title: Nevirapine versus efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and tuberculosis infections in India: a pilot study.
abstract: BACKGROUND
  Administration of rifampicin along with nevirapine reduces the plasma concentration of nevirapine in human immunodeficiency virus positive individuals with concomitant tuberculosis (HIV-TB patients). Nevirapine is a much cheaper drug than its alternative efavirenz, and might be beneficial in resource constrained settings.
  
  
  METHODS
  A randomised open label trial was conducted at All India Institute of Medical Sciences, New Delhi, India. During the regimen of an antiretroviral therapy (ART), naive HIV-TB patients were randomly assigned to receive either nevirapine or efavirenz based ART with concomitant rifampicin based anti-tubercular therapy (ATT). Participants were followed for 24 months after starting ART. The end points were virological, immunological and clinical responses, and progression of HIV disease marked by failure of ART.
  
  
  RESULTS
  Of the 135 HIV-TB patients, who were receiving rifampicin based ATT, 68 were selected randomly to receive efavirenz based ART and 67 to receive nevirapine based ART. The virological failure rates in the overall population, and the nevirapine and efavirenz groups were 14.1% (19/135); 14.9% (10/67) and 13.2% (9/68), respectively (p =0.94). No significant difference was found between the groups in the rate of clinical, immunological or virological failures. The overall mortality was 17% with no significant difference between the two groups. Except for the lead in period on day 14, the mean nevirapine concentration remained above 3 mg/L. No association was found between plasma levels of nevirapine and incidence of unfavourable outcomes in this group.
  
  
  CONCLUSIONS
  Outcome of ART in HIV-TB patients on rifampicin based ATT showed no significant difference, irrespective of whether efavirenz or nevirapine was used. Therefore, nevirapine based ART could be an alternative in the resource limited settings in patients with HIV and tuberculosis co-infection.
  
  
  BACKGROUND
  NCT No. 01805258.
authors.affiliation: Departments of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. drsanjeevsinha2002@yahoo.com.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Sinha
authors.forename: Puroshottam
authors.initials: P
authors.lastname: Raghunandan
authors.forename: Rahul
authors.initials: R
authors.lastname: Chandrashekhar
authors.forename: Surendra K
authors.initials: SK
authors.lastname: Sharma
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Kumar
authors.forename: Sahajal
authors.initials: S
authors.lastname: Dhooria
authors.forename: Meera
authors.initials: M
authors.lastname: Ekka
authors.forename: Thirumurthy
authors.initials: T
authors.lastname: Velpandian
authors.forename: Sanjay
authors.initials: S
authors.lastname: Ranjan
authors.forename: Hafeez
authors.initials: H
authors.lastname: Ahmad
authors.forename: Jyotish Chandra
authors.initials: JC
authors.lastname: Samantaray
authors.forename: Srinivasaraghavan
authors.initials: S
authors.lastname: Venkatesh
authors.forename: Bharat Bhushan
authors.initials: BB
authors.lastname: Rewari
authors.forename: Nawaid Hussain
authors.initials: NH
authors.lastname: Khan
authors.forename: Ravindra Mohan
authors.initials: RM
authors.lastname: Pandey
mesh_terms: D000328:Adult; D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D000995:Antitubercular Agents / Q000627:therapeutic use*; D048588:Benzoxazines / Q000627:therapeutic use*; D060085:Coinfection / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology / Q000821:virology; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000627:therapeutic use*; D010865:Pilot Projects; D012293:Rifampin / Q000627:therapeutic use; D014376:Tuberculosis / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology
chemical_list: D000480:Alkynes; D044966:Anti-Retroviral Agents; D000995:Antitubercular Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019829:Nevirapine; C098320:efavirenz; D012293:Rifampin