Oral Antiviral Treatment Research Articles

Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B.

Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%-2.88%) and an annual rate of 0.22% (.17%-.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80-5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07-6.53]), serum bilirubin (1.11 per mg/dL; [1.06-1.17 mg/dL]), and fatty liver (1.84 [1.03-3.29]). HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver.Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver.

Sofosbuvir-based therapies associated with regression of liver fibrosis in patients with hepatitis C virus infection: A prospective observational study.

Oral direct-acting antiviral (DAA) treatment leads to >95% sustained virological response (SVR) and could be clinically useful in regression of liver fibrosis in chronic hepatitis C virus (HCV) infection. We evaluated if ledipasvir/sofosbuvir or sofosbuvir + ribavirin is associated with regression of fibrosis in HCV patients who achieved SVR.In this prospective cohort study performed at 3 sites in Japan, patients with genotype 1 and genotype 2 were given standard treatment of ledipasvir 90 mg/sofosbuvir 400 mg and sofosbuvir 400 mg + 200–1000 mg/day ribavirin, respectively, for 12 weeks. Liver fibrosis was assessed using Mac-2-binding protein glycosylation isomer (M2BPGi) and other fibrosis markers (platelet count, Fib-4 index, liver stiffness measurement [LSM]) in patients who achieved SVR.A total of 98.1% of (n = 101/103) patients in genotype 1 cohort and 100% (n = 16/16) in the genotype 2 cohort achieved SVR12. Based on per-protocol analysis, M2BPGi levels showed a significant decrease (–2.2 cut-off index [COI], P < .0001) at week 48 after treatment initiation. Forty-three patients showed a significant decrease in Fib-4 index (–1.2, P < .0001), and 44 patients showed improvement in LSM (–5.9 kPa, P < .0001).Achievement of SVR after antiviral therapy was associated with fibrosis regression. M2BPGi correlated well with LSM at week 48 after treatment initiation, supporting the sustainable benefit of HCV therapy.

Validation of Circom comorbidity score in critically-ill cirrhotic patients

Background and aim of workCirCom score has been designed specifically for cirrhotic patients as it is used to reassess which comorbidities associate with mortality of those patients. The current study was designed to assess the performance of CirCom comorbidity score in predicting the mortality of critically ill cirrhotic patients of hepatitis C virus (HCV) etiology. Methodology1085 consecutive patients admitted to the ICU in a two-year period were included. All were anti-HCV Ab positive with liver cirrhosis and portal hypertension as evidenced by clinical examination, laboratory, ultrasonographic and endoscopic features. None of them received oral antiviral treatment. ResultsOut of the 1085 Patients, 321 (29.5%) patients died and 764 (70.4%) survived. Co-morbidities were found in 572 (52.7%), CirCom score 0 in 47.28%, 1 + 0 in 4.33%, 1 + 1 in 7.19%, 3 + 0 in 6.45%, 3 + 1 in 9.4%, 5 + 0 in 12.16%, 5 + 1 in 13.18%. Adjusted ORs for increased risk of death were 2.07, 2.65, 4.62, 6.72, 8.43 and 12.87, respectively. Overall, the model correctly predicted 82.24% of patients. ConclusionThe CirCom score performance as a measure of the burden of comorbidity in critically ill cirrhotic patients is fairly good and 82.24% of patients were correctly predicted by the model. Actual and expected survivals were comparable. This emphasizes the importance of including a measure of comorbidity in comparative studies of cirrhosis survival.

Impact of Hepatitis C virus Infection and direct-acting Oral Antiviral Drugs on glycaemic state in Type 2 Diabetic Patients

Background: Diabetes mellitus (DM) is strongly associated with chronic hepatitis C virus (HCV) infection. This work aimed to estimate the impact of Hepatitis C virus infection on glycaemic state and insulin resistance in type 2 Diabetic patients, and evaluate the effect of direct-acting oral antiviral treatment on the glycaemic state and insulin resistance in type 2 Diabetic patients. Methods: The study was performed on (40 patients) with Type 2 Diabetes who were infected by Hepatitis C Virus and took Direct-acting Oral Antiviral Drugs. The study also included (10 patients) who had Type 2 Diabetes and HCV infection serving as control group. All patients and control were subjected to thorough history taking, clinical examination, and lab. investigations as FBG, PP and HBA1c , Serum fasting Insulin level, And HOMA-IR, HCVab – HBsAg – HIVab, CBC, SGOT, SGPT, Serum Albumin and Bilirubin, PCR for HCV RNA, and Abdominal US. Results: DAAs-based eradication of HCV is associated with improved glycemic control in patients with type 2 diabetes as evidenced by a significant reduction of mean FBG, Fasting insulin, HbA1c, and HOMA IR. There was a positive correlation between the treatment of HCV infection and the reduction of anti-diabetic drugs used in the studied patients. Conclusion: DAAs-based eradication of HCV is associated with improved glycemic control in patients with type 2 diabetes.

