Call for Malaria ACTs appraisal

Literature Review on

Current and Future

Artemisinin-based

Combination Therapy:

Recent Trends

Dr. Jan-Cedric Hansen

Medico-Marketing European Strategist

StratAdviserLtd

Medical Coordinator at Hopital Asselin-Hedelin

France

China and Artemisinin

Known by traditional Chinese Medicine

– since 4th Century

Extracted from “Chinese Absinth”

Key Role of Chinese Researcher Tu Youyou

– 1971 design of a optimal extraction protocol

– 1972 identification of Artemisinin

– 1979 publication in English of first results with

Artemisinin derivatives

5-Nov-11 IDDST 2011 – StratAdviser Ltd 2

Situational Analysis

16 deaths every 10 min worldwide

WHO’s guidelines for the treatment of malaria

– Evidence-based recommendations

– Clear diagnosis criteria

– Safe and effective antimalarial medicines selection

– Therapeutic strategy for given clinical situations

– Referencing point for malaria control programs

Recognition that artemisinin-based combination therapies (ACTs):

1) increase the rates of clinical and parasitological cures

2) decrease the selection pressure (less resistance risk)


Limitation of WHO’s guidelines*

The 2010 second edition literature overview is

– Limited to June 2004

• with the exception of 47 publications released between 2004

and mid 2008

– Promotes Artemether vs Artesunate

• despite no evidence that Artemisinin derivatives differ

• rather than comparing the partner medicines’ influence

– Whilst neglecting nearly 400 papers released on

• “malaria, falciparum/drug therapy” &

"artemisinins/therapeutic use“

* As a recognised Strategic Knowledge Management advisor, StratAdviser has been granted by Sanofi to appraise “WHO’s guidelines for the

treatment of malaria 2nd edition” in an independent manner in order to determine whether there was a bias regarding the fact that the report

opposes Artemether to Artesunate. In order to achieve its assignment, StratAdviser followed a rigorous proprietary methodology.


More complex than expected

Literature review


Methodology

Artemisinin Medline Search Strategy

– Restriction to past 5 years (relevance)

– 2,427 publications on Malaria Drug Therapy between

2006/10 and 2011/10

• 1,421 related to Artemisinin

• 729 dedicated to Artemisinin Malaria Drug Therapy

• 223 clinical trials (163 full access online)


* "malaria/drug therapy"[MeSH Terms] AND "artemisinins"[MeSH Terms] AND (Clinical Trial[ptyp] AND "2006/10/18"[PDat] :

"2011/10/16"[PDat])

Covered Topics

Diagnostic criteria impact on therapeutic success – RDT, microscopy (Dr vs HW), ...

Enhanced efficacy strategy – ACT vs ACT, ACT vs others, blood concentration monitoring, adjunctive treatment, galenic

form, pre-referal treatment, ...

Enhanced tolerance strategy – Intermittent, ACT vs ACT,

Compliance solutions – Mobile phone alert, ...

Administration route – IV, IR, PO, ...

Pharmacology within different population – infant, pregnant, genetic (CP450, G6PD) , ethnic, ...

Delivery model impact – Retail, health workers, ...

Public health impact – Curative, preventive, selection pressure, Cost-effectiveness, ...


Homogeneity of published data

Different

– Methodology

• Double blind, Open label, Cohort, Retrospective, Meta Analysis, ...

– Population

• South America, Western Africa, Eastern Africa, Asia, Oceania, ...

– Clinical situations

• Severe, uncomplicated, age groups, ...

– Treatment strategy

• Dosage, Titration, Regimen, ...

– Efficacy Criteria

• Clinical improvement, gametocyte clearance, relapse, ...


Data Handling

The abundant available literature on Artemisinin

derivatives and partner medicines

– Overcomes individual prescribers (field practitioners)

capacity of integration

– Deserves an international consensus regarding

• Both confidence & relevance of available data

• Both respective indications & related therapeutic strategy

• Both therapeutic success & therapeutic failure indicators


The vast amount of information regarding ACTs make it mandatory to clarify

where, to whom, when and how to prescribe

This can only be achieved by an Independent International Expert Group

Malaria Control Task Force

Call for an international independent expert group


Malaria Control Task Force Overview

It is a Therapeutic Strategy Awareness Program dedicated to the ACTs’ Malaria Control – clarifies the ACTs’ Malaria Control rational and its related therapeutic

strategy because ACTs are clearly the current gold standard

Its objective is to help field practitioners – To understand better the proper use of ACTs

