Raltegravir 1200 mg Once Daily as Maintenance Therapy in Virologically Suppressed HIV-1 Infected Adults : QDISS Open-Label Trial

Background: Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interactions. The use of RAL 1200 mg once daily (qd) for first-line therapy is well established. We assessed efficacy and safety of RAL 1200 mg qd, as part of triple cART, for maintenance strategy.Methods: The QDISS trial (NCT03195452) was a 48-week multicenter, single-arm, open-label study designed to evaluate the ability of 2 NRTIs + RAL 1200 mg qd to maintain virological suppression in HIV-1 infected subjects on a stable cART with 2 NRTIs and a third agent for at least 6 months. The primary endpoint was the proportion of participants with HIV-1 RNA p=0.023) and LDL-cholesterol (p=0.009) decreased, lifestyle and ease subscale significantly improved (p=0.04). The quality of life and Patients Reported Outcomes (PROs) also improved at W12 (p=0.007). Conclusion: RAL 1200 mg qd as part of a maintenance triple therapy showed a high efficacy in virologically suppressed HIV-1 infected subjects, with good safety profile and improved lipid profile and patient reported outcomes.Trial registration = clinical trials.gov NCT03195452 and EudraCT 2016-003702-13