Phase 3 Trial Tests an Integrase Inhibitor–Free, Tenofovir-Free First-Line HIV Regimen

First-line antiretroviral therapy (ART) has become highly standardized around potent, well-tolerated regimens with high rates of viral suppression. Even so, regimen diversity still matters in real-world care—particularly as patients age, accumulate comorbidities, and bring individualized tolerability concerns to shared decision-making.¹

A phase 3, randomized, placebo-controlled trial presented at CROI evaluated an investigational, fixed-dose combination that does not include an integrase strand transfer inhibitor (INSTI) and does not include tenofovir, comparing it with a current US “gold standard” TAF-containing fixed-dose combination in treatment-naive adults without active hepatitis B infection.¹

In an interview with Patient Care Online, coauthor Jürgen Rockstroh, MD, Professor of Medicine at the University Hospital Bonn (Bonn, Germany) and a specialist in HIV and viral hepatitis, described the study as a pivotal test of an “INSTI-free” regimen in treatment-naive individuals, following earlier switch-regimen data in other settings. He also discussed the primary findings presented at CROI 2026.