Quantitative HBV-DNA Research Articles

Evaluation of impact of occult hepatitis B infection in chronic HCV-infected patients: A retrospective cohort study

CONTEXT:Occult hepatitis B infection (OBI) may contribute to liver damage and variable therapeutic response in patients with chronic hepatitis C (CHC) infection.AIMS:To study the prevalence of OBI and to evaluate its impact and/or that of anti-HBc total seropositivity on clinical outcomes and response to directly acting antiviral (DAA) therapy in CHC-infected patients.SETTINGS AND DESIGN:A retrospective cohort study was conducted in a tertiary care liver hospital from January to May 2017.SUBJECTS AND METHODS:Eighty HBsAg-negative CHC patients who were initiated on DAA therapy were retrospectively included. Archived pretreatment baseline plasma samples were retrieved and tested for quantitative HBV DNA, anti-HBs, and anti-HBc total antibodies. HCV RNA, genotype, clinical, biochemical and histopathological parameters & treatment response data were obtained from the hospital information system.STATISTICAL ANALYSIS USED:Comparison of continuous variables was done by Mann–Whitney and Kruskal–Wallis tests and categorical variables by Fisher's exact test or Pearson's Chi-square test.RESULTS:Prevalence of OBI was 1.25%. Anti-HBc total positivity was seen in 25% patients. Based on anti-HBc total status, patients were categorized into two groups namely Group 1 (anti-HBc positive) and Group 2 (anti-HBc negative). Group 1 patients were further categorized into three subgroups based on signal/cutoff (S/Co) of HBc total antibody semi-quantitative values. HBc total antibody levels did not influence the severity of CHC disease. Comparative evaluation of parameters such as median log10 baseline RNA (P = 0.929 and 0.464), median alanine aminotransferase (ALT 0) (P = 0.519 and 0.449), ALT at 12 weeks (P = 0.875 and 0.594), sustained virological response (SVR) at 12 weeks (P = 0.405 and 0.263) and SVR at 24 weeks (P = 0.265 and 0.625) between Groups 1 and 2 and among three categories within Group 1, respectively, were not found to be statistically significant.CONCLUSIONS:Very low prevalence of OBI was seen in CHC patients. HBc total antibody levels did not influence clinical outcome and response to DAA therapy in this cohort.

Monitoring by high-sensitivity HBV DNA assay during treatment in chronic hepatitis B e antigen negative patients

Objective: To explore the efficacy of tenofovir disoproxil and adefovir dipivoxil treatment in patients with hepatitis B virus e antigen (HBeAg) negative was analyzed through the comparison of highly sensitive HBV viral load monitoring with HBV genotyping and drug resistance mutations. Methods: The clinical data of newly diagnosed chronic hepatitis B patients from January 2015 to June 2017 in outpatients and inpatients were randomly divided into tenofovir and adefovir group. Quantitative detection of HBV DNA levels before therapy and at 12, 24, 48, 96, and 120 weeks after therapy were determined for HBV genotypes and drug-resistant mutations in HBeAg-negative patients. Student's t-test was used to compare the measurement data between groups. The data of comparison between groups were tested by χ (2). Results: A total of 106 cases of HBeAg-negative patients were collected. Tenofovir disoproxil had a higher rate of HBV DNA suppression (54%) than adefovir dipivoxil treatment (42%), but the difference was not statistically significant (P = 0.19). After 120 weeks of treatment, a total of 46 patients (93.9%) were enrolled in the tenofovir disoproxil group with HBV DNA quantitation < 2 000 IU / ml. Adefovir dipivoxil group of patients with HBV DNA < 2 000 IU / ml a total of 40 cases, accounting for 75.5%. The difference between the two groups was statistically significant (P < 0.05). For 49 cases of HBeAg-negative patients, HBV B, C, B and C were mixed before tenofovir dipivoxil treatment, and C1653T, A1762T and G1764A mutation sites were detected in patients with D genotype. Patients C, B, C, B, and C were examined for C1673T, G1896, G1858, G1899A. After treatment, the detection rate of the above mutation sites decreased, but C1653T, C1673T and G1899A were not detected. New mutation sites such as G1915A / C, L180M, M204V, V207I / L, T184A and V173L were detected, Low resistance rate (25%). Conclusion: Tenofovir disoproxil can be recommended as a treatment for HBeAg-negative patients. For HBeAg-negative patients, the choice of high-sensitivity detection of HBV DNA levels, better monitoring of anti-HBV efficacy.

