title: Outcome of patients on second line antiretroviral therapy under programmatic condition in India.
abstract: BACKGROUND
  The National AIDS Control Organization of India has been providing free second line antiretroviral therapy (ART) since 2008. This observational study reports the survival and virologic suppression of patients on second-line ART under programmatic condition and type of mutations acquired by those failing therapy.
  
  
  METHODS
  170 patients initiated on second-line therapy between 2008 and 2012 were followed up till 2013. Viral Load (VL) was repeated at 6 months for all patients and at 12 months for those with VL >400 copies/ml at 6 months. Adequate virological response was defined as plasma HIV-1 VL <400 copies/ml and virological failure was defined as VL >1000 copies/ml. Genotyping was done in 16 patients with virological failure.
  
  
  RESULTS
  Out of 170 patients, 110 (64.7 %) were alive and on therapy and 35 (20.5 %) expired. In the first year the occurrence of death was 13.7 /100 person years while between 1 and 5 year it was 3.88 /100 person years. In the first year, duration of immunological failure >12 months, weight <45 kg, WHO clinical stage 3 and 4 and WHO criteria CD4 count less than pretherapy baseline [hazard ratio HR 4.2. 15.8, 11.9 & 4.1 respectively] and beyond first year poor first and second line adherence and first line CD4 count < 200/μL [HR 5.2,15.8, 3.3 respectively] had high risk of death. 119/152 (78.2 %) had adequate virological response and 27/152 (17.7 %) had virological failure. High viral load at baseline and poor second line adherence (Odds Ratio 3.4 & 2.8 respectively) had increased risk of virological failure. Among those genotyped, 50 % had major Protease Inhibitor mutation (M46I commonest) however 87.5 % were still susceptible to darunavir.
  
  
  CONCLUSIONS
  Second line therapy has shown high early mortality but good virological suppression under programmatic conditions.
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. tapadar@gmail.com.
authors.forename: Jaya
authors.initials: J
authors.lastname: Chakravarty
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. drshyamsundar@hotmail.com.
authors.forename: Shyam
authors.initials: S
authors.lastname: Sundar
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. ankita.chourasia21@gmail.com.
authors.forename: Ankita
authors.initials: A
authors.lastname: Chourasia
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. pallav3537sst@gmail.com.
authors.forename: Pallav Narayan
authors.initials: PN
authors.lastname: Singh
authors.affiliation: Indian Council of Medical Research, National AIDS Research Institute, Bhosari, Pune, India. swaralikurle@gmail.com.
authors.forename: Swarali
authors.initials: S
authors.lastname: Kurle
authors.affiliation: Indian Council of Medical Research, National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India. directorjalma@gmail.com.
authors.forename: Srikanth P
authors.initials: SP
authors.lastname: Tripathy
authors.affiliation: Indian Council of Medical Research, National AIDS Research Institute, Bhosari, Pune, India. dn_chaturbhuj@yahoo.com.
authors.forename: Devidas N
authors.initials: DN
authors.lastname: Chaturbhuj
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. raimadhukar1508@gmail.com.
authors.forename: Madhukar
authors.initials: M
authors.lastname: Rai
authors.affiliation: Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. agrawal.amit.77@gmail.com.
authors.forename: Amit Kumar
authors.initials: AK
authors.lastname: Agarwal
authors.affiliation: Department of Community Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. rnmishra_prem@rediffmail.com.
authors.forename: Rabindra Nath
authors.initials: RN
authors.lastname: Mishra
authors.affiliation: Indian Council of Medical Research, National AIDS Research Institute, Bhosari, Pune, India. rparanjape@nariindia.org.
authors.forename: Ramesh S
authors.initials: RS
authors.lastname: Paranjape
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D024882:Drug Resistance, Viral / Q000187:drug effects / Q000235:genetics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics* / Q000472:pathogenicity; D006801:Humans; D007194:India; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D009154:Mutation; D009313:National Health Programs; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects / Q000235:genetics
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine