- DONE [#A] PREGUNTAR a [[Marina]] y [[Silvia]] si tienen claras algunas de las invitaciones que podríamos ir mandando ya para que [[yo]] vaya preparándolo
- [[AK]]. To begin with ty to them. To be part of the STAB meeting and being availsable at the same time. I prepared a presentation which wont take more than 20-25 mins an get your input. We really value this. Adhoc afiliation with Liconsa. Affiliation to FMS. Estuvo en previous stop durante el ALIVE study.
- John Amuasi: physician. Global health infectious diseases and global health department.
- Denise Mupfasoni: NTD department at WHO leading all the STH related activities. Key stakeholder on our. Geneva. Member as an observer in this group. Not a full member.
- WP3 leaded by KEMRI: leaded by modelling and db but also as a siste.
- wp4: the social sciences: acceptabiility feasibility and adherence: also clinical site, but also a leader through their expertise on other projects on acceptaibility.
- We know that the FDC también es util para oncho, lf, scabies y demás pero tenemos que elegir una disease of particular interest to perform the particular studies. So far the achievements have been: submission to EMA through art 58. the main target is leading the way to prequalification to WHO. We did the pivotal trial that demonstrated safety efficacy against T. Trichiura.
- We look for your expertise in these 3 aspects. Our interest is go beyond the science limited to STH and a vision of global health and a program of implementation.
- Generate the evidence and arguments to our policy and access planning communicating with the correct stakehoulders and provide us input and give visibility to the project.
- What type of acceptability studies are really needed to evaluate acceptabilty? End users or los jefes de los sistemas de salud? Either one, or both, can be the right target of these studies.
- Our conclusions and proposal is revisit the dosign strategies for ivm.
- Pat Lammie: A couple of questions: great presentation of the data generated. When you where looking at the reductions in egg with T. t. The scatter that you saw with fdc1 or fdc3. What is going in con la gente que no muestra esa reduction?
- AK: We have hypothesis: people working in the vet world have shown that having a longer exposure to the drug improve the efficacy. We haven't completed the genomic analysis trying to identify if there is a difference. But the pharmacokinetic analysis shows in Phase II we couldn't identify. We only saw it in blood, not where the parasite is.
- AK: We did find larger number of individuals with AE. it was expected. All mild and moderate severity, all self limiting. Non of the participants in the FDC3 had to stop and not take all the doses.
- AK. We didn't find the AE were not age sensitive. but eventhough our inclusion criteria had from 5 to 17 years old, most where 6-11. We couldn't identify any trends. In the smaller group in the phase. Tampoco para antropometric ni nada así. Lo único fue el trial site.
- JULIE: los programs son muy safe y se llevan haciendo décadas. he biggest safety issue is chocking. Oro dispersable mango flavoured. The program siempre se ha basado en uan fixed dose. IVM can be very difficult.
- RAJ: one of the principal concerns that I have heard was around the number of tablets and chocking, and this is really solved by this. Integration of this program into the current programs STH in teh countries or new ones? We might need to think aobut it. Are there any plans to do economic evaluations? The larger impact of this fdc and reduced number of tablets have we thought about would be the requirement for the capacity building for frontline workers and so on?
- AK: Part of the ecnomic analisis lo ahcen los del london school de stop1 y 2. Hace falta algo más? we needed to have a leading indication to do the clinical trials. this could perfecly be used to LF. either program or country, in all the concepts where integrations could be used. We're not limiting our stakeholders to STH or NTD. this could go wider than that.
- RAJ: integration is being used very loosely by many programs. Some use the word withgout providing the evidence. The program managers need to integrate this into the current programs.
- DENISE: Come back on the integration. Alb and ivm has been distributed for a long time for LF and they work for STH. integration within the NTDs. Also scabies. also outside, in immunization programs can be includede because its a fixed dose. We have to think in countries where we don't have LF and dont have access to the donations of ivm. In a country where we have people with obesity is FDC good?
- AK: 2 key comments. confidentiality agreement. This was the initial meeting, the introduction and background and overall goals. We need to check the frequency of our meetings. We'll me doings some proposals for the minutes. Take less presentations and more oportunity to talk.
