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ECDC expert opinion on the efficacy, effectiveness and safety of influenza neuraminidase inhibitors Pasi Penttinen Head of influenza and other respiratory viruses DP (acting) Office of Chief Scientist, ECDC

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ECDC expert opinion on the efficacy, effectiveness and safety of influenza neuraminidase inhibitorsPasi PenttinenHead of influenza and other respiratory viruses DP (acting)Office of Chief Scientist, ECDC

Background

• Each year 10-15% of European population acquire influenza. Complications such as pneumonia, hospitalizations and deaths occur, mostly among the vulnerable.

• Neuraminidase inhibitors (NAIs; oseltamivir and zanamivir) have been subject to much debate about the effectiveness and cost-benefit ratio in preventing and treating influenza.

• Request was made in the ECDC Advisory Forum to assess the evidence base for public health use of antivirals in outbreak settings, specifically in nursing home outbreaks (2013).

• EU Health Security Council requested a review of the evidence from EC and ECDC (2014).

• ECDC convened an expert group to review new evidence with the aim to develop an “ECDC Expert opinion” on the evidence base for public health recommendations

Process – expert review and public consultation Expert meeting held 10-11 February

– Agreement of interpretation of new reviews/ analyses

– Conclusions for public health recommendations 11-20 February

– Drafting of ”expert opinion”– Review with experts

27 February– Outcomes shared with EU Health security

committee August – public consultation on ECDC website (1

month)+

September – finalisation of Expert opinion+

*In addition, additional systematic reviews, RCTs and observational studies were considered, when appropriate+ Estimated

Independent* experts consulted

 Experts

Barbara MichielsKari S. Lankinen (EMA rapporteur-FI)

Regine LehnertDarina O’Flanagan

Anders Tegnell  

Johan GieseckePeter HorbyJohn Watson

Angela CampbellFrederick Hayden

Filip Josephson (EMA rapporteur-SE)

Observers 

Manuela Mura – European Medicines Agency

 

Nikki Shindo – WHO Headquarters

 Caroline Brown –

WHO Regional Office for Europe

 Presenters External to Expert Group(present on day one of meeting only)

 Arnold Monto Jonathan Nguyen-Van-Tam

* Declarations of interest declared according to ECDC independence policy

Current recommendations for antivirals in EU/EEA MS (VENICE) Currently 22 EU/EEA MS have recommendations on

antiviral use according to recent survey conducted by the VENICE network. Antivirals are recommended – in 22 MS in patients with severe or progressive

influenza requiring hospitalisation; – in 14 MS in residents of long-term care facilities in

case of influenza outbreak.

3.65 treatment courses/ 1000 inhabitants/ year

Evidence reviewed included meta-analyses of RCTs and pooled observational studies The Cochrane Collaboration (2014) Intervention

Review ‘Neuraminidase inhibitors for preventing and treating influenza in adults and children’.

The MUGAS (Multiparty Group for Advice on Science) group published ‘Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials’ in 2015

The PRIDE (Post-pandemic review of anti-influenza drug effectiveness) Consortium investigators published ‘Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A(H1N1)pdm09 virus infection: a meta-analysis of individual participant data’ in 2014

Oseltamivir vs placebo for treatment. Time to alleviation of first symptoms in adults

Source: Jefferson 2014 (COCHRANE)

Risk of lower respiratory tract symptoms among oseltamir-treated groups vs placebo

Source: Dobson 2014 (MUGAS)

Survival by time to treatment (PRIDE study)

Preliminary Conclusions – as treatment NAI’s: Decrease time to alleviation of symptoms of

uncomplicated influenza-like illness in previously healthy adults by ~15 - 25 hours

Results on effect on lower respiratory tract infection/pneumonia or hospitalisation in healthy individuals mixed. However, these trials were not designed and powered to assess these outcomes

Decrease mortality among hospitalised adult patients with laboratory-confirmed/clinically confirmed influenza but not in children <16 years in a large world-wide observational study

In current studies the reasons for a more limited effect in children is unknown

Preliminary Conclusions – as prophylaxis NAI’s Reduce the individual and household risk of

symptomatic and laboratory-confirmed influenza infection in previously healthy adults

In out-patient settings and in institutions for long-term care, reduce the risk of symptomatic and laboratory-confirmed influenza in vulnerable individuals due to age, cardiovascular disease, diabetes and immunosuppression

Preliminary Conclusions for public health No evidence was revealed to support a change to the

recommended use of NAIs in EU/EEA Member States. However, further studies in children are needed.

Recommendations to treat patients with severe influenza and provide prophylaxis to the most vulnerable and their families is supported by the expert opinion.

This position is consistent with guidance from the World Health Organization (WHO) and many national public health organizations in Europe, North America, South East Asia, Australia, Japan and New Zealand.

There is room for improvement in efficacy and effectiveness of the NAIs and several new antivirals are being tested alone or in combination with one of the authorised NAIs in on-going RCTs.