Serum fibrosis markers could aid in the prediction of factor for successful oral antiviral treatment in hepatitis C.

It has been demonstrated that there may be a relationship between liver fibrosis and serum biomarkers. The aim of this study was to investigate pre- and postoral antiviral therapy levels of these biomarkers and their relationship with other fibrotic parameters in hepatitis C virus (HCV) patients. The study group comprised HCV patients who were treated with oral antiviral regimens. Prior to, and 8 months after the treatment, serum biomarkers, including transforming growth factor-β (TGF-β), chitinase-3-like protein 1 (YKL-40), collagen type IV, matrix metalloproteinases (MMPs) and hyaluronic acid levels, were examined and fibrosis-4 (Fib-4) and aspartate aminotransferase to platelet ratio index (APRI) scores were calculated at the same times. In total, 45 HCV patients (aged between 27 and 86 years) participated. Of these 20 (44.4%) were cirrhotic and 25 (55.6%) were noncirrhotic. The concentrations of YKL-40 (P = 0.01) and TGF-β (P = 0.032) after treatment were significantly higher than the pretreatment values, whereas hyaluronic acid concentrations decreased after treatment (P = 0.001). Noncirrhotic patients had significantly higher (P = 0.03) YKL-40 levels prior to therapy compared to cirrhotic patients. Median MMP-2 concentrations were higher in men than in women (P = 0.001). Prior to treatment, TGF-β, YKL-40 and collagen type IV levels were negatively correlated with Fib-4 scores, whereas only TGF-β and YKL-40 concentrations were negatively correlated with APRI scores. YKL-40, TGF β and hyaluronic acid may be markers for fibrotic change during oral therapy for HCV. In particular, TGF β concentrations correlated with fibrotic indices. However, these results should be confirmed and validated by further research.

Hepatitis Flare During Immunotherapy in Patients With Current or Past Hepatitis B Virus Infection.

Immunotherapy has dramatically improved the survival of patients with advanced or metastatic malignancies. Recent studies suggest that immunotherapy may increase the risk of hepatitis, whereas it may also induce functional cure of chronic hepatitis B virus (HBV) infection. We evaluated the incidence of hepatitis flare, HBV reactivation, hepatitis B surface antigen (HBsAg) seroclearance or seroreversion in patients with current or past HBV infection who had received immunotherapy. This was a territory-wide observational cohort study in Hong Kong. We identified patients through electronic medical records based on the prescriptions of immune checkpoint inhibitors from July 1, 2014, to December 31, 2019. Patients who were HBsAg positive or HBsAg negative with results for antibody to hepatitis B surface or core antigen (anti-HBs or anti-HBc) were included. A total of 990 patients (397 HBsAg-positive, 593 HBsAg-negative with 482 anti-HBc and/or anti-HBs positive, and 111 both anti-HBc and anti-HBs negative) were identified. All of HBsAg-positive and 15.9% HBsAg-negative patients were put on oral antiviral treatment. Hepatitis flare (alanine aminotransferase >2 times of the upper limit of normal) occurred in 39.3% HBsAg-positive and 30.4% HBsAg-negative patients. High baseline alanine aminotransferase and combination of immunotherapy increased the risk of hepatitis. HBV reactivation (≥2 log increase in HBV DNA from baseline) occurred in 2 HBsAg-positive patients; HBsAg seroclearance and seroreversion was observed in 1 HBsAg-positive and 1 HBsAg-negative patient, respectively (<1%). Hepatitis flare occurs in approximately 40% of HBsAg-positive patients and 30% of HBsAg-negative patients during immunotherapy. HBV reactivation, HBsAg seroclearance, and HBsAg seroreversion are rare. Current or past HBV infection has no impact on the emergence of hepatic flare associated with immunotherapy.

