Publications

Safety of darunavir and atazanavir in HIV-infected children in Europe and Thailand

2016

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

Published in: Antivir Ther. 2016; 21(4): 353-8

Background Surveillance for mid- and long-term antiretroviral therapy (ART) toxicity in children is important for informing treatment guidelines. We assessed the safety of darunavir (DRV) and atazanavir (ATV), commonly used as second-line protease inhibitors following lopinavir/ritonavir,

Interventions to improve treatment, retention and survival outcomes for adolescents with perinatal HIV-1 in high- and middle-income countries: Moving on up.

2016

Authors: Judd A, Sohn A, Collins J.

Published in: Curr Opin HIV AIDS 2016;11(5):477-486.

Purpose of review There is an increasing number of deaths among adult survivors of perinatal HIV. Multiple and complex factors drive this mortality, including problems with retention in care and adherence during adolescence,

Prevalence and effect of pre-treatment drug resistance on the virological response to antiretroviral treatment initiated in HIV-infected children – a EuroCoord-CHAIN-EPPICC joint project.

2016

Authors: Ngo-Giang-Huong N, Wittkop L, Judd A, et al. For EuroCoord-CHAIN-EPPICC joint project study group.

Published in: BMC Infect Dis. 2016;16(1):654.

Background Few studies have evaluated the impact of pre-treatment drug resistance (PDR) on response to combination antiretroviral treatment (cART) in children. The objective of this joint EuroCoord-CHAIN-EPPICC/PENTA project was to assess the prevalence of PDR mutations and their association with virological outcome in the first year of cART in children.

Editorial Overview: Virus–vector interactions

2016

Authors: Kramer LD, Long MT

Published in: Curr Opin Virol. 2016 Dec;21:v-vi

 

Is pregnancy a barrier to the proposed lower dose of efavirenz?

2016

Authors: Schalkwijk S, ter Heine R, Colbers A,  Huitema A, Denti P, Dooley K, Capparelli E, Best B, Cressey T, Greupink R, Russel F, Mirochnick M, Burger D.

Published: 17th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, June 8th-10th 2016, Washington DC.  P_26

 

Timing of the postpartum curve in pharmacokinetic studies in pregnancy should not be too early

2016

Authors: Colbers A, Schalkwijk S, Konopnicki D, Hawkins D, Hidalgo Tenorio C, Moltò J, Taylor G, Weizsacker K, van der Ende M, Burger D

Published: Oral presentation at 17th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, June 8th-10th 2016, Washington DC

 

A Comparison of the Pharmacokinetics of Efavirenz During Pregnancy and Postpartum

2016

Authors: Schalkwijk S, Best B, Colbers A, SteK A, Wang  J, Hawkins D, Mirochnick M, Burger D; for the The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1026s Protocol Team, and the Pharmacokinetics of Newly Developed Antiretroviral Agents in HIV-infected Pregnant Women (PANNA) Study Network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, February 22nd-25th 2016, Boston

 

Etravirine Pharmacokinetics in HIV-Infected Pregnant Women

2016

Authors: Blonk MI, Colbers AP, HidalgoTenorio C, et al.

Published inFront Pharmacol. 2016 Aug 4;7:239.

Background: The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women.

Methods: IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women.

Substantially lowered dolutegravir exposure in a treatment-experienced perinatally HIV-1-infected pregnant woman

2016

Authors: Schalkwijk S, Feiterna-Sperling C, Weizsacker K, et al.

Published in: AIDS. 2016; 30(12):1999-2001.

No Abstract available

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial

2016

Author: Butler K, Inshaw J, Ford D, et al.

Published in:  Health Technol Assess. 2016;20(49):1-108.

Background For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy;

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial

2016

Author: The BREATHER (PENTA 16) Trial Group

Published inLancet HIV. 2016;3(9):e421-430

Background For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).

The pharmacokinetics of abacavir 600 mg once daily in HIV-1-positive pregnant women

2016

Authors: Schalkwijk S, Colbers A, Konopnicki D, et al. For PANNA network

Published inAIDS. 2016;30(8):1239-44.

Objective To describe the pharmacokinetics of abacavir 600 mg once daily (q.d.) in HIV-1-positive women during pregnancy and postpartum.

Design A nonrandomized, open-label, multicentre, phase-IV study.

Methods HIV-positive pregnant women receiving abacavir 600 mg q.d.

High prevalence of herpes simplex virus (HSV)- type 2 co-infection among HIVpositive women in Ukraine, but no increased HIV mother-to-child transmission risk

2016

Authors: Aebi-Popp K, Bailey H, Malyuta R, Volokha A, Thorne C. Ukraine European Collaborative Study in EuroCoord.

