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Characteristics and Mortality of Severe Influenza Cases Treated with Parenteral Aqueous Zanamivir, United Kingdom, October 2009 to January 2011

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Characteristics and Mortality of Severe Influenza Cases Treated with Parenteral Aqueous Zanamivir, United Kingdom, October 2009 to January 2011 Characteristics and mortality of severe influenza cases treated with parenteral aqueous zanamivir, United Kingdom, October 2009 to January 2011. Item Type Article Authors Sherwood Forest Hospitals NHS Foundation Trust Citation Powles, T. et al. (2017) ‘Phase III, Double-Blind, Randomized Trial That Compared Maintenance Lapatinib Versus Placebo After First-Line Chemotherapy in Patients With Human Epidermal Growth Factor Receptor 1/2-Positive Metastatic Bladder Cancer’, Journal of Clinical Oncology: Official Journal of The American Society of Clinical Oncology, 35(1), pp. 48–55. DOI: 10.1111/ irv.12603 Download date 28/09/2021 00:04:40 Link to Item http://hdl.handle.net/20.500.12904/1419 Received: 11 December 2017 | Revised: 28 June 2018 | Accepted: 19 August 2018 DOI: 10.1111/irv.12603 ORIGINAL ARTICLE Characteristics and mortality of severe influenza cases treated with parenteral aqueous zanamivir, United Kingdom, October 2009 to January 2011 Paul Robert Cleary1 | Jonathan Crofts2 | Frances Parry-Ford3 | Meera Chand4 | Nick Phin5 1Field Service, National Infection Service, Public Health England, Liverpool, Background: Aqueous zanamivir solution, an investigational product, was provided UK by the manufacturer on compassionate grounds for parenteral administration to se- 2 Immunisation, Hepatitis, Blood Safety vere H1N1pdm09 influenza cases during the 2009 pandemic. and Countermeasures Response, National Infection Service, Public Health England, Objective: To describe characteristics and outcomes of UK patients receiving paren- London, UK teral zanamivir therapy. 3 Influenza Preparedness and Response Methods: Collaborators at multiple hospital sites gathered retrospective data on pa- Section, National Infection Service, Public Health England, London, UK tients receiving aqueous zanamivir therapy between Q4 2009 and Q1 2011. We pre- 4Reference Microbiology Services, National sent analysis of the demographics, clinical features, treatment and outcomes of this Infection Service, Public Health England, London, UK cohort. 5Interim Deputy Director, National Infection Results: Data on 185 cases were obtained (response rate of 38%; median age Service, Public Health England, London, UK 43 years; 62% male; 17% non- Caucasian ethnic group). Most frequent co- morbidities Correspondence included cancer, immunosuppression and respiratory conditions. Most patients re- Paul Robert Cleary, Field Epidemiology ceived intravenous zanamivir alone (90%), for durations of up to 21 days. 13% of Service, National Infection Service, Public Health England, Liverpool, UK. cases had adverse effects related to zanamivir therapy. Thirty four percentage of Email: [email protected] cases died. No significant relationship was seen between mortality and timing or Funding information route of administration of aqueous zanamivir therapy. GlaxoSmithKline Conclusions: The response rate of this observational study of the outcomes of treat- ment of severe influenza was low, allowing limited conclusions to be drawn. Some potential adverse effects were noted. Clinicians should carefully consider potential risks and benefits of use of this product. New treatment options are urgently re- quired to improve outcomes for patients with severe influenza infections. KEYWORDS critical care outcomes, H1N1, influenza, pandemic, zanamivir 1 | INTRODUCTION cases developed acute respiratory distress syndrome (ARDS) re- quiring respiratory support. Two neuraminidase inhibitors were li- Most cases of pandemic H1N1pdm09 influenza experienced un- censed for influenza in the United Kingdom at the time. Oseltamivir complicated illness or asymptomatic infection.1 A minority of severe may be administered orally and is well absorbed.2 Zanamivir may be This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2018 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd. 44 | wileyonlinelibrary.com/journal/irv Influenza Other Respi Viruses. 