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At one year, telbivudine was superior to other nucleos(t)ide analogues (NAs) in HBeAg seroconversion, among other outcomes, in chronic HBV.
Researchers at Nanfang Hospital, Guangzhou, China, conducted a comprehensive and up-to-date network meta-analysis comparing the efficacy of NAs in patients with chronic HBV. A total of 75 randomised controlled trials (RCTs) were included in the systematic review, which was funded by Novartis.
At one year, telbivudine was associated with significantly higher rates of HBeAg seroconversion than adefovir (odds ratio 1.99), entecavir (odds ratio 2.00) and limivudine (odds ratio 1.49). It was linked to with significantly higher HBeAg loss than entecavir (odds ratio 1.85) and limivudine (odds ratio 1.62), with significantly higher aminotransferase (ALT) normalisation than limivudine (odds ratio 1.50), and with significantly higher rates of HBV DNA suppression than adefovir (odds ratio 2.77) and limivudine (odds ratio 2.97).
At two years, however, the relative efficacy outcomes were not statistically significant.
Effect of telbivudine versus other nucleos(t)ide analogs on HBeAg seroconversion and other outcomes in patients with chronic Hepatitis B: a network meta-analysis. Liang X, Fan R, Sun J et al. Adv Ther. 2016 Feb 26. [Epub ahead of print]
Promoting HBV testing and contact tracing and countering misconceptions of the virus among migrant Somali populations in the UK, should be a priority.
Researchers at the University of Bristol canvassed the views of 30 people with Somali ethnicity living in the area through focus groups and semi-structured interviews.
Most participants lacked awareness of HBV and often identified it with 'jaundice'. There were frequent misconceptions regarding transmission, natural history and diagnosis, with the infection commonly viewed as a relatively trivial, short lived, symptomatic disease. HBV was generally not stigmatised. Lack of understanding of the disease was cited as the major barrier to targeted testing and contact tracing.
Barriers and opportunities for hepatitis B testing and contact tracing in a UK Somali population: a qualitative study. Cochrane A, Collins P, Horwood JP. Eur J Public Health. 2016 Feb 15 [Epub ahead of print]
Both Chinese herbal medicine (CHM) and Western medicine (WM) can lead to drug-induced liver injury (DILI), but with different clinical characteristics, say researchers.
Overall, 1,985 DILI cases were retrospectively collected from 96,857 patients hospitalised because of liver dysfunction in Beijing’s 302 Military Hospital between January 2009 and January 2014.
In the DILI patients, CHM was implicated in 563 cases, 870 cases were caused by WM. In the remaining patients, accounting for 27.8% of the cohort, the combination of WM and CHM was blamed. Polygonum multiflorum was the major implicated CHM.
The cases caused by CHM were more female (51% versus 71%) and positive rechallenge (6.1% versus 8.9%), a much greater proportion of hepatocellular injury (62.2% versus 88.5%), and a higher mortality (2.8% versus 4.8%). However, no differences in the rates of chronic DILI and ALF were found (12.9% versus 12.4%; 7.6% versus 7.6%, respectively).
Based on Roussel Uclaf Causality Assessment Method, 75.6% of cases caused by CHM were classified as probable and only 16.6% as highly probable, significantly different from WM (38.4% and 60.3%).
Comparison between Chinese herbal medicine and western medicine-induced liver injury of 1985 patients. Zhu Y, Niu M, Chen J et al. J Gastroenterol Hepatol. 2016 Feb 20 [Epub ahead of print]
Statins have been associated with a dose-dependent reduction in incident cirrhosis and hepatocellular carcinoma (HCC) among patients with HCV (1).
In the ERCHIVES study, among 9,135 HCV patients, 1,649 developed cirrhosis, and 239 developed incident HCC. Statin use was associated with a 44% reduction in development of cirrhosis (adjusted hazard ratio 0.6). The adjusted hazard ratios of fibrosis progression with statin cumulative defined daily dose (cDDD) 28-89, 89-180, and >180, were 0.74, 0.71, and 0.6 (0.53,0.68), respectively.
Mean change in FIB-4 score with atorvastatin (944) and fluvastatin (34) was -0.17 and -0.13 respectively after adjustment for baseline FIB-4 score and established predictors of cirrhosis. Statin use was also associated with a 49% reduction in incident HCC (adjusted hazard ratio 0.51). A similar dose-response relationship was observed.
However, a US study found statins were used less frequently in patients with HCV compared to those without (2).
In the study of 157 people at W. G. Hefner Veterans Affairs Medical Centre, , a significant difference in statin use was seen between those with and without HCV (54% versus 83%). Although there were a greater number of subjects on statins in the non-HCV group, there was not a significant difference in the proportion of subjects reaching their LDL goal between the two groups.