Analysis of intrahepatic total HBV DNA, cccDNA and serum HBsAg level in Chronic Hepatitis B patients with undetectable serum HBV DNA during oral antiviral therapy

This study aimed to investigate the relationship between intrahepatic cccDNA and serum HBsAg in chronic Hepatitis B (CHB) patients with undetectable serum HBV DNA during antiviral therapy. We investigated HBsAg serum levels and their relationship to intrahepatic total cccDNA and HBV DNA in CHB patients with undetectable serum HBV DNA during oral antiviral therapy. Intrahepatic cccDNA and HBV DNA quantitation were performed in the same needle biopsy material, while serum HBsAg, HBeAg and HBV DNA levels were measured in samples drawn on the day of the liver biopsy. A total of 90 patients who had a liver biopsy were enrolled, including 80 patients with CHB and 10 patients with liver cirrhosis (LC). All the CHB patients were divided into HBeAg-positive and HBeAg-negative group. By using real-time PCR detection, we found that intrahepatic cccDNA and HBV DNA levels were higher in CHB patients than those in LC patients (Intrahepatic cccDNA: 6.15±1.19 vs. 6.12±0.36, HBV DNA: 7.26±0.49 vs. 5.59±0.45, both P<0.05). Intrahepatic cccDNA level was positively correlated with serum HBsAg in HBeAg-negative (r=0.66, P=0.02) and lower serum HBeAg (≤50S/CO) CHB patients (r=0.47, P=0.03), but not in higher serum HBeAg (>50S/CO) CHB patients (both P>0.05). In HBeAg negative patients, serum HBsAg level was correlated with intrahepatic total HBV DNA level (r=0.52, P=0.006). However, no relationship between HBsAg level and intrahepatic total HBV DNA level was found in HBeAg positive patients (both P>0.05). Serum HBsAg can be used to predict intrahepatic cccDNA and HBV DNA level in CHB patients with low serum HBeAg statues, especially in HBeAg negative patients.

Effect of indigenous interferon - alpha on Hepatitis B virus deoxyribonucleic acid level in hepatitis b e antigen-positive chronic Hepatitis B patients

&lt;p class="ABS"&gt;&lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Background and Objective:&lt;/span&gt; HBeAg-positive chronic hepatitis B patients have high serum HBV DNA level showing high viral replication. Goal of treatment of hepatitis B is to prevent cirrhosis, hepatic failure and hepatocellular carcinoma by serum alanine transaminase (ALT) normalization, decrease in serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and loss in hepatitis B e antigen (HBeAg). Interferons (IFNs) have antiviral, anti-proliferative, and immunomodulatory effects. IFN-&lt;span class="Symbol_Bold"&gt;α&lt;/span&gt; is effective in suppressing HBV replication and in inducing remission of liver disease. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Materials and Methods:&lt;/span&gt; In this prospective, single treatment arm study, HBeAg-positive chronic hepatitis patients without decompensated liver disease were enrolled to receive indigenous recombinant IFN-&lt;span class="Symbol_Bold"&gt;α&lt;/span&gt; 2b in the dose of 5 MU daily for 6 days a week subcutaneously for 16 weeks. Quantitative HBV-DNA, HBeAg, and hepatitis B surface antigen (HBsAg) were assessed at baseline and at the end of treatment. ALT level assessment was done at baseline and during therapy at week 1, week 2, week 8, week 12, and week 16. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Res&lt;/span&gt;&lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;ults:&lt;/span&gt; Out of 37 patients enrolled in the study, 8 patients (21.62%) did not complete study due to lost to follow-up (3 patients), discontinuation due to adverse event (3 patients), and consent withdrawal (2 patients). Among 29 patients who completed the study, 10 patients (34.48%) had clearance of HBeAg and 1 patient (3.44%) had lost HBsAg after 16 weeks of therapy. Mean ALT level started decreasing after 4 weeks of therapy but did not come to normal range till 16 weeks of therapy. At least 2 log decreases in HBV DNA was observed in 9 (31.03%) patients and at least 1 log decrease in 18 (62.06%) patients. Overall decline in HBV DNA level was observed in 62% patients after 16 weeks of therapy. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Conclusion:&lt;/span&gt; IFN-&lt;span class="Symbol_Bold"&gt;α&lt;/span&gt; treatment does result in HBeAg and HBsAg loss and decreases HBV-DNA levels in chronic hepatitis B patients. Most of adverse events were mild to moderate in intensity. So, interferon-&lt;span class="Symbol_Bold"&gt;α&lt;/span&gt; therapy was well tolerated, safe, and efficacious to treat HBeAg-positive chronic hepatitis B patients without decompensated liver disease.&lt;/p&gt;

