HIV | PANNA

A population pharmacokinetics analysis assessing the exposure of raltegravir once‐daily 1200mg in pregnant women living with HIV

2020

Authors: Vera E. Bukkems, Teun M. Post, Angela P. Colbers, David M. Burger, Elin M. Svensson

Published in: American Society for Clinical Pharmacology and Therapeutics

 

Abstract: Once‐daily two 600mg tablets (1200mg QD) raltegravir offers an easier treatment option compared to the twice‐daily regimen of one 400mg tablet. No pharmacokinetic, efficacy or safety data of the 1200mg QD regimen have been reported in pregnant women to date as it is challenging to collect these clinical data.

The effect of pregnancy on the pharmacokinetics of total and unbound Dolutegravir and its main metabolite in women living with Human Immunodeficiency Virus

2020

Authors: Bollen P, Freriksen J, Konopnicki D, Weizsäcker K , et al; on behalf of the Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women Network

Published in: Clin infect Dis2020;26.ciaa006

Background Pharmacokinetic and efficacy data on dolutegravir in pregnant women living with human immunodeficiency virus (HIV) are still limited but needed to support its use as one of the preferred antiretroviral agents.

Clinically significant lower elvitegravir exposure during third trimester of pregnant patients living with HIV: data from the PANNA study

2020

Authors: Bukkems V, Necsoi C, Hidalgo Tenorio C, et al. PANNA Network

Published in: Clin infect Dis2020; 24;ciaa488.

Abstract This phase-IV study investigated the influence of pregnancy on the pharmacokinetics of elvitegravir/cobicistat in 14 HIV-1-positive women. The results support the recommendation against elvitegravir/cobicistat use during pregnancy, as the elvitegravir Ctrough was reduced by 77%,

Dolutegravir pharmacokinetics during pregnancy and postpartum

2019

Authors: Colbers A, Bollen P, Freriksen J, Konopnicki D, Weizsäcker K, Hidalgo Tenorio C, Moltó J, Taylor G, Alejandre I,  van Crevel R, Burger D; on behalf of the PANNA network

Published: 26th Conference on Retroviruses and Opportunistic Infections, March 4th – 7th, 2019– Seattle. P_758.

 

Dolutegravir pharmacokinetics during pregnancy and postpartum

2019

Authors: Colbers A, Bollen P, Freriksen J, Konopnicki D, Weizsäcker K, Hidalgo Tenorio C, Moltó J, Taylor G, Alejandre I,  van Crevel R, Burger D.

Published: Oral presentation at 9th edition of the International Workshop on HIV & Women, March 2nd-3rd 2019, Seattle

 

Efavirenz pharmacokinetics during pregnancy and infant washout

2019

Authors: Kreitchmann R, Schalkwijk S, Best B, et al.

Published in: Antivir Ther. 2019;24(2):95-103

Background Limited data exist on efavirenz pharmacokinetics in HIV-positive pregnant women and neonatal washout.

Methods HIV-infected pregnant women receiving 600 mg efavirenz once daily had intensive steady-state 24-h pharmacokinetics profiles during the second trimester (2T),

Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling

2019

Authors: Schalkwijk S, Ter Heine R, Colbers A, et al.

Published in: J Antimicrob Chemother. 2019;30 [Epub ahead of print]

Background Darunavir 800 mg once (q24h) or 600 mg twice (q12h) daily combined with low-dose ritonavir is used to treat HIV-positive pregnant women. Decreased total darunavir exposure (17%-50%) has been reported during pregnancy,

First report of dolutegravir unbond plasma concentrations during pregnancy in HIV-positive women

2018

Authors: Bollen P, Colbers A, Schalkwijk S, Velthoven-Graafland K, Konopnicki D, Weizsacker K, Hidalgo Tenorio C, van Crevel R, Burger D, on behalf of the PANNA network

Published: Oral presentation at 19th edition of the International Workshop on Clinical Pharmacology of Antiviral Therapy, May 22nd-24th 2018, Baltimore

 

Elvitegravir pharmacokinetics during pregnancy and postpartum

2018

Authors: Colbers A, Schalkwijk S, Konopnicki D, Rockstroh  J, Burger D, on behalf of the PANNA network

Published: Oral presentation at 19th edition of the International Workshop on Clinical Pharmacology of Antiviral Therapy, May 22nd-24th 2018, Baltimore.

 

Lowered Rilpivirine Exposure During the Third Trimester of Pregnancy in Human Immunodeficiency Virus Type 1-Infected Women

2017

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

Published in: Clin Infect Dis. 2017; 65(8):1335-1341.

Background The use of antiretroviral therapy during pregnancy is important for control of maternal human immunodeficiency virus (HIV) disease and the prevention of perinatal HIV transmission. Physiological changes during pregnancy can reduce antiretroviral exposure.

Substantially lower rilpivirine plasma concentrations during pregnancy

2017

Authors: Colbers A, Schalkwijk S, Konopnicki D, Gingelmaier A, Lambert J, van der Ende I, Moltó J, Burger D.

Published: 24th Conference on Retroviruses and Opportunistic Infections, February 13th – 16th, 2017 – Seattle. Abstract number 754.

Physiologically Based Modelling of Darunavir/Ritonavir Pharmacokinetics During Pregnancy

2016

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

Published in: Clin Pharmacokinet. 2016;55(3):381-96

Abstract Pregnant women are usually excluded from clinical trials. Physiologically based pharmacokinetic (PBPK) modelling may provide a method to predict pharmacokinetics in pregnant women, without the need to perform extensive in vivo clinical trials.

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

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.

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

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

 

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.

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.

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

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

 

A comparison of the pharmacokinetics of maraviroc during pregnancy and postpartum

2013

Authors:  Colbers A, Brookie B, Wang J, Stek A, Hidalgo-Tenorio C, Hawkins D, Taylor G, Capparelli E, Burger D, Mirochnick M; on behalf of the PANNA network

Published: 20th Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2013, Atlanta. P_931

 

The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women

2013

Authors: Colbers AP, Hawkins DA, Gingelmaier A, et al.

Published in: Aids. 2013; 27(5):739-748.

Objective To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum.

Design A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.

A comparison of the pharmacokinetics of tenofovir during pregnancy and post-partum

2012

Authors: Colbers A, Taylor G, Moltó J, Ivanovic J, Wyen C, Schwarze-Zander C, Weizsäcker K, Gingelmaier A, Hawkins D, Sadiq T, Kabamba K, Burger D; on behalf of the PANNA network

Published: 13th International Workshop on Clinical Pharmacology of HIV Therapy, 2012 April 16th-18th, Barcelona

 

A comparison of the pharmacokinetics of darunavir, atazanavir and ritonavir during pregnancy and post-partum

2012

Authors: Colbers A, Moltó J, Ivanovic J, Hidalgo-Tenori C, Weizsäcker K, van der Ende I, Hawkins D, Taylor G, Sadiq T,  Burger D; on behalf of the PANNA network

Published: 19th Conference on Retroviruses and Opportunistic Infections, March 5th-8th 2012, Seattle. P_103

 

A comparison of the pharmacokinetics of raltegravir during pregnancy and post-partum

2011

Authors: Colbers A, Taylor G, Moltó J, Ivanovic J, Taylor G, Branco T, Wyen C, van der Ende I, Gomes da Silva H, Burger D; on behalf of the PANNA network

Published: 12th International Workshop on Clinical Pharmacology of HIV Therapy, 2011 April 13th-15th, Miami. P_18

 

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