PENTA 20 (Odyssey)

30

Dec, 2021

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

 

Authors: A Turkova, E White, HA. Mujuru, AR. Kekitiinwa, CM. Kityo, A Violari, A Lugemwa, TR. Cressey, P Musoke, E Variava, MF. Cotton, M Archary, et al for the ODYSSEY Trial Team

Published in: New England Journal of Medicine

30

Dec, 2021

Once-daily DTG more effective in treating HIV in children

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The ODYSSEY trial’s final paper Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children has been published in the New England Journal of Medicine. ODYSSEY, sponsored by Penta and funded by ViiV Healthcare, is the first randomised controlled trial to compare the efficacy and safety of dolutegravir-based regimens to non-dolutegravir-based standard-of-care regimens in children and adolescents.

Dolutegravir (DTG) is a drug shown to be highly effective and safe in treating HIV in adults, and ODYSSEY, enrolling more than 700 children from Uganda, South Africa, Zimbabwe, Thailand, UK, Germany, Spain and Portugal, revealed that DTG based treatments in children were more effective and as safe as standard care regimens, with children experiencing fewer adverse effects and better growth. The results of the ODYSSEY substudies played a role in the Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of once-daily dispersible DTG for children as young as 4 weeks old at a substantially low cost.

There are an estimated 1.7 million children currently living with HIV. Treatment options for children are limited  compared to those available to adults. HIV infection in children is a chronic condition, and without access to antiretroviral treatment, the disease progresses rapidly, increasing the likelihood for the development of AIDS and the risk of suffering AIDS-related deaths.

With the new paediatric DTG regimens, ODYSSEY played a part in ensuring children can begin safe and effective treatment against HIV from a young age. A step closer to the realisation of an AIDS-free generation.

 

Read the press release by UCL here

Watch the animated abstract here

 

17

Dec, 2021

Size of HIV-1 reservoir is associated with telomere shortening and immunosenescence in early-treated European children with perinatally acquired HIV-1

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Authors: A Dalzini, G Ballin, S Dominguez-Rodriguez, P Rojo , M.R Petrara, C Foster, N Cotugno, A Ruggiero, E Nastouli, N Klein, S Rinaldi, S Pahwa, P Rossi, C Giaquinto, P Palma , A De Rossi1, and on behalf of EPIICAL Consortium

Published in: Journal of the International AIDS Society

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15

Dec, 2021

Ethical youth engagement in the HIV response

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Penta youth in collaboration with IAS, have organised a webinar taking place on Thursday, 16 December at 12pm CET (GMT+1) on the theme Invest in our future: How to walk the talk of ethical Youth engagement in the HIV response.

The objectives of the webinar are to showcase best practices for youth participation within the HIV sector, to highlight the current gaps in proactive responses to youth participation models and insight, and to discuss the importance of ethical youth engagement being backed by policies co-produced by young people and key stakeholders to ensure accountability and effectiveness.

9

Dec, 2021

Diaskin and tuberculin skin test as tuberculosis diagnostics in Russian children: comparative observational study

 

Authors: Fritschi N, Gureva T, Eliseev P, Crichton S ,Intira Jeannie Collins IJ, Turkova T, Mariandyshev A, Ritz N

Presented at: The 52nd Union World Conference On Lung Health 2021

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7

Dec, 2021

REACH project published in CORDIS

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We are proud to announce that the REACH project’s Result in Brief article, Reducing infectious disease in mothers and children in Russia, has been uploaded on the CORDIS website. This is a great opportunity to share our work, with the rest of the world and will ensure that our study results, when available, are available to many. None of what REACH has achieved would have been possible without the collaborative effort of our partners in Europe and the Russian Federation.

Through the joint commitment of our members, the REACH project has drawn to conclusion, having strengthened, and created new international relationships to elevate research opportunities. We must keep this momentum and not waiver in our drive to improve health responses to pandemics and advance our understanding of HIV, TB, and HCV in order to protect pregnant women and children, the vulnerable populations that are usually considered last for clinical trials.

Visit the CORDIS website to read the Results in Brief article

 

 

 

6

Dec, 2021

Characterisation of the HIV proviral and inducible reservoir in well- suppressed children on long-term ART

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Authors: Gärtner K, Byott M, Heaney J, Pagliuzza A, Spyer M.J Frampton D, Rossi A.D, Palmas P, Giaquinto C, Conejo P.R, Foster C,  Rossi P, Klein N, Chomont N, Nastouli E, for the EPIICAL consortium

Presented at: Keystone symposia on molecular and cellular biology

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3

Dec, 2021

Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial

 

Authors: Hill L.F, Clements M.N, Turner M.A, Donà D, Lutsar I, Jacqz-Aigrain E, Heath P.T, Roilides E, Rawcliffe L, Alonso-Diaz C, Baraldi E, Dotta A, Ilmoja M, Mahaveer A, Metsvaht T, Mitsiakos G,  Papaevangelou V, Sarafidis K, Walker A.S, Sharland M, on behalf of the NeoVanc Consortium

Published in: The Lancet

1

Dec, 2021

World AIDS Day 2021: How paediatric HIV has changed in the last 30 years

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It takes a community of people working together to achieve the results we are looking for: eradication HIV in children

 

The paediatric HIV pandemic has changed from when researchers first began investigating HIV in children to where we stand today.

The burden of perinatal infections, however, remains high. Perinatal infections occur when a pregnant person living with HIV passes HIV to her baby either during pregnancy, delivery or through breastfeeding. Despite unprecedented advances in the prevention of perinatal infections (including those occurring through breastfeeding) utilizing maternal ART and infant post- exposure preventative treatment, new infections continue. An estimated 1.8 million children under 15 years of age are living with HIV-1 globally, and 5 million survive to become adolescents and young adults with perinatal infection. In addition, around 150,000 children are born with HIV-1 annually, with about half of new infections occurring before and during birth and half through breastfeeding. The COVID-19 pandemic, through disruption of clinical care and its economic impact, increased these numbers in 2021 and beyond.

A multidisciplinary, multicultural approach to combat pediatric HIV-1 infection and discover immunotherapeutic strategies towards HIV remission, has been catalyzed by the EPIICAL consortium. The EPIICAL group of investigators and clinicians, through a number of virological and immunological studies conducted both in European HIV infected cohorts as well as in HIV positive African children, has gathered further evidence of efficacy of early therapy to reduce the amount of the virus within individuals and boost of specific immune responses. These studies will pave the way for further therapeutic strategies towards HIV remission using immunotherapeutic approaches.

From the clinical perspective, adherence in mother and child are strongly associated with achieving any therapeutic success. Barriers to the mother taking her therapy often mean that the child will also not be protected! But the mothers, if given the opportunity, do an amazing job at administering therapy to their children. It takes a community of people working together to achieve the results we are looking for and the work of social scientists plays a crucial role in identifying interventions that address non-adherence in mothers and children.

Holly Peay, senior Research Scientist at RTI International and EARTH social and behavioural study lead in EPIICAL, states that “Young children with HIV cannot control their own adherence. It is important to understand attitudes and barriers to adherence experienced by caregivers of children with HIV. That allows us to choose interventions that are targeted to the problems that caregivers experience and gives us hope that improving adherence in children will also improve adherence in their mothers and other HIV positive caregivers.”

The bottom line is, testing should never be delayed and early intervention can save the lives of both mother and the young child because when the mother is suppressed, the child is also likely to be suppressed.

Visit the EPIICAL website to learn more about the project.

Neonatal Intensive Care Unit in Padova University Hospital, Italy

27

Nov, 2021

NeoVanc: New study finds no clear benefit from a shorter optimised vancomycin treatment in babies with Gram positive late onset sepsis

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NeoVanc, a European trial featured in The Lancet Child & Adolescent Health, has published the findings of the largest neonatal vancomycin efficacy trial ever conducted. NeoVanc was a European, multicentre research study coordinated by Penta and funded by the European Commission’s 7th Framework Programme. It compared the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in infants with late onset sepsis. The NeoVanc programme* took place between March 2017 and July 2019 and involved 242 infants with serious infections from 22 neonatal intensive care units in Italy, Greece, Estonia, Spain and the UK. The aim of the study was to compare recovery from sepsis as well as relapses or new infections requiring further treatment between the two groups.

Dr Louise Hill, Lecturer in Paediatric Infectious Diseases at St George’s, University of London said, “Neonatal sepsis is a global health priority with around 3 million cases per year worldwide.  Premature babies and infants in the first 3 months of life represent a particularly vulnerable group because their immune systems are not yet fully developed. In Europe, coagulase-negative staphylococci (CoNS) are the most frequently identified bacteria in neonatal late onset sepsis and vancomycin is the antibiotic most commonly used to treat them.  However, despite being used for over 50 years, there are very few studies comparing different dosing regimens of vancomycin.”

To bridge this gap, the NeoVanc set out to compare the efficacy of administering an optimised regimen with a first (loading) dose of 25 mg/kg of vancomycin followed by lower doses of 15 mg/kg (at intervals determined by postmenstrual age (PMA)) over a shorter 5-day course with a standard 10-day course with lower daily dosing of 15 mg/kg of the drug throughout.

According to the Chief Investigator, Professor Mike Sharland of the Paediatric Infectious Diseases Research Group at St George’s, University of London, “the results of the study show that there is no clear advantage for adopting a shorter 5-day course, with a loading dose, over the standard 10-day course in infants under 3 months of age with severe sepsis.”

What emerged from the study was that babies in the shorter 5-day course group were more commonly assessed as not fully recovered by the end of treatment as compared with babies in the longer course group. Furthermore, twice as many babies (30%) in the short course group failed routine hearing testing compared to the longer course (15%), making further research in this area a priority.

In light of this finding, Professor Sharland added: “A NeoVanc follow-up study is currently underway to collect long-term hearing data on those infants who were affected by hearing dysfunction, particularly in relation to the use of the shorter treatment course.”

Read the paper on The Lancet Child Adolescent Health

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About the article

The article is: Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial

Louise F Hill*, Michelle N Clements*, Mark A Turner, Daniele Donà, Irja Lutsar, Evelyne Jacqz-Aigrain, Paul T Heath, Emmanuel Roilides, Louise Rawcliffe, Clara Alonso-Diaz, Eugenio Baraldi, Andrea Dotta, Mari-Liis Ilmoja, Ajit Mahaveer, Tuuli Metsvaht, George Mitsiakos, Vassiliki Papaevangelou, Kosmas Sarafidis, A Sarah Walker, Michael Sharland, on behalf of the NeoVanc Consortium†

The Lancet Child & Adolescent Health 2021, published online Nov 26 https://doi.org/10.1016/S2352-4642(21)00305-9

Lancet (thelancet.com)


*About NeoVanc
The NeoVanc project set out to analyse the adaptability of an off-label medicine, vancomycin, to the specific needs of neonates and infants, by developing an optimal dosing regimen. Coordinated by Penta and funded by the European Commission’s 7th Framework Programme, NeoVanc has successfully recruited almost 250 participants, and involved more than 20 sites in 5 European countries. This randomised, open label, phase IIb study compares the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in neonates and infants with late onset bacterial sepsis. The study team is currently developing publications to present the results to the wider public.

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