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Human Swine Influenza

Human Swine Influenza. Dr Arthur CW Lau ICU, Pamela Youde Nethersole Eastern Hospital 12 August 2009. Points for discussion. Atypical features CXR features : mostly consolidative changes instead of ground glass opacities in critically ill patients Nebulised zanamivir

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Human Swine Influenza

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  1. Human Swine Influenza Dr Arthur CW Lau ICU, Pamela Youde Nethersole Eastern Hospital 12 August 2009

  2. Points for discussion • Atypical features • CXR features : mostly consolidative changes instead of ground glass opacities in critically ill patients • Nebulised zanamivir • HKSCCM website and H1N1 Forum (www.hksccm.org)

  3. F/51 • DM, HT, Poliomyelitis • BMI 46, BW 106 kg • c/o SOB for 1 day, cough for 2 days • No fever

  4. 9.8.2009 10.8.2009 8.8.2009 12.8.2009 11.8.2009

  5. Progress • CBP: WBC 4 (N3.5, L 0.5, M 0, E 0) • Intubated • Started on tamiflu and nebulised relenza (15 mg in 3 ml NS q6H) + antibiotics • Shock required high dose vasopressor

  6. F/45 • c/o SOB for 3 days + URI symptoms

  7. 31.7.2009 04.08.2009 05.08.2009

  8. Progress • Tamiflu given one day before admission • WBC 4.1 (N 3.1, L 0.2, M 0.1, E 0), Plt 97, Hb 11.8 • Neb relenza added after intubation • MV 2.8.2009 – 7.8.2009 • Discharged from ICU

  9. Information from GSK on 10.8.2009 • Ison MG, Gnann JW, NagyAgren S, et al. Safety and efficacy of nebulized zanamivir in hospitalized patients with serious influenza. Antiviral Ther 2003;183190.* (used IV Zanamivir aqeuous solution instead of powder dissolved in water or NS)

  10. Information from GSK on 10.8.2009 • Summary • In a kinetic study comparing a single dose of zanamivir 10 mg administered via a nebulizer to children >3 months to <5 years to zanamivir 10 mg administration via the Diskhaler to children a >5 years to <12 years, all pharmacokinetic parameters were similar, including AUC0-inf, AUC0-last, Cmax, T1/2 and Tmax. • In a clinical study of hospitalized adults with serious influenza disease, zanamivir 16 mg via a nebulizer plus oral rimantadine was compared to oral rimantadine alone. Medications were administered four times daily for 5 days. Although this study was underpowered to assess efficacy, several findings suggest that the patients who received nebulized zanamivir with rimantadine benefited more than the patients who received rimantadine alone. • A placebo controlled pilot treatment study of adults was conducted to evaluated the safety and efficacy of zanamivir administered via nebulizer (16 mg dose) and intranasally (6.4 mg dose) twice daily for 7 days. The target recruitment was not achieved and as a result there was not a sufficient power to detect a specific treatment difference. A similar proportion of patients in all groups achieved an alleviation of major influenza symptoms by day 3 (primary outcome). • In all studies, zanamivir administered via a nebulizer was generally well tolerated, with most adverse events being classified as mild in intensity.

  11. Reply from GSK on 10.8.2009 • Furthermore, pretaining to your enquiry requiring for aqueous zanamivir solution, GSK has extremely limited supplies of unlicensed aqueous zanamivir solution that may be made available for compassionate use on a named patient basis. Please kindly find enclosed the Physician Guidance document for your perusal. In this document, you can find the inclusion and exclusion criteria of patient as well as the details regarding the use of zanamivir aqueous solution. Please also be informed that: • there is only a very limited supply available • there are time constraints when starting zanamivir (usually within 48 hours of onset of symptoms) • each request will be evaluated on a case-by-case basis by a GSK physician • supply can not be guaranteed

  12. Reply from GSK on 11.8.2009 • Dear Dr Lau • There is no cost for the drug - aqueous zanamivir solution. But, we would be grateful if you can kindly collect the following brief information from the patient for GSK and to report any suspected adverse event to GSK: • Baseline data and relevant medical history • Diagnosis of influenza infection • Relevant medications/interventions • Zanamivir treatment • Collection of virology samples (GSK will arrange for collection and will bear the associated cost) • Collection of pharmacokinetic samples (GSK will arrange for collection and will bear the associated cost) • Clinical progression of influenza and outcome for the patient

  13. If you have patient who you think is suitable for aqueous zanamivir solution, please contact: John Dillon, MD (UK) Telephone: +44 (0) 20 8047 5850 Mobile: +44 (0) 7920 568 451 ORRichard South, MD (UK) Telephone: +44 (0) 20 8047 4904 Mobile: +44 (0) 7771 810 656 Due to the time different between Hong Kong and England, both of them will keep their mobile on until 8pm UK time. If the patient is considered to be suitable for the drug, we can then assist you to apply for the import license from DOH so that we can arrange the drug to be shipped to your hospital in the shortest period of time (e.g. 24-48 hours). In the meantime, if you require further information, please do not hesitate to contact me anytime. Thank you very much for your help.

  14. Summary of points for discussion • Atypical features • CXR features: mostly consolidative changes instead of ground glass opacities in critically ill patients • Nebulised zanamivir • HKSCCM website and H1N1 Forum (www.hksccm.org)

  15. End

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