups: Group I: 20 cirrhotic patients without esophageal varices, Group II: 20 cirrhotic patients, with small esophageal varices and Group III: 20 cirrhotic patients with large esophageal varices. Fasting insulin level was measured and HOMA- IR score was calculated. Abdominal ultrasound and Fibroscan were done to all patients.

Results: Insulin resistance assessed by HOMA -IR score showed a statistically significant difference among the three groups (P<0.001) with a cutoff value equal to or more than 3.40. It could significantly predict EV (AUROC= 0.841) with high sensitivity of 75 %, and excellent specificity 80%. Liver stiffness measurement (LSM) with a cutoff value 40.95 kPa could significantly predict EV (AUROC= 0.629) with sensitivity 75 %, specificity 50 %.

Conclusion: HOMA-IR score is a new independent predictor of the presence of EV.
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http://dx.doi.org/10.2174/1871530318666180803120428DOI Listing
January 2019

Pilot study of orphenadrine as a novel treatment for muscle cramps in patients with liver cirrhosis.

United European Gastroenterol J 2018 Apr 6;6(3):422-427. Epub 2017 Sep 6.

Department of Tropical Medicine and Infectious Diseases, Tanta University, Tanta, Egypt.

Background And Aims: Muscle cramps markedly affect the quality of life in cirrhotic patients with no available highly effective treatment. The aim of this study was to assess the safety and efficacy of orphenadrine in the treatment of muscle cramps in cirrhotic patients.

Methods: The study enrolled 30 liver cirrhosis patients complaining of frequent muscle cramps (≥3 per week), who were randomized to receive either orphenadrine 100 mg or calcium carbonate 500 mg twice daily as a control for one month. Severity, frequency, and duration of the muscle cramps were assessed before and after treatment as well as recurrence after washout of the drug for two weeks. Side effects were recorded.

Results: One month after treatment with orphenadrine; the frequency of muscle cramps decreased significantly to 0.6 ± 0.74 per week compared to 12.53 ± 6.01 at baseline ( < 0.001), the duration of muscle cramps decreased from 1 min to 0.1 min after treatment ( < 0.001). The pain score improved significantly from a score of 8/10 to 0/10 ( < 0.001). The side effects were few, such as dry mouth, drowsiness, and nausea, with no significant difference between their occurrences in the two groups.

Conclusion: Orphenadrine is safe and effective in treatment of muscle cramps in patients with liver cirrhosis.
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http://dx.doi.org/10.1177/2050640617731261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5949967PMC
April 2018

Serum FBLN1 and STK31 as biomarkers of colorectal cancer and their ability to noninvasively differentiate colorectal cancer from benign polyps.

Clin Chim Acta 2018 Aug 30;483:151-155. Epub 2018 Apr 30.

Tanta University Hospital, Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, El-Geesh St., Tanta, Egypt.

Purpose: The aim of this work is to evaluate Fibulin-1 (FBLN1) and serine threonine kinase-31 (STK31) as colorectal cancer (CRC) tumour markers and their ability to differentiate it from colorectal benign lesions.

Material And Methods: In this case-control study, FBLN1 and STK31 serum levels were measured in 120 participants; 49 CRC patients (group I), 26 patients with benign colorectal polyps (group II) and 45 healthy controls (group III).

Results: The means of serum FBLN1 were 1.02 ± 0.95, 6.36 ± 2.55 and 6.26 ± 2.76 in group I, II and III respectively. Significant lower levels were found in group I compared to group II and III (both p < 0.001) with no significant difference between group II and III (p = .983). The means of serum STK31 were 13.51 ± 7.67, 5.98 ± 3.3 and 1.37 ± 1.22 in group I, II and III respectively with significant differences in-between the 3 groups (p < 0.001). Both FBLN1 and STK31 were superior to CEA as CRC screening biomarkers; with sensitivity 90.1% and 93% respectively and specificity 93.9% and 95.9% respectively. FBLN1 differentiated CRC from benign polyps with 91.8% sensitivity and 100% specificity. STK31 differentiated CRC from benign polyps with 93.9% sensitivity and 84.6% specificity.

Conclusion: FBLN1 and STK31 can be possible screening and differentiating biomarkers of CRC.
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http://dx.doi.org/10.1016/j.cca.2018.04.038DOI Listing
August 2018

A Randomized Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy.