Intermittent Pattern of Detection of Hepatitis B Viral DNA After Achieving Undetectable Viral Levels

Introduction: Intermittent detection of hepatitis B viral DNA after suppression to undetectable viral level raises concerns about inadequate viral suppression, viral breakthrough, resistance, or noncompliance. This retrospective review was conducted in order to characterize the frequency and clinical significance of this laboratory finding, which will be referred to as intermittency pattern (IP). Methods: Patients with hepatitis B seen in an outpatient hepatology practice from April 2015 to 2016 who had been treated or were undergoing treatment with oral nucleos(t)ides were included for review. Patients who did not attain viral suppression < 20 IU/ml by PCR amplification for quantitative HBV DNA were excluded. Results: A total of 61 patients with HBV were identified. 10 did not require treatment, another 10 did not achieve viral suppression to < 20 IU/ml. The final study included 41 patients, ranging in age from 33 to 96 years (median 53), 51% female, and HBeAg positive in 27% at time of initiation of therapy. Thirtyeight (93%) were treated with a regimen that included either tenofovir (N=29) or entecavir (N=8) or both (N=1), the remainder were treated with lamivudine or adefovir (N=3). 83% (N=34) reached undetectable viral load, while the remainder had detectable HBV DNA but < 20 IU/ ml at nadir. Of these 34 patients, 50% (N=17) demonstrated IP, with median of 2 occasions of detectable DNA after reaching undetectable level. In all of these cases, viral load was < 20 IU/ml but detectable on PCR. None had concurrent elevation in ALT or symptoms at times of viral detectability. In those with IP, median age was 55 years, 58% were female, HBeAg was present in 23%, 6% had cirrhosis, and median time to reach viral suppression < 20 IU/ml was 2 years. In those without IP (N=17) median age was 52 years, 41% were female, HBeAg was present in 29%, and 17% had cirrhosis. Conclusion: 50% of patients with long term viral suppression demonstrated IP by PCR. There was a slight female predominance and fewer patients with cirrhosis in patients with IP compared to those without. Possible explanations for the IP phenomenon include low level of viral replication fluctuating around the level of detectability in patients whose virus is adequately suppressed by treatment, incomplete medication compliance, and false positivity of the assay. Given that IP was not associated with concurrent elevation of ALT, symptoms, or quantifiable viral level, IP appears to have little clinical significance.

Characterization of the 3rd International Standard for hepatitis B virus surface antigen (HBsAg)

BackgroundHBsAg is the most important marker for laboratory diagnosis of HBV infection. Validation and quality control of HBsAg tests requires International Standards (IS). Recently the 2nd IS was replaced by the 3rd IS. Both IS are made from plasma-derived hepatitis B vaccines, but production and geographical origin are different. ObjectiveCharacterization of the HBsAg in the source material (SM) for the 3rd IS and comparison with the 2nd IS and native HBsAg. Study designThe SM was analyzed using solid-phase immunoassays, quantitative immune electrophoresis, ultracentrifugation, immunoblotting and HBV DNA sequencing. ResultsThe plasma-derived HBsAg of the SM originated from at least two different HBV strains, both of subgenotype (sgt) B4, typical for Vietnam. The HBsAg subtype was heterogeneous with ayw1 and adw2. The HBsAg concentration was 23,700 IU/ml as determined by solid-phase immunoassay; immune electrophoresis calibrated with sgt B2 revealed a concentration of 24,500 IU/ml while calibration with sgt D1 provided lower values. Proteins in the SM are heterogeneous in size containing only traces of preS. The protein subunits are partially cross-linked. ConclusionsThe antigenicity of the 3rd IS is suitable for HBsAg calibration in laboratory tests. In contrast to the 2nd IS, the 3rd IS is representative for a highly endemic region. Similar to the 2nd IS and different from native HBsAg, preS domains are depleted, protein subunits are partially cross-linked and the HBsAg particles are partially aggregated in the 3rd IS. The HBV subgenotype differences between the two IS may lead to variations in different quantitative assays.

