Sherief Abd-Elsalam

Randomized-controlled trial of rifaximin versus norfloxacin for secondary prophylaxis of spontaneous bacterial peritonitis.

Background and aims Spontaneous bacterial peritonitis (SBP) is a serious complication of liver cirrhosis with a high recurrence rate and a marked increase in mortality. Norfloxacin is used widely for the secondary prophylaxis of SBP; however, its extensive long-term use has led to an increase in the incidence of quinolone-resistant and Gram-positive SBP. Rifaximin is a nonabsorbable broad-spectrum antibiotic and does not appear to promote emergence of resistance. The aim of this study was to compare the safety and efficacy of rifaximin versus norfloxacin for the secondary prevention of SBP in patients with liver cirrhosis and ascites. Materials and methods Two hundred and sixty two cirrhotic patients with ascites and a previous episode of SBP were assigned randomly to receive either 1200 mg rifaximin or 400 mg of norfloxacin daily for 6 months. All patients were monitored clinically each month and with ascitic fluid examination at the end of 2 and 6 months if not clinically suspected of recurrence earlier. Results Recurrence of SBP was significantly lower in the rifaximin group (3.88 vs. 14.13%) compared with the norfloxacin group (P=0.04). The mortality rate was significantly decreased in the rifaximin group (13.74 vs. 24.43%) compared with the norfloxacin group (P=0.044). The causes of death between the two groups did not show a significant difference (P=0.377), but encephalopathy-related deaths were three folds higher in the norfloxacin group. There was a significant decrease in the side effects in the rifaximin group versus the norfloxacin group (P=0.033). Conclusion Rifaximin was more effective than norfloxacin in the secondary prevention of SBP. Encephalopathy-related mortality and side effects were fewer in the rifaximin group.

Pigtail Catheter: A Less Invasive Option for Pleural Drainage in Egyptian Patients with Recurrent Hepatic Hydrothorax

Background and Aims. Treatment of hepatic hydrothorax is a clinical challenge. Chest tube insertion for hepatic hydrothorax is associated with high complication rates. We assessed the use of pigtail catheter as a safe and practical method for treatment of recurrent hepatic hydrothorax as it had not been assessed before in a large series of patients. Methods. This study was conducted on 60 patients admitted to Tanta University Hospital, Egypt, suffering from recurrent hepatic hydrothorax. The site of pigtail catheter insertion was determined by ultrasound guidance under complete aseptic measures and proper local anesthesia. Insertion was done by pushing the trocar and catheter until reaching the pleural cavity and then the trocar was withdrawn gradually while inserting the catheter which was then connected to a collecting bag via a triple way valve. Results. The use of pigtail catheter was successful in pleural drainage in 48 (80%) patients with hepatic hydrothorax. Complications were few and included pain at the site of insertion in 12 (20%) patients, blockage of the catheter in only 2 (3.3%) patients, and rapid reaccumulation of fluid in 12 (20%) patients. Pleurodesis was performed on 38 patients with no recurrence of fluid within three months of observation. Conclusions. Pigtail catheter insertion is a practical method for treatment of recurrent hepatic hydrothorax with a low rate of complications. This trial is registered with ClinicalTrials.gov Identifier: NCT02119169.

Randomized placebo-controlled study of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Background and aims Muscle cramps adversely influence the quality of life of patients with liver cirrhosis. Indeed, to date, a well-established therapy for this complication is still lacking. This is the first randomized placebo-controlled trial of baclofen in the treatment of muscle cramps in patients with liver cirrhosis. Patients and methods A total of 100 patients with liver cirrhosis and muscle cramps signed an informed consent to participate in this study. They were recruited from the Department of Tropical Medicine-Tanta University Hospital. They were randomized to receive either baclofen or placebo for 3 months. Patients were followed monthly and 1 month after withdrawal. At each visit, the clinicoepidemiological data were recorded, the muscle cramp questionnaire was filled, and any drug-related side effects were reported. Results In the baclofen group, the frequency of muscle cramps decreased significantly after 1 and 3 months of treatment (P<0.005), with a significant relapse after withdrawal (P<0.001). Patients receiving baclofen showed a significant decrease in the severity and duration of muscle cramps (P<0.001). After 3 months of baclofen therapy at a dose of 30 mg/day, muscle cramps disappeared completely in 72%, reduced in 20%, and led to no change in 8% of patients. No significant changes in the frequency, severity, and duration of muscle cramps were noted in the placebo group. There were few but nonsignificant side effects in the baclofen group compared with the placebo group. Conclusion Baclofen was well tolerated, safe, and effective in the treatment of muscle cramps in patients with liver cirrhosis.