Cross-sectional retrospective analysis of clinical characteristics of chronic hepatitis B patients with oral antiviral treatment in eastern China

BackgroundIn China, more than 20 million patients with chronic hepatitis B need antiviral treatment. Side effects of antiviral treatment such as renal complications can be problematic, particularly in an aging population.MethodsThe data were retrospectively extracted from the hospital medical charts of five centers in eastern China from January 1 to December 31, 2018.ResultsA total of 8309 patients with CHB was enrolled in this study. The median age of the patients was 46 years. The prevalence of diabetes mellitus, hypertension, and hepatic cirrhosis was respectively 3.49%, 4.42%, and 23.72%. The prevalence of these comorbidities increased with age (P < 0.001). Of the patients with CHB, 5332 had complete renal function results. Among them, patients with an estimated glomerular filtration rate of < 60 mL/min/1.73m2 accounted for 4.14%, and those with proteinuria for 8.33%. According to the definition of chronic kidney disease, the proportion of patients with chronic kidney disease was 11.37%. The prevalence of chronic kidney disease increased with age (P < 0.001). In a multivariate analysis, age group [odds ratio (OR) = 2.387], diabetes mellitus (OR = 1.486), hypertension (OR = 2.557), hepatic cirrhosis (OR = 1.295), and a history of exposure to adefovir dipivoxil (OR = 1.644) were significantly associated with CKD (P < 0.05). Among patients with CKD, 17.66% (107/606) had a history of lamivudine exposure, and 34.65% (210/606) had a history of nucleotide analogue exposureConclusionThe management of Chinese patients with CHB should take into consideration age, previous medication history, and renal impairment.

Oral antiviral may halve COVID-19 hospitalisation risk, claims manufacturer

An investigational antiviral treatment may significantly reduce the risk of hospitalisation or death in at-risk non-hospitalised patients with COVID-19, according to a statement released by the pharmaceutical company, Merck. In what could become the first oral antiviral treatment for COVID-19, molnupiravir — which is being developed by Merck in collaboration with Ridgeback Biotherapeutics — […]

A comparative study to evaluate effects on HCV-RNA-PCR by current oral anti-viral therapy with Sofosbuvir and Daclatasvir in Hepatitis C patients with and without Diabetes Melitis in Pakistan

Objective: To compare the effects of antiviral therapy such as sofosbuvir and daclatasvir in HCV patients which were diagnosed by HCV-RNA PCR without Diabetes Melitis.&#x0D; Study Design: Cross-sectional comparative study&#x0D; Inclusion Criteria: HCV Positive patients after PCR test conformation between 20-75 years age.&#x0D; Methodology: In this cross-sectional analysis total of 100 Hepatitis c infected patients selected, Sofosbuvir plus Daclatasvir treatment given for 03 months period. Different parameters were recorded such as Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, Hb levels, Serum ALT levels, and Serum ALP level. The statistical relation of the mentioned variables was analyzed through SPSS version 15.&#x0D; Results: Out of a total of 100 patients, 47% (47) were males, 53% (53) were females, 44% (44) patients had a history of prior interferon therapy, 23% (23) patients were having low hemoglobin levels before starting treatment. Both groups completed oral antiviral treatment for 12 weeks &amp; resulting data showed the equality of treatment on group B and group A as no decrease in hemoglobin (p=0.799), ALT normalization (p=1.000) &amp; no rise in serum bilirubin (p=0.817) during 1st month of treatment was noted in both groups while the SVR noted of both groups also showed no significant difference to each other i.e. 92% &amp; 94 % (p=0.696).&#x0D; Conclusion: This study concluded to monitor the anti-viral drug response against HCV patients.

Metabolism of Direct-acting Antiviral Agents (DAAs) in Hepatitis C Therapy: A Review of the Literature.

