Evaluation of the seroprevalence and the demographic and clinical findings of fascioliasis patients in the Dicle River Basin in Turkey: a nine-year experience at a university hospital.

OBJECTIVE: Fasciola hepatica and Fasciola gigantica are liver trematodes that cause fascioliasis in humans and animals. In Turkey, the medical importance of fascioliasis has been increasing in humans, and it continues to cause great economic loss in the field of animal husbandry. Therefore, it is important to diagnose fascioliasis quickly and reliably. The aim of this study is to show that the ELISA test is a reliable and specific method for diagnosing fascioliasis both in the early stage and in the acute stage. PATIENTS AND METHODS: In this study, 640 individuals aged 7-75 years who showed one or more symptoms of fascioliasis, such as abdominal pain, fever, weight loss, weakness, fatigue, headache, sweating, nausea, vomiting, allergic urticaria, liver mass, hypereosinophilia, or liver enzyme elevation, were recruited from the Dicle University Research and Application Hospital in southeastern Turkey. Serum and fecal samples were taken from them to investigate if the Fasciola hepatica IgG antibody was present in the serum and if eggs were present in the feces. To detect the IgG antibodies, an enzyme-linked immunosorbent assay (ELISA) kit was used. The stool samples were analyzed for three consecutive days in mini Parasep fecal parasite concentrator tubes using the native-lugol and sedimentation methods. Abdominal ultrasonography and computed tomography were performed in all the patients. RESULTS: Among the subjects of this study, 90 (14%) were positive for fascioliasis, of whom 85 (94.4%) were adults and 5 (5.5%), children; 73 (81.1%) were women and 17 (18.8%), men; 57 (63.3%) lived in the rural areas and 33 (36.6%), in the city center; 90 (14%) were positive for Fasciola hepatica IgG antibodies; (20%) had helminth eggs in their stools; and 85 (94.4%) had a history of eating watercress. CONCLUSIONS: According to the epidemiological classification for fascioliasis by Mas-Coma, the Dicle Basin, which is the setting of this study, is indeed a hyperendemic region. Thus, ELISA is a reliable and specific method of diagnosing fascioliasis, both in the early phase and in the acute phase, when the eggs are no longer seen in the stool.

Comparison of three techniques in bladder stone surgery: Which technique is more effective and safe?

Background: In our study, we aimed to compare the success and complication rates of percutaneous cystolithotripsy (PCCL), transurethral cystolithotripsy (TUCL), and Ho: YAG laser lithotripsy in the surgery of bladder stones that occurred due to various reasons. Patients and Methods: Patients diagnosed with single or multiple bladder stones with long axis larger than 2 cm, resulting for various reasons, were included in ou study. Sizes of the stones, cystolithotripsy and discharge times, catheter removal times, complications observed, and the visual pain scale (VPS) were retrospectively evaluated separately from the surgical techniques implemented for accompanying patients and their data. Results: TUCL (group 1) was implemented in 40, PCCL (group 2) was implemented in 44, and transurethral Ho: YAG laser lithotripsy (group 3) was implemented in 30 of the 121 patients included in the study. The bladder stone long axe group 1 average was 3,7 cm (2,2-5,3), group 2 average was 3,74 cm (2,1-5,1), and group 3 average was 3,7 cm (2,3-4,7). Urethral stricture evolved in two patients who underwent TUCL. A statistically significant difference was observed on behalf of PCCL in terms of operation time. There was significance in the Ho: YAG laser cystolithotripsy group in comparison with VPS scores. No significant differences were found in terms of age, stone size, urethral catheter removal times, and discharge times. The average follow-up time was 6 months. Conclusion: Although all three methods were quite successful in bladder stone surgery, average cystolithotripsy times were significantly low in the PCCL technique. Thinking that the most common cause of bladder stone is BPH, it is stated that the suprapubic inserted tube ease the bladder drainage during transurethral resection of the prostate (TUR-P). In this way, the duration of the most common accompanying surgeries is shortened and performed more safely.

Comparison of success, complication and satisfaction rates of TOT and TVT-O surgical techniques.

