scholarly journals A new therapeutic option for chronic hepatitis B: Reduced dose and shorter duration of a combination therapy with pegylated interferon and entecavir

2019 ◽  
Vol 45 (3) ◽  
pp. 143-148
Author(s):  
Mamun Al Mahtab ◽  
Shahina Tabassum ◽  
Afzalun Nesa ◽  
Munira Jahan ◽  
Md. Sakirul Islam Khan ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Standard Dose ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Control Group ◽  
Control Groups ◽  
Reduced Dose ◽  
Group 2 ◽  
Group 1

Background: Although several drugs are available for treatment of chronic hepatitis B (CHB), the outcome is still far from being satisfactory. The study was conducted to develop a therapeutic strategy for CHB by a combination therapy with reduced dose and duration of antiviral drugs. Objectives: Therapeutic effects of reduced dose and shorter duration of combination of pegylated interferon (Peg-IFN) and entecavir were evaluated in patients with CHB with two control groups. Methods: Fifty-four patients with CHB were treated with reduced dose of Peg-IFN (90 microgram in spite of standard dose of 180 microgram) and standard dose of entecavir (0.5 mg) for reduced duration of 24 weeks (Case of group). There were two control groups that adhered to inclusion and exclusion criteria. Patients of Control group-1 (n=50) received regular doses (180 microgram) of Peg-IFN, once weekly for 48 consecutive weeks. Patients of Control group-2 (n=50) were treated with regular does of entecavir (0.5 mg, daily) for 48 weeks. Results: The treatment regimens were safe for all patients. At the end of therapy (EOT), hepatitis B virus DNA negativity (HBV DNA <250 copies/mL) was found in 67%, 50% and 80% of patients of Control Group-1, Control group-2, and case group, respectively. HBV DNA negativity was found in more patients in cases (89% from 67%) 24 weeks after EOT. However, it declined in patients of Control group-1 (80% to 56%) and remained almost similar in Control group-2 (50% versus 56%). There was no significant difference in alanine transaminase (ALT) negativity and hepatitis E antigen (HBeAg) seronegativity among 3 groups at EOT and 24 weeks after EOT. Conclusion: A patient-friendlytherapeutic strategy with reduced dose of Peg-IFN and regular dose of entecavir for shortened duration for CHB patientshave been documented and it would be also cheap for usage of patients with CHB.

scholarly journals Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B

2020 ◽  
Author(s):  
Yi-Wen Huang ◽  
Chao-Wei Hsu ◽  
Sheng-Nan Lu ◽  
Ming-Lung Yu ◽  
Chien-Wei Su ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon ◽  
Preliminary Evaluation ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8–14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B. Methods Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24). Results The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log10 S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%). Conclusion In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B. Graphic abstract

scholarly journals EFFICACY AND SAFETY OF OZONE THERAPY FOR PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER, RANDOMIZED CLINICAL TRIAL

2018 ◽  
Vol 2 (2) ◽  
Author(s):  
Hong Yu ◽  
Pingyan Chen ◽  
Jilin Chen ◽  
Wei Dai ◽  
Zhimin Wu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Virologic Response ◽  
Hbv Dna ◽  
Ozone Therapy ◽  
Group 2 ◽  
Medical Ozone ◽  
Group 1