Correlation of Quantitative HbsAg with Quantitative HBV DNA in Different Phases of Chronic Hepatitis B (CHB) Patients

Background: Quantitative HBsAg (qHBsAg) level is increasingly recognized as an important marker in the course of HBV infection; however, its role in natural history of disease is still unclear. Aim: To study the baseline serum qHBsAg level and its association with quantitative HBV DNA levels in different phases of Indian chronic hepatitis B (CHB) patients. Materials: We conducted cross-sectional study of consecutive 120 CHB patients (mean age 37 [SD 13] years, 67% males). HBV DNA was measured by RT PCR and serum qHBsAg levels by Abott Architect Assay. Results: 90.8% were HBe-negative patients. Median serum qHBsAg of study cohort was 3.74 log10 IU/mL. Overall correlation between qHBsAg levels and HBV DNA levels was weak (spearmen r= 0.298) and also in HBe-negative patients (r= 0.179). Patient having qHBsAg/HBV DNA ratio > 49.09 have shown good correlation between qHBsAg levels and HBV DNA levels. Conclusion: Quantitative HBsAg level was widely distributed among the different phases of CHB. Serum qHBsAg may not replace serum HBV DNA test in majority of adult CHB population which are mainly in HBe-negative low replicate stage.

Is Quantitative HBsAg Measurement a Reliable Substitute for HBV DNA Quantitation

Is Quantitative HBsAg Measurement a Reliable Substitute for HBV DNA Quantitation

Primary non-Hodgkin’s lymphoma of liver

A 65-year-old male was presented his primary care physician with a two-month history of constipation, upper right abdominal pain and occasional right groin pain. His past medical history included hypertension and hepatitis B from which he had recovered (HBsAg negative). The biochemical analyses revealed alanine transaminase 35 U/L, aspartate transaminase 38 U/L and bilirubin level 26 mmol/L with normal blood count. The result of quantitative HBV DNA revealed an undetectable viral load which is generally lower than 300 copies/mL. Magnetic resonance imaging (MRI) scan of the abdomen showed a mass in the right lobe of the liver with a diameter of 10 cm, located on the right hemiliver (Figure 1A). The tumors markers CA19-9 was 57.3 IU/ mL (normal range <27 IU/mL), carcinoma antigen 15-3 was 29.6 IU/mL (normal range <5 IU/mL), and CA125 was 72.4 IU/mL (normal range <35 IU/mL). Alphafetoprotein and carcinoembryonic antigen were within normal range. Liver biopsy confirmed non-Hodgkin’s lymphoma, staining positive for CD20 lymphocytes.

Effectiveness of hepatitis B virus vaccination program in Egypt: Multicenter national project.

To assess the effectiveness of hepatitis B virus (HBV) vaccination program among fully vaccinated children. A national community based cross-sectional study was carried out in 6 governorates representing Egypt. A total of 3600 children aged from 9 mo to 16 years who were fully vaccinated with HBV vaccine during infancy were recruited. Face to face interviews were carried out and sera were evaluated for hepatitis B surface antigen (HBsAg), anti-HBV core antibodies (total) and quantitative detection of hepatitis B surface antibody using enzyme linked immunoassays techniques. Samples positive to HBsAg/anti-HBV core antibodies were subjected to quantitative HBV-DNA detection by real time polymerase chain reaction with 3.8 IU/L detection limit. Sero-protection was detected among 2059 children (57.2%) with geometric mean titers 75.4 ± 3.6 IU/L compared to 3.1 ± 2.1 IU/L among non-seroprotected children. Multivariate logistic analysis revealed that older age and female gender were the significant predicting variables for having non sero-protective level, with adjusted odds ratio 3.3, 9.1 and 14.2 among children aged 5 to < 10, 10 to < 15 and ≥ 15 years respectively compared to those < 5 years and 1.1 among girls compared to boys with P < 0.01. HBsAg was positive in 0.11% and breakthrough infection was 0.36% and 0.39% depending on positivity of anti-HBc and DNA detection respectively. The prevalence of HBV infection was significantly higher among children aged ≥ 7 years (0.59%) compared to 0.07% among younger children with odds ratio equal to 8.4 (95%CI: 1.1-64.2) and P < 0.01.The prevalence was higher among girls (0.48%) than boys (0.29%) with P > 0.05. The Egyptian compulsory HBV vaccination program provides adequate protection. Occult HBV infection exists among apparently healthy vaccinated children. Adherence to infection control measures is mandatory.

