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The effect of timing of initiation of ART on loss to follow up in HIV-TB co infected patients in South Africa: An open label randomized controlled trial
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Details:
  • Pubmed ID:
    26990824
  • Pubmed Central ID:
    PMC4927384
  • Description:
    Objective

    To evaluate the effect of early integrated, late integrated and delayed antiretroviral therapy (ART) initiation during tuberculosis (TB) treatment on incidence rates of loss to follow-up (LTFU) and to evaluate the effect of ART initiation on LTFU rates within trial arms in patients co-infected with TB and HIV.

    Methods

    A sub-study within a three-armed open label, randomised, controlled trial. Patients were randomised to initiate ART either early or late during TB treatment or after the TB treatment completion. We reported incidence and predictors of LTFU from TB treatment initiation during the 24 months of follow-up. LTFU was defined as having missed 4 consecutive monthly visits with inability to make contact.

    Results

    Of the 642 patients randomised, a total of 96 (15.0%) were LTFU at a median of 6.0 (interquartile range (IQR): 1.1 to 11.3) months after TB treatment initiation. Incidence rates of LTFU was 7.5 per 100 person-years (py) (95% confidence interval (CI), 4.9 to 11), 10.9 per 100 py (95% CI, 7.6 to 15.1) and 11.0 per 100 py (95% CI, 7.6 to 15.4) in the early integrated, late integrated and delayed treatment arm (p=0.313). Incidence rate of LTFU before and after ART initiation was 31.7 per 100 py (95% CI, 11.6 to 69.0) vs. 6.1 per 100 py (95% CI, 3.7 to 9.4), incidence rate ratio (IRR): 5.2 (95% CI, 2.1 to 13.0), p<0.001 in the early integrated arm; 31.9 per 100 py (95% CI, 20.4 to 47.5) vs. 4.7 per 10 py (95% CI: 2.4 to 8.2), IRR: 6.8 (95% CI, 3.4 to 13.6), p<0.0001 in the late integrated arm and 21.9 per 100 py (95% CI, 14.6 to 31.5) vs. 2.8 per 100 py (95% CI, 0.9 to 6.6), IRR: 7.7 (95% CI, 3.0 to 19.9), p<0.0001 in the sequential arm.

    Conclusion

    LTFU rates were not significantly different between the three trials arms. However, ART initiation within each trial arm resulted in a significant reduction in LTFU rates among TB patients.

  • Document Type:
  • Collection(s):
  • Funding:
    D43 TW000231/TW/FIC NIH HHS/United States
    U19 AI051794/AI/NIAID NIH HHS/United States
    U2G PS001350/PS/NCHHSTP CDC HHS/United States
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