title: Early changes in hepatic function among HIV-tuberculosis patients treated with nevirapine or efavirenz along with rifampin-based anti-tuberculosis therapy.
abstract: OBJECTIVE
  To describe the longitudinal changes in hepatic function among HIV-infected tuberculosis (TB) patients receiving once-daily nevirapine (NVP)- or efavirenz (EFV)-based antiretroviral treatment (ART) along with rifampin-containing anti-TB treatment.
  
  
  METHODS
  This was a nested study within a randomized clinical trial, taking place between May 2006 and June 2008 at the National Institute for Research in Tuberculosis, Chennai, India. Antiretroviral-naïve HIV-infected TB patients were initiated on an intermittent short-course regimen and randomized to receive didanosine and lamivudine with either NVP (400 mg) or EFV (600 mg) once-daily. Blood was analyzed for alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum alkaline phosphatase (SAP), and bilirubin at baseline, at ART initiation, fortnightly after ART initiation until 2 months, then monthly until 6 months and 6-monthly thereafter.
  
  
  RESULTS
  Of the 168 patients included (79% men, median CD4 count 93 cells/mm3, median viral load 242,000 copies/ml), 104 were on EFV-based ART and 64 on NVP-based ART. There was a small but statistically significant elevation in ALT and SAP at 2 weeks and AST at 6 weeks after ART initiation. The proportion of patients with rate-limiting toxicity of liver enzymes was small. None had treatment terminated because of hepatotoxicity.
  
  
  CONCLUSIONS
  Hepatotoxicity is not a major concern when HIV-infected TB patients, with normal baseline liver function initiate treatment for both infections simultaneously.
authors.affiliation: National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Salai, Chetput, Chennai 600 031, India.
authors.forename: C
authors.initials: C
authors.lastname: Padmapriyadarsini
authors.forename: P K
authors.initials: PK
authors.lastname: Bhavani
authors.forename: Alice
authors.initials: A
authors.lastname: Tang
authors.forename: Hemanth
authors.initials: H
authors.lastname: Kumar
authors.forename: C
authors.initials: C
authors.lastname: Ponnuraja
authors.forename: G
authors.initials: G
authors.lastname: Narendran
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hannah
authors.forename: C
authors.initials: C
authors.lastname: Ramesh
authors.forename: C
authors.initials: C
authors.lastname: Chandrasekar
authors.forename: Christine
authors.initials: C
authors.lastname: Wanke
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
mesh_terms: D000328:Adult; D000480:Alkynes; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D048588:Benzoxazines / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D060085:Coinfection; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000097:blood* / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008099:Liver / Q000201:enzymology; D008111:Liver Function Tests; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage; D012293:Rifampin / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014376:Tuberculosis / Q000097:blood* / Q000188:drug therapy* / Q000276:immunology; D019562:Viral Load
chemical_list: D000480:Alkynes; D000995:Antitubercular Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019829:Nevirapine; C098320:efavirenz; D012293:Rifampin
keywords: ART; Anti-tuberculosis therapy; HIV–TB co-infection; Hepatic function; Nevirapine