Background: Ozone therapy has a long history. Some studies proved that ozone therapy was useful in treatment of virus hepatitis.Objective: To evaluate the efficacy and safety of new medical ozone therapy system for the treatment of chronic hepatitis B.Method One hundred eighty-nine patients with chronic hepatitis B were included in this open-label, phase 3 study, and randomly assigned to receive ozone autohemotherapy with experimental ozone generator TianYi (group 1) or with ozone generator Humares (group 2) or oral diammonium glycyrrhizinate capsules (group 3) in a 1:1:1 ratio for 12 weeks. The primary efficacy end point was sera HBV DNA level of less than 1×103 IU/ml or having a more than 2 log10 reduction in HBV DNA level at the end of 12 weeks treatment as compared to baseline HBV DNA level. Secondary end points included HBeAg seroconversion, biochemical response, and combined response.Results At the end of 12 weeks treatment, the proportion of patients reached the primary end point of virologic response in group 1, group 2, and group 3 were 22.4% (13/58, 95% CI, 12.5 to 35.3), 14.7 (9/61, 95% CI, 7.0 to 26.2) and 3.9% (2/51, 95% CI, 0.5 to 13.5), respectively (p=0.021) in the pre-protocol population. Virologic response occurred in more patients receiving ozone therapy with experimental device than patients receiving oral diammonium glycyrrhizinate capsules (mean difference 18.5%, 95% CI 6.3 to 31.5, p=0.005). However, there was no statistical difference in VR12 rates between the treatment of medical ozone therapy system with experimental device (group 1) and with Humares (group 2) (mean difference 7.7%, 95% CI -6.5 to 22.0, p=0.282). More HBeAg seroconversion in patients treated by Tianyi ozone therapy system than those treated by Humares ozone therapy device and oral diammonium glycyrrhizinate capsules (14.8%, 5.1% and 7.3%, respectively, P = 0.272). Higher biochemical response rate was observes in patients receiving ozone therapy than oral diammonium glycyrrhizinate capsules (31.6%, 36.7% and 24.0%, respectively, p = 0.359). The safety profile was similar for the three treatment groups and adverse events were .scare infrequent and mild.Conclusions: Ozone therapy had superior antiviral efficacy with a similar safety profile as compared with oral diammonium glycyrrhizinate capsules through week 12 treatment. Ozone therapy is also associated with normalized ALT and AST levels, demonstrating that ozone therapy could benefit the patients with chronic hepatitis B.

scholarly journals Lingmao Formula Combined with Entecavir for HBeAg-Positive Chronic Hepatitis B Patients with Mildly Elevated Alanine Aminotransferase: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Xiao-Jun Zhu ◽  
Xue-Hua Sun ◽  
Zheng-Hua Zhou ◽  
Shun-Qing Liu ◽  
Hua Lv ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Treatment Group ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Alanine Aminotransferase ◽  
Hbv Dna ◽  
Control Group ◽  
Hbeag Loss ◽  
Histological Improvement ◽  
Positive Chronic Hepatitis

Objective. To determine the efficacy and safety of Lingmao Formula combined with entecavir for HBeAg-positive chronic hepatitis B patients with mildly elevated alanine aminotransferase (ALT).Methods. 301 patients were randomly assigned to receive Lingmao Formula combined with entecavir (treatment group) or placebo combined with entecavir (control group) for 52 weeks. The outcomes of interest included the reduction of serum HBV DNA level, HBeAg loss, HBeAg seroconversion, ALT normalization, and histological improvement.Results. The mean decrease of serum HBV DNA level from baseline and the percentage of patients who had reduction in serum HBV DNA level ≥2 lg copies/mL in treatment group were significantly greater than that in control group (5.5 versus 5.4 lg copies/mL,P=0.010; 98.5% versus 92.6%,P=0.019). The percentage of HBeAg loss in treatment group was 22.8%, which was much higher than a percentage of 12.6% in control group (P=0.038). There was no significant difference between the two groups in histological improvement. Safety was similar in the two groups.Conclusions. The combination of Lingmao Formula with entecavir could result in significant decrease of serum HBV DNA and increase of HBeAg loss for HBeAg-positive chronic hepatitis B patients with mildly elevated ALT without any serious adverse events. Clinical trial registration number isChiCTR-TRC-09000594.

scholarly journals Genome-wide Association Study Identifies Genetic Variants Associated With Early and Sustained Response to (Pegylated) Interferon in Chronic Hepatitis B Patients: The GIANT-B Study

2019 ◽  
Vol 69 (11) ◽  
pp. 1969-1979
Author(s):  
Willem P Brouwer ◽  
Henry L Y Chan ◽  
Pietro Lampertico ◽  
Jinlin Hou ◽  
Pisit Tangkijvanich ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Association Study ◽  
Chronic Hepatitis B ◽  
Genetic Variants ◽  
Genome Wide Association Study ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Genome Wide Association ◽  
Genome Wide

