Zanamivir is a prescription drug used in the treatment and prevention of influenza in adults and children over the age of 5 years. Limited data are available on pregnancy outcomes with maternal exposure to zanamivir during pregnancy. It can be difficult to estimate use of medicines in pregnant women, and it is important to understand how many pregnant women are prescribed zanamivir to treat influenza. Therefore, this request has two objectives, 1) to assess the ability of the CPRD data source to identify women of childbearing potential (WOCBP) and pregnant women hospitalized with influenza to determine the feasibility of future studies of intravenous (IV) Zanamivir use in WOCBP and pregnant women 2) to assess the ability of the CPRD data source to identify WOCBP and pregnant women prescribed inhaled Zanamivir to determine the exposure prevalence in WOCBP and pregnant women to determine the feasibility of future studies of inhaled Zanamivir use in WOCBP and pregnant women.
Relenza, inhaled Zanamivir, is a neuraminidase inhibitor that was first authorized in Sweden in June 1999 and is approved in the European Union (EU) through mutual recognition. It is indicated for treatment and prevention of influenza in adults and children over the age of 5 years. Limited data are available on pregnancy outcomes with maternal exposure to zanamivir during pregnancy. Understanding how many pregnant women are exposed to this product would help to inform on the prevalence of use in this population.
Additionally, Dectova, zanamivir 10 mg/mL solution for infusion, was approved by EMA in April 2019 for the treatment of complicated influenza. GSK made a voluntary commitment to conduct a prospective, descriptive, observational Phase IV pregnancy registry study (category 3 post-authorization safety study [PASS]) to assess the safety of Dectova exposure in pregnant women with complicated influenza and their offspring. Capturing the exposure of Dectova in pregnant women outside of an influenza epidemic/pandemic, has been challenging with a need to investigate new approaches to meet our voluntary obligation to EMA. We would like to explore whether CPRD can capture the data on flu we require for our commitment to EMA. This includes understanding feasibility counts for hospital influenza episodes for WOCBP and pregnant women in CPRD, to inform decision making and future study designs.
• Prescribed medications for treatment of influenza. Specifically, use of Relenza, in pregnant women and women of childbearing potential.
• The number of women of childbearing potential (WOCBP) with influenza who were hospitalized during the 10 years from June 1, 2009 to May 31, 2019, i.e. 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, 2016/17, 2017/18, 2018/19.
• The number of pregnant women with influenza who were hospitalized during the10 years from June 1, 2009 to May 31, 2019, i.e. 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, 2016/17, 2017/18, 2018/19.
• The number of WOCBP who were admitted to the ICU during the 10 years from June 1, 2009 to May 31, 2019, i.e. 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, 2016/17, 2017/18, 2018/19.
• The number of pregnant women who were admitted to the ICU during the last 10 years from June 1, 2009 to May 31, 2019, i.e. 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, 2016/17, 2017/18, 2018/19.
Linked HES data will be used to identify hospitalisations and ICU admissions that are associated with a diagnosis of influenza in England and Wales. The Pregnancy Register will then identify patients hospitalised with influenza that were also pregnant at any time during their hospitalisation. The Pregnancy Register and HES Admitted Patient Care linked datasets will enable an estimate of the number of pregnant women admitted to hospital with influenza, while the Pregnancy Register will enable an estimate of the number of pregnant women prescribed zanamivir, estimates that will benefit patients in England and Wales as the use of zanamivir in this population is further explored.
Keele Wurst - Chief Investigator - GlaxoSmithKline - UK
Keele Wurst - Corresponding Applicant - GlaxoSmithKline - UK
Mary Betsey Georgiou - Collaborator - GSK
CPRD GOLD Pregnancy Register;HES Admitted Patient Care