Published in: BMC Pregnancy Childbirth. 2016;27;16:94

Background Over 3500 HIV-positive women give birth annually in Ukraine, a setting with high prevalence of sexually transmitted infections. Herpes simplex virus Type 2 (HSV-2) co-infection may increase HIV mother-to-child transmission (MTCT) risk.

Neurocognition and quality of life after reinitiating antiretroviral therapy in children randomized to planned treatment interruption

2016

Authors: Ananworanich J, Melvin D, Ramos Amador JT, et al; on behalf of the PENTA 11 study group.

Published in: AIDS. 2016;30(7):1075-81.

Objective Understanding the effects of antiretroviral treatment (ART) interruption on neurocognition and quality of life (QoL) are important for managing unplanned interruptions and planned interruptions in HIV cure research.

Design Children previously randomized to continuous (continuous ART, 

First reported use of elvitegravir and cobicistat during pregnancy

2016

Authors: Schalkwijk S, Colbers A, Konopnicki D, Greupink R, Russel FG, Burger D; PANNA network.

Published inAIDS. 2016;30(5):807-8.

Abstract not available

Children and young people with perinatal HIV in Europe: epidemiological situation in 2014 and implications for the future

2016

Authors: Writing group for the Kids to Adults Working Group and Data Management and Harmonisation Group in EuroCoord.

Published inEuro Surveill.2016;21(10): 30162

Abstract Accurate ascertainment of the number of children living with human immunodeficiency virus (HIV) is important to plan paediatric and adolescent health services. In Europe, the first generation of perinatally HIV-infected survivors are transferring to adult care and their health needs are unknown.

The European Paediatric Mycology Network (EPMyN): Towards a Better Understanding and Management of Fungal Infections in Children

2016

Author: Warris A; European Paediatric Mycology Network (EPMyN)*.

Published in: Curr Fungal Infect Rep. 2016;10:7-9.

Abstract: The European Paediatric Mycology Network (EPMyN) was launched in 2014 to create a European platform for research and education in the field of paediatric mycology. The EPMyN aims to address the lack of paediatric specific evidence and knowledge needed to (1) improve the management and outcome of invasive fungal infections in children and neonates and to (2) enhance and develop paediatric anti-fungal stewardship programmes.

When information does not suffice: young people living with HIV and communication about ART adherence in the clinic

2016

Authors: S. Bernays, S. Paparini, D. Gibb & J. Seeley

Published in: Vulnerable Child Youth Stud. 2016;11(1):60-68

Abstract Despite mounting evidence recommending disclosure of human immunodeficiency virus (HIV) status to young people with perinatally acquired HIV as a central motivating factor for adherence to antiretroviral therapy, many young people continue to experience disclosure as a partial event,

Darunavir population pharmacokinetics in pregnancy

2015

Authors: Moltò J, Valle M, Colbers A, Clotet V, Burger D.

Published: 16th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, May 26th – 28th 2015, Westin Alexandria

 

HIV-1 Drug Resistance and Second-line Treatment in Children Randomized to Switch at Low versus Higher RNA Thresholds

2015

Authors: Harrison L, Melvin A, Fiscus S, et al. For PENPACT-1 (PENTA 9PACTG 390) Study Team.

Published in: JAIDS 2015;70(1):42-53

Background The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold.

Methods PENPACT-1 had a 2 × 2 factorial design,

I was like, oh my God, what happens if it doesn’t work’? Young people living with HIV, clinical trial participation and the truth economy

2015

Authors: Bernays S, Seeley J, Paparini S, Rhodes T

Published: BSA Medical Sociology Conference, York, 9-11 September 2015 (Paper ID No: W0012148)

Raltegravir in HIV-1 Infected Pregnant Women: Pharmacokinetics, Safety, and Efficacy

2015

Authors: Blonk MI, Colbers AP, Hidalgo-Tenorio C, et al. Pharmacokinetics of Newly Developed Antiretroviral Agents in HIV-Infected Pregnant Women PANNA Network; PANNA Network.

Published in: Clin Infect Dis. 2015; 61(5):809-816. 

BackgroundThe use of raltegravir in human immunodeficiency virus (HIV)–infected pregnant women is important in the prevention of mother-to-child HIV transmission,

Ritonavir pharmacokinetics in pregnancy

2015

Authors: Colbers A, Clotet V, Burger D.

Published: 16th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, May 26th – 28th 2015, Westin Alexandria

 

Etravirine pharmacokinetics during pregnancy and postpartum

2015

Authors: Best B, Colbers A, Wang J, Taylor G, Stek A, van Kasteren M, Mirochnick M, Burger D.

Published: 24th Conference on Retroviruses and Opportunistic Infections, March 23rd-26th 2015, Seattle. P_892

 

Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

2015

Authors: Colbers A, Best B, Schalkwijk S, et al. PANNA Network and the IMPAACT 1026 Study Team.