Artificial neural network accurately predicts hepatitis B surface antigen seroclearance.

Background & AimsHepatitis B surface antigen (HBsAg) seroclearance and seroconversion are regarded as favorable outcomes of chronic hepatitis B (CHB). This study aimed to develop artificial neural networks (ANNs) that could accurately predict HBsAg seroclearance or seroconversion on the basis of available serum variables.MethodsData from 203 untreated, HBeAg-negative CHB patients with spontaneous HBsAg seroclearance (63 with HBsAg seroconversion), and 203 age- and sex-matched HBeAg-negative controls were analyzed. ANNs and logistic regression models (LRMs) were built and tested according to HBsAg seroclearance and seroconversion. Predictive accuracy was assessed with area under the receiver operating characteristic curve (AUROC).ResultsSerum quantitative HBsAg (qHBsAg) and HBV DNA levels, qHBsAg and HBV DNA reduction were related to HBsAg seroclearance (P<0.001) and were used for ANN/LRM-HBsAg seroclearance building, whereas, qHBsAg reduction was not associated with ANN-HBsAg seroconversion (P = 0.197) and LRM-HBsAg seroconversion was solely based on qHBsAg (P = 0.01). For HBsAg seroclearance, AUROCs of ANN were 0.96, 0.93 and 0.95 for the training, testing and genotype B subgroups respectively. They were significantly higher than those of LRM, qHBsAg and HBV DNA (all P<0.05). Although the performance of ANN-HBsAg seroconversion (AUROC 0.757) was inferior to that for HBsAg seroclearance, it tended to be better than those of LRM, qHBsAg and HBV DNA.ConclusionsANN identifies spontaneous HBsAg seroclearance in HBeAg-negative CHB patients with better accuracy, on the basis of easily available serum data. More useful predictors for HBsAg seroconversion are still needed to be explored in the future.

New marker for follow up of anti-HBV - retrospective study

Hepatitis related to HBV manifests itself in many forms and can be treated with excellent results in the acute phase whereas, in the chronic phase, only a sustained immunological control (SIC) in time can be achieved. The current gold standard test for therapy is the quantitative HBV DNA which, by itself, does not allow an assessment of the SIC. For the reason we did a retrospective study of 13 patients over a 19 month period during which we simultaneously evaluated both HBV DNA and the new marker: quantitative HbsAg; this test was carried out in house. The relationship that exists between the markers and which could provide the clinician with more information was evaluated in three types: High similarity, Low similarity, No similarity between the performance curves of the two markers probably connected by many types of therapeutic answers: sustained immunological control, low immunological control and no immunological control.

Correlation between Serum Quantitative HBsAG and HBV-DNA Levels with Histological Activity Index and Hepatic HBsAG Expression in Liver Biopsy Specimens of Patients with Treatment Naive Chronic Viral Hepatitis B Infection

Background and objectives: Chronic viral hepatitis B is a leading cause of chronic liver disease in the south-east Asia region. Various surrogate markers have been evaluated for correlation with severity of liver disease, includes aminotransferase levels, HBV surface and envelope antigens and HBV-DNA levels. Qualitative and quantitative estimation of tissue expression of viral antigens have been evaluated for correlation with severity of liver disease only in a few studies till date. The current study aims at assessing the correlation between serological markers and hepatic immuno-histochemical expression of HBsAg with histological activity of the disease in patients with treatment naïve chronic viral hepatitis B infection.