Hepatitis C virus (HCV) infection is still one of the leading causes of chronic liver disease, with chronically infected making up approximately 1% of the global population. Of those infected, 70% (55-85%) will develop chronic HCV infection. Chronic HCV infection causes substantial morbidity and mortality, with complications including cirrhosis, end-stage liver disease, hepatocellular carcinoma, and eventually death. Therapeutic options for chronic HCV infection have evolved dramatically since 2014, with a translation from pegylated interferon and ribavirin (associated with suboptimal cure and high treatment-related toxicity) to oral direct-acting antiviral treatment. There are four classes of direct-acting antivirals which differ by their mechanism of action and therapeutic target. They are all pointed to proteins that form the cytoplasmic viral replication complex. Multiple studies have demonstrated that direct-acting antiviral therapy is extremely well tolerated, highly efficacious, with few side effects. We performed an indexed MEDLINE search with keywords regarding specific direct-acting antiviral regimes and their pharmacokinetics, drug-drug interactions, and metabolism in specific settings of pregnancy, lactation, liver cirrhosis, liver transplantation and HCC risk, kidney failure and kidney transplantation. We present a comprehensive overview of specific direct-acting antiviral metabolism and drug-drug interaction issues in different settings. Despite its complex pharmacokinetics and the possibility of drug-drug interactions, direct-acting antivirals are highly efficacious in providing viral clearance, which is an obvious advantage compared to possible interactions or side effects. They should be administered cautiously in patients with other comorbidities, and with tight control of immunosuppressive therapy.

The Different Effects of Nucleotide and Nucleoside Analogues on the Prognosis of HBV-Related HCC After Curative Resection

BackgroundPostoperative oral antiviral treatment with nucleoside or nucleotide analogues can suppress viral replication and reduce tumour recurrence for patients with hepatitis b virus–related hepatocellular carcinoma (HBV-related HCC) after curative resection. However, the superior antiviral treatment is still unclear. We conducted this study to investigate the different effects of nucleotide and nucleoside analogues on the prognosis of HBV-related HCC after curative resection. MethodsFrom February 2007 to February 2016, 487 consecutive patients with newly diagnosed HCC according to the Milan criteria who underwent R0 resection were enrolled according to the inclusion and exclusion criteria. According to their postoperative antiviral treatment, they were divided into the nucleotide group (NtA, n = 111) and the nucleoside group (NsA, n = 376). ResultsThe baseline characteristics, serologic parameters, tumour characteristics, and operative data of the 2 groups were comparable. Nucleotide analogue use significantly decreased HCC recurrence (P = 0.028) and HCC-related death (P = 0.004), with hazard ratios (HRs) of 0.685 (95% CI, 0.484 to 0.971, P = 0.033) and 0.507 (95% CI, 0.310 to 0.830, P = 0.004), respectively, in multivariate Cox analyses. After the study patients were stratified according to three variables, we found that nucleotide analogue use was significantly associated with increased disease-free and overall survival among patients with cirrhosis, HBeAg-negative patients, and patients with positive HBV-DNA. ConclusionsIn patients with HBV-related HCC, nucleotide analogues but not nucleoside analogues significantly reduced HCC recurrence and improved overall survival after R0 hepatic resection.

Stopping oral antiviral treatment to cure chronic hepatitis B, is it in sight?

Stopping oral antiviral treatment to cure chronic hepatitis B, is it in sight?

Immune-pathological phases of chronic Hepatitis B infections among Sudanese individuals towards personalization of management

Background: Hepatitis B virus (HBV) infection is an immune liver disease affecting millions worldwide. Despite availability of an efficacious vaccine, elimination of HBV infections is aloft. This study aimed to identify the immune-pathological phases of chronic HBV infection (CHBV) among Sudanese individuals to refine management strategies. Materials and methods: In a prospective cross-sectional study and following informed consent, 1593 individuals with HBs Ag reactivity were enrolled. Serum total protein/ albumin, ALT, AST, total bilirubin, HBs Ag/Ab, HBe Ag/Ab, HBc IgM/HBc total antibodies and HBV viral loads were measured. Results: Mean aminotransferase levels for HBs Ag-reactive individuals were significantly higher compared to apparently normal individuals, while the mean total protein and serum albumin were within normal ranges. The majority of HBs Ag-reactive individuals were reactive to total anti-HBc and HBe Ab, while concurrent HBe Ag/Ab reactivity was seen in a minority. Inactive carriers constituted the majority of HBs Ag reactive individuals, while the immune tolerance CHBV phase could not be identified. The reactivation phase had the highest viral load. Conclusion: inactive carrier state is the predominant immune-pathological phase among Chronic HBV Sudanese individuals. Regular follow ups and no oral anti-viral drug treatment as the management of choice to reduce cost, drug-associated toxicities and emergence of resistant strains.

Dynamic prediction of liver cirrhosis risk in chronic hepatitis B patients using longitudinal clinical data.

