A long-term multicenter study: Entecavir versus Tenofovir in treatment of nucleos(t)ide analogue-naive chronic hepatitis B patients.

BACKGROUND: Entecavir (ETV) and tenofovir disoproxil fumarat (TDF) are the two first-line therapies recommended in the treatment of chronic hepatitis B because of having potent antiviral effect and high genetic barriers against resistance. We aimed to compare efficacy of these drugs and to evaluate predictors of viral suppression. METHODS: This multicenter retrospective study was conducted in nucleos(t)ide analogue-naive chronic hepatitis B (CHB) patients from different 6 centers. RESULTS: Of the 252 patients, 166 received ETV and 86 TDF. The two groups were similar in terms of age, gender, baseline ALT levels and fibrosis scores. ETV had significantly higher baseline HBV DNA, histological activity index and lower hepatitis B early antigen (HBeAg) seropositivity. Treatment duration was longer in ETV group (P<0.001). In univariate analysis, undetectable HBV DNA and ALT normalization rates were detected significantly higher in ETV groups (P<0.001 and 0.049, respectively). There was no significant difference between groups in terms of HBeAg seroconversion, virological breakthrough, time to virological breakthrough and time to ALT normalization. Entecavir was more effective in reducing HBV DNA levels at the 3rd, 6th and 12th months of the treatment (P=0.06, 0.021 and 0.012, respectively). However, multivariate Cox regression analysis indicated that TDF therapy compared to ETV had an increased probability of achieving complete viral suppression (HR=1, 66; 95% CI 1.21-2.33; P=0.010). Hepatitis B surface antigen (HBsAg) seroconversion was occurred in only one patient in ETV group. CONCLUSION: ETV leads to an early response on HBV DNA decline in the first year of the treatment. However, TDF is more successful than entecavir in achieving virological suppression.

Quality of life and related factors among chronic hepatitis B-infected patients: a multi-center study, Turkey.

BACKGROUND: The aim of this study was to assess health-related quality of life (HRQOL) among chronic hepatitis B (CHB) patients in Turkey and to study related factors. METHODS: This multicenter study was carried out between January 01 and April 15, 2015 in Turkey in 57 centers. Adults were enrolled and studied in three groups. Group 1: Inactive HBsAg carriers, Group 2: CHB patients receiving antiviral therapy, Group 3: CHB patients who were neither receiving antiviral therapy nor were inactive HBsAg carriers. Study data was collected by face-to-face interviews using a standardized questionnaire, Short Form-36 (SF-36) and Hepatitis B Quality of Life (HBQOL). Values equivalent to p < 0.05 in analyses were accepted as statistically significant. RESULTS: Four thousand two hundred fifty-seven patients with CHB were included in the study. Two thousand five hundred fifty-nine (60.1 %) of the patients were males. Groups 1, 2 and 3, consisted of 1529 (35.9 %), 1721 (40.4 %) and 1007 (23.7 %) patients, respectively. The highest value of HRQOL was found in inactive HBsAg carriers. We found that total HBQOL score increased when antiviral treatment was used. However, HRQOL of CHB patients varied according to their socio-demographic properties. Regarding total HBQOL score, a higher significant level of HRQOL was determined in inactive HBV patients when matched controls with the associated factors were provided. CONCLUSIONS: The HRQOL score of CHB patients was higher than expected and it can be worsen when the disease becomes active. Use of an antiviral therapy can contribute to increasing HRQOL of patients.

Comparison of adefovir dipivoxil and pegylated interferon alpha-2a treatment in chronic hepatitis B patients.

OBJECTIVE: In this study, we aimed to evaluate the efficacy of pegylated interferon alpha 2a and adefovir dipivoxil treatment in chronic hepatitis B patients. METHODS: This study was performed on patients treated for chronic hepatitis B in the Infectious Disease Clinic of Eskisehir Osmangazi University between 01.09.2005 and 31.03.2008. A total of 30 patients aged between 18 and 65 years constituted the study group. One of patient groups received (10 HBeAg negative, 4 HBeAg positive) PEG-IFN alpha 2a at a dose of 180 µg/once a week, whereas the other group (11 HBeAg negative, 5 HBeAg positive) received daily oral doses of 10 mg ADV. Treatment responses were evaluated at week 48. RESULTS: Reductions in serum HBV DNA levels at the end of 48 weeks were 4.8 log10 copy/ml and 4.2 log10 copy/ml in HBeAg negative patients who received ADV or PEG-IFN alpha 2a, respectively. Biochemical response rates were 60% and 91% in PEG-IFN alpha 2a and ADV groups, respectively. Among HBeAg positive patients, reductions in serum HBV DNA levels were 3. 2 log10 copy/ml and 4 log10 copy/ml in ADV and PEG-IFN alpha 2a groups, at week 48, respectively. Biochemical response rates were 50% and 40% in PEG-IFN alpha 2a and ADV groups, respectively. No significant difference was determined in biochemical and virological responses in HBeAg positive and negative patients between PEG-IFN alpha 2a and ADV groups, at week 48. When both treatment groups were evaluated for side effects, it was observed that side effects were significantly common in PEG-IFN alpha 2a group. CONCLUSION: When we compared PEG-IFN alpha 2a and ADV treatment in both HBeAg positive and negative patients, biochemical and virological response rates at 48 weeks were similar.

Several Cytokines and Protein C Levels with the Apache II Scoring System for Evaluation of Patients with Sepsis.

OBJECTIVE: We investigated whether determination IL-6, IL-8, IL-1beta and TNF-alpha at baseline, total protein C (PC) levels at time of admission and 48 hours after initiation could complement the Acute Physiology and Chronic Health Evaluation (APACHE) II scoring system to identify patients with sepsis, severe sepsis or septic shock for clinical outcome. MATERIAL AND METHODS: The study was carried out prospectively. 60 consecutive patients with sepsis, severe sepsis or septic shock were included. Blood samples were obtained at baseline and 48 hours after initiation. Cytokines and PC levels in plasma were measured with an enzyme-linked immunoabsorbent assay (ELISA). APACHE II score was calculated on admission. RESULTS: Baseline IL-6 levels and PC levels 48 hours after initiation were predictive of increased mortality (p=0.016, p=0.044 respectively). Baseline IL-6, IL-8 and TNF-alpha baseline levels correlate with the severity of physiologic insult, as determined by the APACHE II score. However, our multiple logistic regression analysis of these did not reveal any predictive value in combination with the APACHE II score. CONCLUSION: Determination of baseline IL-6 and PC 48 hours after initiation were of predictive value for prognostic evaluation of septic patients, but did not significantly increase predictive power of the APACHE scoring system to identify patients with sepsis for fatal clinical outcome.

[Is pneumatic sample transport system also a carrier for microorganisms?]. / Pnömatik sistem mikroorganizmalar için de tasiyici mi?

The purpose of this study was to evaluate the possible infection and contamination risk of the pneumatic system used in our hospital and to establish essential infection control measures. The study was conducted in a quaternary health care center with 1.000 bed capacity. A total of 614 specimens were taken 2 times weekly from the pneumatic transport system and its carriers at 22 wards, 5 intensive care units, 3 laboratories, 2 blood taking units, and pharmacy. Samples were also obtained from the fingertips of 33 subjects using the system, before and after contact with the carriers. A questionnaire that consisted of 8 questions was applied to 224 subjects who worked in those units, evaluating the degree of compliance to the obligations for the cleaning of the pneumatic system and carriers and their approach in case of visible pollution at the system. Bacterial growth was observed in 15.2% (45/296) of samples in the 1st week and 7.6% (18/238) of the samples in the 2nd week, making a total of 11.8% (63/534) bacterial growth. No growth was detected from the areas where the carriers were placed. Of these 69.8% were coagulase negative staphylococci, 11.1% diphteroids, 7.9% Acinetobacter Iwoffii, 4.8% Staphylococcus aureus, 4.8% Bacillus spp. and 1.6% Enterococcus durans. Acinetobacter baumannii and Aspergillus were detected at two fingertip samples taken before the contact with carriers, while again A. baumannii and Enterobacter cloacae were detected at the samples following contact. Moreover, 31.3% of the subjects noted that they cleaned the carriers only if any visible contamination was present. In addition, 14.3% reported that they have encountered broken or spilled up material in the system for more than 5 times, 10.3% reported that they followed the instructions in case of presence of infected material inside the carriers, 23.7% reported that they always washed their hands after any contact with the carriers, 9.8% noted that they always used gloves during contact with the system. Of the subjects 73.7% declared that they had no information about cleaning and decontamination procedures related to the system. These data revealed that the pneumatic system used in our hospital carried contamination risk and the rules for hygiene and disinfection regarding the pneumatic transport system has to be determined, implemented and checked in order to establish appropriate infection control measures.