Correlation between Serum Quantitative HBsAG Levels and Quantitative HBV-DNA Levels in Patients with Treatment Naïve Chronic Hepatitis B Virus Infection

Correlation between Serum Quantitative HBsAG Levels and Quantitative HBV-DNA Levels in Patients with Treatment Naïve Chronic Hepatitis B Virus Infection

Correlation between Serum Quantitative HBsAG Levels, Quantitative HBV-DNA Levels, Histological Activity Index and Hepatic HBsAG Expression in Patients with Treatment Naive Chronic Hepatitis B Virus Infection

Background and objectives: To date little is known about the role of HBsAg quantification in HBV infection. The current study aims at assessing the correlation between serum quantitative HBsAg levels, quantitative HBVDNA levels, hepatic immuno-histochemical expression of HBsAg and histological activity of disease in chronic HBV infection.

Entecavir 1 mg versus combined lamivudine/adefovir dipivoxil in chronic HBV Egyptian patients resistant to LAM monotherapy, non-randomised controlled study

Background and study aimsThe development of antiviral-resistant mutations with long-term treatment remains a major concern in the treatment of chronic hepatitis B virus (HBV) infection. The study aimed to compare the therapeutic efficacy of entecavir 1mg versus combined lamivudine/adefovir dipivoxil (Lam/Adv) in chronic HBV patients resistant to lamivudine monotherapy. Patients and methodsThis study included two groups of lamivudine-resistant patients who received lamivudine 100mg for 1–3years. Group 1 was composed of 25 cases (52% HBeAg+ve) who received combined Lam/Adv, and group 2 was composed of 13 patients (30.8% HBeAg+ve) who received entecavir 1mg. Pre-enrolment assessment included biochemical, serological and quantitative HBV-DNA testing as well as HBeAg and hepatitis B envelope antibody (HBeAb) assessment. Evaluation was done at 3, 6, 12, 24 and 36months of treatment by the same parameters. Hepatitis B surface antigen and antibody (HbsAg and HBsAb) were assessed after each year of treatment. ResultsAt the end of 36months of treatment, 16 cases (69%) in group 1 completed the study period, versus 13 (100%) in group 2. Two cases in group 1 underwent HBeAg seroconversion, accompanied by HBV-DNA undetectability, at 6 and 12months, respectively; no cases were seroconverted in group 2. Both treatments achieved improvement in alanine aminotransferase (ALT), bilirubin and alpha-foetoprotein equally at the end of the study. HBV-DNA undetectability was better achieved in group 2 when compared to group 1. HBeAg seroconversion was only achieved in two cases in group 1, whereas no cases lost HBeAg in group 2. None of our cases achieved HbsAg seroconversion or loss at the end of the study period. ConclusionThe entecavir 1-mg monotherapy group achieved better HBV-DNA undetectability starting at 3months of treatment when compared to the Lam/Adv group; however, both lines of treatment showed almost similar results over the rest of the study period. HBeAg seroconversion was only achieved in two cases in the combined Lam/Adv group, whereas no cases lost HBeAg in the other group.

A Case of Drug Hepatopathy which was Suspected of HBV Reactivation during Oral Cancer Therapy

Hepatitis B virus (HBV) reactivation induced by cytotoxic chemotherapy or immunosuppressive therapy is an important issue in carcinoma patients. We report a case of drug hepatopathy in a patient with oral carcinoma which was suspected of HBV reactivation during oral cancer therapy. The patient was a 63-year-old man. He was given a diagnosis of lower gingiva squamous cell carcinoma. He received preoperative chemotherapy with docetaxel and underwent an operation. To prevent postoperative swelling, he was administered steroids. Six days after the operation, blood testing revealed a high AST and ALT. Although we suspected HBV reactivation at first, the quantitative HBV-DNA level was low and the diagnosis was eliminated. With intravenous fluid therapy, AST and ALT gradually decreased and returned to within normal limits. As a result, he was given a diagnosis of drug hepatopathy through the treatment progress. Our findings suggest that attention should be paid to HBV reactivation in an HBV carrier who receives cytotoxic chemotherapy or immunosuppressive therapy.

