HIV: fetal outcomes with TDF-FTC-LPV/r on par with other regimens

  • Rough K & al.
  • N Engl J Med
  • 26 Apr 2018

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • Tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF-FTC-LPV/r) carry similar risk for adverse pregnancy outcomes as TDF-FTC-ATV/r (ritonavir-boosted atazanavir) and zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV-3TC-LPV/r) in HIV-infected women.

Why this matters

  • Findings suggest parity among antiretroviral therapy (ART) regimens in terms of adverse fetal outcomes. 
  • Benefits of ART for maternal health, reduced perinatal transmission continue to outweigh risks.

Key results

  • 4646 birth outcomes, 3847 unique women.
  • Exposures: 2.8% (128) to TDF-FTC-LPV/r as initial ART, 11.6% (539) to TDF-FTC-ATV/r, 20.5% (954) to ZDV-3TC-LPV/r.
  • 10 fetal losses, 1.6% (n=2) in women receiving TDF-FTC-LPV/r as the first regimen, 0.4% (n=2) receiving TDF-FTC-ATV/r, 0.6% (n=6) receiving ZDV-3TC-LPV/r.
  • Across regimens, preterm birth risk ranged from 16.1% to 21.4%, low birthweight from 16.2% to 23.8%.
  • Comparatively, TDF-FTC-LPV/r and ZDV-3TC-LPV/r has close to the null value for preterm birth (risk ratio [RR], 0.90; 95% CI, 0.60-1.33), low birth rate (RR, 1.13; 95% CI, 0.78-1.64), and adverse events (RR, 0.92; 95% CI, 0.67-1.28).
  • TDF-FTC-based regimens were associated with lower preterm birth risks (RR, 0.77; 95% CI, 0.62-0.96).

Study design

  • Pairwise, comparative cohort analysis of adverse birth outcomes with in utero exposure to TDF-FTC-LPV/r, TDF-FTC-ATV/r, and/or ZDV-3TC-LPV/r.
  • Funding: NIH, others.

Limitations

  • Selection bias.
  • Limited power to detect safety.
  • Nongeneralizable.

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