Efficacy of Sofosbuvir Plus Ribavirin with or Without Peginterferon- Alfa in Treatment of a Cohort of Egyptian Patients with Hepatitis C Virus Infection

Background & Aims: Sofosbuvir is a powerful drug for the treatment of hepatitis C virus (HCV) infection. In comparison to preceding remedies, sofosbuvirbased regimens provide a higher cure rate, fewer side effects, and much lower duration of treatment. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ribavirin with or without peginterferon-alfa in the treatment of a cohort of Egyptian patients with hepatitis C virus infection. METHODS Two hundred treatment naive patients who were HCV-antibody positive and HCV RNA by PCR positive aged more than 18 years were enrolled in the study and patients were classified into two groups: Group I which included 100 patients who received dual therapy with sofosbuvir plus oral weight based ribavirin for 24 weeks and Group II which included 100 patients on triple therapy with sofosbuvir plus oral weight based ribavirin (as with the dual therapy) and a 180 mcg Peg-INF alpha 2a subcutaneous injection weekly for 12 weeks. The primary end point was a sustained virological response at 12 weeks after end of the treatment determined by quantitative PCR for HCV. RESULTS Both patients groups had high sustained virological response that was higher in patients receiving triple than dual therapy (94% vs 83%). The adverse events that occurred in the two groups of patients were more evident in a group of patients receiving triple therapy. The side effects were mainly flu like symptoms. CONCLUSIONS The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus as well as sofosbuvir and ribavirin alone wit.

Randomized controlled study of a novel triple nitazoxanide (NTZ)‐containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection

Helicobacter pylori infection has become more and more resistant to conventional first‐line treatment regimens. So, there is a considerable interest in evaluating new antibiotic combinations and regimens. Nitazoxanide is an anti‐infective drug with demonstrated activity against protozoa and anaerobic bacteria including H. pylori. This work is designed to evaluate the efficacy and safety of a unique triple nitazoxanide‐containing regimen as a treatment regimen in Egyptian patients with H. pylori infection.

Role of low-molecular-weight heparins in prevention of thromboembolic complication after transarterial chemoembolization in hepatocellular carcinoma.

Background and aim Portal vein thrombosis (PVT) is a common complication after transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC). This is the first clinical study to evaluate the role of low-molecular-weight heparins (LMWHs) with TACE in HCC for the prevention of thromboembolism complications (PVT). Patients and methods This study was carried out on 40 patients with HCC requiring TACE who presented to the Tropical Medicine Department, Tanta University and Interventional Radiology Department of Ain-Shams University Hospitals starting from April 2015. Patients were divided in two groups: group I included 20 patients with HCC treated by TACE only. Group II included 20 patients with HCC treated by TACE and an adjuvant dose of LMWH. Radiological assessment of efficacy of procedure and detection of PVT as a complication was performed using ultrasound abdomen and pelvis and triphasic spiral computed tomography with contrast. Results This study was carried out on 40 patients with HCC requiring TACE who presented to the Tropical Medicine Department of Tanta University and Interventional Radiology Department of Ain-Shams University Hospitals. The incidence of PVT after TACE was higher in group I than group II, with seven cases in group I and only one case in group II. Conclusion LMWH with TACE in HCC is strongly recommended for prevention of thromboembolism complications (PVT). However, larger randomized-controlled studies are needed to confirm these obvious findings.

Randomized controlled trial of rivaroxaban versus warfarin in the management of acute non-neoplastic portal vein thrombosis

