Meetings and events

31

Dec, 2017

Impact of time of ART initiation on HIV specific T cell functionality in perinatally infected young adults

 

Authors: Rinaldi S, Cotugno N, Pallikkuth S, Palma P, Pahwa S; on behalf of the EPIICAL Consortium

Published: 8th Conference on HIV Persistence

Background Early initiation of antiretroviral therapy (ART) in vertically HIV-infected children provides an opportunity to limit the size of reservoir, but whether and how the time of ART treatment initiation can durably impact host immune responses associated with HIV infection is still unknown. In this study, we analyzed HIV-specific CD4 T cell functionality in vertically HIV-infected children in whom ART was initiated early or late after birth.

 

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30

Dec, 2017

Congenital Cytomegalovirus. A european expert consensus statement on diagnosis and management

 

Authors: Luck SE, Wieringa JW, Blazquez-Gamero D, et al.

Published in: Pediatr Infect Dis J. 2017;36(12):1205-1213

 

27

Dec, 2017

Safety of zidovudine/lamivudine scored tablets in children with HIV infection in Europe and Thailand.

 

Authors: European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord.

Published inEur J Clin Pharmacol. 2017;73(4):463-468

Background Zidovudine (ZDV) has been associated with risk of haematological toxicity. Safety data from clinical trials is generally limited to 48 weeks. We assessed the short- and mid-term toxicity of ZDV/lamivudine (3TC) fixed-dose combination scored tablets in HIV-infected children followed in the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) network.

Methods Fourteen cohorts provided data on patients <18 years of age taking ZDV/3TC scored tablets between 2008 and 2012. Rates of Division of AIDS (DAIDS) grade ≥3 laboratory adverse events (AEs) for hepatobiliary and haematological disorders were estimated by duration on drug (<12, 12–24, >24 months). Clinical adverse events and reasons for tablet discontinuation were described.

Results Of 541 patients on ZDV/3TC, 388 (72%) had weight and dose data available, of whom 350 (90%) weighed ≥14 kg and were eligible for tablet use; 161 (41%) were aged <10 years on an approved dose, 189 (49%) aged ≥10 years on an approved dose, and 30 (8%) were on an unapproved dose. Median age at ZDV/3TC start was 10 years, and 79% had taken ART previously (60% had prior exposure to ZDV/3TC). Overall rates of grade ≥3 AEs for absolute neutrophil counts, bilirubin, haemoglobin, platelet counts, white blood cell counts (WBC), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were ≤2/100 person years (PY) for patients taking approved doses. Two hundred thirty-three (43%) patients were not on ZDV/3TC tablets at most recent follow-up; a small number (17 (7%)) discontinued due to AEs (17 (7%)), and the most common reason for discontinuation was treatment simplification (73 (31%)).

Conclusions Scored ZDV/3TC tablets, both approved and taken off-label, appear to be well tolerated with few side effects. Few patients discontinued treatment due to toxicity. As ZDV/3TC tablets are taken with other antiretrovirals, it is difficult to infer association between toxicities and specific agents, highlighting the importance of widening long-term pharmacovigilance to a broader spectrum of drug combinations.

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27

Dec, 2017

ID-EPTRI Kick-off-meeting, January 15th-16th 2018, Rome – Italy

 

PENTA is involved in the recently approved ID-EPTRI project, financed under the H2020-INFRADEV-01-2017 programme, which is aimed to design a new Research Infrastructure (RI) in Europe completely dedicated to Paediatrics. The project is led by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) and will last 24 months.

The Kick-off meeting will gather a consortium of 26 partners, from 19 EU and non-EU countries, to launch the project activities. In particular, it will be aimed to give all participants a better understanding of the tasks and goals of the project and to illustrate the key elements of the new research infrastructure.

 

 

21

Dec, 2017

Registrations to the 2nd International Meeting on Childhood Tubercolosis 2018 now open

 

The 2nd International Meeting on Childhood Tubercolosis is the only international European meeting entirely focusing on updates in prevention and treatment of TB in children and adolescents.