Published in: Clin Infect Dis. 2015; 61(10):1582-1589.

Objective To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)–infected women during pregnancy and post partum.

Methods HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery.

I am scared of getting caught up in my lie’: challenges to self-reported adherence for young people living with HIV

2015

Authors:  Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams.

Published in: accepted for presentation at AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)

Young people, clinical trials and ‘the HIV experience’: What can similarities across time and place tell us about growing up with HIV?

2015

Authors:  Paparini S on behalf of Bernays S, Seeley S,  Rhodes T,  Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

“But it’s my story”: exploring the experience and effect of telling children how they have acquired HIV

2015

Authors:  Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S,  Rhodes T and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

Early antiretroviral therapy in children perinatally infected with HIV: a unique opportunity to implement immunotherapeutic approaches to prolong viral remission

2015

Authors: Klein N, Palma P, Luzuriaga K, et al.

Published in: Lancet Infect Dis. 2015;15(9):1108-1114

Abstract From the use of antiretroviral therapy to prevent mother-to-child transmission to the possibility of HIV cure hinted at by the Mississippi baby experience, paediatric HIV infection has been pivotal to our understanding of HIV pathogenesis and management. Daily medication and indefinite antiretroviral therapy is recommended for children infected with HIV.

“But it’s my story”: exploring the experience and effect of telling children how they have acquired HIV

2015

Authors: Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S,  Rhodes T and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

Young people, clinical trials and ‘the HIV experience’: What can similarities across time and place tell us about growing up with HIV?

2015

Author: Paparini S on behalf of Bernays S, Seeley S, Rhodes T, Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

‘I am scared of getting caught up in my lie’: challenges to self-reported adherence for young people living with HIV; accepted for presentation at AIDS Impact

2015

Authors: Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams

Published in: AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)

The EPIICAL project: an emerging global collaboration to investigate immunotherapeutic strategies in HIV-infected children

2015

Authors: Palma P, Foster C, Rojo P, et al.

Published in: J Virus Erad. 2015;1(3):134-139.

Abstract The EPIICAL (Early-treated Perinatally HIV-infected Individuals: Improving Children’s Actual Life with Novel Immunotherapeutic Strategies) project arises from the firm belief that perinatally infected children treated with suppressive antiretroviral therapy (ART) from early infancy represent the optimal population model in which to study novel immunotherapeutic strategies aimed at achieving ART-free remission.

Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update Decemebr 2014

2015

Authors: Antinori A., Marcotullio S., Andreoni M., Ammassari A., d’Arminio Monforte A., Galli M., Girardi E., Mazzotta F., Mussini C., Puoti M., Lazzarin A.; Italian HIV Guidelines Working Group.

Published inNew Microbiol. 2015, 38: 299-328

Abstract: This short version complies with the intention expressed in the introduction to the full text Italian Guidelines for the use of antiretroviral drugs and the diagnostic-clinical management of people with HIV-1 infection.

Pediatric drug safety surveillance in FDA-AERS: a description of adverse events from GRIP project.

2015

Authors:  De Bie S., Ferrajolo C., Straus S.M., Verhamme K.M., Bonhoeffer J., Wong I.C., Sturkenboom M.C., GRiP network

Published in: PLoS One. 2015, 10: 0130399.

Abstract: Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Treating hepatitis C virus in children: time for a new paradigm

2015

Authors: Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E.

Published in: J Virus Erad. 2015 Jul 1;1(3):203-5.

Abstract Hepatitis C virus infection is a leading cause of liver-related morbidity and mortality. In the paediatric population, HCV infection is underdiagnosed and undertreated in the absence of robust screening policies worldwide, and a lack of tolerable,

HCV treatment in children and young adults with HIV/HCV co-infection in Europe.

2015

Authors: Turkova A, Giacomet V, Goetghebuer T, et al.

Published in: J Virus Erad. 2015;1(3):179-184

Objectives To describe use of treatment for chronic hepatitis C virus (HCV) infection in HIV/HCV co-infected children and young people living in Europe and to evaluate treatment outcomes.

Methods HCV treatment data on children and young people aged <25 years with HIV/HCV co-infection were collected in a cohort collaboration of 11 European paediatric HIV cohorts.

Once vs. twice-daily lopinavir/ritonavir in HIV-1-infected children.

2015

Authors: Paediatric European Network for Treatment of AIDS (PENTA).

Published in: AIDS 2015. 29(18):2447-2457

Objective To evaluate whether once daily (q.d.) lopinavir/ritonavir is noninferior to twice daily (b.i.d.) dosing in children.

Design International, multicentre, phase II/III, randomized, open-label, noninferiority trial (KONCERT/PENTA18/ANRS150).

Setting Clinical centres participating in the PENTA,

Once- versus twice-daily lopinavir/ritonavir in HIV-1 infected children: a randomised controlled trial (KONCERT/PENTA18/ANRS150).

2015

Authors:

Published in: AIDS 2015, 29:2447-2457

Objective To evaluate whether once daily (q.d.) lopinavir/ritonavir is noninferior to twice daily (b.i.d.) dosing in children.

Design International, multicentre, phase II/III, randomized, open-label, noninferiority trial (KONCERT/PENTA18/ANRS150).

Setting Clinical centres participating in the PENTA, HIV-NAT and PHPT networks.

Participants Children/adolescents with HIV-1 RNA viral load less than 50 copies/ml for at least 24 weeks on lopinavir/ritonavir-containing antiretroviral therapy.

ART With Weekends Off Is Noninferior to Continuous ART in Young People on EFV+2NRTI

2015

Authors: Karina M. Butler on behalf of the BREATHER trial team

Published in: CROI 2015, Seattle, USA, Feb 23 -26 2015.

Abstract For HIV-1 infected young people (YP) facing lifelong ART, short cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity and better adherence, as well as cost savings.

Long-term consequences of planned treatment interruption in HIV-1-infected children.

2015

Authors: Freguja R, De Rossi A, Paulson H, Klein N, Del Bianco P, Compagnucci A, Saidi Y, Giaquinto C, Harper L, Gibb D, on behalf of the PENTA Steering Committee

Published in: CROI 2015, Seattle, USA, Feb 23 -26 2015. Poster presentation abstract 919

Pharmacokinetics of total and unbound darunavir in HIV-1-infected pregnant women

2015

Authors: Colbers A, Molto J, Ivanovic J, et al. PANNA Network

Published in: J Antimicrob Chemother. 2015; 70(2):534-542

Objectives To describe the pharmacokinetics of darunavir in pregnant HIV-infected women in the third trimester and post-partum.

Patients and Methods This was a non-randomized, open-label, multicentre, Phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.

HIV-1 Drug Resistance and Second-line Treatment in Children Randomized to Switch at Low versus Higher RNA Thresholds

2015

Authors: Harrison L, Melvin A, Fiscus S, et al; PENPACT-1 (PENTA 9PACTG 390) Study Team.

Published in: J Acquir Immune Defic Syndr. 2015;70(1):42-53

Background The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold.

Atazanavir exposure is effective during pregnancy regardless of tenofovir use

2015

Authors: Colbers A, Hawkins D, HidalgoTenorio C, et al.

Published in: Antivir Ther. 2015; 20(1):57-64

Background We studied the effect of pregnancy on atazanavir pharmacokinetics in the presence and absence of tenofovir.

Methods This was a non-randomized, open-label, multicentre Phase IV study in HIV-infected pregnant women recruited from European HIV treatment centres.

Pharmacokinetics, safety and transplacental passage of rilpivirine in pregnancy: two cases

2014

Authors: Colbers A,  Gingelmaier A, van der Ende M, Rijnders, B, Burger D.

Published in: AIDS 2014;28(2): 288-290

Adherence to antiretroviral therapy in pregnancy and during the first year post-partum in HIV-positive women in Ukraine

2014

Authors: Bailey H, Townsend C, Semenenko I, Malyuta R, Cortina-Borja, Thorne C; for the Ukraine European Collaborative Study in EuroCoord

Published in: BMC Public Health. 2014; 24(14):993

Background Poor adherence to antiretroviral therapy (ART) is associated with HIV disease progression and, during

pregnancy, increased mother-to-child transmission risk. In Ukraine, access to combination ART is expanding but data

on adherence are scarce.

Effective exposure to atazanavir during pregnancy, regardless of tenofovir use

2014

Authors:  Colbers A, Hawkins D, Hidalgo-Tenorio C, van der Ende M, Kabeya K, Gingelmaier A, Weizsäcker K, Lambert J, Rockstroh J, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_892

 

A comparison of the pharmacokinetics of raltegravir during pregnancy and postpartum

2014

Authors: Blonk M, Colbers A, Hidalgo-Tenorio C, Weizsäcker K, Moltó J, Hawkins D, van der Ende M, Gingelmaier A, Taylor G, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_890

 

Low darunavir exposure during pregnancy with 800/100mg darunavir/r QD dosing

2014

Authors: Colbers A, Moltó J, Ivanovic J, Hawkins D, Sadiq T, Kabeya K,  Gingelmaier A, Weizsäcker K, Taylor G, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_887

 

Uptake and outcomes of HCV treatment in children and young adults with HIV/HCV co-infection in Europe

2014

Authors: Turkova A; for the European Paediatric HIV/HCV Co-infection Study Group in the European Pregnancy and Paediatric HIV Cohort Collaboration in EuroCoord.

Published in: 20th International AIDS Conference (AIDS 2014), July 20th-25th 2014, Melbourne, Australia.

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