| Summary: | Objectives: In the HIV-1-positive population, a paradigm shift from three-drug regimens (3DRs) to dolutegravir-based two-drug regimens (2DRs) both as initial and switch treatment is beginning to take place, supported virologically by the availability of new potent drugs with high genetic barrier to overcome, at least in certain conditions, the dogma of 3DRs in effective HIV-1 therapy. This manuscript reviews the increasing evidence on their excellent and sustained long-term effectiveness and safety. Methods: This review includes the most recent results on dolutegravir plus rilpivirine or lamivudine 2DRs from randomised clinical trials, meta-analyses and real-life studies, including relevant data presented at international conferences up to August 2019. Results: As an initial treatment strategy, dolutegravir plus lamivudine showed high efficacy and safety over 96 weeks in 1441 patients from the GEMINI-1&2 phase III non-inferiority trials. In the SWORD 1&2 trials in virologically-suppressed patients, switching to once-daily dolutegravir plus rilpivirine maintained efficacy over 148 weeks. Similarly, in the TANGO trial, no confirmed virological withdrawals were observed with dolutegravir/lamivudine through Week 48. Consistent results were observed in real-life cohorts. No emergent dolutegravir-resistant virus has ever been reported in a patient in whom dolutegravir was prescribed in the context of such 2DRs. Switching to once-daily dolutegravir plus rilpivirine or lamivudine was generally well tolerated and was associated with favourable renal and bone safety. Conclusion: The results available so far support dolutegravir-based 2DRs as excellent treatment options for adults with HIV-1 infection, either naïve or already virologically suppressed on their current antiretroviral regimen.
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