Efficacy and Safety of Switching to Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate (TDF) or Elvitegravir/Cobicistat/Emtricitabine/TDF in Virologically Suppressed HIV-Infected Patients in Clinical Practice

Results From a Multicentre, Observational Study

G Baldin; A Ciccullo; A Capetti; S Rusconi; G Sterrantino; MV Cossu; A Giacomelli; F Lagi; A Latini; P Bagella; A De Luca; S Di Giambenedetto; G Madeddu


HIV Medicine. 2019;20(2):164-168. 

In This Article

Abstract and Introduction


Objectives: The aim of the study was to compare the efficacy and tolerability of switching antiretroviral therapy to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (TDF) with those of switching to elvitegravir/cobicistat/emtricitabine/TDF in clinical practice.

Methods: In a multicentre real-life observational study, we analysed data for HIV-infected patients on antiretroviral treatment with viral load < 50 HIV-1 RNA copies/mL switching to dolutegravir + emtricitabine/TDF (dolutegravir group) or elvitegravir/cobicistat/emtricitabine/TDF (elvitegravir group). Follow-up was censored at 48 weeks.

Results: The 48-week estimated proportion maintaining virological efficacy was 96.1% with dolutegravir (n = 123) and 95.4% with elvitegravir (n = 186; P = 0.941). Patients in the dolutegravir group showed more treatment discontinuations, but these were mainly as a result of simplification. The elvitegravir group showed more discontinuations because of renal adverse events (2.7% versus 0% with dolutegravir). Interestingly, no difference was observed between the two regimens in central nervous system toxicity-related discontinuations. Switching to dolutegravir was associated with a better blood lipid profile.

Conclusions: Switching to dolutegravir + emtricitabine/TDF was associated with similar efficacy and tolerability to switching to elvitegravir/cobicistat/emtricitabine/TDF in virologically suppressed patients in clinical practice, although reasons for discontinuation showed differences between regimens. These results should be interpreted with caution, as this is a nonrandomized comparison.


In patients achieving stable suppression of plasma HIV-1 RNA on combination antiretroviral therapy (cART), the aim of strategies of switching to integrase inhibitor (INI)-based regimens is to increase adherence and reduce the risk of development of long-term toxicities. However, comparative data on the efficacy and safety of different INI-based combinations in clinical practice are lacking. The combination of dolutegravir + emtricitabine/tenofovir disoproxil fumarate (TDF) is recommended as an initial regimen but no data are available on use of this combination in switch strategies.[1–3] The co-formulation of elvitegravir/cobicistat/emtricitabine/TDF has proven effective in switch strategies.[4,5] The aim of our study was to compare the efficacy and safety of switching to one of these two regimens in clinical practice with those of switching to the other.