title: Evaluating patients for second-line antiretroviral therapy in India: the role of targeted viral load testing.
abstract: BACKGROUND
  The identification and management of first-line antiretroviral therapy (ART) failure is a key challenge for HIV programs in resource-limited settings. In 2008, the National AIDS Control Organisation, India piloted a national strategy to provide second-line ART. We assessed the National AIDS Control Organisation second-line ART evaluation algorithm.
  
  
  METHODS
  Adult patients who had received 6 months or more of standard first-line ART were referred for second-line ART evaluation if they demonstrated CD4 decline to pre-ART values, CD4 drop to less than 50% of peak on-treatment value, failure to achieve CD4 greater than 100 c/mm(3), or development of a new World Health Organization Stage 3 or 4 AIDS-defining illness. Patients received HIV RNA testing, and those with HIV RNA 10,000 c/mL or greater qualified to switch to second-line ART. World Health Organization-defined clinical and CD4 criteria for ART failure were compared against virologic failure criteria.
  
  
  RESULTS
  Between January and June 2008, 154 patients met criteria for evaluation. Of 122 (79%) patients who had HIV RNA testing, 87 (71%) had viral load 10,000 c/mL or greater and were recommended to start second-line ART, 29 (24%) had viral load less than 400 c/mL, and six (5%) had viral load between 400 and 10,000 c/mL. The positive predictive value of World Health Organization clinical/immunologic criteria to detect virologic failure was 71% (95% confidence interval, 63% to 79%).
  
  
  CONCLUSIONS
  Second-line ART was initiated in the public sector in India using an approach combining clinical and immunologic evaluation with confirmation of virologic failure. Almost 25% of patients who met clinical/immunologic failure criteria demonstrated virologic suppression. Inclusion of targeted HIV RNA testing in the evaluation of treatment failure can prevent unnecessary switches to second-line ART.
authors.affiliation: National AIDS Control Organisation, Government of India, Ministry of Health and Family Welfare, New Delhi, India.
authors.forename: Bharat B
authors.initials: BB
authors.lastname: Rewari
authors.forename: Damodar
authors.initials: D
authors.lastname: Bachani
authors.forename: Sikhamani
authors.initials: S
authors.lastname: Rajasekaran
authors.forename: Alaka
authors.initials: A
authors.lastname: Deshpande
authors.forename: Po Lin
authors.initials: PL
authors.lastname: Chan
authors.forename: Padmini
authors.initials: P
authors.lastname: Srikantiah
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D048588:Benzoxazines / Q000494:pharmacology / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D005260:Female; D006678:HIV / Q000187:drug effects* / Q000502:physiology; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D006801:Humans; D007194:India; D019259:Lamivudine / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000494:pharmacology / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood*; D018119:Stavudine / Q000494:pharmacology / Q000627:therapeutic use; D017211:Treatment Failure; D019562:Viral Load; D015215:Zidovudine / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D012367:RNA, Viral; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine; C098320:efavirenz