BACKGROUND AND AIM Anticoagulation therapy is the main line of treatment for acute portal vein thrombosis (PVT) in the absence of cirrhosis. However, the use of this therapy in cirrhotic PVT is still with doubtful evidence. We aimed to evaluate the efficacy and safety of rivaroxaban compared to warfarin for the management of acute non-neoplastic PVT in Hepatitis C virus (HCV)-related compensated cirrhosis. METHODS Out of 578 patients with chronic HCV infection, 80 patients with acute PVT who had undergone splenectomy due to hypersplenism and 4 patients with acute PVT due to portal pyemia were selected. The patients were randomly assigned (1:1) to the study group (n = 40), in which the patients received rivaroxaban 10 mg/12 h, or the control group (n = 40), in which the patients received warfarin. RESULTS In the rivaroxaban group, the resolution of PVT was achieved in 34 patients (85%) within 2.6 ± 0.4 months and delayed, partial recanalization after 6.7 ± 1.2 months (n = 6.15%). Complications such as major bleeding, abnormal liver functions, death, or recurrence did not occur during treatment, and patients in this group showed improved short-term survival rate (20.4 ± 2.2 months) compared to the survival rate in the control group (10.6 ± 1.8 months) in which warfarin achieved complete resolution in 45% of patients. Complications such as severe upper GI tract bleeding (43.3%), hepatic decompensation (22.5%), progression to mesenteric ischemia (12.5%), recurrence (10%), and death (20%) were observed in the control group. The duration until complete resolution of thrombus correlated with age, the extent of the thrombus, creatinine level, and MELD score. The recurrence after complete resolution of thrombus correlated with age, the extent of the thrombus, thrombogenic gene polymorphism, and the use of warfarin. CONCLUSION Rivaroxaban was effective and safe in acute HCV-related non-neoplastic PVT with improved short-term survival rate; ClinicalTrials.gov Identifier: NCT03201367.

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

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 (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. 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.

Correlation of platelets count with endoscopic findings in a cohort of Egyptian patients with liver cirrhosis

AbstractScreening endoscopy is recommended for early detection of esophageal varices (EVs) in cirrhotic patients with portal hypertension. However, this approach is limited by its invasiveness and cost. The aim of the study was to determine if platelet count can predict the presence of EVs, especially large (grade III, IV) EVs in need of prophylactic therapy, in a cohort of Egyptian patients with liver cirrhosis. In all, 110 patients with cirrhosis were prospectively analyzed. The presence of medium or large EVs was correlated with patients’ platelet count and FIB-4. Esophageal varices were present in 87 (79.09%) patients. Among those with thrombocytopenia (platelet level below 150,000), 25.97% (20 patients) and 27.27% (21 patients) had EV grade II and EV grade III or IV, respectively. Whereas in patients in whom the platelet count was above 150,000, only 21.21% (7 patients) and 9.09% (3 patients) of patients had grade II EV and EV grade III or IV, respectively. A platelet count cut-off value of 149,000 was found to have specificity of 82% and sensitivity 39% for detection of presence of varices. A FIB-4 cut-off value of 3.175 was found to have an 83.3% sensitivity and 39.5% specificity in detecting large (grade III, IV) EVs. Platelet count is a noninvasive parameter with high accuracy for prediction of EVs. Cirrhotic patients with normal platelet counts (above 150,000), especially in financially deprived developing countries, can avoid screening endoscopy as they are at a low risk for variceal bleeding, and presence of large EVs in these patients is much less common than in those with thrombocytopenia. A 3.175 cut-off value of FIB-4 could be useful as a noninvasive predictor of large varices requiring prophylactic banding in cirrhotic patients.

A 2-week Nitazoxanide-based quadruple treatment as a rescue therapy for Helicobacter pylori eradication: A single center experience.

AbstractAs there are increasing reports of fluoroquinolone resistance on use as a first- or second-line treatment for Helicobacter pylori (H pylori), we aimed at evaluation of the efficacy and safety of nitazoxanide-based regimen as a rescue regimen in Egyptian patients whose previous traditional treatment for H pylori infection failed.In total, 100 patients from the outpatient clinic of the Tropical medicine department, Tanta University hospital in whom the standard triple therapy (clarithromycin-based triple therapy) failed were enrolled in the study. Nitazoxanide (500 mg bid), levofloxacin (500 mg once daily), omeprazole (40 mg bid), and doxycyclin (100 mg twice daily) were prescribed for 14 days. Eradication was confirmed by stool antigen for H pylori 6 weeks after the end of treatment. Among the patients enrolled in the study, 44% of patients were men and the mean age for the participants in the study was 46.41 ± 8.05, 13% of patients were smokers, and 4% of patients had a previous history of upper gastro-intestinal bleeding. A total of 94 patients (94%) completed the study with excellent compliance. Only 1 patient (1%) discontinued treatment due to intolerable side effects and 5 patients (5%) did not achieve good compliance or were lost during follow up. However, 83 patients had successful eradication of H pylori with total eradication rates 83% (95 % CI 75.7–90.3%) and 88.30% (95 % CI 81.8–94.8%) according to an intention-to-treat and per-protocol analysis, respectively. Adverse events were reported in 21% of patients: abdominal pain (6%), nausea (9%) and constipation (12%), (2%) headache, and (1%) dizziness. A 2-week nitazoxanide-based regimen is an effective and safe rescue therapy in Egyptian patients whose previous standard triple therapy has failed.