title: Toxicity and clinical outcomes in patients with HIV on zidovudine and tenofovir based regimens: a retrospective cohort study.
abstract: BACKGROUND
  Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. The less toxic tenofovir regimen is an alternative, but is seldom considered due to the higher costs. This study compared adverse drug reactions and other clinical outcomes resulting from the use of these two treatment regimens in India.
  
  
  METHODS
  Baseline, clinical characteristics and follow-up outcomes were collected by chart reviews of HIV-positive adults and compared using univariate/multivariate analysis, with and without propensity score adjustments.
  
  
  RESULTS
  Data were collected from 129 and 92 patients on zidovudine (with lamivudine and nevirapine) and tenofovir (with emtricitabine and efavirenz) regimens, respectively. Compared to patients receiving the zidovudine regimen, patients receiving the tenofovir regimen had fewer adverse drug reactions (47%, 61/129 vs 11%, 10/92; p<0.01), requiring fewer regimen changes (36%, 47/129 vs 3%, 3/92; p0.01). With the propensity score, the zidovudine regimen had 8 times more adverse drug reactions (p<0.01). Opportunistic infections were similar between regimens without propensity score, while the zidovudine regimen had 1.2 times (p=0.63) more opportunistic infections with propensity score. Patients on the tenofovir regimen gained more weight. Increase in CD4 levels and treatment adherence (>95%) was similar across regimens.
  
  
  CONCLUSIONS
  Patients on a tenofovir regimen have better clinical outcomes and improved general health than patients on the zidovudine regimen.
authors.affiliation: Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India tvsowmy@gmail.com Sowmyanarayanan.thuppal@tufts.edu.
authors.forename: Sowmyanarayanan V
authors.initials: SV
authors.lastname: Thuppal
authors.affiliation: Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Wanke
authors.affiliation: Institute for Clinical Research and Health Policy Studies, Research Design Center/Biostatistics Research Center, Tufts University School of Medicine, Boston, MA 02111, USA.
authors.forename: Farzad
authors.initials: F
authors.lastname: Noubary
authors.affiliation: Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health, Tufts University School of Medicine, Boston, MA 02111, USA.
authors.forename: Joshua T
authors.initials: JT
authors.lastname: Cohen
authors.affiliation: Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Mkaya
authors.initials: M
authors.lastname: Mwamburi
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Abraham C
authors.initials: AC
authors.lastname: Ooriapdickal
authors.affiliation: Department of Gastrointestinal Sciences, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Jayaprakash
authors.initials: J
authors.lastname: Muliyil
authors.affiliation: Department of Gastrointestinal Sciences, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Gagandeep
authors.initials: G
authors.lastname: Kang
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: George M
authors.initials: GM
authors.lastname: Varghese
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Priscilla
authors.initials: P
authors.lastname: Rupali
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Karthik
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Rajkumar
authors.initials: R
authors.lastname: Sathasivam
authors.affiliation: Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Peace
authors.initials: P
authors.lastname: Clarance
authors.affiliation: Department of Dermatology, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Susanne A
authors.initials: SA
authors.lastname: Pulimood
authors.affiliation: Department of Dermatology, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Dincy
authors.initials: D
authors.lastname: Peter
authors.affiliation: Department of Dermatology, Christian Medical College, Vellore, TN 632004, India.
authors.forename: Leni
authors.initials: L
authors.lastname: George
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*; D015430:Weight Gain / Q000187:drug effects*; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine; D000068698:Tenofovir
keywords: Adverse drug reaction; Clinical outcome; HIV; Propensity score analysis; Tenofovir; Zidovudine