title: Lamivudine Monotherapy: Experience of Medium-term Outcomes in HIV-infected Children Unable to Adhere to Triple Therapy.
abstract: HIV-infected children in resource-poor settings who fail or default from first-line antiretroviral therapy have limited alternative options. By preferentially selecting the M184V mutation, lamivudine monotherapy (LM) is occasionally used while awaiting patient readiness for second- or third-line therapy, but this strategy has not been widely studied.
  
  
  
  A retrospective review of all eligible LM events (≥3 months) from a cohort of two linked health facilities in the Eastern Cape Province, South Africa was undertaken. Events were disaggregated according to absolute CD4 count at initiation (Group 1: >200cells/μl, n=64; Group 2: ≤200cells/μl, n=7). Study endpoints were defined as a decline of absolute CD4 by ≥25% or to ≤200 cells/μl or World Health Organization stage 3 or 4 event (immunologic outcomes) or (re)initiation of second- or third-line therapy (real-world outcomes).
  
  
  
  Eligible LM events were identified among 71 children (56.4% male; median age at LM initiation 9.6 years). 71.8% (n = 51) had a drop in CD4 count of ≥25%, 15.6% (n = 10) of those whose CD4 counts had been >200 cells/μl dropped to ≤200 cells/μl and 8.1% (n = 6) experienced a stage 3 or 4 event; CD4 decreases and stage 3 or 4 events did not differ significantly between groups. No deaths were recorded. Children commencing LM with CD4 counts ≤200cells/μl had a shorter mean "real-world" duration of LM before switching to second/third line therapy (11.38 months vs. 26.1 months, P < 0.0001) and experienced immunologic outcomes at an earlier stage (5.29 vs. 9.2 months, P = 0.023).
  
  
  
  LM offers a potential alternative approach to antiretroviral therapy management in young patients pending availability and/or willingness to adhere to second- or third-line therapies but is associated with substantial immunologic decline. This strategy should be avoided in patients with CD4 ≤200 cells/μl.
authors.affiliation: From the *Department of Pediatrics, Frere Hospital, Eastern Cape, South Africa; †Department of Infectious Diseases, Mater Misericordiae University Hospital, Dublin, Ireland; ‡The Relevance Network, Johannesburg, South Africa; §Infectious Diseases, Rotunda Hospital, Dublin, Ireland; and ¶ School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.
authors.forename: Verena
authors.initials: V
authors.lastname: Linder
authors.forename: Cheree
authors.initials: C
authors.lastname: Goldswain
authors.forename: Hugh
authors.initials: H
authors.lastname: Adler
authors.forename: Craig
authors.initials: C
authors.lastname: Carty
authors.forename: Kim
authors.initials: K
authors.lastname: Harper
authors.forename: Valerie
authors.initials: V
authors.lastname: Jackson
authors.forename: John S
authors.initials: JS
authors.lastname: Lambert
authors.forename: Gerald
authors.initials: G
authors.lastname: Boon
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count / Q000379:methods; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics / Q000276:immunology / Q000382:microbiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D012189:Retrospective Studies; D013019:South Africa; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine