TOPLINE:

Same-day initiation of antiretroviral therapy (ART) in patients with HIV infection and tuberculosis (TB) symptoms was noninferior to deferring ART until TB test results were available, achieving similar viral suppression after 6 months. Safety outcomes were also comparable, with no increase in TB-associated immune reconstitution inflammatory syndrome (IRIS). 

METHODOLOGY:

• Researchers conducted a randomized noninferiority trial to determine whether same‑day ART initiation in patients with HIV infection and TB symptoms was noninferior to deferring ART until TB test results were available for achieving viral suppression.
• A total of 590 patients with HIV infection in Lesotho and Malawi (median age, 37 years; 60% male) who were initiating or reinitiating ART and had at least one TB symptom were randomly assigned to receive same-day ART (n = 298) or to start ART after TB was confirmed or ruled out (n = 292).
• The primary outcome was HIV viral suppression (< 400 copies per mL) at 26 weeks after enrollment; noninferiority was confirmed if the lower bound of the 95% CI did not cross the 10% margin.
• Secondary outcomes included retention and engagement in care, serious adverse events, occurrence of TB-associated IRIS, and incident active TB until 30 weeks.
• Patients were followed according to routine national visit schedules, without additional study-related visits; the median time to ART initiation in the group that initiated ART after TB test results became available was 2 days.

TAKEAWAY:

• Across all patients who adhered to their assigned group, 71% in the group that received same-day ART and 72% in the group that received ART after TB results achieved viral suppression at 26 weeks; the absolute risk difference was -1.6% (95% CI, -9.1 to 6.0), meeting the prespecified noninferiority criteria.
• Results were similar when patients were analyzed according to their randomized group. Retention in care, engagement in care, disengagement, and loss to follow-up did not differ meaningfully between the groups.
• TB-associated IRIS events occurred at similar rates in both the groups; incident active TB through 30 weeks was also similar.
• Deaths and serious adverse events were comparable between the groups: the same-day ART group experienced nine deaths and 11 nonfatal serious adverse events, while the group initiating ART after TB results had six deaths and 10 nonfatal serious adverse events.

IN PRACTICE:

“The SaDAPT findings suggest that ambulatory people with HIV being investigated for tuberculosis can safely start ART before results are available in settings where tuberculosis NAATs [nucleic acid amplification tests] are available without delays to receiving results,” experts wrote in the commentary accompanying the journal article.

SOURCE:

The study was led by Felix Gerber, PhD, University Hospital Basel, Basel, Switzerland. It was published online on February 12, 2026, in The Lancet HIV.

LIMITATIONS:

Procedures varied across sites due to limited standardization. The trial used passive surveillance without extra study visits; therefore, only events that prompted patients to seek care or report the event were captured. Determinations of TB-associated IRIS relied solely on clinical case review without additional radiology or laboratory testing; hence, assessments may have varied between clinicians.

DISCLOSURES:

The trial was funded by the Swiss National Science Foundation. One author disclosed receiving travel grants for conferences from Gilead Sciences and ViiV Healthcare, and another disclosed serving as chair of the IMPROVE trial’s data and safety monitoring board.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.