EPIICAL

28

Jul, 2019

Neonatal ART < 7 days VS 7-28 days reduced time to suppression

 

Authors: Tagarro A, Dominguez Rodriguez S, Puthanakit T, et al.

Published: Oral presentation at 27th Conference on Retroviruses and Opportunistic Infections, March 4th-7th, 2019 – Seattle, WA

Abstract: Early antiretroviral therapy (ART) in children is associated with better clinical and virological outcome. Few data are available about long-term outcome of children starting ART in the neonatal period. Our hypothesis is that HIV-perinatally infected neonates initiating ART within <7 days of life have a better long-term clinical and virological response than neonates treated ≥7 days and ≤28 days of life.

44 children with perinatal HIV aged ≤28 days at start of ART were included from 4 cohorts (11%UK, 52% Spain, 7% Italy, and 29% Thailand). Primary endpoints were clinical – mortality, and progression to AIDS – and virological: time to suppression, time to virological failure, and proportion of time suppressed. Data were collected up to 15-years of follow-up. Those subjects who received triple postpartum prophylaxis and subsequently transitioned to ART within <15 days were considered as starting ART from date of prophylaxis initiation. A flexible spline interval censored survival model was applied adjusting for CD4 and viral load (VL) at the start of ART.

57% were female and 35% preterm. Median follow-up was 11.5[IQR 8.2-15.6] years. No patient died. 84% received postpartum prophylaxis. At ART initiation, children were aged 15.5 [0.00;24.2] days, with CD4 total 2766[2126;3368], CD4:CD8 2.5[1.6;3.1], and log10VL 4.2[2.9;5.2] copies/ml. 36/44 (83%) ever suppressed (VL≤50). Time to viral suppression was 0.57[0.25;1.04] years. 12/44 (34%) had subsequent virological failure after suppression (median time to failure, 2.40 [1.01;9.61] years). Participants had 2.9 ±1.8 ART regimen switches, 26% progressed to AIDS. 19/44 (43%) patients started ART <7 days of age. Viral load was higher in children treated <7 days (log10VL 4.4 [4.2;5.4] vs 3.3 [2.9;4.4], p=0.018). Time to suppression was shorter in those treated in the first 7 days of life (18.9[7;41.7] y 44.1[24.6;61.0] weeks, p = 0.038). The probability of suppression decreased by 24% for each week the ART initiation was delayed (aHR=0.76 [0.6;0.97], p=0.035, Figure 1). No differences were observed in progression to AIDS, ART switches, time to immunological recovery (CD4:CD8>1), time to virological failure or proportion of time suppressed.

Even among children initiating ART<28 days of age, children starting ART in the first week of life suppress earlier. There was similar long-term clinical, virological and immunological outcomes in children treated <7 days vs. 7 to 28 days.

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25

Jul, 2019

Penta and CROMSOURCE Announce their Partnership to Improve Paediatric Drug Development

 

Verona, Italy, 25 July, 2019 – CROMSOURCE, an international contract research organization (CRO) providing a comprehensive portfolio of services to the pharmaceutical, biotechnology, and medical device industries, and Penta ID Innovation, the recently established SMO stemmed from the Penta Global Paediatric Research Network, announced today their partnership focused on improving drug development for paediatric patients.

The strategic collaboration combines Penta’s expertise in paediatric infectious diseases and CROMSOURCE’s capabilities in managing worldwide drug development programs to address the challenges of bringing new therapies to children. 

“We are thrilled to partner with such a prestigious and dynamic organisation,” said Oriana Zerbini, CEO of CROMSOURCE. “The partnership will enable us to share scientific, therapeutic, regulatory and operational expertise, creating a high-quality, highly scalable clinical development capability for paediatric research. Our strategic partnership will accelerate the availability of new products to address unmet medical needs of children around the world.” 

Penta ID Innovation CEO, Luigi Comacchio, said ”CROMSOURCE is an ideal partner for Penta ID Innovation because of its proven track record of quality in addition to its attention to detail and commitment to delivery of services at every phase of clinical development.” 

About CROMSOURCE 

CROMSOURCE is an ISO-certified, international contract research organization providing a comprehensive portfolio of services to the pharmaceutical, biotechnology, and medical device industries. Specializing in clinical development and flexible resourcing solutions, they offer a flexible approach to ensure their clients’ unique needs are supported. CROMSOURCE operates offices across all regions of Europe and North America.

www.cromsource.com

About Penta ID Innovation 

Penta ID Innovation is a site management organisation specialised in paediatric infectious diseases projects relying on a network of high performing clinical sites in Europe and around the globe. Aiming at reducing the gap between industry and academia, it can tap into the established expertise of the Penta ID Network to deliver high-level scientific consultancy services and guarantee well performing recruitment to the pharmaceutical industry.

www.penta-id.org

21

Jul, 2019

Di Gibb awarded honorary degree of Doctor of the University of York

 

We extend our hearty congratulations to Professor Di Gibb, who has recently been awarded the honorary degree of Doctor from the University of York. This much deserved award comes as recognition for her outstanding contributions to the area of global and child health, particularly in low-middle income settings.

Di travelled to York on Wednesday 17th July with her husband Tony Ades to receive the honorary degree. Di was introduced at the ceremony by her colleague Prof. Mark Sculpher (Professor of Health Economics at the University of York) with Prof. Sir Mark Grant (Chancellor of the University) presenting the doctorate.

Di’s extensive research and work have improved the lives of a countless number of people across the world. She is a Paediatrician, Professor of Epidemiology and Programme Leader of a large paediatric programme of trials and cohorts in HIV and other infections at the MRC Clinical Trials Unit at UCL. Over the last thirty years she has worked on large paediatric clinical trials (including with Penta) in Europe, Thailand, South America, Africa and India addressing questions in paediatric infections, particularly HIV but also sepsis, TB, malaria and hepatitis.

A long-standing and valued member of Penta, Di is also vice-president of the Penta Board of Directors. She has been collaborating with the Penta network since its establishment almost 30 years ago and was crucial in setting up and coordinating the aforementioned network of clinical trials and cohorts.

From everyone here at the Penta team – well done Di!

17

Jul, 2019

Penta at IAS 2019

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We are delighted to announce that the 10th International AIDS Society Conference on HIV Science has accepted two presentations of interest to the Penta network. The IAS Conference is the world’s most influential meeting on HIV research and its applications. Gathering more than 5,000 participants from over 140 countries, IAS 2019 in Mexico City will present the most critical advances in basic, clinical and operational HIV research that moves science into policy and practice.

Pablo Rojo will present a poster on behalf of the EPIICAL consortium at both ‘IAS 2019’ and the pre-meeting ‘2019 HIV & HBV Cure Forum’. The poster, co-authored with Caroline Foster, will focus on the key CARMA study within the project. During the sessions he will illustrate the main factors associated with low viral reservoir in a large multi-centre cohort of early treated children infected with HIV on sustained suppressive ART for more than a decade.

Meanwhile, Hylke Waalewijn will deliver a late breaker oral presentation on the Penta sponsored study ODYSSEY (PENTA 20), more specfically on the PK substudy nested within the trial. Hylke is currently working as a PhD student at the Radboud Institute for Health Sciences in Nijmegen, The Netherlands. His research focuses on the pharmacokinetics of antiretroviral drugs, specifically in HIV infected children.

Furthermore, the IAS affiliated independent event ‘11th International Workshop on HIV Paediatrics 2019‘ on 19 – 20 July will host a series of other presentations by members of the Penta network. Martina Penazzato will provide an update on What’s New from WHO on Paediatric Antiretroviral Therapy. Penta board member Claire Thorne will deliver an Update on Preconception ARVs and Birth Defects. In addition to these, two oral abstract presentations will also talk place: Lizzie Chappell of the MRC CTU at UCL, and on behalf of EPPICC, will speak on Malignancies in Children With HIV Across Eastern and Western Europe and Thailand, whereas Siobhan Crichton, also working at the MRC CTU at UCL, will speak on Virological Outcomes and ART Discontinuation in Children Switching to Dolutegravir in The UK/Ireland: A Propensity Score Analysis. Siobhan will also present a poster on the key CHIPS study during the Paediatric Antiretroviral Drugs poster walk: Children and Adolescents in the UK/ Ireland CHIPS Cohort on Integrase Inhibitors: Safety and Effectiveness.

You can find more information on IAS 2019 on the official website.

14

Jul, 2019

Minor groove binder modification of widely used TaqMan hydrolysis probe for detection of dengue virus reduces risk of false-negative real-time PCR results for serotype 4

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Authors: Gray ER, Heaney J, Ferns RB, Sequeira PC, Nastouli E, Garson JA

Published in: J Virol Methods. 2019;268:17-23

Abstract Dengue is a vector-transmitted viral infection that is a significant cause of morbidity and mortality in humans worldwide, with over 50 million apparent cases and a fatality rate of 2.5 % of 0.5 million severe cases per annum in recent years. Four serotypes are currently co-circulating. Diagnosis of infection may be by polymerase chain reaction, serology or rapid antigen test for NS1. Both pan-serotype and serotype-specific genome detection assays have been described, however, achieving adequate sensitivity with pan-serotype assays has been challenging. Indeed, as we show here, inspection of components and cycling parameters of a pan-serotype RT-qPCR assay in use in laboratories worldwide revealed insufficient probe stability to accommodate potential nucleotide mismatches, resulting in false-negatives. A minor–groove binder (MGB)-modified version of the probe was designed and its performance compared with that of the original probe in 32 samples. Eight of the samples were undetected by the original probe but detected by the MGB modified probe and six out of seven of these that could be serotyped belonged to serotype 4. Sequencing of the region targeted by the probe in these samples revealed two mismatches which were also universally present in all other serotype 4 sequences in a public database. We therefore recommend adoption of this MGB modification in order to reduce the risk of false-negative results, especially with dengue serotype 4 infections.