Background: Two different surgical techniques "inside-out" and "outside-in" have been described for transobturator tape procedure, one of the most preferred methods for the surgical treatment of stress urinary incontinence in the last ten years. This study aimed to compare the success, complication, and patient satisfaction rates related to both techniques in patients who underwent transobturator tape procedure due to stress urinary incontinence in a 21-month period. Patients and Method: A total of 71 patients including 46 patients who underwent transobturator tape operation with "outside-in" technique and 25 patients who underwent tension-free vaginal tape obturator operation with "inside-out" technique were involved in this study. Patients were evaluated in aspect of postoperative complications, pelvic examination results, stress test results, satisfaction, and quality of life scales. Results: Patients operated with both techniques were similar in terms of age, body mass index 15, and menopausal status. Considering the complication rates, dyspareunia was found to be higher in the group using the inside-out technique (p = 0.002). Operation success rates were similar in the two surgical techniques both in subjective and objective evaluation. In addition, although there were differences between the two groups in terms of patient satisfaction rate and quality of life score, overall satisfaction rates were found to be high. Conclusion: Transobturator tape operation is a procedure that provides high success rates in the treatment of stress urinary incontinence regardless of the used technique. Operation success rates, patient satisfaction rates, and postoperative quality of life scores were found to be almost similar in both surgical techniques.

Serum levels of gamma-glutamyl transpeptidase in relation to HCC human biology and prognosis.

BACKGROUND AND AIM: Hepatocellular carcinoma (HCC) biomarkers are limited, as even the best studied, alpha-fetoprotein (AFP), is elevated in no more than 50% of HCC patients. The aim was to evaluate several serum liver function tests in relation to survival and tumor characteristics in a large cohort of Turkish HCC patients. METHODS: We retrospectively examined the serum levels of gamma glutamyl transpeptidase (GGT) in relation to patient survival. RESULTS: Kaplan-Meier analysis showed that only GGT and albumin amongst liver function tests, were significantly associated with survival. Survival worsened with increase in GGT levels semi-quantitatively. Increase in GGT levels was also found to significantly correlate with an increase in maximum tumor diameter from 4.5 to 7 cm, a 20-fold increase in serum alpha-fetoprotein level, an increase in tumor multifocality from 20 to 54% of patients, and a doubling in percent of patients with portal vein thrombosis (PVT) from 20 to 40%. Serum GGT levels also showed significant survival differences for patients with low AFP levels. A doublet combination of serum GGT with albumin levels was associated with higher hazard ratios in a Cox regression analysis, as compared with single parameter GGT. The combination parameter pair was also prognostically useful in the low-AFP patient subcohort and was associated with significant differences in patient tumor characteristics. CONCLUSIONS: Serum GGT levels and especially combination serum GGT plus albumin levels, were significantly associated both with HCC patient survival and tumor aggressiveness characteristics, regardless of AFP levels in a large Turkish cohort. This might be especially useful since the majority of HCC patients do not have elevated levels of AFP.

Plasma lipids, tumor parameters and survival in HCC patients with HBV and HCV.

INTRODUCTION AND AIMS: Hepatocellular carcinoma (HCC) is a consequence of chronic liver disease, particularly from hepatitis B or C and increasingly from obesity and metabolic syndrome. Since lipids are an important component of cell membranes and are involved in cell signaling and tumor cell growth, we wished to evaluate the relationship between HCC patient plasma lipids and maximum tumor diameter and other indices of HCC human biology. METHODS: We examined prospectively-collected data from a multi-institutional collaborative Turkish HCC working group, from predominantly HBV-based patients, for plasma lipid profiles, consisting of triglycerides, total cholesterol, LDL-cholesterol (LDL) and HDL-cholesterol (HDL) and compared these with the associated patient maximum tumor diameter (MTD), portal vein thrombosis, alpha-fetoprotein (AFP) and also with patient survival. RESULTS: We found that both low HDL (p=0.0002) and high LDL (p=0.003) levels were significantly associated with increased MTD, as well as in a final multiple linear regression model on MTD. The combination of low HDL combined with high HDL levels were significant in a regression model on MTD, PVT and an HCC Aggressiveness Index (Odds Ratio 12.91 compared to an Odds Ratio of 1 for the reference). Furthermore, in a Cox regression model on death, the HDL plus LDL combination had a significantly higher Hazard Ratio than the reference category. CONCLUSIONS: Low plasma HDL, high plasma LDL and especially the combination, were significantly related to more aggressive HCC phenotype and the combination was significantly related to a higher Hazard Ratio for death.

