We conducted a randomized, placebo-controlled clinical study evaluating famciclovir (500 mg 3 times daily and 1.5 g once daily) for 1 year (6 months post-treatment follow-up) in patients with chronic hepatitis B e antigen (HBeAg)-positive hepatitis B virus (HBV) infection. The study was conducted in 80 centers in North America, Europe, and Australia/ New Zealand. A total of 417 patients with histologically documented chronic hepatitis B (histologic activity index [HAI] 9.5-11.0) received famciclovir (500 mg 3 times daily or 1.5 g once daily) or placebo. Famciclovir 500 mg 3 times daily significantly reduced HBV DNA and median HAI scores versus placebo. By week 8, median HBV DNA decreased from 1,645 to 283 MEq/mL (famciclovir 500 mg 3 times daily) and from 1,147 to 304 MEq/mL (famciclovir 1.5 g once daily), while increasing for placebo (1,617 to 1,685 MEq/mL). Median change in HBV DNA at the end of therapy was ؊76% (famciclovir 500 mg 3 times daily; P < .01) and ؊60% (famciclovir 1.5 g once daily; P ؍ .25) versus ؊37% for placebo. Median change in HAI was ؊1.5 points (famciclovir 500 mg 3 times daily; P ؍ .02) and ؊1.0 point (famciclovir 1.5 g once daily; P ؍ .35) and zero for placebo. Fifty percent of patients receiving famciclovir 500 mg 3 times daily (P ؍ .07) and 43% receiving 1.5 g once daily (P ؍ .41) experienced >2 points improvement in HAI versus 37% for placebo. Nine percent of patients treated with famciclovir 500 mg 3 times daily underwent anti-HBeAg seroconversion with undetectable HBV DNA at end of follow-up versus 3% in the placebo group (P ؍ .05). Famciclovir was well tolerated; the incidence of post-treatment alanine transaminase (ALT) elevations was comparable with placebo. In conclusion, famciclovir 500 mg 3 times daily gave modest suppression of viral replication, but translated into significant histologic improvement in median HAI score at 1 year. (HEPATOLOGY 2000;32:413-417.)Hepatitis B virus (HBV) infection is a major cause of chronic liver disease, with an estimated 350 million carriers worldwide. HBV induces a spectrum of clinical manifestations, ranging from mild, unapparent disease to fulminant hepatitis, severe chronic liver disease, and cirrhosis. The virus has also been clearly implicated in the development of primary hepatocellular carcinoma, causing one million deaths per year. [1][2][3] Interferon alfa is widely licensed for the treatment of chronic hepatitis B e antigen (HBeAg)-positive HBV infection. The drug is administered to patients with well-compensated liver disease who can tolerate the potential side effects, which may require dose reduction or discontinuation of treatment. In addition, interferon requires parenteral administration. Efficacy defined as HBe-seroconversion is limited to approximately 30% of treated patients. 4 Availability of nucleoside analogues with activity against HBV offers promise of improved efficacy, greater convenience (i.e., oral formulation) and applicability to patients with well and poorly compensated HBV infection. Lamivudine, the (...
BackgroundThe audit process may help improve performance indicators for colonoscopy quality but it is unclear whether this is sustained over several years.Methods44138 procedures for 28 endoscopists from 2004 to 2019 were analysed for polyp detection rate and withdrawal time. From 2012, 14 endoscopists were analysed with additional data on polyp histology and number of polyps removed.ResultsPolyp detection increased from 40.7% in 2004 to 62.2% in 2019; removal of polyps>1 cm remained constant (11%). Adenoma detection rate was 25.8% in 2012 and 28.3% in 2019. Sessile serrated polyp (SSP) detection rate increased from 4.5% to 14.7%; most of the increase was in the first 2 years of the histology part of the audit. There was a significant correlation of adenoma detection rate with mean number of adenomas (r=0.72, p=0.004) and a significant correlation of SSP detection with mean number of SSPs (r=0.85, p=0.0001).ConclusionThe audit process appears to encourage a higher rate of polyp detection. This was due to increased detection of smaller polyps and increased detection of SSPs.
IntroductionAn overall increase in polyp detection rate is encouraging but is of uncertain benefit unless histology is also included confirming that significant polyps (TA and SSP) have been detected and removed. The detection of SSP may be encouraged by an audit process with yearly feedback meetings.MethodThere has been a continuous audit process that has included histology at a MercyAscot, a private endoscopy clinic, from 2012 to 2016. There have been yearly feedback meetings to encourage endoscopists to improve performance. Polyp histology was recorded as adenomas (TA), sessile serrated polyps (SSP) and hyperplastic polyps (HP). Only endoscopists with more than 100 procedures were included. The number of TA and SSP per procedure was recorded from 2014. The mean number of TA and SSP is expressed per total number of procedures.Results12555 procedures were performed by 15 endoscopists. Polyp detection has increased over five years; 56.6% in 2012 to 65% in 2016. The detection rate for adenoma has remained stable after an initial increase in the second year of the audit (26% in 2012 to 31.5% in 2016). There has been a rapid increase in detection of SSP; 4.9% in 2012 to 17.1% in 2016. Twelve of 15 endoscopists increased their detection rate for SSP over the 5 years. Detection of hyperplastic polyps remained relatively constant at 25%–26%. There was no increase in polypectomy where no polyp was proven on histology (4% of procedures). The mean number of adenomas per procedure was unchanged; 0.60 in 2014, 0.56 in 2015 and 0.60 in 2016. The mean number of sessile serrated polyps per procedure was 0.26 in 2014, 0.32 in 2015 and 0.32 in 2016. The increase in detection of SSP has been achieved with only a small increase in mean withdrawal time (where polyps were not detected); 2012 8.1 mins, 2013 8.4 mins, 2014 8.3 mins, 2015 8.5 mins and 2016 8.4 mins. Three endoscopists were detecting SSP in more than 8% of procedures at the start of the audit (2012); 4 endoscopists started from less than 3%. Detection of polyps>1 cms decreased slightly from 10.7% in 2012 to 8.3% in 2016.ConclusionThe detection of SSP is a new skill that needs to be learnt over several years. The steady increase in overall polypectomy rate appears to be due to the detection and removal of SSPs that were previously undetected rather than the renaming of hyperplastic polyps by the pathology service. The different starting points and trends for each endoscopists would also support the conclusion that this trend is not due to reclassification by pathology service. The audit process could potentially increase the detection of diminutive polyps (mainly hyperplastic or no detected polyp) - i.e “gaming of the audit”. This has not occurred, perhaps because of the knowledge that histology was being evaluated.Disclosure of InterestNone Declared
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