@article{fdi:010070375,
  title = {{A}ssessment of nevirapine prophylactic and therapeutic dosing regimens for neonates},
  author = {{C}ressey, {T}. {R}. and {P}unyawudho, {B}. and {L}e {C}oeur, {S}. and {J}ourdain, {G}onzague and {S}aenjum, {C}. and {C}apparelli, {E}. {V}. and {J}ittayanun, {K}. and {P}hanomcheong, {S}. and {L}uvira, {A}. and {B}orkird, {T}. and {P}uangsombat, {A}. and {A}arons, {L}. and {S}ukrakanchana, {P}. {O}. and {U}rien, {S}. and {L}allemant, {M}arc and {P}hpt-5 {S}tudy {T}eam},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground: {N}evirapine ({NVP}) is a key component of antiretroviral prophylaxis and treatment for neonates. {W}e evaluated current {W}orld {H}ealth {O}rganization ({WHO}) weight-band {NVP} prophylactic dosing recommendations and investigated optimal therapeutic {NVP} dosing for neonates. {M}ethods: {T}he {PHPT}-5 study in {T}hailand assessed the efficacy of "{P}erinatal {A}ntiretroviral {I}ntensification" to prevent mother-to-child transmission of {HIV} in women with <8 weeks of antiretroviral treatment before delivery ({NCT}01511237). {I}nfants received a 2-week course of zidovudine/lamivudine/{NVP} ({NVP} syrup/once daily: 2 mg/kg for 7 days; then 4 mg/kg for 7 days). {I}nfant samples were assessed during the first 2 weeks of life. {NVP} population pharmacokinetics ({PK}) parameters were estimated using nonlinear mixed-effects models. {S}imulations were performed to estimate the probability of achieving target {NVP} trough concentrations for prophylaxis (>0.10 mg/{L}) and for therapeutic efficacy (>3.0 mg/{L}) using different infant dosing strategies. {R}esults: {S}ixty infants (55% male) were included. {A}t birth, median (range) weight was 2.9 (2.3-3.6) kg. {NVP} concentrations were best described by a 1-compartment {PK} model. {I}nfant weight and postnatal age influenced {NVP} {PK} parameters. {B}ased on simulations for a 3-kg infant, >= 92% would have an {NVP} trough >0.1 mg/{L} after 48 hours through 2 weeks using the {PHPT}-5 and {WHO}-dosing regimens. {F}or {NVP}-based therapy, a 6-mg/kg twice daily dose produced a trough >3.0 mg/{L} in 87% of infants at 48 hours and 80% at 2 weeks. {C}onclusion: {WHO} weight-band prophylactic guidelines achieved target concentrations. {S}tarting {NVP} 6 mg/kg twice daily from birth is expected to achieve therapeutic concentrations during the first 2 weeks of life.},
  keywords = {nevirapine ; mother-to-child transmission ; {T}hailand ; pharmacokinetics ; {THAILANDE}},
  booktitle = {},
  journal = {{JAIDS} - {J}ournal of {A}cquired {I}mmune {D}eficiency {S}yndromes},
  volume = {75},
  numero = {5},
  pages = {554--560},
  ISSN = {1525-4135},
  year = {2017},
  URL = {https://www.documentation.ird.fr/hor/fdi:010070375},
}