@article{fdi:010061148,
  title = {{S}witching {HIV} treatment in adults based on {CD}4 count versus viral load monitoring : a randomized, non-inferiority trial in {T}hailand},
  author = {{J}ourdain, {G}onzague and {L}e {C}oeur, {S}ophie and {N}go-{G}iang-{H}uong, {N}icole and {T}raisathit, {P}. and {C}ressey, {T}. {R}. and {F}regonese, {F}. and {L}eurent, {B}. and {C}ollins, {I}. {J}. and {T}echapornroong, {M}. and {B}anchongkit, {S}. and {B}uranabanjasatean, {S}. and {H}alue, {G}. and {N}ilmanat, {A}. and {L}uekamlung, {N}. and {K}linbuayaem, {V}. and {C}hutanunta, {A}. and {K}antipong, {P}. and {B}owonwatanuwong, {C}. and {L}ertkoonalak, {R}. and {L}eenasirimakul, {P}. and {T}ansuphasawasdikul, {S}. and {S}ang-{A}-{G}ad, {P}. and {P}athipvanich, {P}. and {T}hongbuaban, {S}. and {W}ittayapraparat, {P}. and {E}iamsirikit, {N}. and {B}uranawanitchakorn, {Y}. and {Y}utthakasemsunt, {N}. and {W}iniyakul, {N}. and {D}ecker, {L}uc and {B}arbier, {S}. and {K}oetsawang, {S}. and {S}irirungsi, {W}. and {M}c{I}ntosh, {K}. and {T}hanprasertsuk, {S}. and {L}allemant, {M}arc},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground: {V}iral load ({VL}) is recommended for monitoring the response to highly active antiretroviral therapy ({HAART}) but is not routinely available in most low-and middle-income countries. {T}he purpose of the study was to determine whether a {CD}4-based monitoring and switching strategy would provide a similar clinical outcome compared to the standard {VL}-based strategy in {T}hailand. {M}ethods and {F}indings: {T}he {P}rograms for {HIV} {P}revention and {T}reatment ({PHPT}-3) non-inferiority randomized clinical trial compared a treatment switching strategy based on {CD}4-only ({CD}4) monitoring versus viral-load ({VL}). {C}onsenting participants were antiretroviral-naive {HIV}-infected adults ({CD}4 count 50-250/mm(3)) initiating non-nucleotide reverse transcriptase inhibitor ({NNRTI})-based therapy. {R}andomization, stratified by site (21 public hospitals), was performed centrally after enrollment. {C}linicians were unaware of the {VL} values of patients randomized to the {CD}4 arm. {P}articipants switched to second-line combination with confirmed {CD}4 decline >30% from peak (within 200 cells from baseline) in the {CD}4 arm, or confirmed {VL} >400 copies/ml in the {VL} arm. {P}rimary endpoint was clinical failure at 3 years, defined as death, new {AIDS}-defining event, or {CD}4,50 cells/mm(3). {T}he 3-year {K}aplan-{M}eier cumulative risks of clinical failure were compared for non-inferiority with a margin of 7.4%. {I}n the intent to treat analysis, data were censored at the date of death or at last visit. {T}he secondary endpoints were difference in future-drug-option ({FDO}) score, a measure of resistance profiles, virologic and immunologic responses, and the safety and tolerance of {HAART}. 716 participants were randomized, 356 to {VL} monitoring and 360 to {CD}4 monitoring. {A}t 3 years, 319 participants (90%) in {VL} and 326 (91%) in {CD}4 were alive and on follow-up. {T}he cumulative risk of clinical failure was 8.0% (95% {CI} 5.6-11.4) in {VL} versus 7.4% (5.1-10.7) in {CD}4, and the upper-limit of the one-sided 95% {CI} of the difference was 3.4%, meeting the pre-determined non-inferiority criterion. {P}robability of switch for study criteria was 5.2% (3.2-8.4) in {VL} versus 7.5% (5.0-11.1) in {CD}4 (p = 0.097). {M}edian time from treatment initiation to switch was 11.7 months (7.7-19.4) in {VL} and 24.7 months (15.9-35.0) in {CD}4 (p = 0.001). {T}he median duration of viremia >400 copies/ml at switch was 7.2 months (5.8-8.0) in {VL} versus 15.8 months (8.5-20.4) in {CD}4 (p = 0.002). {FDO} scores were not significantly different at time of switch. {N}o adverse events related to the monitoring strategy were reported. {C}onclusions: {T}he 3-year rates of clinical failure and loss of treatment options did not differ between strategies although the longer-term consequences of {CD}4 monitoring would need to be investigated. {T}hese results provide reassurance to treatment programs currently based on {CD}4 monitoring as {VL} measurement becomes more affordable and feasible in resource-limited settings. registration:},
  keywords = {{THAILANDE}},
  booktitle = {},
  journal = {{P}los {M}edicine},
  volume = {10},
  numero = {8},
  pages = {e1001494},
  ISSN = {1549-1676},
  year = {2013},
  DOI = {10.1371/journal.pmed.1001494},
  URL = {https://www.documentation.ird.fr/hor/fdi:010061148},
}