[Analysis of the risk factors in nosocomial urinary tract infections and effect of urinary catheter use on distribution of the causative agents]. / Nozokomiyal üriner sistem enfeksiyonlarinda risk faktörlerinin analizi ve üriner kateter kullaniminin etkenlerin dagilimi üzerine etkisi.

Nosocomial urinary tract infections (NUTI) which are usually in the first rank in health care associated infections, significantly influence mortality, morbidity, hospitalization period and cost. In this retrospective study, it was aimed to analyze the risk factors in NUTI and also to investigate the effect of urinary catheter application on the distribution of pathogens in patients with NUTI. The study included 1236 NUTI episodes in 1103 patients (age range: 18-95 years; 641 female, 462 male) between January 2000-December 2006. Diagnosis of NUTI was agreed according to CDC criteria. Asymptomatic UTI (urinary tract infection) and other UTIs were excluded and only symptomatic UTI was evaluated. Of NUTIs, 87.9% (1086/1236) were found to be associated with urinary catheter use. No statistically significant difference by means of age, gender and mean interval between admission date and date of determination of infection was determined between the two patient groups, with and without urinary catheter (p>0.05). However, catheter associated NUTI development was statistically significantly higher in intensive care unit patients than patients in other wards (p<0.001). Respiratory failure, unconsciousness, multiple trauma, surgery, central vascular catheter, tracheostomy, mechanical ventilation and peritoneal dialysis were observed more frequently in patients who developed catheter-associated NUTIs (p<0.001). Escherichia coil was isolated in 23.6%, Candida albicans in 18% and non-albicans Candida spp. in 11% of the NUTI episodes. When all Candida species were taken into consideration, they were the most frequent causative agents of NUTI. C. albicans was the most frequent agent in catheter-associated NUTI and E. coli in non-catheter-associated NUTI, their isolation rates being statistically significant (p=0.007 and p=0.005, respectively). No statistically significant difference was detected in the distribution of the other organisms in the two study groups. These data revealed that in urinary tract infections Candida species have replaced the first rank which was occupied by E. coli previously.

Adverse effects of high-dose interferon-alpha-2a treatment for chronic hepatitis B.

The aim of this study was to assess morbidity and the incidence of adverse effects during interferon (IFN)-alpha-2a treatment of patients with chronic hepatitis B. This prospective study included 48 consecutive patients with chronic hepatitis B who underwent IFN-alpha-2a treatment from January 2003 to August 2005. Adverse effects related to IFN treatment were recorded during this period and for 6 mo after treatment. Adverse effects that led to dose reduction or early discontinuation of IFN treatment were examined. Complete response was reported in 25% of patients. At least 1 adverse effect was documented in 88% of patients. Flu-like symptoms were the most frequently observed adverse effects (88%), and thrombocytopenia (63%), leukopenia (54%), and anemia (23%) were also reported. Bleeding occurred in 2 patients. Other adverse effects included neuropsychiatric signs (21%), alopecia (19%), weight loss (17%), thyroid disorders (19%), menstrual cycle irregularities (8%), skin lesions (8%), and dry cough (4%). Adverse effects that led to dose reduction or early discontinuation of IFN treatment occurred in 19% of patients and included impotence, depression, seizure, thyroid disorders, severe thrombocytopenia, and intestinal bleeding. These effects were found to be unrelated to treatment response. No relationship was detected between patient age, duration of treatment, and adverse effects of IFN. Although IFN-alpha-2a treatment induced various adverse effects in patients with chronic hepatitis B, most of these effects were reversible or could be ameliorated. Adverse effects that led to dose reduction or early discontinuation of IFN treatment were found to be unrelated to complete response.