Rapid vs same-day treatment initiation for patients with tb symptoms at HIV diagnosis

ABSTRACT

Background: Delays in ART initiation for TB testing are associated with high rates of loss to follow-up. There are limited data on outcomes with same-day testing and treatment for patients with TB symptoms at HIV diagnosis. Methods: We conducted a randomized trial comparing same-day and rapid (7 days) TB testing and treatment initiation among adult patients with TB symptoms at HIV diagnosis at GHESKIO in Haiti. The same-day group received Xpert Ultra results and initiated either TB medication or ART on the day of HIV diagnosis. The rapid group received Ultra results within the first week and started ART on Day 7 if not diagnosed with TB. Dolutegravir (DTG) replaced efavirenz (EFV) as the first-line anchor drug in December 2018. The primary outcome was 48-week HIV-1 RNA <200 copies/mL. Results: Between November 2017 and December 2019, 500 participants were randomized to rapid (n=250) or same-day treatment (n=250) (Table 1). 234 (46.8%) were female, median age was 37 (IQR 30, 45), and median CD4 count was 278 (134, 421). In the rapid group, 40/41 (97.6%) participants diagnosed with TB started TB drugs;244 (97.6%) started ART. In the same-day group, 45/45 (100%) diagnosed with TB started TB drugs;250 (99.6%) started ART. There were no statistically significant differences in 48-week outcomes between groups. In the rapid group, 224/250 (89.6%) were retained in care, and of these, 171 (76.3%) had HIV-1 RNA <200 copies/mL. In the same-day group, 219/250 (87.6%) were retained in care, and of these, 155 (70.8%) had HIV-1 RNA <200 copies/mL. The primary outcome (48-week HIV-1 RNA <200 copies/mL) was achieved by 171/250 (68.4%) in the rapid group and 155/250 (62.0%) in the same-day group (p=0.133). Outcomes were superior among participants who initiated ART with DTG instead of EFV, with HIV-1 RNA <200 copies/mL in 82.4% vs. 68.1%, respectively, (p=0.001) among those receiving viral load testing, and 75.3% vs. 60.4% among those randomized (p<0.001). Conclusion: Among patients with TB symptoms at HIV diagnosis, both rapid and same-day treatment are associated with near-universal initiation of TB treatment and ART, with no significant difference in 48-week outcomes. Viral suppression rates were lower than anticipated, which we attribute to high rates of transmitted EFV resistance, political instability with a national lockdown, and the SARS-CoV-2 outbreak in Haiti during the study period. Viral suppression rates are superior with DTG, supporting the rapid transition from EFV to DTGbased ART.