@article{fdi:010088881,
  title = {{D}urability of the efficacy and safety of dolutegravir-based and low-dose efavirenz-based regimens for the initial treatment of human immunodeficiency virus type 1 infection in {C}ameroon : week 192 data of the {NAMSAL}-{ANRS}-12313 {S}tudy},
  author = {{M}poudi-{E}tame, {M}. and {S}anchez, {T}. {T}. and {B}ousmah, {M}arwan-al-{Q}ays and {B}assega, {P}. {O}. and {O}linga, {J}. and {M}imbe, {E}. and {F}oalem, {M}. and {C}hiep, {C}. and {E}dimo, {S}. and {V}arloteaux, {M}. and {P}elloquin, {R}aphael and {L}amare, {N}. and {B}oyer, {S}. and {P}eeters, {M}artine and {R}eynes, {J}. and {C}almy, {A}. and {H}ill, {A}. and {D}elaporte, {E}. and {K}ouanfack, {C}. and {N}ew {A}ntiretroviral {M}onitoring,},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground. {A} prospective study was extended to the new antiretroviral and monitoring strategies in {HIV}-infected adults in low-income countries ({NAMSAL}-{ANRS})-12313 trial, a 96-week open-label, multicenter, randomized phase 3 trial comparing dolutegravir ({DTG}) 50 mg with efavirenz 400 mg ({EFV}400), both administered with tenofovir disoproxil fumarate and lamivudine ({TDF}/3{TC}) as first-line treatment for antiretroviral therapy ({ART})-naive people living with human immunodeficiency virus type 1 ({HIV}). {N}oninferiority of {DTG} to {EFV}400 was demonstrated at 48-week and sustained at 96 weeks. {H}ere, we present results at 192-week.{M}ethods. {P}revious trial participants were reconsented and followed up on their initial randomization arm (1:1 {DTG}/{TDF}/3{TC}:{EFV}400/{TDF}/3{TC}). {A}ssessments included changes in viral suppression, biological parameters, and new serious adverse events ({SAE}s).{R}esults. {A}mong the participants enrolled in the trial, 81% (499/613) were analyzed at week 192: 84% (261/310) on {DTG}/{TDF}/3{TC} and 78% (238/303) on {EFV}400/{TDF}/3{TC}. {HIV} {RNA} suppression was maintained in 69% (214/310) on {DTG}/{TDF}/3{TC}-based and 62% (187/303) on {EFV}400/{TDF}/3{TC}-based regimens (difference, 7.3% [95% confidence interval, -.20 to 14.83]; {P} = .057). {F}ive ({DTG}/{TDF}/3{TC} = 2; {EFV}400/{TDF}/3{TC} = 3) new viral failures ({W}orld {H}ealth {O}rganization definition) without related resistance {DTG} mutations and 24 new {SAE}s were observed ({DTG}/{TDF}/3{TC} = 13; {EFV}400/{TDF}/3{TC} = 11). {M}ean weight gain was +9.4 kg on {DTG}/{TDF}/3{TC} and +5.9 kg on {EFV}400/{TDF}/3{TC}. {T}he percentage of participants with obesity increased from 6.9% to 27.7% on {DTG}/{TDF}/3{TC} ({P} < .0001) and from 8.3% to 16.7% on {EFV}400/{TDF}/3{TC} ({P} = .0033).{C}onclusions. {F}our-year follow-up of people with {HIV} on {DTG}- and {EFV}400-based regimens showed long-term efficacy and safety of both {ART}s, markedly among participants on {DTG}/{TDF}/3{TC} with high baseline viral load. {H}owever, unexpected substantial weight gain over time was prominent among participants on {DTG}/{TDF}/3{TC}, which should be closely monitored.},
  keywords = {dolutegravir ; efficacy-durability ; {HIV}-1 ; low-dose-efavirenz ; weight gain ; {CAMEROUN}},
  booktitle = {},
  journal = {{O}pen {F}orum {I}nfectious {D}iseases},
  volume = {10},
  numero = {12},
  pages = {ofad582 [10 ]},
  ISSN = {2328-8957},
  year = {2023},
  DOI = {10.1093/ofid/ofad582},
  URL = {https://www.documentation.ird.fr/hor/fdi:010088881},
}