- Initiation of isoniazid during vs after pregnancy is noninferior with regard to maternal adverse events (AEs) in HIV-infected pregnant women on antiretroviral therapy (ART) but is linked to a higher composite adverse outcome.
- The composite outcome included stillbirth or spontaneous abortion, low infant birth weight, preterm delivery, or congenital anomalies.
Why this matters
- Consider administering isoniazid to ART-treated, HIV-infected pregnant women during postpartum vs immediate pregnancy period.
- Shorter courses (i.e., 1 or 3 months) might optimise outcomes.
- 956 participants (477 immediate, 479 deferred isoniazid).
- Composite adverse pregnancy outcomes: 23.6% for immediate vs 17.0% for deferred use (difference, 6.7 percentage points; P=.01).
- Intent-to-treat (ITT) population: grade ≥3 maternal AEs were similar with immediate and deferred use (15.1% vs 15.2%; incidence rate, 15.03 vs 14.93 per 100 person-years [PY]; Δ=0.10; 95% CI, −4.77 to 4.98).
- ITT: incidence rate for any grade 3/4 AE was likewise similar (34.95 vs 31.26 per 100 PY; Δ=3.69 [95% CI, −4.07 to 11.45]).
- Hepatotoxicity incidence rates were similar (5.80 vs 6.69 per 100 PY; Δ=−0.89 [95% CI, −3.98 to 2.19]).
- 6 postpartum deaths (2 immediate, 4 deferred); rate difference, −0.39 (95% CI, −1.33 to 0.56).
- Multicentre, double-blind, noninferiority trial assessing immediate vs deferred initiation of isoniazid through week 48 postdelivery among HIV-infected pregnant women living in high-risk areas.
- Funding: NIH.
- Noninferiority margin not reached.
- Intensive laboratory monitoring, misclassifications.