– Thanks to a non product specific, accredited education programs

It would be an academic program – Elicited by its Co-Chairs

– Potentially run by StratAdviserLtd

– Funded by Third Parties

It would be supported by an associative organisation – “Loi 1901” if housed in France

– “Unincorporated Association” if housed in the UK


Co-Chairs are 3 key Malaria High Profile KOL who want to promote CRS as a key issue

Board Members are 10 to 12 Malaria KOL who are recognised by their peers regarding Clinical and/or susceptibility and/or Pharmacology... (each specialty being involved in a way or another regarding Malaria Control)

Supporters are numerous Field Practitioners who are interested in upgrading their practice skills regarding Malaria Control (early adopter profile) – they are organised as “clubs” in each countries. They will be invited to register to a CME programme to become “Malaria Control experts”

Followers are other KOL, Field Practitioners and Healthcare Authorities Representatives that pay attention and then adhere to the Malaria Control “package” thanks to the noise generated by the above mentioned ones

Stakeholders include all of the above plus sponsors, governments, patient associations, third parties...

Malaria Control Task Force Organisation


Co-Chairs determine topics & questions

Board Members elaborate content & advocate Malaria Control

Supporters disseminate Malaria Control messages Followers adhere to Malaria Control messages

Stakeholders

Malaria Control Task Force Methodology

Board members meet once a year

– They have one to two video conferences per year

They liaise in a monthly basis

– Together in order to produce and/or validate the

scientific/educational/informative production of the

group

– With Supporters to disseminate their Output

They designate speakers

– to advocate Malaria Control Task Force outputs during

congresses and conferences


Malaria Control Task Force Outputs

Grading of available literature and guidelines

– EBM approach (AGREE, GRADE, Proprietary ...)

Classification of Malaria Clinical Presentation

– Severity Score, ...

Proposition of relevant therapeutic strategy

– 1st, 2nd, 3rd line treatment ....

Identification of adequate QA indicators

– Artemisinin Resistance Containment ...


The clarification of the responsible use of ACTs calls for a sustained and robust

dissemination program to ensure field prescribers adhesion

Malaria Control Task Force Tools

Media Releases

– written or recorded supports providing stakeholders, via media, with an information subsidy containing the basics needed

to develop a news story regarding Malaria Control Task Force such as scheduled upcoming events, Board Members

promotions, awards, new educational services, accomplishments, etc.

Flyers

– recto-verso folded supports to advertise the existence of Malaria Control Task Force, invite to a CME session, a Malaria

Control seminar, to register to a Malaria Control mailing list, to visit a given website, ...

Pamphlets

– 8 to 16 stitched supports to disseminate interviews of Malaria Control Task Force board members and short messages

links to Malaria Control

Reprints

– duplex supports to allow disseminating original articles with Malaria Control Task Force board members comments printed

over the folder – original articles are selected by board members due to their interest regarding Malaria Control

Congress Abstracts

– “400 to 600” words supports to advocate and disseminate Malaria Control Task Force Therapeutic Strategy backup,

grading scale, guidelines, and related topics

CRS satellite symposia

– Malaria Control Task Force Board Members are welcome to perform lectures regarding ACTs’ Therapeutic Strategy

whenever they are invited to national and international congresses – sponsor may as well organise satellite symposia

dedicated to ACTs

CME programs

– printed or dematerialized supports to allow appropriation of ACTs’ Therapeutic Strategy management

Newsletter

– printed or dematerialized supports to duplicate any of the above to maximize the chances to influence the target audience


Future Trends and Breakthrough

ACTs and their environment


2010/2011 Proposed Shortlist

Novartis Institute for Tropical Diseases (NITD), Swiss Tropical & Public Health Institute and Scripps Research Institute discovery of a next generation treatment for drug resistant malaria

WHO/Roll Back Malaria 2011 Global Plan for Artemisinin Resistance Containment (GPARC)

AstraZeneca and Medicines for Malaria Venture (MMV) collaborative agreement to identify novel candidate drugs for the treatment of malaria.

Sanofi and Medicines for Malaria Venture (MMV) alliance agreement to research malaria treatments

Institute for OneWorldHealth, University of California, Berkeley, Amyris, and Sanofi semisynthetic (Microbially Derived) Artemisinin Project

GSK malaria vaccine Phase III published results


Thank You

Dr. Jan-Cedric Hansen Medico-Marketing European Strategist

StratAdviserLtd

Medical Coordinator at Hopital Asselin-Hedelin

France

[email protected]

Call for Malaria ACTs appraisal

Health & Medicine

Transcript of Call for Malaria ACTs appraisal