2019;13:44–53. CLEARY ET al. | 45 administered by powder inhaler.3 Nebulised administration of zana- relationship with zanamivir treatment. A serious adverse event was mivir inhalation powder as a liquid formulation is not recommended.4 defined as an adverse event that results in death; is life- threatening; Few alternative antiviral formulations were available for critically ill requires hospitalisation or prolongation of existing hospitalisation; patients with oseltamivir- resistant infections, impaired gastric motil- results in disability or incapacity; or results in a congenital anomaly ity, malabsorption and/or gastrointestinal bleeding. or birth defect. Zanamivir aqueous solution is an investigational product which We summarised the characteristics of cases treated with par- may be administered via nebulisation or intravenously. At the onset enteral zanamivir aqueous solution in terms of demographics; co- of the 2009 pandemic, published evidence of the safety and ef- morbidities, pregnancy and body weight; influenza vaccination fectiveness of intravenous or nebulised zanamivir aqueous solution status; clinical and radiographic findings; prior antiviral therapy; was limited and it was not licensed for use in any country.5 From timing, route and duration of aqueous zanamivir administration; May 2009, zanamivir aqueous solution was made available by the other medical treatment and respiratory support; complications manufacturer on a named- patient basis under a global “compas- and co- infections; reported adverse events; length of stay and sionate use programme” for treatment of severe influenza where mortality. We calculated case fatality ratios stratified by each licensed antiviral drugs were not effective or practical. A total of variable. Confidence intervals for case fatality ratios were calcu- 485 issues of aqueous zanamivir were made in the UK, to 153 sites lated using the Wilson interval.8 Odds ratios for mortality with in 113 trusts or health boards in the UK, constituting just under confidence intervals were calculated for categorical explanatory 40% of global use (Glaxo- Smith- Kline, personal communication). variables. Although completion of case report forms was a requirement of In all analyses, P values of <0.05 were considered significant. the programme, only 29 case reports (6%) were returned to the Statistical analyses were conducted using IPython9 and R version manufacturer. 3.1.3.10 Public Health England (PHE) retrospectively collected data Ethical approval of the study was granted for all NHS sites taking on use of aqueous zanamivir between October 2009 and January part in the study from the East of Scotland Research Ethics Service 2011. This report describes characteristics and outcomes of patients (EoSRES). receiving parenteral zanamivir therapy and risk factors for severe outcome. 3 | RESULTS 2 | METHODS Data were returned for 185 cases (out of 457 questionnaires sent; response rate 38%). Thirty- four sites each provided data for be- All sites that had received aqueous zanamivir from the manufac- tween 1 and 21 cases (median three cases). Data completeness was turer under the compassionate use programme (CUP) between >95% for the majority of key variables. October 2009 and January 2011 were approached by PHE or via the ICS “Linkman” network of intensive care professionals. The 3.1 | Clinical/demographic characteristics manufacturer provided information to responding sites to identify patients who received aqueous zanamivir treatment. Cases were Table 1 describes the characteristics of the cases. A total of 181 defined as intensive care patients for whom parenteral zanamivir cases (98%) had laboratory- confirmed H1N1pdm09 influenza A. Of aqueous solution was provided by the manufacturer under the CUP. the remaining 4, 2 had influenza B and 2 had influenza A of another/ Collaborators completed a standardised case report form provid- unknown strain. Resistance to oseltamivir was documented for two ing anonymised demographic, clinical, microbiological, hospitalisa- cases (this was not part of the minimum data set). The majority of tion, treatment and outcome information including adverse events. cases (81%) were reported from England. Most cases (163; 88%) Sequential Organ Failure Assessment (SOFA) scores at initiation of were treated in calendar quarters 2009 Q4, 2010 Q4 or 2011 Q1. 6 aqueous zanamivir therapy were provided for each case. Data col- The age distribution of cases ranged from <1 to 74 years of age (me- lection began in March 2013 and was completed in March 2015. dian age 43 years). Most cases were male (62%). Female cases were Follow- up information was available for 457 of the 485 cases for significantly younger than male cases (median of 34 years, vs 48.5 whom parenteral zanamivir was issued. for males; Wilcoxon rank sum test P value <0.001). Ethnic group was The recommended adult dosage of intravenous aqueous zana- available for 157 cases: of these, 80% were White, 8% of African mivir was 600 mg twice daily for 5 days; adjustments were required descent and 8% of Asian/Oriental descent. 7 for renal impairment. Children, adolescents and pregnant women The recorded date of hospital admission preceded the recorded required weight- based dosing. The recommended adult nebulised date of onset of influenza symptoms in 28 cases (15%): by more dose was 25 mg four times daily. than 7 days in most cases (64%) and by two or fewer days in only
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