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BACKGROUND: Metabolic-associated fatty liver disease (MAFLD) and cardiovascular diseases have mutual risk factors that contribute to pathogenic processes, increasing mortality and morbidity. This study aimed to evaluate variations in left ventricular (LV) structure and diastolic function among different subtypes and severity degrees of MAFLD patients, allowing early identification, intervention, and prevention of severe cardiac outcomes in high-risk populations. RESULTS: The cross-sectional study included 142 MAFLD patients and 142 non-MAFLD participants as a control group. All participants underwent abdominal ultrasound, transient elastography, transthoracic echocardiography, tissue Doppler, and strain imaging. The results showed a significant impairment in the diastolic left ventricular function, as assessed with tissue Doppler, and the left atrial (LA) function, as evaluated with strain imaging, in the MAFLD group. Additionally, the left atrial stiffness was significantly higher in the MAFLD group. CONCLUSION: The use of strain imaging facilitated the detection of subtle impairments of the left atrial reservoir, contraction, conduit function, and left ventricular diastolic function in MAFLD patients.
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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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Antivirais/uso terapêutico , Fígado Gorduroso/diagnóstico , Fígado Gorduroso/tratamento farmacológico , Hepacivirus/efeitos dos fármacos , Hepatite C/tratamento farmacológico , Adulto , Antivirais/farmacologia , Carcinoma Hepatocelular/epidemiologia , Carcinoma Hepatocelular/etiologia , Egito/epidemiologia , Técnicas de Imagem por Elasticidade , Fígado Gorduroso/epidemiologia , Fígado Gorduroso/virologia , Feminino , Hepacivirus/fisiologia , Hepatite C/complicações , Hepatite C/diagnóstico , Hepatite C/epidemiologia , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/tratamento farmacológico , Cirrose Hepática/epidemiologia , Cirrose Hepática/virologia , Neoplasias Hepáticas/epidemiologia , Neoplasias Hepáticas/etiologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
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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Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Cateterismo/métodos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colecistectomia Laparoscópica , Ducto Colédoco/cirurgia , Humanos , Pancreatite/etiologiaRESUMO
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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Antivirais/uso terapêutico , Tratamento Farmacológico da COVID-19 , Ivermectina/uso terapêutico , Adulto , Idoso , COVID-19/diagnóstico , COVID-19/mortalidade , Egito/epidemiologia , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Respiração Artificial , SARS-CoV-2/efeitos dos fármacos , Resultado do TratamentoRESUMO
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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Amidas/uso terapêutico , Antivirais/uso terapêutico , Tratamento Farmacológico da COVID-19 , Pirazinas/uso terapêutico , SARS-CoV-2/efeitos dos fármacos , Adulto , Cloroquina/uso terapêutico , Feminino , Humanos , Tempo de Internação , Masculino , Respiração Artificial/estatística & dados numéricos , Resultado do TratamentoRESUMO
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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Colestase Intra-Hepática , Colestase , Colestase/complicações , Colestase Intra-Hepática/complicações , Colestase Intra-Hepática/terapia , Estudos Transversais , Egito , Humanos , PruridoRESUMO
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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Antivirais/uso terapêutico , Plaquetas/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , Cirrose Hepática/tratamento farmacológico , Adolescente , Adulto , Idoso , Egito , Feminino , Hepatite C Crônica/sangue , Hepatite C Crônica/diagnóstico , Hepatite C Crônica/virologia , Humanos , Cirrose Hepática/sangue , Cirrose Hepática/diagnóstico , Cirrose Hepática/virologia , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Estudos Retrospectivos , Resposta Viral Sustentada , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
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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Hepatite C Crônica , Hepatite C , Antivirais/efeitos adversos , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Hepatite C/tratamento farmacológico , Hepatite C Crônica/complicações , Hepatite C Crônica/tratamento farmacológico , Humanos , Cirrose Hepática/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
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 (75/50/12.5âmg) 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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Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Falência Renal Crônica/complicações , Adulto , Idoso , Anilidas/uso terapêutico , Carbamatos/uso terapêutico , Ciclopropanos , Quimioterapia Combinada , Egito , Feminino , Humanos , Lactamas Macrocíclicas , Compostos Macrocíclicos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prolina/análogos & derivados , Estudos Prospectivos , Ribavirina/uso terapêutico , Ritonavir/uso terapêutico , Sulfonamidas , Resposta Viral Sustentada , ValinaRESUMO
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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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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Cãibra Muscular , Orfenadrina , Humanos , Cirrose Hepática/complicações , Cãibra Muscular/tratamento farmacológico , Cãibra Muscular/etiologia , Dor , Resultado do TratamentoRESUMO
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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Hepatite B , Doenças Reumáticas , Adulto , Estudos Transversais , DNA Viral , Feminino , Hepatite B/complicações , Antígenos de Superfície da Hepatite B , Vírus da Hepatite B , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Reumáticas/complicações , Prata , Adulto JovemRESUMO
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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Líquido Ascítico/metabolismo , Infecções Bacterianas/diagnóstico , Biomarcadores/metabolismo , Proteínas Sanguíneas/metabolismo , Fígado/imunologia , Peritonite/diagnóstico , Proteína Amiloide A Sérica/metabolismo , Adulto , Proteína C-Reativa/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Referência , Sensibilidade e EspecificidadeRESUMO
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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Antígenos de Neoplasias/sangue , Colonoscopia/métodos , Neoplasias Colorretais , Proteínas Nucleares/sangue , Biomarcadores Tumorais/sangue , Estudos de Casos e Controles , Pólipos do Colo/diagnóstico , Neoplasias Colorretais/sangue , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Detecção Precoce de Câncer/métodos , Egito/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Lesões Pré-Cancerosas/diagnóstico , Valor Preditivo dos TestesRESUMO
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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Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Interferons/uso terapêutico , Cirrose Hepática/tratamento farmacológico , Fígado/efeitos dos fármacos , Adulto , Antivirais/efeitos adversos , Quimioterapia Combinada , Egito , Técnicas de Imagem por Elasticidade , Feminino , Hepatite C Crônica/diagnóstico , Hepatite C Crônica/virologia , Humanos , Interferons/efeitos adversos , Fígado/diagnóstico por imagem , Fígado/virologia , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/virologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão , Resposta Viral Sustentada , Fatores de Tempo , Resultado do TratamentoRESUMO
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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Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Simeprevir/uso terapêutico , Sofosbuvir/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Combinada , Egito , Feminino , Genótipo , Hepacivirus/classificação , Hepacivirus/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , RNA Viral/genética , Resposta Viral Sustentada , Resultado do Tratamento , Adulto JovemRESUMO
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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Antivirais/uso terapêutico , Hepatite C Crônica/sangue , Hepatite C Crônica/tratamento farmacológico , Resposta Viral Sustentada , alfa-Fetoproteínas/metabolismo , Adolescente , Adulto , Idoso , Antivirais/farmacologia , Biomarcadores/sangue , Egito/epidemiologia , Feminino , Hepatite C Crônica/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , alfa-Fetoproteínas/antagonistas & inibidoresRESUMO
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%.