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10

Jul, 2019

Get involved in c4c!

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We encourage patients and their families to get involved in c4c activities. The active participation of children, young people and their carers is one of the key objectives of the project. Some good examples of activities in which patients will be involved include protocol revision and meetings to discuss paediatric unmet needs. If you wish to be part of the c4c pool of expert patients, you can find out more by following the instructions here!

7

Jul, 2019

Field diagnosis and genotyping of chikungunya virus using a dried reverse transcription loop-mediated isothermal amplification (LAMP) assay and MinION sequencing

 

Authors: Hayashida K, Orba Y, Sequeira PC, et al.

Published in: PLoS Negl Trop Dis. 2019;13(6):e0007480

Abstract Detection and sequencing of chikungunya virus (CHIKV) genome was performed using a combination of a modified reverse transcription loop-mediated isothermal amplification (RT-LAMP) method and a MinION sequencer. We developed the protocol for drying all the reagents for the RT-LAMP in a single reaction tube. Using this system, the CHIKV genome was effectively amplified under isothermal conditions, and used as a template for MinION sequencing with a laptop computer. Our in-house RT-LAMP method and MinION sequencing system were also validated with RNAs and serum samples from recent outbreaks of CHIKV patients in Brazil. The obtained sequence data confirmed the CHIKV outbreaks and identified the genotype. In summary, our established inexpensive on-site genome detection and sequencing system is applicable for both diagnosis of CHIKV infected patients and genotyping of the CHIKV virus in future outbreak in remote areas.

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3

Jul, 2019

Penta website survey – don’t miss out!

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If you haven’t already taken our survey on the restyled Penta website, then we’d love to hear your thoughts!

We hope your feedback will help us make improvements to our online communication and prioritize new features. We have extended the deadline to July 31st, so don’t miss out!

It only takes 5 minutes, and your responses are completely anonymous. We really appreciate your input!

If you have any questions about the survey, please email us at info@penta-id.org.

 

2

Jul, 2019

16th International course on Dengue, Zika and other emergent arboviruses

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The PAHO/WHO Collaborating Centre for the Study of Dengue and its Control of the Institute of Tropical Medicine “Pedro Kourí”/MINSAP, the Cuban Society of Microbiology and Parasitology, the Cuban Ministry of Public Health and PAHO/WHO have announced the 16th International Course on Dengue, Zika and Other Emergent Arboviruses. It will be held in Havana, Cuba from 12 – 23 August 2019.

Participants will include medical doctors, virologists, immunologists, social scientists, epidemiologists and entomologists and the aim, during the two-week course, will be to provide the latest scientific information on the regional and global epidemiological situation of important arboviruses, in particular dengue, Zika and chikungunya.

A prestigious faculty of professors from across the globe will present sessions and hold discussions on interesting and important topics including: clinical management, vector control, scientific advances in pathogenesis, vaccines and antiviral development, new vector control tools, the influence of host genetics as well as the genetics of the vector and the viruses, emergency control, new international initiatives for arbovirus control and prevention.

The deadline for registration is 20 July. You can find complete information about the course and registration here.

1

Jul, 2019

PediCAP: New website is online!

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We are pleased to announce the launch of the brand new PediCAP project website!

Take a look at this new website, which describes the background, goals and the different activities foreseen in the PediCAP project, as well as an overview of the project consortium.

The colorful style and the structure are similar to other projects websites created by Penta, such as Odyssey and REACH, all contributing to our brand and distinguishing us in the field of paediatric research. As a novelty, we have included a roadmap in order to make the project development and its milestone achievements easier to follow.

Please also visit the Our Activities – PediCAP page if you would like to know more about the project!

PediCAP is a collaboration between Penta and partners in Uganda, South Africa, Zambia, Zimbabwe, Belgium, Switzerland and the UK, bringing together different paediatric groups into a new consortium.

The website can be found at: www.projectpedicap.org.

Funded by the EDCTP programme, PediCAP is a 5-year research project focused on antibiotic therapy of severe and very severe childhood community acquired pneumonia. Through a collaboration between African and European partners, it aims to provide data on optimal duration and oral step-down therapy for paediatric community acquired pneumonia.

NEWSLETTER

We would like to update you on our recent activities