6/28/23, 11:06 PM HPTN 052 Pathway Feedback Search Clinical Topics Home Studies HPTN 052 HPTN 052 Disease Human immunodeficiency virus i Trial question What is the role of early antiretroviral therapy in HIV-1 serodiscordant couples? Study design Multi-center Open label RCT Population Characteristics of study participants 50.0% female N = 1763 50.0% male 1763 patients (873 female, 890 male) Inclusion criteria: HIV-1 serodiscordant couples (one partner HIV-1-positive and the other HIV- 1-negative) with CD4 counts between 350 and 550 cells/mm Key exclusion criteria: history of injection drug use within the last 5 years, AIDS-defining illness, use of ART drugs, acute hepatitis within 30 days prior to enrollment, acute therapy for serious medical illnesses, or allergy/sensitivity to any study drug or their formulations Interventions N=886 early antiretroviral therapy (immediate antiretroviral therapy) N=877 delayed antiretroviral therapy (after decline in the CD4 count or the onset of HIV-1- related symptoms) Primary outcome HIV-1 transmission in HIV-1-negative partners 1.7 % 1.7 https://web.pathway.md/studies/recdCfZkTjjU4CBFw 1/2 6/28/23, 11:06 PM HPTN 052 Pathway 1.3 % 0.8 % Significant decrease 0.4 % NNT = 63 0.1 0.0 % Early antiretroviral therapy Delayed antiretroviral therapy Significant decrease in HIV-1 transmission in HIV-1-negative partners (0.1% vs. 1.7%; HR 0.04, 95% CI 0.01 to 0.27) Secondary outcomes Significant decrease in HIV-1-related clinical event or death (2.4% vs. 4%; HR 0.59, 95% CI 0.4 to 0.88) No significant difference in death (10 vs. 13; HR 0.77, 95% CI 0.34 to 1.76) Safety outcomes No significant differences in grade 3 or 4 severe or life-threatening adverse events (14% vs. 14%, p=0.64). Significant differences in grade 3 or 4 laboratory abnormalities (27% vs. 18%, p < 0.001). Conclusion In HIV-1 serodiscordant couples (one partner HIV-1-positive and the other HIV-1-negative) with CD4 counts between 350 and 550 cells/mm , early antiretroviral therapy was superior to delayed antiretroviral therapy with respect to a HIV-1 transmission in HIV-1-negative partners. Reference Cohen MS, Chen YQ, McCauley M et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. Open reference URL https://web.pathway.md/studies/recdCfZkTjjU4CBFw 2/2