title: Long-Term Outcomes on Antiretroviral Therapy in a Large Scale-Up Program in Nigeria.
abstract: BACKGROUND
  While there has been a rapid global scale-up of antiretroviral therapy programs over the past decade, there are limited data on long-term outcomes from large cohorts in resource-constrained settings. Our objective in this evaluation was to measure multiple outcomes during first-line antiretroviral therapy in a large treatment program in Nigeria.
  
  
  METHODS
  We conducted a retrospective multi-site program evaluation of adult patients (age ≥15 years) initiating antiretroviral therapy between June 2004 and February 2012 in Nigeria. The baseline characteristics of patients were described and longitudinal analyses using primary endpoints of immunologic recovery, virologic rebound, treatment failure and long-term adherence patterns were conducted.
  
  
  RESULTS
  Of 70,002 patients, 65.2% were female and median age was 35 (IQR: 29-41) years; 54.7% were started on a zidovudine-containing and 40% on a tenofovir-containing first-line regimen. Median CD4+ cell counts for the cohort started at 149 cells/mm3 (IQR: 78-220) and increased over duration of ART. Of the 70,002 patients, 1.8% were reported as having died, 30.1% were lost to follow-up, and 0.1% withdrew from treatment. Overall, of those patients retained and with viral load data, 85.4% achieved viral suppression, with 69.3% achieving suppression by month 6. Of 30,792 patients evaluated for virologic failure, 24.4% met criteria for failure and of 45,130 evaluated for immunologic failure, 34.0% met criteria for immunologic failure, with immunologic criteria poorly predicting virologic failure. In adjusted analyses, older age, ART regimen, lower CD4+ cell count, higher viral load, and inadequate adherence were all predictors of virologic failure. Predictors of immunologic failure differed slightly, with age no longer predictive, but female sex as protective; additionally, higher baseline CD4+ cell count was also predictive of failure. Evaluation of long-term adherence patterns revealed that the majority of patients retained through 84 months maintained ≥95% adherence.
  
  
  CONCLUSIONS
  While improved access to HIV care and treatment remains a challenge in Nigeria, our study shows that a high quality of care was achieved as evidenced by strong long-term clinical, immunologic and virologic outcomes.
authors.affiliation: Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Seema T
authors.initials: ST
authors.lastname: Meloni
authors.affiliation: Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Charlotte A
authors.initials: CA
authors.lastname: Chang
authors.affiliation: Center for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Eisen
authors.affiliation: AIDS Prevention Initiative in Nigeria, Limited by Guarantee, Abuja, Federal Capital Territory, Nigeria.
authors.forename: Toyin
authors.initials: T
authors.lastname: Jolayemi
authors.affiliation: AIDS Prevention Initiative in Nigeria, Limited by Guarantee, Abuja, Federal Capital Territory, Nigeria.
authors.forename: Bolanle
authors.initials: B
authors.lastname: Banigbe
authors.affiliation: AIDS Prevention Initiative in Nigeria, Limited by Guarantee, Abuja, Federal Capital Territory, Nigeria.
authors.forename: Prosper I
authors.initials: PI
authors.lastname: Okonkwo
authors.affiliation: Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Phyllis J
authors.initials: PJ
authors.lastname: Kanki
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009549:Nigeria; D012189:Retrospective Studies; D000068698:Tenofovir / Q000627:therapeutic use; D017211:Treatment Failure; D019562:Viral Load; D055815:Young Adult; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D000068698:Tenofovir