AbstractBackground(Pegylated) Interferon ([Peg]IFN) therapy leads to response in a minority of chronic hepatitis B (CHB) patients. Host genetic determinants of response are therefore in demand.MethodsIn this genome-wide association study (GWAS), CHB patients, treated with (Peg)IFN for at least 12 weeks ± nucleos(t)ide analogues within randomized trials or as standard of care, were recruited at 21 centers from Europe, Asia, and North America. Response at 24 weeks after (Peg)IFN treatment was defined as combined hepatitis B e antigen (HBeAg) loss with hepatitis B virus (HBV) DNA <2000 IU/mL, or an HBV DNA <2000 IU/mL for HBeAg-negative patients.ResultsOf 1144 patients, 1058 (92%) patients were included in the GWAS analysis. In total, 282 (31%) patients achieved the response and 4% hepatitis B surface antigen (HBsAg) loss. GWAS analysis stratified by HBeAg status, adjusted for age, sex, and the 4 ancestry components identified PRELID2 rs371991 (B= −0.74, standard error [SE] = 0.16, P = 3.44 ×10–6) for HBeAg-positive patients. Importantly, PRELID2 was cross-validated for long-term response in HBeAg-negative patients. G3BP2 rs3821977 (B = 1.13, SE = 0.24, P = 2.46 × 10–6) was associated with response in HBeAg-negative patients. G3BP2 has a role in the interferon pathway and was further examined in peripheral blood mononuclear cells of healthy controls stimulated with IFNα and TLR8. After stimulation, less production of IP-10 and interleukin (IL)-10 proteins and more production of IL-8 were observed with the G3BP2 G-allele.ConclusionsAlthough no genome-wide significant hits were found, the current GWAS identified genetic variants associated with (Peg)IFN response in CHB. The current findings could pave the way for gene polymorphism-guided clinical counseling, both in the setting of (Peg)IFN and the natural history, and possibly for new immune-modulating therapies.Clinical Trials RegistationNCT01401400.

scholarly journals Inhibition of Corneal Neovascularization by Topical and Subconjunctival Tigecycline

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Sertan Goktas ◽  
Ender Erdogan ◽  
Rabia Sakarya ◽  
Yasar Sakarya ◽  
Mustafa Yılmaz ◽  
...  
Keyword(s):  
Topical Administration ◽  
Corneal Neovascularization ◽  
Control Group ◽  
Therapeutic Effects ◽  
Control Groups ◽  
Group 4 ◽  
Percentage Area ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective. To investigate the effects of topical and subconjunctival tigecycline on the prevention of corneal neovascularization.Materials and Methods. Following chemical burn, thirty-two rats were treated daily with topical instillation of 1 mg/mL tigecycline (group 1) or subconjunctival instillation of 1 mg/mL tigecycline (group 3) for 7 days. Control rats received topical (group 2) or subconjunctival (group 4) 0.9% saline. Digital photographs of the cornea were taken on the eighth day after treatment and analyzed to determine the percentage area of the cornea covered by neovascularization. Corneal sections were analyzed histopathologically.Results. The median percentages of corneal neovascularization in groups 1 and 3 were 48% (95% confidence interval (CI), 44.2–55.8%) and 33.5% (95% CI, 26.6–39.2%), respectively. The median percentages of corneal neovascularization of groups 1 and 3 were significantly lower than that of the control group (P=0.03andP<0.001, resp.). Histologic examination of samples from groups 1 and 3 showed lower vascularity than that of control groups.Conclusion. Topical and subconjunctival administration of tigecycline seems to be showing promising therapeutic effects on the prevention of corneal neovascularization. Furthermore, subconjunctival administration of tigecycline is more potent than topical administration in the inhibition of corneal neovascularization.

Cytomorphometric and Morphological Analysis in Women with Trichomonas vaginalis Infection: Micronucleus Frequency in Exfoliated Cervical Epithelial Cells

2015 ◽  
Vol 59 (3) ◽  
pp. 258-264 ◽  
Author(s):  
Zehra Safi Oz ◽  
Banu Doğan Gun ◽  
Mustafa Ozkan Gun ◽  
Sukru Oguz Ozdamar
Keyword(s):  
Epithelial Cells ◽  
Trichomonas Vaginalis ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
The Mean ◽  
The Difference ◽  
Group 2 ◽  
And Control ◽  
Group 1

Objectives: The aim of this study was to explore the cytomorphometric and morphological effects of Trichomonas vaginalis in exfoliated epithelial cells. Study Design: Ninety-six Pap-stained cervical smears were divided into a study group and two control groups as follows: T. vaginalis cases, a first control group with inflammation, and a second control group without inflammation. Micronucleated, binucleated, karyorrhectic, karyolytic, and karyopyknotic cells and cells with perinuclear halos per 1,000 epithelial cells were counted. Nuclear and cellular areas were evaluated in 70 clearly defined cells in each smear using image analysis. Results: The frequencies of morphological parameters in the T. vaginalis cases were higher than the values of the two control groups, and the difference among groups was found to be significant (p < 0.05). The nuclear and cytoplasmic areas of epithelial cells were diminished in patients with trichomoniasis. The mean nucleus/cytoplasm ratio in T. vaginalis patients was higher than the value in the control groups, and the difference between the study group and control group 1 was significant. However, there was no statistically significant increase between the study group and control group 2. Conclusions:T. vaginalis exhibited significant changes in the cellular size and nuclear structure of the cells. The rising frequency of micronuclei, nuclear abnormalities, and changing nucleus/cytoplasm ratio may reflect genotoxic damage in trichomoniasis.

scholarly journals Prior Exposure to Lamivudine Increases Entecavir Resistance Risk in Chronic Hepatitis B Patients without Detectable Lamivudine Resistance

2014 ◽  
Vol 58 (3) ◽  
pp. 1730-1737 ◽  
Author(s):  
Jeong-Hoon Lee ◽  
Yuri Cho ◽  
Dong Hyeon Lee ◽  
Minjong Lee ◽  
Jeong-ju Yoo ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Tertiary Hospital ◽  
Lamivudine Resistance ◽  
Genotypic Resistance ◽  
Resistance Risk ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

ABSTRACTThe efficacy of entecavir (ETV) treatment in chronic hepatitis B (CHB) patients who were exposed to lamivudine (LAM) but had no detectable LAM resistance (LAM-R) is not well evaluated. In this study, we aimed to evaluate whether the probability of developing genotypic resistance to ETV in LAM-exposed patients with or without LAM-R is comparable to that in antiviral-naive patients. This retrospective cohort study included 500 consecutive patients with CHB who started ETV monotherapy at a single tertiary hospital in Korea. The patients were divided into three groups: nucleos(t)ide analogue (NA)-naive patients (group 1,n= 142), patients who were previously exposed to LAM and had no currently or previously detected LAM-R (group 2,n= 233), and patients with LAM-R when starting ETV (group 3,n= 125). The overall median ETV treatment duration was 48.7 months. The probabilities of virologic breakthrough were significantly increased not only in group 3 (hazard ratio [HR] = 14.4,P< 0.001) but also in group 2 (HR = 5.0,P< 0.001) compared to group 1. Genotypic ETV resistance (ETV-R) developed more frequently in group 2 (HR = 13.0,P= 0.013) as well as group 3 (HR = 43.9,P< 0.001) than in group 1: the probabilities of developing ETV-R in groups 1, 2, and 3 were <1.0%, 8.0%, and 28.2%, respectively, at month 48. The results of this study indicate that ETV-R occurred more frequently in LAM-exposed patients, even though they had no detectable LAM-R, than in NA-naive patients. Therefore, LAM-exposed CHB patients, regardless of the presence or absence of LAM-R, should be monitored more cautiously for the development of ETV-R during ETV monotherapy.