Into the occult: Strategies for preventing transfusion-transmissible infections

Transfusion services all over the world are constantly trying to improve blood safety and to reduce the residual risk of transfusion-transmissible infections (TTI). Current mandatory tests to detect TTI in India include testing for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies, syphilis, and malaria. Studies from Europe and America suggest that the addition of nucleic acid testing (NAT) will increase the detection rate of the transmissible viral infections, thereby increasing safety of blood transfusion [1–6]. In India, NAT is not mandatory although several major blood banks have already included this in their screening profile. The article by Sodhi et al. [7] in this issue of the Journal highlights this question. Six percent of their 150 patients who had multiple transfusions developed evidence of hepatitis B virus infection, with seven of the nine patients developing clinical viral hepatitis. The authors showed that testing stored serum samples from the blood donor for antihepatitis B core (HBc) antibody and HBV DNA quantitation by realtime polymerase chain reaction (PCR) detected HBV infection in six of the nine donors. HBV DNA was detected in four of them; the two othershaving only IgG anti-HBc. In the other three patients, they concluded that the source of hepatitis B infection was other than the transfusion. The prevalence of HBsAg in healthy blood donors, as reported in their paper was 0.56 %. Sensitivity and specificity of the currently used fourthgeneration enzyme-linked immunosorbent assays are much better than the earlier versions but it is clear that they fail to detect donors in the window period and with occult infections without detectable levels of circulating HBsAg. It has been suggested that the addition of anti-HBc testing may be a cost

Response and seroconversion rates among HBeAg-positive chronic HBV Egyptian patients treated with peginterferon alpha 2a (Pegasys), a single-centre experience

Background and study aimsWe aimed to evaluate the therapeutic efficacy of pegylated interferon alpha-2a 180μg as a treatment for hepatitis B ‘e’ antigen (HBeAg)-positive genotype D chronic hepatitis B patients. Patients and methodsThirty patients attending the outpatient clinic at the National Hepatology and Tropical Medicine Research Institute were treated with peg.interferon alpha-2a (180μg) weekly for a period of 48weeks. Pre-enrolment assessment was performed through biochemical, serological and quantitative HBV DNA testing. Liver biopsy was performed in all patients. Evaluation was done at weeks 12, 24 and 48 of treatment by liver enzymes, complete blood count (CBC), HBeAg/HBeAb and quantitative HBV DNA testing. ResultsAt the end of 48weeks of treatment only three cases (10%) of the study population showed HBeAg seroconversion and an undetectable HBV DNA level. None of responders exhibited hepatitis B surface antigen (HbsAg) loss. There were five (16.7%) primary non-responders, four (13.3%) relapsers, four (13.3%) cases flared at week 12, and 14 (46.6%) cases who were non-responders. No specific predictors of response could be identified among patients. ConclusionOne year of peg. interferon alpha-2a 180μg weekly led to HBeAg seroconversion and an undetectable HBV DNA level in 10% of cases. Considering the privilege of a finite duration of treatment, tailoring of treatment and proper patient selection is of great importance in considering this therapy as a first line of treatment among HBeAg-positive chronic HBV Egyptian patients.

The relationship between serum HBsAg levels and liver inflammation and fibrosis in patients with chronic hepatitis B

To investigate the relation of hepatitis B surface antigen (HBsAg) level with chronic hepatitis B (CHB) and liver inflammation and fibrosis. A total of 301 patients who diagnosed CHB and underwent liver biopsy were enrolled into the study. Meantimes, the biochemical markers, ferritin (FERR), serum HBsAg and HBV DNA quantitation were detected. The relation between HBsAg level and liver pathology were determined by spearman rank correlation analysis. The receiver operating characteristic curve was used to evaluate the accuracy of HBsAg level for liver inflammation and fibrosis. The body mass index (BMI), age, gender, genotype and family history had no effective on liver inflammation and fibrosis (P < 0.05). With the progressing of inflammation and fibrosis, the serum AST and ALT raise obviously (chi2 = 71.193, 96.344, 47.847, 63.981; P = 0.000, 0.000, 0.000, 0.000). When fibrosis reached to S4, the level of HBV DNA decreased obviously (chi2 = 33. 322; P = 0.000). With the aggravation of inflammation and fibrosis, the serum HBsAg gradually descended (chi2 = 68.173,15.719; P = 0.000, 0.000). The areas under operating characteristics curves of HBsAg predicted < or = G3 and < or = S3 were 0.732 and 0.793, and the specificity were 0.778, 0.891, and sensitivity were 0.685, and 0.633, respectively. The level of HBsAg of Chinese CHB patients descended gradually with the aggravation of liver inflammation and fibrosis. The serum HBsAg had a higher specificity to predict < or = G3 and < or = S3 of CHB patients. But there had superiority of predicting fibrosis than inflammation.