title: Virologic outcomes in early antiretroviral treatment: HPTN 052.
abstract: The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure.
  
  
  
  To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052.
  
  
  
  1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350-550 cells/mm3at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm3at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation.
  
  
  
  Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by three months; lower VL and higher CD4 at ART initiation were also associated with virologic failure.
  
  
  
  Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention.
authors.affiliation: a Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.
authors.forename: Susan H
authors.identifier: 0000-0002-4587-791X
authors.initials: SH
authors.lastname: Eshleman
authors.affiliation: b Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle , WA , USA.
authors.forename: Ethan A
authors.identifier: 0000-0002-9120-3182
authors.initials: EA
authors.lastname: Wilson
authors.affiliation: b Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle , WA , USA.
authors.forename: Xinyi C
authors.initials: XC
authors.lastname: Zhang
authors.affiliation: b Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle , WA , USA.
authors.forename: San-San
authors.initials: SS
authors.lastname: Ou
authors.affiliation: a Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.affiliation: c Department of Medicine , University of North Carolina at Chapel Hill , Chapel Hill , NC , USA.
authors.forename: Joseph J
authors.identifier: 0000-0002-4938-0644
authors.initials: JJ
authors.lastname: Eron
authors.affiliation: d Science Facilitation Department , FHI 360 , Washington , DC , USA.
authors.forename: Marybeth
authors.initials: M
authors.lastname: McCauley
authors.affiliation: e Science Facilitation Department , FHI 360 , Durham , NC , USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Gamble
authors.affiliation: f Southwest CARE Center , Santa Fe , NM , USA.
authors.forename: Joel E
authors.initials: JE
authors.lastname: Gallant
authors.affiliation: g University of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases , Chapel Hill , NC , USA.|h UNC Project-Malawi, Institute for Global Health and Infectious Diseases , Lilongwe , Malawi.
authors.forename: Mina C
authors.initials: MC
authors.lastname: Hosseinipour
authors.affiliation: i YRGCARE Medical Centre, VHS , Chennai , India.
authors.forename: Nagalingeswaran
authors.initials: N
authors.lastname: Kumarasamy
authors.affiliation: j Department of Medicine , University of Zimbabwe , Harare , Zimbabwe.
authors.forename: James G
authors.identifier: 0000-0002-5981-9331
authors.initials: JG
authors.lastname: Hakim
authors.affiliation: k College of Medicine-Johns Hopkins Project , Blantyre , Malawi.
authors.forename: Ben
authors.initials: B
authors.lastname: Kalonga
authors.affiliation: l Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz , Rio de Janeiro , Brazil.
authors.forename: Jose H
authors.identifier: 0000-0003-0521-8597
authors.initials: JH
authors.lastname: Pilotto
authors.affiliation: m Instituto Nacional de Infectologia Evandro Chagas-INI-Fiocruz , Rio de Janeiro , Brazil.
authors.forename: Beatriz
authors.identifier: 0000-0003-3692-5155
authors.initials: B
authors.lastname: Grinsztejn
authors.affiliation: n National AIDS Research Institute (ICMR) , Pune , India.
authors.forename: Sheela V
authors.identifier: 0000-0001-6537-9064
authors.initials: SV
authors.lastname: Godbole
authors.affiliation: o Research Institute for Health Sciences, Chiang Mai University , Chiang Mai , Thailand.
authors.forename: Nuntisa
authors.initials: N
authors.lastname: Chotirosniramit
authors.affiliation: p Hospital Nossa Senhora da Conceição , Porto Alegre , Brazil.
authors.forename: Breno Riegel
authors.identifier: 0000-0002-2888-2573
authors.initials: BR
authors.lastname: Santos
authors.affiliation: q Botswana Harvard AIDS Institute , Gaborone , Botswana.
authors.forename: Emily
authors.initials: E
authors.lastname: Shava
authors.affiliation: r Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention and Kenya Medical Research Institute (KEMRI)/CDC Clinical Research Site , Kisumu , Kenya.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Mills
authors.affiliation: s University of the Witwatersrand, Perinatal HIV Research Unit, Soweto HPTN CRS , Soweto , South Africa.
authors.forename: Ravindre
authors.identifier: 0000-0002-3601-0839
authors.initials: R
authors.lastname: Panchia
authors.affiliation: t Clinical HIV Research Unit, Department of Medicine , University of the Witwatersrand , Johannesburg , South Africa.
authors.forename: Noluthando
authors.identifier: 0000-0002-8189-6149
authors.initials: N
authors.lastname: Mwelase
authors.affiliation: u The Fenway Institute, Fenway Health/Infectious Disease Division, Beth Israel Deaconess Medical Center, Department of Medicine , Harvard Medical School , Boston , MA , USA.
authors.forename: Kenneth H
authors.identifier: 0000-0001-7460-733X
authors.initials: KH
authors.lastname: Mayer
authors.affiliation: b Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle , WA , USA.
authors.forename: Ying Q
authors.initials: YQ
authors.lastname: Chen
authors.affiliation: c Department of Medicine , University of North Carolina at Chapel Hill , Chapel Hill , NC , USA.
authors.forename: Myron S
authors.identifier: 0000-0001-5917-9664
authors.initials: MS
authors.lastname: Cohen
authors.affiliation: a Department of Pathology , Johns Hopkins University School of Medicine , Baltimore , MD , USA.
authors.forename: Jessica M
authors.identifier: 0000-0003-3143-9000
authors.initials: JM
authors.lastname: Fogel
mesh_terms: D000328:Adult; D000349:Africa; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D001208:Asia; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055502:Secondary Prevention; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents
keywords: Early ART; HIV; HIV prevention; HPTN 052; Viral suppression; Virologic failure; Virologic outcomes