title: High rates of regimen change due to drug toxicity among a cohort of South Indian adults with HIV infection initiated on generic, first-line antiretroviral treatment.
abstract: OBJECTIVE
  To determine the rates, reasons and predictors of treatment change of the initial antiretroviral treatment (ART) regimen in HIV-infected south Indian adults.
  
  
  METHODS
  In this prospective cohort study, ART-naive adults initiated on generic, fixed dose combination ART as per the National AIDS Control Organization guidelines were followed up at an academic medical center. Treatment change was defined as any event which necessitated a change in or discontinuation of the initial ART regimen.
  
  
  RESULTS
  Two hundred and thirty persons with HIV infection (males 74.8% and median age 37 years) were followed up for median duration of 48 weeks. The majority (98.7%) had acquired HIV infection through the heterosexual route. Most (70.4%) had advanced IV infection (WHO clinical stage 3 or 4) and 78% had CD4+ T-lymphocyte counts below 200 cells/microL. The initial ART regimens used were: Lamivudine (3TC) with Stavudine (d4T) (in 76%) or Azidothymidine (AZT) and Nevirapine (NVP) (in 86%) or Efavirenz (EFV). The cumulative incidence of treatment change was 39.6% (91 patients). Drug toxicity (WHO grade 3 or 4) was the reason for treatment change among 62 (27%) (incidence rate 35.9/100 person-years). The most common toxicities were attributable to the thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), d4T and AZT [lactic acidosis (8.7%), anemia (7%) and peripheral neuropathy (5.2%)]. The other toxicities were rash (3.9%) and hepatitis (1.3%) due to NVP. The mortality (4.6/100 person-years) and disease progression rates (4.1/100 person-years) were low.
  
  
  CONCLUSIONS
  The ART regimens used in this study were effective in decreasing disease progression and death. However, they were associated with high rates of drug toxicities, particularly those attributable to thymidine analogue NRTI. As efforts are made to improve access to ART, treatment regimens chosen should not only be potent, but also safe.
authors.affiliation: Department of Medicine, Christian Medical College, Vellore.
authors.forename: Ajith
authors.initials: A
authors.lastname: Sivadasan
authors.forename: O C
authors.initials: OC
authors.lastname: Abraham
authors.forename: Priscilla
authors.initials: P
authors.lastname: Rupali
authors.forename: Susanne A
authors.initials: SA
authors.lastname: Pulimood
authors.forename: Joyce
authors.initials: J
authors.lastname: Rajan
authors.forename: S
authors.initials: S
authors.lastname: Rajkumar
authors.forename: Anand
authors.initials: A
authors.lastname: Zachariah
authors.forename: Rajesh
authors.initials: R
authors.lastname: Kannangai
authors.forename: Abraham Joseph
authors.initials: AJ
authors.lastname: Kandathil
authors.forename: G
authors.initials: G
authors.lastname: Sridharan
authors.forename: Dilip
authors.initials: D
authors.lastname: Mathai
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D044966:Anti-Retroviral Agents / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D016001:Confidence Intervals; D018450:Disease Progression; D016568:Drugs, Generic; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects; D013601:T-Lymphocytes; D016903:Drug Monitoring
chemical_list: D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D016568:Drugs, Generic; D018894:Reverse Transcriptase Inhibitors