J Clin Gastroenterol 2019 03;53(3):226-230

Tropical Medicine & Infectious Diseases, Tanta University Faculty of Medicine, Tanta.

Background And Aims: Hepatic encephalopathy (HE) is a reversible spectrum of neuropsychiatric abnormalities associated with liver dysfunction. Lactulose is a nonabsorbable disaccharide presently used to treat HE. Nitazoxanide (NTZ) has a broad-spectrum activity against urease-producing bacteria, so it decreases ammonia production and is therefore expected to reverse the symptoms of HE. A previous pilot study on HE patients given NTZ and lactulose had encouraging results with regard to amelioration of the clinical picture. Patients showed improvement in mental status and the drug was well-tolerated. Results such as these are encouraging larger studies. The aim of this study was to compare the safety and adequacy of NTZ plus lactulose versus lactulose and placebo in management of overt HE.

Methods: In total, 120 cirrhotic patients suffering from overt HE were randomly designated to take either NTZ plus lactulose (n=60) or lactulose and placebo (n=60). The Clinical Hepatic Encephalopathy Staging Scale (CHESS) score was assessed for all patients on inclusion to the study and 1 week from the start of treatment.

Results: Both groups evinced an improvement in CHESS score at 1 week, yet the improvement was significantly better in the NTZ group as the score decreased from 4.15±2.09 to 0.00±0.00 compared with 4.96±2.29 to 1.28±0.91 in patients receiving lactulose and placebo (P-value <0.001).

Conclusions: NTZ significantly decreases the CHESS score and improves mental status in the form of patient alertness, orientation, response to stimulation, and ability to talk. NTZ is safe and well-tolerated apart from infrequent epigastric pain.
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http://dx.doi.org/10.1097/MCG.0000000000001040DOI Listing
March 2019

Epidemiology of liver cancer in Nile delta over a decade: A single-center study.

South Asian J Cancer 2018 Jan-Mar;7(1):24-26

Department of Medical Oncology, Tanta University Faculty of Medicine, Tanta, Egypt.

Background: In Egypt, there has been a remarkable increase in the proportion of hepatocellular carcinoma (HCC) among chronic liver diseases patients. This rising proportion may be explained by the increasing risk factors as hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, improvement of the diagnostic tools of HCC as well as the extended survival among patients with cirrhosis to allow time for some of them to develop HCC. The aim of this study was to study the epidemiology of HCC in Nile delta over the last decade.

Methods: The study was carried out on patients diagnosed as HCC in liver cancer clinic in Tanta University Hospital, Egypt, from January 2005 to January 2015. This retrospective study reviewed the files of HCC patients with special stress on age, sex, residence, occupation, smoking, and viral markers.

Results: Over the last decade, 1440 HCC patients were diagnosed or referred to liver cancer clinic in Tropical Medicine Department in Tanta University Hospital from January 2005 to January 2015. The mean age of HCC patients was 56.13 ± 9.53 years. Nearly, half of the patients with HCC were smokers and quarter of HCC patients were diabetics. HBV surface antigen-positive patients were only 3.26%, and the majority of patients were HCV-Ab positive (94.86% of patients).

Conclusions: In Nile delta, hepatitis C rather than hepatitis B was linked to the development of HCC in our region which may be related to the high prevalence of HCV in this area.
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http://dx.doi.org/10.4103/sajc.sajc_82_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865090PMC
March 2018

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

Infect Drug Resist 2018 1;11:295-298. Epub 2018 Mar 1.

Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Background And Aims: Treatment 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 Methods: In 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.

Results: Group I patients showed statistically significant (<0.05) higher SVR12 compared with group II patients (99% vs. 80%). There was no statistical difference (>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.

Conclusion: Sofosbuvir 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.
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http://dx.doi.org/10.2147/IDR.S153060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840188PMC
March 2018

Response.

Gastrointest Endosc 2018 03;87(3):904-905

Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

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http://dx.doi.org/10.1016/j.gie.2017.12.010DOI Listing
March 2018

Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease.

Int J Hepatol 2017 26;2017:8462756. Epub 2017 Sep 26.

Tropical Medicine Department, Tanta University, Tanta, Egypt.