1) Atorvastatin and fluvastatin are associated with dose-dependent reductions in cirrhosis and HCC, among patients with HCV. Results from ERCHIVES. Simon TG, Bonilla H, Yan P et al. Hepatology. 2016 Feb 18 [Epub ahead of print]
2) Treatment of dyslipidemia with statins by primary care providers in Veterans with and without chronic Hepatitis C. Chandra R, Dolder NM, Dolder CR et al.Am J Health Syst Pharm. 2016 Mar 1;73(5 Suppl 1)
A real time study in the Netherlands found that adherence to ribavirin during PEG-interferon containing therapy in chronic HCV was high.
In this randomized controlled trial at the University Medical Centre of Utrecht, 35 patients (the intervention group) received a medication dispenser that monitored ribavirin intake real-time during 24 weeks of PEG-interferon/ribavirin±boceprevir or telaprevir. Thirty-seven patients in a control group received standard-of-care. Adherence was also measured by pill count.
Median adherence by pill count was 96% with 30 (94%) of patients exhibiting 80% adherence. Perfect adherence (i.e. 100%) was similar in intervention and control groups: 22 (85%) versus 15 (75%). Adherences by real-time medication monitoring and by pill count did not correlate. No predictors of poor adherence could be identified.
Ribavirin trough levels after eight weeks (median: 2.4mg/L versus 2.7mg/L) and 24 weeks (median: 3.0mg/L versus 3.0mg/L), and virological responses did not differ between the intervention and control groups.
Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: results from a randomized controlled trial using real-time medication monitoring. van Vlerken LG, Lieveld FI, van Meer S et al. Clin Res Hepatol Gastroenterol. 2016 Feb 8 [Epub ahead of print]
Adding ezetimibe to pegylated interferon and ribavirin (peg-IFN/RBV) significantly improved early virological response rates in obese chronic HCV patients.
In a study at Al-Azhar University, Cairo, 144 chronic HCV genotype four patients were divided into two groups; group 1 included 76 non-obese patients and group two 68 obese patients. Each group was further sub-classified into equal control and treated groups. The control groups received peg-IFN/RBV combination for 24 weeks, and the treated groups received peg-IFN/RBV plus ezetimibe for 12 weeks and then only peg-IFN/RBV for the remaining 12 weeks
Early virological response significantly improved in the obese patients (85.3% versus 64.7% in the treated and control groups, respectively) without any significant improvement in the non-obese patients. Biochemical responses (defined as normalisation of alanine aminotransferase at week 12) were markedly improved in the treated groups in both the non-obese and obese groups compared with their respective controls.
Coadministration of ezetimibe with pegylated interferon plus ribavirin could improve early virological response in chronic hepatitis C obese Egyptian patients. Helal GK, Gad MA, Abd-Ellah MF et al. Eur J Gastroenterol Hepatol. 2016 Feb 11. [Epub ahead of print]
Two studies have found diabetes, smoking, alcohol and HBV to be among the main risk factors for hepatocellular carcinoma (HCC) and its mortality.
Researchers from the National Taiwan University College of Medicine followed up 51,164 participants. They were aged 44 to 94, did not have chronic HBV or HCV, and were enrolled from nationwide health screening units (1) . Between 1998 and 2008 there were 253 deaths from HCC. A history of diabetes was associated with deaths from HCC for both total participants (adjusted hazard ratio 2.97 ) and ever smokers with current or past smoking habits (hazard ratio 1.92).
Both never smokers (hazard ratio 0.46) and quitters (hazard ratio 0.62) had a lower adjusted risk of HCC deaths compared with current smokers. Among all ever smokers with current or past smoking habits, as compared with diabetic smokers, only quitters without diabetes had a lower adjusted risk of HCC deaths (hazard ratio 0.37). However, quitters with diabetes had a similar risk of deaths from HCC when compared with smokers with diabetes.
The researchers concluded that clinicians should promote diabetes and smoking prevention in order to reduce subsequent HCC mortality, even in adults without chronic viral hepatitis.
Another study, from China, concluded HBV and alcohol intake were still the major risk factors for HCC (2).
Researchers at Xiamen University conducted a case-control study of 314 HCC cases and 346 controls was conducted in Xiamen, which is an epidemic area in China for both HBV and HCC. Face-to-face interviews were conducted and enzyme-linked immunosorbent assay kits were used to determine the status of serological markers of HBV infection.
As expected, HBV and alcohol intake remained the major risk factors of HCC. Liver disease history and passive smoking are also associated with elevated HCC risk. Indoor air pollution and pesticide exposure were newly identified as risk factors. The researchers suggested alcohol prevention should be promoted and that the consumption of fruit and tea intake could significantly lower the HCC risk .