Topics covered by renowned Childhood TB experts will include: Towards zero death – tackling childhood TB in Europe and abroad, Clinical course of childhood TB, New insights into an old disease – from basic science to new diagnostics and MDR TB as a new threat.

You can help to enhance the programme by submitting an abstract. Bursaries are available to support young investigators.

Dates: Wednesday 21st to Friday 23rd March 2018

Venue: Crowne Plaza Vilnius, M. K. Čiurlionio g. 84, Vilnius 03100, Lithuania www.cpvilnius.com

Conference website: https://www.ptbnetvilnius2018.com/

About pTBnet: pTBnet is an international network of almost 200 clinicians and researchers in paediatric TB founded in 2009. The first International Meeting on Childhood Tuberculosis was organised by pTBnet in Padova, Italy in March 2013. This meeting was pivotal in bringing together experts in many aspects of paediatric TB, and was attended by over 100 delegates from across the globe.

21

Dec, 2017

Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

 

Authors: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T.

Published inBMJ Open. 2017;7(2):e012934

Objectives A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8–24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development.

Setting Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1).

Participants All BREATHER trial participants who were over the age of 10 and aware of their HIV diagnosis were invited to participate. 49 young people from both arms of the BREATHER trial (31 females and 18 males; 40% of the total trial population in the respective sites; age range 11–24) gave additional consent to participate in the qualitative study.

Results Young people from both trial arms had initial concerns about the impact of SCT on their health and adherence, but these decreased over the early months in the trial. Young people randomised to SCT reported preference for SCT compared with CT pre-trial. Attitudes to SCT did not vary greatly by gender or country. Once short-term adaptation challenges were overcome, SCT was positively described as reducing impact of side effects, easing the pressure to carry and remember medication and enabling more weekend social activities. Young people on both arms reported frequent medication side effects and occasional missed doses that they had rarely voiced to clinical staff. Participants liked SCT by trial end but were concerned that peers who had most problems adhering could find SCT disruptive and difficult to manage.

Conclusions To realise the potential of SCT (and mitigate possible risks of longer interruptions), careful dissemination and communication post-trial is needed. SCT should be provided alongside a package of monitoring, support and education over 3 months to allow adaptation.

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21

Dec, 2017

GRiP project: a Results in brief article from CORDIS

 

CORDIS (the Community Research and Development Information Service of the European Commission) has recently published a Results in Brief article about the EU-funded GRiP project.

The key objective of GRIP was to generate a Network of Excellence and provide the necessary infrastructure and knowledge for drug evaluation and development in the paediatric population. The project mobilised 22 institutions from Europe, North America and Japan, as well as the WHO.

 To read the article, go to CORDIS website at: http://cordis.europa.eu/result/rcn/91590_en.html 

19

Dec, 2017

Top recruiting numbers for PED-MERMAIDS!

 

We are delighted to announce that the enrollment to the PED-MERMAIDS study is proceeding at a remarkable pace and we have reached 230 patients this month. A big thank to all partners and their teams for the hard work they are doing to make this possible!

A special thank to the top recruiting site, the Hippokrateion Hospital at the Aristotle University of Thessaloniki. Congratulations and thank you for the outstanding contribution to the study!

PED-MERMAIDS is part of the project PREPARE (Platform for European Preparedness Against (Re-)emerging Epidemics), an EU funded network for harmonized large-scale clinical research studies on infectious diseases, prepared to rapidly respond to any severe ID outbreak, providing real-time evidence for clinical management of patients and for informing public health responses.

PREPARE is funded by the European Commission’s FP7 Programme under grant number 602525.

13

Dec, 2017

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

 

Authors: Namukwaya S, Paparini S, Seeley J, Bernays S.

Published in: Front Public Health. 2017;5:343.

