title: Virological efficacy with first-line antiretroviral treatment in India: predictors of viral failure and evidence of viral resuppression.
abstract: OBJECTIVE
  Combination antiretroviral therapy (ART) has improved in efficacy, durability and tolerability. Virological efficacy studies in India are limited. We determined incidence and predictors of virological failure among patients initiating first-line ART and described virological resuppression after confirmed failure, with the goal of informing national policy.
  
  
  METHODS
  Therapy-naïve patients initiated on first-line ART as per national guidelines were monitored every 3 months for adherence and virological response over 2 years. Genotyping on baseline samples was performed to assess primary drug resistance. Multivariate Cox regression analysis was used to assess predictors of virological failure.
  
  
  RESULTS
  Virological failure rate among 599 eligible patients was 10.7 failures per 100 person-years. Cumulative failure incidence was 13.2% in the first year and 16.5% over 2 years. Patients initiated on tenofovir had a significantly lower rate of virological failure than those on stavudine or zidovudine (6.7 vs. 11.9 failures per 100 person-years, P = 0.013). Virological failure was independently associated with age <40 years, mean adherence <95%, non-tenofovir-containing regimens and presence of primary drug resistance. In a subset of 311 patients who were reassessed after treatment failure, 19% (11/58) patients resuppressed their viral load to <400 copies/ml after confirmed virological failure.
  
  
  CONCLUSIONS
  Our results support the inclusion of tenofovir as first-line ART in resource-limited settings and a role for regular adherence counselling and virological monitoring for enhanced treatment success. Detection of early virological failure should provide an opportunity to augment adherence counselling and repeat viral load testing before therapy switch is considered.
authors.affiliation: Department of Pediatrics, St. John's Medical College Hospital, Bangalore, India.|Division of Global Health, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Anita
authors.initials: A
authors.lastname: Shet
authors.affiliation: Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Ujjwal
authors.initials: U
authors.lastname: Neogi
authors.affiliation: YRG Center for AIDS Research and Education, Chennai, India.
authors.forename: N
authors.initials: N
authors.lastname: Kumarasamy
authors.affiliation: Division of Global Health, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Ayesha
authors.initials: A
authors.lastname: DeCosta
authors.affiliation: National AIDS Control Organization, Department of AIDS Control, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
authors.forename: Suresh
authors.initials: S
authors.lastname: Shastri
authors.affiliation: National AIDS Control Organization, Department of AIDS Control, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
authors.forename: Bharat Bhushan
authors.initials: BB
authors.lastname: Rewari
keywords: 
  HIV
  ; 
  VIH
  ; Inde; India; adherence; adherencia; adhésion; fallo virológico; first-line antiretroviral therapy; primera línea de tratamiento antirretroviral; thérapie antirétrovirale de première ligne; virological failure; échec virologique