scholarly journals Serum miR-192-5p Levels Predict the Efficacy of Pegylated Interferon Therapy for Chronic Hepatitis B

2021 ◽  
Author(s):  
Yoshihito Nagura ◽  
Kentaro Matsuura ◽  
Etsuko Iio ◽  
Koji Fujita ◽  
Takako Inoue ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hepatitis B Surface Antigen ◽  
Multivariate Logistic Regression Analysis ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Multivariate Logistic Regression ◽  
Hepatitis B E Antigen ◽  
End Of Treatment

Abstract We examined the association between serum miRNA (-192-5p, -122-3p, -320a and − 6126-5p) levels and the efficacy of pegylated interferon (Peg-IFN) monotherapy for chronic hepatitis B (CHB) patients. We enrolled 61 CHB patients treated with Peg-IFNα-2a weekly for 48 weeks, of whom 12 had a virological response (VR) and 49 did not VR (non-VR). A VR was defined as HBV DNA < 2,000 IU/ml, hepatitis B e antigen (HBeAg)-negative, and nucleos(t)ide analogue free at 48 weeks after the end of treatment. The non-VR group showed a significantly higher HBeAg-positivity rate, ALT, HBV DNA, and serum miR-192-5p levels at baseline (P = 0.024, P = 0.020, P = 0.007, P = 0.021, respectively). Serum miR-192-5p levels at 24 weeks after the start of treatment were also significantly higher in the non-VR than the VR group (P = 0.011). Multivariate logistic regression analysis for predicting VR showed that miR-192-5p level at baseline was an independent factor. Serum miR-192-5p levels were significantly correlated with the levels of HBV DNA, hepatitis B core-related antigen, and hepatitis B surface antigen (r = 0.484, 0.384 and 0.759, respectively). The serum miR-192-5p level was useful as a biomarker for the therapeutic efficacy of Peg-IFN in CHB treatment.

scholarly journals The Value of Serum Adiponectin in Patients with Polycystic Ovary Syndrome

2021 ◽  
pp. 186-197
Author(s):  
Hagar Abd Elrahman Deghaidy ◽  
Mona Khalid Omar Amira Youssef Ahmed ◽  
Elsayed Fetouh Rakha
Keyword(s):  
Polycystic Ovary ◽  
Serum Adiponectin ◽  
Control Group ◽  
Control Groups ◽  
Ovary Syndrome ◽  
Group 4 ◽  
Group 3 ◽  
Obese Control ◽  
Group 2 ◽  
Group 1

Background: Polycystic ovary syndrome (PCOS) is a common condition in women at reproductive age associated with reproductive and metabolic dysfunction. It may be the most common cause of anovulation, early pregnancy loss, and later pregnancy complications. Adiponectin is the most abundant adipokine and is mainly secreted from visceral fat cells. It might be responsible for the metabolic and neuroendocrine derangements characteristic of obesity and obesity-related disease, such as PCOS. We aimed to evaluate the level of serum adiponectin in PCOS and the potential use of adiponectin as a biomarker for PCOS. Methods: This case control study was carried on 100 patients, aged between 20–35 years, who were equally divided into four groups based on the diagnosis of PCOS; 2 case groups and 2 control groups. Group 1 were non-obese PCOS subjects with body mass index (BMI) <25 kg/m2. Group 2 were obese PCOS subjects with BMI >25 kg/m2. Control groups were selected as; group 3 were non-obese control group with BMI <25 kg/m2. Group 4 were obese control group with BMI >25 kg/m2. Results: Adiponectin was significantly lower in group 1 than group 3 and 4 (P2 and P3 <0.001). While it was significantly lower in group 2 than group 1, 3 and 4 and was significantly lower in group 4 than group 3 (P1 = 0.021, P4 and P5 <0.001). Conclusion: Serum adiponectin level may be taken into consideration as a biomarker for confirmation of PCOS diagnosis. The relationship between adiponectin and BMI suggests that adiponectin could serve as a marker for disease risk and provide opportunity for earlier intervention.

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