Abstract: Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10-12 years old, children should be made fully aware of their HIV-positive status. However, this awareness is often delayed until much later in their adolescence. Few studies have been conducted to investigate what influences caregivers’ decision-making process in this regard in low-income settings. In this article, we present an analysis of care dyads of caregivers and HIV-positive young people in Kampala, Uganda, as part of the findings of a longitudinal qualitative study about young people’s adherence to antiretroviral therapy embedded in an international clinical trial (BREATHER). Repeat in-depth interviews were conducted with 26 young people living with HIV throughout the course of the trial, and once-off interviews with 16 of their caregivers were also carried out toward the end of the trial. In this article, we examine why and how caregivers decide to disclose a young person’s HIV status to them and explore their feelings and dilemmas toward disclosure, as well as how young people reacted and the influence it had on their relationships with and attitudes toward their caregivers. Caregivers feared the consequences of disclosing the young person’s positive status to them and disclosure commonly occurred hurriedly in response to a crisis, rather than as part of an anticipated and planned process. A key impediment to disclosure was that caregivers feared that disclosing would damage their relationships with the young people and commonly used this as a reason to continue to postpone disclosure. However, young people did not report prolonged feelings of blame or anger toward their caregivers about their own infection, but they did express frustration at the delay and obfuscation surrounding the disclosure process. Our findings can inform the ways in which mainstream HIV services support caregivers through the disclosure process. This includes providing positive encouragement to disclose fully and to be more confident in initiating and sustaining the timely process of disclosure.

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10

Dec, 2017

Enhanced prophylaxis plus antiretroviral therapy for advanced HIV infection in Africa

 

Authors: Hakim J, Musiime V, Szubert AJ; REALITY Trial Team

Published in: N Engl J Med. 2017;377(3):233-245

Background In sub-Saharan Africa, among patients with advanced human immunodeficiency virus (HIV) infection, the rate of death from infection (including tuberculosis and cryptococcus) shortly after the initiation of antiretroviral therapy (ART) is approximately 10%.

Methods In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled HIV-infected adults and children 5 years of age or older who had not received previous ART and were starting ART with a CD4+ count of fewer than 100 cells per cubic millimeter. They underwent simultaneous randomization to receive enhanced antimicrobial prophylaxis or standard prophylaxis, adjunctive raltegravir or no raltegravir, and supplementary food or no supplementary food. Here, we report on the effects of enhanced antimicrobial prophylaxis, which consisted of continuous trimethoprim-sulfamethoxazole plus at least 12 weeks of isoniazid-pyridoxine (coformulated with trimethoprim-sulfamethoxazole in a single fixed-dose combination tablet), 12 weeks of fluconazole, 5 days of azithromycin, and a single dose of albendazole, as compared with standard prophylaxis (trimethoprim-sulfamethoxazole alone). The primary end point was 24-week mortality.

ResultsA total of 1805 patients (1733 adults and 72 children or adolescents) underwent randomization to receive either enhanced prophylaxis (906 patients) or standard prophylaxis (899 patients) and were followed for 48 weeks (loss to follow-up, 3.1%). The median baseline CD4+ count was 37 cells per cubic millimeter, but 854 patients (47.3%) were asymptomatic or mildly symptomatic. In the Kaplan-Meier analysis at 24 weeks, the rate of death with enhanced prophylaxis was lower than that with standard prophylaxis (80 patients [8.9% vs. 108 [12.2%]; hazard ratio, 0.73; 95% confidence interval [CI], 0.55 to 0.98; P=0.03); 98 patients (11.0%) and 127 (14.4%), respectively, had died by 48 weeks (hazard ratio, 0.76; 95% CI, 0.58 to 0.99; P=0.04). Patients in the enhanced-prophylaxis group had significantly lower rates of tuberculosis (P=0.02), cryptococcal infection (P=0.01), oral or esophageal candidiasis (P=0.02), death of unknown cause (P=0.03), and new hospitalization (P=0.03). However, there was no significant between-group difference in the rate of severe bacterial infection (P=0.32). There were nonsignificantly lower rates of serious adverse events and grade 4 adverse events in the enhanced-prophylaxis group (P=0.08 and P=0.09, respectively). Rates of HIV viral suppression and adherence to ART were similar in the two groups.

Conclusions Among HIV-infected patients with advanced immunosuppression, enhanced antimicrobial prophylaxis combined with ART resulted in reduced rates of death at both 24 weeks and 48 weeks without compromising viral suppression or increasing toxic effects.

 

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