In longitudinal studies, serum biomarkers are often measured longitudinally which is valuable to predict the risk of disease progression. Previous risk prediction models for liver cirrhosis restrict data to baseline or baseline and a single follow-up time point, which failed to incorporate the time-dependent marker information. The aim of this study is to develop risk model in patients with chronic hepatitis B for dynamic prediction of cirrhosis by incorporating longitudinal clinical data. Data from the hospital-based retrospective cohort at the Third Affiliated Hospital of Sun Yat-sen University, from 2004 to 2016, were analyzed. Using the multilevel logistic regression model, the time-dependent marker information and individual characteristics were taken as input, and the risk of at different time as the output. At the end of follow-up, 8.8% of patients progressed to cirrhosis, the average estimate values of hepatitis B virus DNA and alanine aminotransferase demonstrated a downward trend, the aspartate aminotransferase/alanine aminotransferase ratio showed a flat trend overall. The important predictors were as follows: age, oral antiviral treatment, hepatitis B virus DNA. This risk prediction model had an area under the receiver operator characteristic curve of 0.835 (95% confidence interval: 0.772-0.899) and 0.809 (95% confidence interval: 0.708-0.910) in the derivation and validation sets, respectively. Longitudinal prediction model can be used for dynamic prediction of disease progression and identify changing high-risk patients.

COVID-19 Diagnosed by Serological Antibody Test: A Case Report

The new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), first reported in Wuhan, China, is causing a pandemic. With an increased understanding of the disease, the diagnosis and treatment guidelines are being updated and improved. In addition to nucleic acid detection, antibody detection kits are also being developed and approved. A medical worker suspected of having COVID-19 in our hospital had fatigue and loss of appetite and pulmonary infection indicated by CT, but the nucleic acid test was negative three times. Finally, she was confirmed to have COVID-19 by a serological antibody test. After rest and oral antiviral treatment, she recovered and returned to work. This is a case report that focuses on suspected mild patients who tested negative for nucleic acids. Such a group of patients had to choose home isolation treatment during the outbreak. The majority of them did not make a definitive diagnosis or rule out COVID-19 by the time they recovered. The antibody test is of great significance to identify infected patients with multiple negative nucleic acid tests. It can complement nucleic acid testing to enhance diagnostic efficiency. We have reviewed the literature and realized that further validation and standardization of serological tests are needed for more mature application of antibody tests to clinical diagnosis and vaccine development.

Ultrasound‐Guided Cervical Nerve Root Block for the Treatment of Acute Cervical Herpes Zoster: A Randomized Controlled Clinical Study

To evaluate the efficacy and safety of ultrasound-guided cervical nerve root block (CRB) on acute pain and its preventive effects on post-herpetic neuralgia (PHN) in patients with cervical herpes zoster (HZ). 140 recruited participants were randomized 1:1 to receive ultrasound-guided CRB with either mixed drug liquid (treatment group) or similar looking placebo (placebo group). All patients received a 7-day course of oral antiviral treatment, pregabalin, and analgesics as needed. The primary efficacy was assessed on the basis of HZ burden of illness (HZ-BOI) scores over 30days (BOI-30AUC ). Secondary outcomes included HZ-BOI scores through 30 to 90days (BOI-30-90AUC ) and 90 to 180days (BOI-90-180AUC ), quality of life (QoL) outcomes, concomitant analgesic consumption, and the incidence of PHN. Adverse events were recorded to evaluate safety. The BOI-30AUC values were 92.55 and 112.72 for the treatment and placebo groups, respectively (P<0.01). Both the BOI-30-90AUC and BOI-90-180AUC in the treatment group were lower than those in the placebo group (P<0.01). The incidence of PHN at 90days was significantly less than that at 180days in the treatment group (P=0.036). A better improvement in QoL was found in the treatment group (P<0.05). There was a greater decrease in analgesic use in the treatment group as compared to the placebo group (P<0.05). No serious adverse events were observed. Ultrasound-guided CRB represented an early intervention and preventive strategy to reduce the BOI due to acute HZ in the cervical dermatome region, and might be feasible to reduce the incidence of PHN.

