XIX International AIDS Conference


TUAB02 PK, Efficacy and Safety of ART in Infants and Children
  Oral Abstract Session : Track B
Venue: Session Room 8
Time: 24.07.2012, 11:00 - 12:30
Chair: Philippa Musoke, Uganda
 
 

11:00
TUAB0201
Abstract
Powerpoint
Webcast
Tenofovir disoproxil fumarate (TDF) pharmacokinetics (PK) with daily dosing in the first week of life (HPTN 057)
K. Nielsen-Saines1, M. Mirochnick2, N. Kumwenda3, E.C. Joao4, R. Kreitchmann5, J. Pinto6, B. Santos7, T. Parsons8, P. Richardson8, T. Taha3, L. Mofenson9, P. Sato10, B. Kearney11, M.G. Fowler12
1David Geffen School of Medicine at UCLA, Los Angeles, United States, 2Boston University, Boston, United States, 3Johns Hopkins Bloomberg School of Public Health, Baltimore, United States, 4Hospital dos Servidores do Estado, Rio de Janeiro, Brazil, 5Irmandade da Santa Casa de Misercordia de Porto Alegre, Porto Alegre, Brazil, 6Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 7Grupo Hospitalar Conceicao, Porto Alegre, Brazil, 8Johns Hopkins Univ. School of Medicine, Baltimore, United States, 9NICHD/PAMAB, Bethesda, United States, 10NIAID, Bethesda, United States, 11Gilead Sciences, Forest City, United States, 12Johns Hopkins Medical Institutes, Kampala, Uganda
K. Nielsen-Saines, United States

11:15
TUAB0202
Abstract
Powerpoint
Webcast
Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-positive four weeks to < two year-old children (48-week data, study APV20002, a prospective, open-label, multi-centre, 48-week cohort study)
M. Cotton1, H. Cassim2, N. Pavía-Ruz3, L. Ross4, S. Ford4, N. Givens5, K. Cheng5, J. Sievers5
1Tygerberg Children's Hospital, Tygerberg, South Africa, 2Perinatal HIV Research Unit, Johannesburg, South Africa, 3Universidad Nacional Autonoma de Mexico, Facultad de Medicina, Mexico, DF, Mexico, 4GlaxoSmithKline, Research Triangle Park, United States, 5GlaxoSmithKline, Uxbridge, United Kingdom
J. Sievers, United Kingdom

11:30
TUAB0203
Abstract
Powerpoint
Webcast
Pharmacokinetics, safety and efficacy of dolutegravir (DTG; S/GSK1349572) in HIV-1-positive adolescents: preliminary analysis from IMPAACT P1093
R. Hazra1, R. Viani2, E. Acosta3, N. Zheng4, C. Alvero4, E. O'Gara5, E. Petzold6, B. Heckman7, D. Steimers8, I. Song8, S. Piscitelli8, A. Wiznia9, P1093 Study Team
1NIH/NICHD, Pediatric Adolescent and Maternal AIDS Branch, Bethesda, United States, 2University of California San Diego School of Medicine, La Jolla, United States, 3University of Alabama at Birmingham School of Medicine, Birmingham, United States, 4Harvard School of Public Health, Boston, United States, 5NIH/NIAID, International Maternal, Adolescent and Pediatric Branch, Bethesda, United States, 6Social & Scientific Systems, Durham, United States, 7Frontier Science and Technology Research Foundation, Inc., Amherst, United States, 8GlaxoSmithKline, Research Triangle Park, United States, 9Jacobi Medical Center, Bronx, United States
R. Hazra, United States

11:45
TUAB0204
Abstract
Powerpoint
Webcast
Safety and efficacy of etravirine in HIV-1-infected, treatment-experienced children and adolescents: PIANO 48-week results
G. Tudor-Williams1, P. Cahn2, K. Chokephaibulkit3, J. Fourie4, C. Karatzios5, S. Dincq6, T.N. Kakuda7, S. Nijs6, L. Tambuyzer6, F. Tomaka7
1Imperial College Department of Medicine, London, United Kingdom, 2Fundación Huesped, Buenos Aires, Argentina, 3Mahidol University, Bangkok, Thailand, 4Dr Jan Fourie Medical Practice, Dundee, South Africa, 5McGill University Health Centre, Montréal, Canada, 6Janssen Infectious Diseases BVBA, Beerse, Belgium, 7Janssen Research & Development, LLC, Titusville, United States
G. Tudor-Williams, United Kingdom