Objectives: We aimed to investigate the safety and efficacy of propofol plus fentanyl versus midazolam plus fentanyl as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Methods: A total of 100 patients with liver cirrhosis referred for upper endoscopy were enrolled and divided equally in two groups, midazolam plus fentanyl group and propofol plus fentanyl group. All patients were subjected to history taking, estimation of level of sedation, endoscopist rating, and hemodynamic parameters including oxygen saturation, heart rate, mean arterial pressure, incidence of side effect as (bradycardia, hypotension, hypoxia, nausea and vomiting, cough, shivering, or diplopia), time needed for complete recovery, and time needed for discharge.

Results: There was no statistical significant difference between the studied groups regarding age, sex, weight, Child-Pugh classification score, type and duration of endoscopic intervention, time needed for complete recovery, or time needed for discharge. Complication rates were similar in both groups except for mean arterial blood pressure which was significantly lower in group of patients receiving propofol and fentanyl ( = 0.001).

Conclusion: The use of either propofol or midazolam in combination to fentanyl is effective in sedation of patients with advanced liver diseases presented for upper GIT endoscope. The trial is registered with ClinicalTrials.gov Identifier: NCT03063866.
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http://dx.doi.org/10.1155/2017/8462756DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5634622PMC
September 2017

A novel scoring system for prediction of esophageal varices in critically ill patients.

Clin Exp Gastroenterol 2017 7;10:315-325. Epub 2017 Dec 7.

Tropical Medicine Department, Tanta University, Tanta.

Background And Aims: Patients with advanced systemic illness or critically ill patients may present with upper gastrointestinal tract (GIT) bleeding which may need endoscopic intervention; however, this may expose them to unnecessary endoscopy. The aim was to validate a novel scoring system for risk stratification for urgency of GIT endoscopy in critically ill patients.

Methods: This is an observational study conducted from January 2013 to January 2016 to analyze 300 patients with critical medical conditions and presenting with upper gastrointestinal bleeding. Meticulous clinical, laboratory, and sonographic evaluations were performed to calculate Glasgow Blatchford score (GBS) and variceal metric score for risk stratification and prediction of the presence of esophageal varices (OV). Finally, this score was applied on a validation group (n=100).

Results: The use of GBS and variceal metric scores in critically ill patients revealed that patients who showed a low risk score value for OV (0-4 points) and GBS <2 can be treated conservatively and discharged safely without urgent endoscopy. In patients with a low risk for varices but GBS >2, none of them had OV on endoscopy. In patients with intermediate risk score value for OV (5-8 points) and with GBS >2, 33.33% of them had varices on endoscopy. In patients with high risk score value for varices (9-13) and GBS >2, endoscopy revealed varices in 94.4% of them. Finally, in patients with very high risk score for varices (14-17), endoscopy revealed varices in 100% of them.

Conclusion: GBS and variceal metric score were highly efficacious in identifying critically ill patients who will benefit from therapeutic endoscopic intervention.
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http://dx.doi.org/10.2147/CEG.S144700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724407PMC
December 2017

Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice.

Arch Virol 2018 Jan 5;163(1):51-56. Epub 2017 Oct 5.

Department of General Medicine, Al-Azhar University, Cairo, Egypt.

Egypt has the highest hepatitis C virus (HCV) prevalence in the world. Sofosbuvir is a new highly effective drug for treatment of HCV infection. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to fourfold reduced duration of therapy. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin in Egyptian patients with liver cirrhosis due to chronic HCV infection. We studied 2400 cirrhotic Egyptian patients with chronic HCV infection who were treated with dual therapy with sofosbuvir and ribavirin for 24 weeks. Efficacy was determined by assessment of serum HCV RNA. Any adverse events during treatment were recorded. Two thousand four hundred cirrhotic Egyptian patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24 weeks were enrolled in the study. The mean age of the studied group (± SD) was 53.9 ± 6.5 years, 1549 (64.54%) were males, all were cirrhotic patients, 3.41% were treatment-experienced, the baseline mean HCV RNA concentration was 4.33 × 10 IU/mL, and 94.37% of the patients had completed the full course of therapy. The overall SVR12 rate was 71.2%. The most common adverse events were fatigue, myalgia, headache, insomnia, and anemia. One hundred thirty-five (5.63%) patients stopped treatment permanently due to the appearance of complications that prevented continuation of treatment. The sofosbuvir and ribavirin combination is safe and effective in treatment of HCV patients with liver cirrhosis. However, further studies are needed to establish the optimal treatment regimen for those cases.
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http://dx.doi.org/10.1007/s00705-017-3573-0DOI Listing
January 2018
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