Placebo-controlled trial of recombinant alfa-2-interferon (rIFN) in Chinese HBsAg carrier children

ArticleinThe Lancet 2(8564):877-80 · November 1987with6 Reads
DOI: 10.1016/S0140-6736(87)91371-7 · Source: PubMed
24 Chinese children aged 1.5-5 years and positive for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus DNA polymerase (HBV DNAp), and HBV DNA on at least three occasions in the 6 months before the trial were randomised to receive either vitamin B complex or intramuscular recombinant alpha 2-interferon (r-IFN) ('Roferon') 10 X 10(6) IU/m2 thrice weekly for 12 weeks. In all 12 subjects receiving r-IFN, HBV DNAp and HBV DNA levels fell during the course of r-IFN injections. Within 4 weeks of cessation of r-IFN injection, the HBV DNAp and HBV DNA returned to pre-trial levels except in 2 subjects, in whom loss of HBV DNAp and HBV DNA was sustained for up to 18 months from onset of the trial. 1 child lost HBeAg at 18 months. 2 of the 12 children in the placebo group also had a sustained loss of HBV DNAp and HBV DNA during the 18 months, with 1 child losing HBeAg at 18 months. All 24 subjects remained positive for HBsAg. r-IFN produced very slight side-effects except for pyrexia and the "flu" syndrome, both of which showed rapid tachyphylaxis. In the dose given r-IFN was safe but had no long-term beneficial effects on HBsAg carriage in Chinese children.
    • "lts in terms of reducing cirrhosis and HCC incidence over the following years in responding patients. @BULLET Children: The efficacy of IFN in children is similar to that in adults. However, most children have normal ALT levels, and less than 10% of children with intermittently elevated ALT levels who received IFN had achieved HBeAg seroconversion. [98] @BULLET HBeAg-negative CHB: Most Saudi adults with chronic HBV reach this stage of the natural HBV course in their third or fourth decade of life, and can either be inactive carriers (if associated with a low viral load and normal ALT levels and histology) who require no treatment or progress to a pre-core mutant HBV state (due to immun"
    [Show abstract] [Hide abstract] ABSTRACT: The Saudi Association for the Study of Liver diseases and Transplantation (SASLT) has formed a working group to develop hepatitis B virus (HBV) practice guidelines in the Kingdom of Saudi Arabia. This working group was organized and then started during the second quarter of 2012. The methodology used to develop these guidelines was based on reviewing the available evidence, local data, and major international practice guidelines on the management of HBV. These practice guidelines have been developed to assist healthcare providers in the management of HBV in Saudi Arabia. Additionally, the guidelines summarize the major studies performed on HBV epidemiology in Saudi Arabia to emphasize the major change in the prevalence of this virus in the region. The grading of our summary of recommendations was based on the best available evidence that is applicable to Saudi patients, and this system was adopted from major international practice guidelines on the management of HBV
    Full-text · Article · Feb 2014
    • "If antiviral treatments were able to achieve complete viral control (i.e., anti-HBs seroconversion), the ideal children to treat would be those tolerant to HBV, in order to obtain the production of neutralizing antibodies before the onset of complications. These children, who have normal or mildly elevated ALT levels and a high viral load, have been shown not to respond to isolated interferon treatment [59,60,666768 and are not good candidates for current NA therapy because of the risk of developing antiviral resistance [69] . A pilot open study in small cohort of tolerant children has shown promising results with a combined protocol, in which 8 weeks of lamivudine treatment to decrease the viral load were followed by 44 weeks of combined lamivudine and IFN-a treatment [70]. "
    Full-text · Article · Oct 2013
    • "Outside of these special cases, how treatment with polymerase inhibitors might prevent progression in people with low to undetectable viral load is not clear but deserves consideration. Interferons have been shown to be ineffective in this population as well545556. It is conceivable that polymerase inhibitors would have long term benefits in individuals with very low to undetectable levels of viral DNA in their circulation since there may still be viral replication occurring at low levels in hepatocytes. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: There are now seven antivirals approved for use in the management of chronic HBV infection in the US. Current professional guidelines recommend the use of antiviral treatment in only a distinct subset of the total HBV chronically infected population, estimated to be more than 350 million worldwide. The subset of chronically HBV-infected individuals for whom the antivirals have been demonstrated to produce desirable outcomes are those with abnormal liver enzymes and a viral load above a defined threshold, presumably identifying those at highest risk for development of cirrhosis and hepatocellular carcinoma. However, some individuals whose clinical features place them outside these guidelines, for whom treatment is not recommended, are also at significant risk for liver disease complications and liver-related death. Methods: In this report, we produce new estimates of the age-specific risks of liver-related death in people outside the current treatment guidelines using published data from multiple populations. Results: Our results indicate that the age-specific 10-year risks of liver-related mortality in these individuals range from 0.3-4% in the West to 0.3-20% in Asia. Conclusions: The magnitude of these risks and the estimated size of the global population that falls outside of current treatment guidelines have led us to consider whether medical interventions are also needed for these individuals, either with currently approved therapeutics or yet-to-be-discovered medications targeting new mechanisms of antiviral effect. Potential targets for development of new medications are discussed.
    Full-text · Article · Aug 2012
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