1) The relationship of diabetes and smoking status to hepatocellular carcinoma mortality. Chiang CH, Lu CW, Han HC et al. Medicine (Baltimore). 2016 Feb;95(6):e2699
2) The epidemiological investigation on the risk factors of hepatocellular carcinoma: a case-control study in Southeast China. Niu J, Lin Y, Guo Z et al. Medicine (Baltimore). 2016 Feb;95(6):e2758
Although HBV patients who received simultaneous liver-kidney transplant (SLKT) had higher early-stage infection rates, they had higher long-term survival rates than those who received liver transplant (LT) alone.
In a study at the Organ Transplant Centre of the Shanghai First People's Hospital, 21 patients with HBV and renal failure (any degree) underwent SLKT and 25 underwent LT alone.
The one, three and five year survival rates of the SLKT recipients were 90.5%, 81.0%, and 81.0%, respectively. The incidence of acute hepatic allograft rejection between SLKT recipients and LT recipients (33% versus 16%) did not reach significance. Despite higher infection rate, more prevalent HBV relapse, and longer stays in the intensive care unit, the SLKT recipients experienced 90.5% one-year survival rates compared with 60% amongst the LT recipients.
Multivariate regression analysis revealed that post-operative renal failure (odds ratio 48) and Risk/Injury/Failure/Loss/End-stage (RIFLE) stage (odds ratio 8) were independent risk factors for postoperative death after LT.
The researchers suggest that SLKT might be a better choice for RIFLE stage 2 or 3 patients than LT alone.
Long-term outcomes of simultaneous liver-kidney transplant patients with Hepatitis B compared to liver transplant alone. Li H, Fan MQ, Men TY et al. Med Sci Monit. 2016 Feb 1;22:332-340
Novel benzothiazepinecarboxamide (BTC) inhibitors that interfere with early and late steps of the HCV viral life cycle have been identified.
Upon screening synthetic small molecule libraries with the infectious HCV cell culture system, researchers at the Korean Pasteur Institute identified a BTC scaffold that inhibits HCV. A structure-activity relationship (SAR) study with BTCs was performed, and modifications that led to nanomolar antiviral activity and improved the selective index (CC50/EC50) by more than 1,000-fold were identified. In addition, a pharmacophore modeling study determined that the tricyclic core and positive charge on the piperidine moiety were essential for antiviral activity.
Furthermore, the researchers demonstrated that BTC interferes with HCV glycoprotein E1/E2-mediated viral entry and the generation of infectious virions by using HCV pseudoparticle and cell culture supernatant transfer assays, respectively. BTC showed potent antiviral activity against HCV genotype 2 but was less potent against a genotype 1/2 chimeric virus, which expressed the structural proteins of HCV genotype 1.
Benzothiazepinecarboxamides: Novel hepatitis C virus inhibitors that interfere with viral entry and the generation of infectious virions. Kim HY, Kong S, Oh S et al. Antiviral Res. 2016 Feb 2 [Epub ahead of print]
In an analysis of studies, the use of interferon (IFN)- and ribavirin (RBV)-free regimens in older adults with HCV resulted in significant improvement of patient-reported outcomes (PROs).
Researchers at Inova Fairfax Hospital, Falls Church, USA, assessed the effect of different treatment regimens for chronic HCV on the PROs of patients aged 65 and older. PRO data from eight multinational phase two and three clinical trials were included.
Of 3,120 participants in these clinical trials, 229 had a mean age of 67.8. Of these, 75% were treatment-naïve, and 22% were cirrhotic. Ninety of these received ledipasvir plus sofosbuvir (LDV + SOF), 119 received SOF plus ribavirin (SOF + RBV), and 20 received pegylated IFN, SOF, and RBV (IFN + SOF + RBV).
The participants aged 65 and older had slightly more pretreatment PRO impairment in their physical functioning than younger individuals (-3.1% on a normalised 0-100% PRO scale).
Despite this, these participants experienced significant PRO improvement during treatment with IFN-free RBV-free regimens (up to +8.0%), similar to improvements in younger participants. In contrast, participants aged 65 and older experienced substantial decline in PROs while receiving IFN- or RBV-containing regimens (up to -18.9% in IFN + SOF + RBV, -10.4% in IFN-free SOF+RBV), and some were greater than in the younger group.
Nevertheless, after achieving sustained viral clearance at post-treatment week 12, PROs in participants aged 65 and older improved regardless of the regimen (up to +10.4%). In multivariate analysis of the cohort aged 65 and older, the use of IFN and RBV was consistently associated with PRO impairment during treatment.
Patient-reported outcomes of elderly adults with chronic Hepatitis C treated with interferon- and ribavirin-free regimens. Younossi ZM, Stepanova M, Nader F et al. J Am Geriatr Soc. 2016 Jan 30 [Epub ahead of print]