Preliminary report of in vitro and in vivo effectiveness of dornase alfa on SARS-CoV-2 infection.

Dornase alfa, the recombinant form of the human DNase I enzyme, breaks down neutrophil extracellular traps (NET) that include a vast amount of DNA fragments, histones, microbicidal proteins and oxidant enzymes released from necrotic neutrophils in the highly viscous mucus of cystic fibrosis patients. Dornase alfa has been used for decades in patients with cystic fibrosis to reduce the viscoelasticity of respiratory tract secretions, to decrease the severity of respiratory tract infections, and to improve lung function. Previous studies have linked abnormal NET formations to lung diseases, especially to acute respiratory distress syndrome (ARDS). It is well known that novel coronavirus disease 2019 (COVID-19) pneumonia progresses to ARDS and even multiple organ failure. High blood neutrophil levels are an early indicator of COVID-19 and predict severe respiratory diseases. Also it is reported that mucus structure in COVID-19 is very similar to that in cystic fibrosis due to the accumulation of excessive NET in the lungs. In this study, we showed the recovery of three individuals with COVID-19 after including dornase alfa in their treatment. We followed clinical improvement in the radiological analysis (two of three cases), oxygen saturation (Spo2), respiratory rate, disappearance of dyspnoea, coughing and a decrease in NET formation and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load after the treatment. Also here, we share our preliminary results suggesting that dornase alfa has an anti-viral effect against SARS-CoV-2 infection in a green monkey kidney cell line, Vero, and a bovine kidney cell line, MDBK, without determined cytotoxicity on healthy peripheral blood mononuclear cells.

Characteristics of Hepatocellular Carcinoma Aggressiveness Factors in Turkish Patients.

A large cohort of hepatocellular carcinoma (HCC) patients from several collaborating Turkish institutions were examined for the tumor parameters of maximum diameter (MTD), portal vein thrombosis (PVT), and α-fetoprotein (AFP) levels. A relationship was found between MTD and blood platelet levels. Patients with large ≥5 cm tumors who had normal platelet levels had significantly larger tumors, higher percent of PVT, and significantly lower blood total bilirubin and liver cirrhosis than similar ≥5 cm tumor patients having thrombocytopenia. A comparison of patients with and without PVT showed significantly larger tumors, greater multifocality, blood AFP, and C-reactive protein levels, and, interestingly, lower HDL levels in the patients with PVT. Fifty-eight percent of the total cohort had AFP levels ≤100 IU/mL (and 42.1% had values ≤20 IU/mL). These patients had significantly smaller tumors, less tumor multifocality and percent PVT, lower total bilirubin, and less cirrhosis. There was considerable geographic heterogeneity within Turkey in the patterns of HCC presentation, with areas of higher and lower hepatitis B virus, hepatitis D virus, cirrhosis, and tumor aggressiveness parameters. Turkish patients thus have distinct patterns of presentation, but the biological relationships between MTD and both platelets and bilirubin levels are similar to the relationships that have been reported in other ethnic patient groups.

Tumour necrosis factor-alpha, interleukin-10, interferon-gamma and vitamin D receptor gene polymorphisms in patients with chronic hepatitis delta.

No data exist to assess certain polymorphisms that have a potential effect on the immune response in patients with chronic hepatitis delta (CHD). The aim of this study was to investigate polymorphisms in 6 polymorphic sites: IL-10 -1082 (rs1800896), IL-10 -627 (rs1800872), IFN-γ +874 (rs62559044), TNF-α -308 (rs1800629), vitamin D receptor (VDR) FokI (rs2228570) and VDR TaqI (rs731236). The genotypes of 67 patients with CHD and 119 patients with chronic hepatitis B (CHB) were compared. In addition, 56 individuals with resolved hepatitis B virus (HBV) infection were used as a control group for patients with CHB. Polymorphisms in TNF-α, IL-10, and VDR genes were analysed using polymerase chain reaction/restriction fragment length polymorphism methods. The IFN-γ gene polymorphism was detected by allele-specific polymerase chain reaction (PCR). Patients with CDH were more likely to have advanced liver disease compared with patients with CHB (P < 0.0001). IL-10 -1082 and VDR TaqI polymorphisms showed significant differences between patients with CHD and CHB. The high secretory IL-10 -1082 genotype GG was less frequent in CHD compared with patients with CHB and resolved HBV (17.7%, 37.4% and 47.1%, respectively (P < 0.05 for CHD vs CHB and resolved HBV). The frequency of the high secretory VDR TaqI TT genotype was 86.6% in patients with CHD, 62.7% in patients with CHB and 62.5% in resolved HBV individuals (CHD vs CHB: P < 0.05). None of the polymorphisms analysed had an effect on HBV persistence. IL-10 -1082 and VDR TaqI polymorphisms may contribute to the more severe liver disease associated with CHD compared with CHB.

Low vitamin D levels are associated with increased risk for fatty liver disease among non-obese adults.

Recent data have revealed an inverse relationship between insulin resistance, which is associated with fatty liver disease, and blood 25-hydroxy-vitamin D (25(OH)D) levels. The aim of the present study was to determine the association of vitamin D levels with the presence and stage of fatty liver disease among non-obese subjects and to determine the effect of vitamin D status on fatty liver disease development. A total of 613 non-obese (body mass index <30 kg/m(2)) gastroenterology and internal medicine outpatients (472 women and 141 men) were enrolled in the study. The patients' laboratory values, including liver function tests, lipid profiles, C-reactive protein, fasting blood glucose, insulin, calcium and 25(OH)D levels were studied. Low vitamin D levels, higher triglyceride levels and higher alanine aminotransferase levels were found to be the significant determinants for non-alcoholic fatty liver disease. When the patients were evaluated as low or normal vitamin D groups, low vitamin D levels was determined to be a risk factor for fatty liver disease, with an odds ratio of -1.59 (confidence interval -1.22 to -1.97). The increased risk for fatty liver disease among patients with low vitamin D status may be suggestive of mechanisms promoting fat flow and accumulation in the liver. Molecular studies are warranted to elucidate the action of vitamin D on the liver with respect to fat metabolism.

Evaluation of hepatitis B viraemia levels in patients with HBeAg-negative chronic hepatitis B virus infection.

OBJECTIVES: To evaluate patients with chronic hepatitis B virus (HBV) infection and low-level viraemia in terms of determining HBV DNA cut-off values and levels of alanine aminotransferase (ALT) and other possible markers for discriminating between chronic hepatitis B e-antigen (HBeAg)-negative patients and hepatitis B surface antigen (HBsAg) inactive carriers. METHODS: HBV-infected patients who were HBeAg-negative with undetectable HBV DNA by standard hybridization assay and high (HBeAg-negative group, n = 81) or normal (HBsAg inactive carrier group, n = 77) ALT levels were enrolled. Quantitative polymerase chain reaction assay using a COBAS Amplicor HBV monitor test was performed to detect low HBV DNA levels. RESULTS: The HBV DNA level was found to be significantly higher in the HBeAg-negative chronic HBV group (mean ± SD 94,477 ± 167,528 copies/ml) compared with the HBsAg inactive carrier group (mean ± SD 19,215 ± 57,970 copies/ml). CONCLUSIONS: A low level of viral replication may persist in chronic HBV-infected patients who are HBeAg-negative, and the level of HBV DNA was higher in the HBeAg-negative group than in the inactive HBsAg carrier group. Necroinflammation also persisted in the HBeAg-negative group and these patients had a higher level of ALT than the inactive HBsAg carriers.