12:00
TUAB0205
Abstract
Powerpoint
Webcast
IMPAACT P1066: raltegravir (RAL) safety and efficacy in HIV infected (+) youth two to 18 years of age through week 48
S. Nachman1, E. Acosta2, N. Zheng3, H. Teppler4, B. Homony4, X. Xu4, C. Alvero3, E. Handelsman5, C. Worrell6, B. Graham7, M. Toye8, E. Petzold9, A. Wiznia10, and the P1066 Group
1SUNY Stony Brook, Pediatrics, Stony Brook, United States, 2University of Alabama at Birmingham, Birmingham, United States, 3Harvard School of Public Health, Boston, United States, 4Merck, North Wales, United States, 5Division of AIDS, NIAID, NIH, Bethesda, United States, 6Natl Inst of Child Hlth and Human Devt, Bethesda, United States, 7Frontier Science Inc, Buffalo, United States, 8Baystate Medical Center, Springfield, United States, 9Social and Scientific Systems, Durham, United States, 10Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, United States
S. Nachman, United States

Powerpoints presentations
Tenofovir disoproxil fumarate (TDF) pharmacokinetics (PK) with daily dosing in the first week of life (HPTN 057) - Karin Nielsen-Saines

Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-positive four weeks to < two year-old children (48-week data, study APV20002, a prospective, open-label, multi-centre, 48-week cohort study) - Jorg Sievers

Pharmacokinetics, safety and efficacy of dolutegravir (DTG; S/GSK1349572) in HIV-1-positive adolescents: preliminary analysis from IMPAACT P1093 - Rohan Hazra

Safety and efficacy of etravirine in HIV-1-infected, treatment-experienced children and adolescents: PIANO 48-week results - Gareth Tudor-Williams

IMPAACT P1066: raltegravir (RAL) safety and efficacy in HIV infected (+) youth two to 18 years of age through week 48 - Sharon Nachman



Rapporteur report

Track B report by Dr. Omar Sued


During the session several open trials for evaluating pediatric formulations were presented. All presented acceptable PK parameters, efficacy and safety profile, promising further more options for HIV children, in particular with studies including integrase inhibitors:

1)      The HPTN 057 is a Phase I trial of tenofovir at the peripartum involving 33 mothers and their children in Brazil and Malawi. Dose was 600 mg for mothers and 6 mg/kg suspension x 7 doses in newborns. The administration of TDF was safe and the TDF exposure was adequate. Only 1 case of MTCT was confirmed but was considered intra utero-HIV infection (PCR positive at delivery). Tenofovir might be appropriate for use in MTCT and neonates, although relevance under new PMTCT guidelines need to be considered.

2)      The APV2002 study is a prospective study of FPV/r in naïve or exposed children (6 m to < 2 years or 4 weeks to < 6 months) in South Africa and Mexico. Dose used was 45/7mg/kg in the first group and 45/10mg/kg in the second group. In the first group the FPV/r dosing regimens achieved plasma APV exposures comparable to those from regimens approved in adults. In the second group APV Cτ was lower.

3)      The P1093 is a Phase 1/2 study of DTG plus OBR for children, at doses of 10 to 50mg QD according the weight. Ten ARV experienced adolescents (12-18 years) were enrolled, PK showed adequate levels and VL at week 4 was < 40 c/mL in 7/10 subjects, supporting further DTG investigation and younger pediatric cohort initiation.

4)      The PIANO study is a Phase II open-label trial using etravirine 5.2mg/kg (maximum dose 200mg) BID plus  OBR in children (6-18 years) failing to a previous therapy. Week 48 data for 101 patients were presented. Only 75% completed the trial. Adverse events (mostly rash) and trial non-compliance were frequents. At week 48 56% of participant achieved < 50 c/mL (ITT, NC=F). NNRTI resistance was developed in 60% of failures. Adherence was the big issue in this trial with only 39% reporting >95% adherence by pill count.

5)      The IMPAACT P1066 is a Phase I/II of multiple RAL and OBR formulations in ART experienced children. After dose selection the 400 mg BID regimen (6-18 years) and weight-based dosing (~6mg/kg BID) of RAL for 2 to < 12 years were selected. At Week 48, 56.7% presented VL <50 with adequate immune recovery.




   

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