@article{fdi:010068761,
  title = {{S}afety of darunavir and atazanavir in {HIV}-infected children in {E}urope and {T}hailand},
  author = {{B}ailey, {H}. and {C}ollins, {I}. {J}. and {C}hilds, {T}. and {T}ostevin, {A}. and {G}oetghebuer, {T}. and {V}alerius, {N}. and {K}onigs, {C}. and {G}alli, {L}. and {M}arczynska, {M}. and {M}arques, {L}. and {E}ne, {L}. and {V}oronin, {E}. and {O}khonskaia, {L}. and {N}oguera-{J}ulian, {A}. and {R}ojo, {P}. and {A}mador, {J}. {T}. {R}. and {N}aver, {L}. and {R}udin, {C}. and {J}ourdain, {G}onzague and {T}ookey, {P}. and {G}iaquinto, {C}. and {J}udd, {A}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground: {S}urveillance for mid-and long-term antiretroviral therapy ({ART}) toxicity in children is important for informing treatment guidelines. {W}e assessed the safety of darunavir ({DRV}) and atazanavir ({ATV}), commonly used as second-line protease inhibitors following lopinavir/ritonavir, in {E}urope and {T}hailand. {M}ethods: {C}ohorts contributed individual patient data on adverse events ({AE}) in those aged < 18 years taking {DRV} and {ATV}, respectively, to 02/2014. {R}ates of {D}ivision of {AIDS} ({DAIDS}) grade >= 3 laboratory {AE}s were calculated. {R}esults: {O}f 431 patients on {DRV} and 372 on {ATV}, 317 (74%) and 301 (81%), respectively, had weight and dose data available, of whom 56 (18%) and 33 (9%) took the drugs at a non-approved age or dose. {M}edian age at {DRV} and {ATV} start was 14.8 years ({IQR} 12.8-16.1) and 13.5 years (11.4-15.2); 43% and 26% had received >= 8 {ART} drugs previously. {O}verall rates of grade <= 3 {AE}s for absolute neutrophils, total cholesterol, triglycerides, pancreatic amylase, lipase and alanine aminotransferase ({ALT}) were <= 3/100 person-years ({PY}) on approved doses of both drugs, but 66/100 {PY} (95% {CI} 52, 84) for bilirubin after < 12 months on {ATV} declining to 32/100 {PY} (95% {CI} 23, 44) after > 24 months. {F}ive serious drug-related clinical {AE}s were reported in four patients on {ATV} (one discontinued) and three in three patients on {DRV} (all discontinued), and did not substantially differ in those on approved compared to non-approved doses. {P}roportions on the drugs at last follow-up were 89% (383/431) for {DRV} and 81% (301/372) for {ATV} (including 73/92 with grade = 3 hyperbilirubinaemia). {C}onclusions: {AE}s were few in number and comparable for the two drugs, with the exception of high rates of hyperbilirubinaemia for {ATV}; few patients discontinued due to toxicity.},
  keywords = {{THAILANDE} ; {EUROPE}},
  booktitle = {},
  journal = {{A}ntiviral {T}herapy},
  volume = {21},
  numero = {4},
  pages = {353--358},
  ISSN = {1359-6535},
  year = {2016},
  DOI = {10.3851/imp3008},
  URL = {https://www.documentation.ird.fr/hor/fdi:010068761},
}