Tuberculosis incidence after 36 months’ isoniazid prophylaxis in HIV-infected adults in Botswana: a posttrial observational analysis

Details

• Alternative Title:
  AIDS
• Personal Author:
  Samandari, Taraz ; Agizew, Tefera B. ; Nyirenda, Samba ; Tedla, Zegabriel ; Sibanda, Thabisa ; Mosimaneotsile, Barudi ; Motsamai, Oaitse I. ; Shang, Nong ; Rose, Charles E. ; Shepherd, James
• Description:
  Objective
  
  Thirty-six months of isoniazid preventive therapy (36IPT) was superior to 6 months of IPT (6IPT) in preventing tuberculosis (TB) among HIV-infected adults in Botswana. We assessed the posttrial durability of this benefit.
  
  Design
  
  A 36-month double-blind placebo controlled trial (1 : 1 randomization) with recruitment between November 2004 and July 2006 and observation until June 2011.
  
  Methods
  
  One thousand, nine hundred and ninety-five participants were followed in eight public health clinics. Twenty-four percent had a tuberculin skin test ≥5 mm (TST-positive). A minimum CD4+ lymphocyte count was not required for enrolment. Antiretroviral therapy (ART) was provided in accordance with Botswana guidelines; 72% of participants retained by June 2011 had initiated ART. Multivariable analysis using Cox regression analysis included treatment arm, TST status, ART as a time-dependent variable and CD4+ cell count at baseline and updated at 36 months.
  
  Results
  
  In the posttrial period, 2.13 and 2.14 per 100 person-years accumulated, whereas 0.93 and 1.13% TB incidence rates were observed in the 36IPT and 6IPT arms, respectively (P = 0.52). The crude hazard ratio of TB during the trial and posttrial was 0.57 [95% confidence intervals (CI) 0.33, 0.99] and 0.82 (95% CI 0.46, 1.49), and when restricted to TST-positive participants was 0.26 (95% CI 0.08, 0.80) and 0.40 (95% CI 0.15, 1.08), respectively. Multivariable analysis showed that ART use was associated with reduced death (adjusted hazard ratio 0.36, 95% CI 0.17–0.75) but not TB (0.92, 95% CI 0.55–1.53) in the posttrial period.
  
  Conclusion
  
  The benefit of 36IPT for TB prevention declined posttrial in this cohort. Adjunctive measures are warranted to prevent TB among HIV-infected persons receiving long-term ART in TB-endemic settings.
  
  
• Subjects:
  Adult Antiretroviral Therapy Antitubercular Agents Article Botswana Double-Blind Method Female HIV HIV Infections Humans Incidence Isoniazid Male Placebos Pre-Exposure Prophylaxis Preventive Therapy Tuberculin Tuberculosis

  More +
• Source:
  AIDS. 29(3):351-359
• Pubmed ID:
  25686683
• Pubmed Central ID:
  PMC5131631
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Volume:
  29
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:72596afccf7cbc370d930a5e902ab7f0f506428bc7b7dd535dd997fee264b202
• Download URL:
  https://stacks.cdc.gov/view/cdc/43112/cdc_43112_DS1.pdf
• File Type:
  [PDF - 454.90 KB ]