Publications

30

Dec, 2014

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

 

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

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

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18

Dec, 2014

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

 

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.

Methods Cross-sectional surveys of HIV-positive women were conducted i) at delivery (on antenatal ART adherence)

and ii) during the first year postpartum (on ART adherence in the preceding four weeks). Factors associated with a

score ≤11 on the self-report Case Adherence Support Evaluation (CASE) index or ≥1 self-reported missed dose were

assessed using Fisher’s exact test.

Results Of 185 antenatal participants and 102 postnatal participants, median ages were 27.5 and 29.5 years

respectively: 28% (50/180) and 27% (26/98) reported an unplanned pregnancy, and 13% (24/179) and 17% (17/98) an

illicit drug-use history (excluding marijuana). One quarter (49/180 antenatally, 27/101 postnatally) screened positive for

depression. The proportion reporting ‘low’ ART-related self-efficacy (i.e. unable to do ≥1/5 ART-taking activities) was

20% (28/141) antenatally and 17% (11/66) postnatally. Antenatally, 14% (95% CI 10-21%) had a CASE score ≤11 and

35% (95% CI 28-42%) reported missing ≥1 dose. Factors associated with a CASE score ≤11 were unplanned pregnancy

(25% (12/48) vs. 11% (13/120) where planned, p = 0.03) and living with extended family (23% (13/57) vs. 10% (12/125)

living with partner/alone, p = 0.04). Self-report of ≥1 missed dose antenatally was additionally associated with

younger age (p = 0.03) and lower self-efficacy (50% (14/28) reported ≥1 missed dose vs. 28% (30/108) of those

with high self-efficacy, p = 0.04). Of 102 postnatal participants, 8% (95% CI 4-15%) had a CASE score ≤11 and 31%

(95% CI 22-41%) reported ≥1 missed dose. Of 11 women with low self-efficacy, 3 (27%) had a CASE score ≤11

compared with 3/55 (5%) of those with high self-efficacy (p = 0.05). Current smokers more commonly reported ≥1

missed dose postnatally (50% (13/26) vs. 25% (18/72) of non-smokers, p = 0.03).

Conclusions Our results highlight unmet needs for counselling and support. We identify some groups at risk of

poor ART adherence, including women with markers of social vulnerability and those with low ART-related

self-efficacy, who may benefit from targeted interventions.

 

 

 

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23

Sep, 2014

Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

 

Authors: Ruggieri L., Giannuzzi V., Baiardi P., Bonifazi F., Davies E.H., Giaquinto C. , Bonifazi D., Felisi M., Chiron C., Pressler R., Rabe H., Whitaker M.J., Neubert A., Jacqz-Aigrain E., Eichler I., Turner M.A., Ceci A; GRiP Consortium.

Published in: Eur J Pediatr. 2015, 174: 481-91.

Abstract: The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.

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30

Aug, 2014

Effective exposure to atazanavir during pregnancy, regardless of tenofovir use

 

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

 

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30

Aug, 2014

A comparison of the pharmacokinetics of raltegravir during pregnancy and postpartum

 

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

 

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30

Aug, 2014

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

 

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

 

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18

Jul, 2014

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

 

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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18

Jul, 2014

Children living with HIV in Ukraine: response to antiretroviral therapy (ART) and duration of first-line regimens

 

Authors: Bagkeris E, Bailey H, Malyuta R, Volokha A, Thorne C

Published in: 6th International Workshop on HIV Pediatrics, July 18th-19th  2014, Melbourne, Australia.

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18

Apr, 2014

Using CD4 Percentage and Age to Optimize Pediatric Antiretroviral Therapy Initiation

 

Authors: Yin D., Warshaw M., Miller W., Castro H., Fiscus S., Harper L., Harrison L., Klein N., Lewis J., Melvin A., Tudor-Williams G., McKinney R.

Published in: Pediatrics, 2014;134(4):e1104-16

Background Quantifying pediatric immunologic recovery by highly active antiretroviral therapy (HAART) initiation at different CD4 percentage (CD4%) and age thresholds may inform decisions about timing of treatment initiation.

Methods HIV-1-infected, HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1. Data from 162 vertically infected children, with at least World Health Organization “mild” immunosuppression and CD4% <10th percentile, were analyzed for improvement to a normal CD4% (≥10th percentile) within 4 years after HAART initiation. Data from 209 vertically infected children, regardless of immune status, were analyzed for CD4% outcomes at 4 years and viral failure within 4 years.

Results Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years. Compared with “severe” immunosuppression, more children with “mild” immunosuppression (difference 36%, 95% confidence interval [CI]: 22% to 49%) or “advanced” immunosuppression (difference 20.8%, 95% CI: 5.8% to 35.9%) recovered a normal CD4%. For each 5-year increase in baseline age, the proportion of children achieving a normal CD4% declined by 19% (95% CI: 11% to 27%). Combining baseline CD4% and age effects resulted in >90% recovery when initiating HAART with “mild” immunosuppression at any age or “advanced” immunosuppression at age <3 years. Baseline CD4% effects became greater with increasing age (P = .02). At 4 years, most immunologic benefits were still significant but diminished. Viral failure was highest in infancy (56%) and adolescence (63%).

Conclusions Initiating HAART at higher CD4% and younger ages maximizes potential for immunologic recovery. Guidelines should weigh immunologic benefits against long-term risks.

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18

Apr, 2014

Post-licensing safety of fosamprenavir in HIV-infected children in Europe.

 

Authors: Judd A, Duong T, Galli L, et al; on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration study group in EuroCoord.

Published in: Pharmacoepidemiol  Drug Saf. 2014;23(3):321-5

Purpose Fosamprenavir, combined with low-dose ritonavir (FPV/r), is indicated for treatment of HIV-infected children aged ≥6 years in Europe. Our purpose was to assess the safety of licensed use of FPV/r in HIV-infected children reported to six cohorts in the European Pregnancy and Paediatric HIV Cohort Collaboration.

Methods Retrospective analysis of individual patient data for all children aged 6–18 years taking the licensed dose of FPV up to 31/12/10. Adverse events (clinical events and absolute neutrophil counts, total cholesterol and triglycerides, and alanine transaminase) were summarised and DAIDS gradings characterised severity.

Results Ninety-two HIV-infected children aged 6–18 years took the licensed dose, comprising 3% of the total number of children in follow-up in participating cohorts. Median age at antiretroviral therapy initiation was 6 years (interquartile range 1–11 years), and median age at start of FPV/r was 15 years (12–17 years). Estimated median time on an FPV-containing regimen was 52 months, with a total of 266.9 patient years of exposure overall. Half (54%) were on an FPV-containing regimen at last follow-up. Rates of grade 3/4 events were generally low for all biochemical toxicity markers, and no serious adverse events considered to be causally related to FPV/r were reported.

Conclusions Results suggest that long-term licensed dose FPV-containing regimens appear to be generally well tolerated with few reported toxicities in HIV-infected children in Europe, although relatively infrequently prescribed. No serious events were reported.

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