Role of p53 codon 72 polymorphism in chromosomal aberrations and mitotic index in patients with chronic hepatitis B

Polymorphisms of the p53 gene, which participates in DNA repair, can affect the functioning of the p53 protein. The Arg and Pro variants in p53 codon 72 were shown to have different regulation properties of p53-dependent DNA repair target genes that can affect various levels of cytogenetic aberrations in chronic hepatitis B patients. The present study aimed to examine the frequency of chromosomal aberrations and the mitotic index in patients with chronic hepatitis B and their possible association with p53 gene exon 4 codon 72 Arg72Pro (Ex4+119 G>C; rs1042522) polymorphism. Fifty-eight patients with chronic hepatitis B and 30 healthy individuals were genotyped in terms of the p53 gene codon 72 Arg72Pro polymorphism by PCR-RFLP. A 72-h cell culture was performed on the same individuals and evaluated in terms of chromosomal aberrations and mitotic index. A high frequency of chromosomal aberrations and low mitotic index were detected in the patient group compared to the control group. A higher frequency of chromosomal aberrations was detected in both the patient and the control groups with a homozygous proline genotype (13 patients, 3 control subjects) compared to patients and controls with other genotypes [Arg/Pro (38 patients, 20 control subjects) and Arg/Arg (7 patients, 7 control subjects)]. We observed an increased frequency of cytogenetic aberrations in patients with chronic hepatitis B. In addition, a higher frequency of cytogenetic aberrations was observed in p53 variants having the homozygous proline genotype compared to variants having other genotypes both in patients and healthy individuals.

Role of p53 codon 72 polymorphism in chromosomal aberrations and mitotic index in patients with chronic hepatitis B.

Polymorphisms of the p53 gene, which participates in DNA repair, can affect the functioning of the p53 protein. The Arg and Pro variants in p53 codon 72 were shown to have different regulation properties of p53-dependent DNA repair target genes that can affect various levels of cytogenetic aberrations in chronic hepatitis B patients. The present study aimed to examine the frequency of chromosomal aberrations and the mitotic index in patients with chronic hepatitis B and their possible association with p53 gene exon 4 codon 72 Arg72Pro (Ex4+119 G>C; rs1042522) polymorphism. Fifty-eight patients with chronic hepatitis B and 30 healthy individuals were genotyped in terms of the p53 gene codon 72 Arg72Pro polymorphism by PCR-RFLP. A 72-h cell culture was performed on the same individuals and evaluated in terms of chromosomal aberrations and mitotic index. A high frequency of chromosomal aberrations and low mitotic index were detected in the patient group compared to the control group. A higher frequency of chromosomal aberrations was detected in both the patient and the control groups with a homozygous proline genotype (13 patients, 3 control subjects) compared to patients and controls with other genotypes [Arg/Pro (38 patients, 20 control subjects) and Arg/Arg (7 patients, 7 control subjects)]. We observed an increased frequency of cytogenetic aberrations in patients with chronic hepatitis B. In addition, a higher frequency of cytogenetic aberrations was observed in p53 variants having the homozygous proline genotype compared to variants having other genotypes both in patients and healthy individuals.

Renal function during treatment with adefovir plus peginterferon alfa-2a vs either drug alone in hepatitis B/D co-infection.

