Use of Dolutegravir and Lamivudine in Real-world Settings

This technical report presents findings on the use of dolutegravir (DTG) and lamivudine (3TC) in real-world settings, focusing on their effectiveness among people living with HIV (PWH). The report outlines data from over 41,000 patients treated with DTG/3TC or its individual components, highlighting high rates of virologic effectiveness observed at Week 48 across various cohorts. Systematic literature reviews identified treatment-naïve and treatment-experienced patients, with results consistent with Phase 3 clinical trials. The report details the clinical development program, including non-inferiority studies comparing DTG/3TC to other regimens. It also summarizes real-world cohort data, including treatment-naïve and treatment-experienced patients, and discusses virologic failure rates and safety profiles. The findings indicate that DTG/3TC is effective in maintaining viral suppression, with low rates of discontinuation due to adverse events. The report concludes with a summary of systematic literature reviews conducted to evaluate the safety and effectiveness of DTG/3TC.