@article{fdi:010060462, title = {{M}onitoring of {HIV} viral load, {CD}4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings ({S}tratall {ANRS} 12110/{ESTHER}) : a cost-effectiveness analysis}, author = {{B}oyer, {S}. and {M}arch, {L}. and {K}ouanfack, {C}. and {L}aborde-{B}alen, {G}. and {M}arino, {P}. and {A}ghokeng {F}obang, {A}velin and {M}poudi-{N}gole, {E}. and {K}oulla-{S}hiro, {S}. and {D}elaporte, {E}ric and {C}arrieri, {M}. {P}. and {S}pire, {B}. and {L}aurent, {C}hristian and {M}oatti, {J}ean-{P}aul}, editor = {}, language = {{ENG}}, abstract = {{B}ackground {I}n low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy ({ART}) remains controversial in view of persistent resource constraints. {T}he {S}tratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. {W}e aimed to evaluate the costs and cost-effectiveness of the {ART} monitoring approaches assessed in the {S}tratall trial. {M}ethods {T}he randomised, controlled, non-inferiority {S}tratall trial was done in a decentralised setting in {C}ameroon. {B}etween {M}ay 23, 2006, and {J}an 31, 2008, {ART}-naive adults were randomly assigned (1:1) to clinical monitoring ({CLIN}) or viral load and {CD}4 cell count plus clinical monitoring ({LAB}) and followed up for 24 months. {W}e calculated costs, number of life-years saved ({LYS}), and incremental cost-effectiveness ratios ({ICER}s) with data from patients who had been followed up for at least 6 months. {W}e considered two cost scenarios in which viral load plus {CD}4 cell count tests cost either {US}$95 (scenario 1; {A}bbott {R}eal{T}ime {HIV}-1 assay) or $63 (scenario 2; generic assay). {W}e compared {ICER}s with a {WHO}-recommended threshold of three times the per-person gross domestic product ({GDP}) for {C}ameroon ($3670-3800) and an alternative lower threshold of $2385 to determine cost-effectiveness. {W}e assessed uncertainty with one-way sensitivity analyses and cost-effectiveness acceptability curves. {F}indings 188 participants who underwent {LAB} and 197 who underwent {CLIN} were followed up for at least 6 months. {I}n scenario 1, {LAB} increased costs by a mean of $489 ({SD} 430) per patient and saved 0.103 life-years compared with {CLIN} ({ICER} of $4768 [95% {CI} 3926-5613] per {LYS}). {I}n scenario 2, the incremental mean cost of {LAB} was $343 ({SD} 425)-ie, an {ICER} of $3339 (2507-4173) per {LYS}. {A} combined strategy in which {LAB} would only be used in patients starting {ART} with a {CD}4 count of 200 cells per mu {L} or fewer suggests that 0.120 life-years would be saved at an additional cost of $259 per patient in scenario 1 ({ICER} of $2167 [95% {CI} 1314-3020] per {LYS}) and $181 in scenario 2 ({ICER} of $1510 [692-2329] per {LYS}) when compared with {CLIN}. {I}nterpretation {L}aboratory monitoring was not cost effective in 2006-10 compared with clinical monitoring when the {A}bbott {R}eal{T}ime {HIV}-1 assay was used according to the $3670 cost-effectiveness threshold (three times per-person {GDP} in {C}ameroon), but it might be cost effective if a generic in-house assay is used.}, keywords = {}, booktitle = {}, journal = {{L}ancet {I}nfectious {D}iseases}, volume = {13}, numero = {7}, pages = {577--586}, ISSN = {1473-3099}, year = {2013}, DOI = {10.1016/s1473-3099(13)70073-2}, URL = {https://www.documentation.ird.fr/hor/fdi:010060462}, }