Long-term safety of treatment with hepatitis B virus (HBV) polymerase inhibitors is a concern. Adefovir dipivoxil (ADV) therapy has previously been associated with impairment of renal function. Limited data are available on the safety of combination therapy with nucleos(t)ide analogues and interferon alfa (IFNα). The aim of this analysis was to assess the renal function during combination therapy with peginterferon alfa-2a (PegIFNα-2a) plus ADV vs either drug alone in patients with hepatitis B/D co-infection. We performed a retrospective analysis of renal function data of patients treated in the Hep-Net/International Delta Hepatitis Intervention Trial 1(HIDIT-1-trial), a European multicenter study to investigate the efficacy of 48 weeks of therapy with PegIFNα-2a+ADV vs either drug alone in 90 patients with chronic hepatitis B/D co-infection. Glomerular filtration rates (GFR) were calculated by Cockcroft-Gault (CG), abbreviated Modification of Diet in Renal Disease (MDRD) study and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. After 48 weeks of therapy GFR values were significantly lower in patients receiving adefovir-containing treatment vs PegIFNα-2a alone [mean difference 16.1 mL/min (CG) and 10.2 mL/min (MDRD), respectively, P < 0.05] while no differences were observed between patients receiving adefovir alone vs combination treatment. Twenty-four weeks after treatment GFR values did not differ between treatment arms. A decrease in GFR ≥ 20% was observed more often in patients during adefovir-containing treatment vs PegIFNα-2a alone (P < 0.05) which was confirmed by Kaplan-Meier analysis. Adefovir-containing but not PegIFNα-2a treatment was associated with a decrease in GFR values in about one-fifth of patients. Combination treatment of PegIFNα-2a+ADV in chronic hepatitis B/D co-infection did not lead to any further impairment of kidney function.

Treatment of chronic delta hepatitis with lamivudine vs lamivudine + interferon vs interferon.

Chronic delta hepatitis is the most severe form of chronic viral hepatitis for which interferon (IFN) is the only available treatment. In 39 patients (25 were treatment-naïve, 14 had previously used IFN), efficacy of 1-year treatment with IFN (9 MU, t.i.w.) or lamivudine (LAM; 100 mg, q.d.) alone was compared with IFN and LAM combination (2 months of LAM to be followed by combination treatment). IFN monotherapy was given only to treatment-naïve patients. In both treatment-naïve and previous IFN users, end of treatment virological and biochemical responses were similar with IFN-LAM combination and superior to LAM monotherapy (P < 0.05). Improvement in liver histology occurred more often with IFN +/- LAM than with LAM alone (P < 0.05). In treatment-naïve patients, combination treatment was not superior to IFN monotherapy. After treatment discontinuation, virological and biochemical response rates decreased in LAM and IFN combination and IFN monotherapy. On treatment virological response at month 6 of treatment predicted sustained virological response. The results of this study suggest that addition of LAM to IFN for the treatment of delta hepatitis is of no additional value and that both treatment modalities are superior to LAM monotherapy.

A pilot study of 2 years of interferon treatment in patients with chronic delta hepatitis.

High dose interferon treatment for 1 year is the only established treatment for chronic hepatitis D, but it is associated with a high relapse rate after treatment discontinuation. In this study, patients were treated with 10 MU interferon alpha 2b, thrice weekly for 2 years. Twenty-three patients were recruited and 15 completed the 2-year treatment and 6 months follow-up periods. Treatment response was assessed biochemically [normal alanine aminotransferase (ALT)], virologically (undetectable hepatitis D virus RNA) and histologically (at least 2 point decrease in the Knodell score) at the end of treatment (EOT) and at the end of follow-up. Out of 15 patients who finished the 2-year treatment period, seven patients (47%) had a biochemical response but only two (13%) had a normal ALT after follow-up. ALT decreased from the baseline value of 143.1 +/- 121.7 (mean +/- SD) to 39.7 +/- 20.6 (P < 0.01) at EOT. Virological response was observed in six patients at EOT and in two patients at follow-up. Two patients lost hepatitis B surface antigen. Of the 12 patients with paired liver biopsies, a histological improvement was observed in eight patients. Interferon treatment leads to a complete or partial response in a substantial number of patients but 2 years of treatment does not appear to increase sustained response rates over 1 year treatment.

Hepatitis B virus genotype D prevails in patients with persistently elevated or normal ALT levels in Turkey.

