Response to Pegylated Interferon in Chronic Hepatitis B, Effect of with and without Precore Mutant Stain: A Multicenter Tunisian Study

Background and Study Aims: To evaluate the effectiveness of pegylated interferon in patients with chronic hepatitis B infection in a real life setting.Patients and Methods: Fifteen hospitals in Tunisia were included in this study. Data from consecutively treated chronic hepatitis B (CHB) patients, who received pegylated interferon, were collected retrospectively. Baseline demographic and clinical data, on-treatment virological and serological responses and adverse events (AE) were recorded. Sustained virologic response (SVR) is defined as an hepatitis B virus (HBV) DNA concentration of less than 2,000 IU/mL six months after the completion of therapy.Results: A total of 351 CHB patients under peg interferon alfa-2a treatment were included in this multicenter, open label, non-interventional study.Thirty five HBeAg positive patients were identified (62% male, 23% advanced fibrosis). Six months after therapy, 24% had viral loads < 2000 IU/mL, 20% achieved HBeAg seroconversion and 5, 7% achieved HBs Ag loss.Three hundreds sixteen HBeAg negative patients were treated (72, 5% male, 24% advanced fibrosis). Six months post-treatment, 14 % had viral loads < 2000 IU/mL and 1, 2% achieved HBs Ag loss.Treatment was well tolerated in 92% of cases and was stopped in 5.2% of patients.In multivariate analysis, predictors of response to pegylated interferon were: age less than 50 years (P=0,04 IC [0,169-0,737]), precore mutant stain infection (p=0,04 IC [0,60-0,69]), a body mass index < 30kg/m2 (P=0,05 IC [0,225-0,320]), and a pre-treatment serum HBV DNA level <20000IU/ml (P=0,03 IC [1,316-2,225]).Conclusion: PEG-IFN therapy in chronic hepatitis B (CHB) is well tolerated and can achieve a good response especially if we select good responders

Treatment of Helicobacter pylori infection 14‐day concomitant quadruple therapy versus triple therapy: A parallel double‐blind randomized controlled trial

Abstract Background and Aims Successful Helicobacter pylori (Hp) eradication with the traditional 7‐day course of proton pump inhibitor triple therapy is declining. Prolonging therapy to 14 days is associated with better eradication rates. Most learned societies recommend concomitant quadruple therapy (QC) as a first‐line alternative therapy for this bacterial infection. The aim of this study is to compare the efficacy and safety of triple therapy (TT) and QC for the eradication of Hp infection. Methods A parallel double‐blind randomized controlled trial was conducted. The diagnosis of Hp infection was made by pathological examination of gastric biopsies. Patients were randomly assigned to two treatment groups: either QC (esomeprazole 80 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and metronidazole 1000 mg daily) or triple therapy (esomeprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses) for 14 days. The efficacy of the treatment is defined by Hp eradication attested by a negative breath test performed 6 weeks after the completion of treatment. Treatment outcomes were compared using the chi‐square test, while binary logistic regression identified predictors of treatment failure. Results Ninety‐two patients were included. Forty‐two patients belonged to the QC group and 50 to the TT group. No significant difference was noted between the two groups concerning the rate of Hp eradication either by intention to treat (81% vs. 72% respectively, p = 0.31) or per protocol (81.6% vs. 76.1% respectively, p = 0.54). Likewise, there was no difference between the two groups in terms of tolerance to treatment (59.5% for QC vs. 58% for TT, p = 0.88). No factor has been associated with treatment failure. Conclusion There was no significant difference in the rate of HP eradication between the QC and the 14‐day triple therapy. Neither regimen should be used topically because of their low eradication rates

Epidemiology of heart failure and long-term follow-up outcomes in a north-African population: Results from the NAtional TUnisian REgistry of Heart Failure (NATURE-HF)

International audienceThe NATURE-HF registry was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). This is a prospective, multicenter, observational survey conducted in Tunisian Cardiology centers. A total of 2040 patients were included in the study. Of these, 1632 (80%) were outpatients with chronic HF (CHF). The mean hospital stay was 8.7 ± 8.2 days. The mortality rate during the initial hospitalization event for AHF was 7.4%. The all-cause 1-year mortality rate was 22.8% among AHF patients and 10.6% among CHF patients. Among CHF patients, the older age, diabetes, anemia, reduced EF, ischemic etiology, residual congestion and the absence of ACEI/ ARBs treatment were independent predictors of 1-year cumulative rates of rehospitalization and mortality. The female sex and the functional status were independent predictors of 1-year all-cause mortality and rehospitalization in AHF patients. This study confirmed that acute HF is still associated with a poor prognosis, while the mid-term outcomes in patients with chronic HF seems to be improved. Some differences across countries may be due to different clinical characteristics and differences in healthcare systems

Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study

BackgroundThe frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa). ObjectiveThe aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial. MethodsA total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface. ResultsAt the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study. ConclusionsThe NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia. Trial RegistrationClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675 International Registered Report Identifier (IRRID)DERR1-10.2196/1226