title: Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts above 350 cells/μl in rural Uganda.
abstract: BACKGROUND
  HIV antiretroviral therapy (ART) is being rapidly scaled up in sub-Saharan Africa, including recently patients with CD4 T-cell counts above 350 cells/μl. However, concerns persist about adherence and virologic suppression among these asymptomatic, high CD4 cell count individuals.
  
  
  OBJECTIVE
  To determine the virologic efficacy and safety of ART among asymptomatic HIV-positive Ugandan adults with high CD4 cell counts above 350 cells/μl via a streamlined model of care.
  
  
  METHODS
  Prospective nonrandomized clinical study (EARLI Study: clinicaltrials.gov NCT#01479634).
  
  
  METHODS
  Prototypic rural Ugandan HIV clinic.
  
  
  METHODS
  Asymptomatic, ART-naive adults (aged >18 years, N = 197) with CD4 at least 350 cells/μl, without pregnancy or WHO stage 3/4 illness.
  
  
  METHODS
  ART included tenofovir/emtricitabine/efavirenz, with ritonavir/lopinavir substitution for efavirenz available. Streamlined ART model included nurse-driven visits with physician back-up, basic safety laboratory monitoring with HIV viral load, clinician telephone contact, and defaulter tracking. No incentives were provided.
  
  
  RESULTS
  Undetectable viral load (≤400 copies/ml) at 24 and 48 weeks [intention to treat (ITT); missing = detectable), self-reported ART adherence, retention in care, and laboratory/clinical ART toxicities.
  
  
  RESULTS
  Of the 197 patients with CD4 above 350 cells/μl, median CD4 cell count was 569 cells/μl (interquartile range 451-716). Undetectable viral load was achieved in 189 of 197 (95.9%, ITT) and 189 of 195 (96.9%, ITT) of participants at weeks 24 and 48, respectively. Self-reported adherence was 98% and 192 of 197 (97%) of the patients were retained at week 48. Laboratory adverse events and hospitalizations were rare.
  
  
  CONCLUSIONS
  We demonstrate high virologic suppression, retention, and safety among asymptomatic individuals with CD4 above 350 cells/μl in a prototypic Ugandan clinic. Our results challenge current concerns that individuals with high CD4 cell count lack motivation for ART, and may not achieve sustained virologic suppression.
authors.affiliation: aHIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco (UCSF), California, USA bMakerere University-UCSF (MU-UCSF) Research Collaboration cMakerere University Joint AIDS Program (MJAP), Kampala, Uganda dGilead Sciences, Foster City, California, USA eCenter for AIDS Prevention Studies (CAPS), UCSF, California, USA fDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: Vivek
authors.initials: V
authors.lastname: Jain
authors.forename: Dathan M
authors.initials: DM
authors.lastname: Byonanebye
authors.forename: Gideon
authors.initials: G
authors.lastname: Amanyire
authors.forename: Dalsone
authors.initials: D
authors.lastname: Kwarisiima
authors.forename: Doug
authors.initials: D
authors.lastname: Black
authors.forename: Jane
authors.initials: J
authors.lastname: Kabami
authors.forename: Gabriel
authors.initials: G
authors.lastname: Chamie
authors.forename: Tamara D
authors.initials: TD
authors.lastname: Clark
authors.forename: James F
authors.initials: JF
authors.lastname: Rooney
authors.forename: Edwin D
authors.initials: ED
authors.lastname: Charlebois
authors.forename: Moses R
authors.initials: MR
authors.lastname: Kamya
authors.forename: Diane V
authors.initials: DV
authors.lastname: Havlir
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D058070:Asymptomatic Diseases; D018791:CD4 Lymphocyte Count; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011247:Pregnancy; D011446:Prospective Studies; D012424:Rural Population; D016896:Treatment Outcome; D014454:Uganda; D019562:Viral Load; D016903:Drug Monitoring
chemical_list: D044966:Anti-Retroviral Agents