BACKGROUND: The clinical relevance of hepatitis B virus (HBV) genotypes are poorly understood and it is unclear if the prevalence of HBV genotypes differs with the various clinical features of HBV carriers. The aim of our study was to examine the prevalence of the HBV genotype in a group of patients with chronic hepatitis B, compared to a group with chronic inactive hepatitos B surface antigen (HbsAg) carriers. PATIENTS AND METHODS: HBV genotypes were determined in 32 patients with chronic hepatitis B and in 12 chronic inactive HBsAg carriers. 35 males and nine females with a mean age of 33.95 +/- 13.04 were studied. Serum samples were examined for the presence of HBV DNA by polymerase chain reaction (PCR). Samples negative in first round PCR were further amplified with nested PCR. The PCR product was sequenced with the Cy5/5.5 dye primer kit on a Long Read Tower automated DNA sequencer. RESULTS: HBV DNA was detectable in 29 (66%) and 44 (100%) patients by the PCR with universal primers and nested-PCR, respectively. All patients were found to be infected with HBV genotype D. Genotype D was the only detected type found in different clinical forms of chronic HBV infection, in all hepatitis B e antigen (HbeAg)-positive and negative patients, in all patients who had elevated or normal alanine transaminase (ALT) levels and in all ages. CONCLUSION: In the present study we could not find any association between genotype D and distinct clinical phenotypes. Genotype D is the predominant type among hepatitis B carriers residing in our region and is not associated with more severe liver diseases. This genotype did not influence clinical manifestations in carriers with chronic hepatitis B virus infection. However, additional large-scale longitudinal studies are needed to find the relationship of HBV genotypes to liver disease severity and clinical outcomes.

Specific hepatitis B vaccine therapy in inactive HBsAg carriers: a randomized controlled trial.

BACKGROUND: Hepatitis B virus (HBV) vaccine therapy has two major areas of application: for preventive purposes and for treating patients with chronic hepatitis B. This study aimed to investigate the effect of therapeutic vaccination of inactive hepatitis B surface antigen (HbsAg) carriers using a recombinant hepatitis B vaccine in a randomized-controlled study. PATIENTS AND METHODS: The 71 studied patients had never received prior antiviral therapies, were anti-HBe positive, had undetectable HBV-DNA and persistently normal alanine transaminase levels. 31 patients were given three 20 mg intramuscular injections of a preS2/S vaccine (GenHevac-B) on days 0, 30 and 60 and the remaining 40 patients were included in the control group. The efficacy of vaccination was evaluated by testing for HBsAg seroconversion to anti-HBs. Post-vaccination follow-up was for 12 months after the first dose. RESULTS: At the end of the follow-up, three out of 31 patients (10%) who received vaccine therapy were able to clear HBsAg from their sera and concomitantly develop anti-HBs antibodies. In contrast, none of the 40 control patients who did not received vaccine therapy had decreased their levels of HBsAg or elicited anti-HBs antibodies (p = 0.079). In three vaccinated patients serum HBsAg became undetectable approximately by the 3rd month of vaccine therapy and HBsAg seroconversion was seen to be durable in all patients in the follow-up period. CONCLUSION: This study offers the first direct evidence, based on a controlled study, that the recombinant HBV vaccine has no great effect in enhancing the rate of HBsAg seroconversion in inactive HBsAg carriers. More efficient strategies, such as an increase in the dose and number of immunizations, should be evaluated further in large controlled trials.

Horizontal transmission of HBV infection among students in Turkey.

In this study, the HBsAg carrier state and the role of horizontal transmission were investigated among primary and high school students in southeastern Anatolia where HBsAg seropositivity is remarkably high. In total, 350 students from primary school first grade, 350 students from fifth grade, 400 students from high school eleventh grade and 400 healthy adults as a control group were studied. In all cases HBsAg and anti-HBs were screened by ELISA. HBsAg positivity was 2.4% in first grade, 6.1% in fifth and 6.7% in eleventh grade students. Anti-HBs positivity was 14% in first grade, 20% in fifth and 21% in eleventh grade students. HBsAg positivity was 9% and anti-HBs, 49% in the control group. There is a significant difference between first and fifth grade students for HBsAg positivity (2.1% vs 6.1% and P<0.05). This difference decreased during the high school years (6.2% and P>0.05). There is also a similar statistically significant difference for anti-HBs positivity during the primary school years (14% vs 20%, P<0.05). These findings show that the risk of horizontal transmission of HBV is especially important during elementary school years between the ages of 7 and 11 y. All infants or at least elementary school first grade students in Turkey should have HBV vaccinations.