Towards finite oral antiviral treatment for chronic hepatitis B

Towards finite oral antiviral treatment for chronic hepatitis B

Epidemiological and clinical characteristics and the approach to infant chickenpox in primary care

Chickenpox is not common in the first year of life (infant varicella) and there is a lack of data on its presentation, especially in primary care. A year-long observational study (July 2015-2016) carried out by a research network of primary care pediatricians throughout Spain.Two hundred and sixty-four pediatricians gathered data from 358 cases of clinically diagnosed chickenpox in infants. The illness was considered mild in 78% of infants < 7months compared to 65% in those aged 7 to 12months (p = 0.0144). Fever (46%) was present in 35% of children ≤ 6months compared to 55% in older children (p = 0.0005). The number of skin lesions was > 50 in 35% of children ≤ 6months old compared to 47% in > 7months (p = 0.0273). From the 2% of hospitalized children 86% were younger than 7months. Oral antiviral treatment was given in 33% of cases ≤ 6months compared to 18% in older patients (p = 0.0023). Doubts about administering the chickenpox vaccine at a later date were expressed by 18% of pediatricians.Conclusion: Chickenpox is considered benign, having a mild effect on most infants. There is less clinical effect in infants ≤ 6months although this age group is hospitalized more and is prescribed more antiviral treatment. There are doubts among pediatricians about the subsequent need for vaccination. What is Known: • Chickenpox is uncommon and of uncertain evolution in the first year of life • Hospital admissions for chickenpox are more frequent in the first year of life What is New: • The course of chickenpox in the first year of life is mild, especially in infants younger than 7months despite the fact they are hospitalized more and are treated more frequently with antivirals. Antivirals are prescribed to 1 in 4 children with chickenpox under 12months of age. • Almost 50% of pediatricians recommend a subsequent vaccination against chickenpox especially if it occurs in the first 6months of life.

Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis

Background and AimsHepatitis B surface antigen (HBsAg) loss is the ideal clinical endpoint but is achieved rarely during oral antiviral treatment. A current unmet need in CHB management is achievement of HBsAg loss with a finite course of oral antiviral therapy, thereby allowing discontinuation of treatment. Significantly higher rates of HBsAg loss at 72 weeks post-treatment have been demonstrated when tenofovir disoproxil fumarate (TDF) was combined with pegylated interferon (PEG-IFN) for 48 weeks compared with either monotherapy. This analysis provides follow-up data at week 120.MethodsIn an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus PEG-IFN for 48 weeks (group A), TDF plus PEG-IFN for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or PEG-IFN for 48 weeks (group D). Efficacy and safety at week 120 were assessed.ResultsRates of HBsAg loss at week 120 were significantly higher in group A (10.4%) than in group B (3.5%), group C (0%), and group D (3.5%). Rates of HBsAg loss and HBsAg seroconversion in group A were significantly higher than rates in group C (P < 0.001 for both) or group D (HBsAg loss: P = 0.002; HBsAg seroconversion: P < 0.001).ConclusionsThe results of this analysis confirm the results from earlier time points which demonstrate the increased rate of HBsAg loss in patients treated with a finite course of PEG-IFN plus TDF compared with the rates in patients receiving either monotherapy.

CARDIOVASCULAR EFFECTS OF ORAL ANTIVIRAL TREATMENT FOR NON-CARDIAC HCV PATIENTS

Background: The prevalence of hepatitis C virus (HCV) in Egypt is quite high, and the combined oral direct-acting antiviral agents (DAAs) may have impressive results. Objectives: To assess the cardiovascular effects of oral antiviral treatment in non-cardiac HCV patients. Paitents and Methods: The study enrolled 100 patients with positive HCV who were enrolled for the new oral antiviral therapy in the form of Sofosbuvir and dclatsavir with or without ribavirin for 3 or 6 months. All patients on our study were subjected to follow up pre-and post-oral antiviral course, and the end point of the study was the development of a major cardiovascular event, e.g. congestive heart failure, echocardiographic evidence of left ventricular dysfunction, occurrence of significant arrhythmias, or acute coronary syndrome. The following parameters were accomplished: medical history and clinical examination, electrocardiogram, Echo-Doppler study, and laboratory investigations. Results: No significant differences were found between the patients regarding demographic criteria. None of the patients had developed any major cardiac event. No significant changes were observed regarding ST segment and T wave abnormalities, arrhythmias, or QT interval. None of patients developed echocardiographic regional wall motion abnormalities at baseline or at study end. Systolic function parameters showed minute non-significant changes over study visits. Diastolic function parameters showed non-significant changes between baseline and post oral antiviral course visit. Conclusion: The DAAs used in combination regimen didn’t significantly affect the cardiovascular system.