In our multicenter cohort of virologically suppressed PLWHIV switched to DTG + 3TC, we were able to assess the efficacy, safety, and overall tolerability of this 2DR in the long period. It has been been over 5 years that DTG + 3TC has been introduced in clinical practice as a feasible switch strategy, and results from this study appear in line with the results from clinical trials and other observational studies, including previous results from our cohort.[8,9] Compared with patients enrolled in the TANGO study, our cohort is composed of older patients, with a longer history of HIV and ARV, and over one-fifth of the analyzed patients have experienced at least 1 VF; these differences further reinforces the strength of this combination in the real-life setting.
In this work, we observed a low VF rate (0.9 VF per 100 PYFU), with no patient experiencing the emergence of resistance mutation at failure, reflecting the safety and high genetic barrier of dolutegravir. Moreover, confirming previous findings, we did not observe an overall increase in the VF rate in patients with the M184V resistance mutation, but those with a reduced time of virological suppression at baseline showed an increased risk of VF in the presence of M184V.
In patients discontinuing study regimen, toxicity remained the leading cause of treatment interruption, with most events being of neuropsychological nature. The previously observed correlation between neuropsychiatric disorders and HCV coinfections was confirmed.[8,14]
Our study has some limitations, such as its retrospective nature, the lack of a control group, and the lack of recording of data on patients' compliance or minor adverse events not leading to TD. Other limitations are the low number of patients with available information regarding previous M184V mutation and the wide confidence intervals for some of the findings. However, the study also presents several strengths, including its long follow-up time, its sample size, and the real-life setting.
In conclusion, DTG+3TC confirmed its efficacy in maintaining virological suppression in a large proportion of PLWHIV in a real-life setting; clinicians should always consider patients' clinical and viro-immunological history when considering the switch to a dual regimen.
This study was funded by ViiV Healthcare. The study sponsor did not contribute to design of the study and collection, analysis and interpretation of data, and in writing of the manuscript.
J Acquir Immune Defic Syndr. 2021;88(3):234-237. © 2021 Lippincott Williams & Wilkins