Another attempt at monotherapy with DTG.

[Jim Allen]

Another attempt at DTG monotherapy. Interesting, but too small of a sample size for conclusions.

Aidsmap article in full: https://www.aidsmap.com/news/jun-2023/dolutegravir-alone-maintains-hiv-suppression-those-treated-early

In short:

Dolutegravir-based single-drug therapy was an effective long-term maintenance regimen in people who had started treatment soon after acquiring HIV in a small study published in the journal Clinical Infectious Diseases.

Due to excellent virological efficacy, dolutegravir has been tried as a single-drug therapy (monotherapy) several times before. Yet, those attempts have invariably led to unsatisfactory long-term viral suppression. Unlike previous studies, this one looked at the possibility of maintaining viral suppression on monotherapy specifically in people who had started treatment very early (in the first six months after infection) and had been continuously undetectable..

Dr Emily West and her colleagues at the University of Zurich tried to determine whether dolutegravir alone could be as effective as standard therapy (composed of three drugs) in maintaining viral control.

From 2015 to 2017, 101 participants were enrolled in the study, a third of whom continued their standard therapy, while the other 68 switched to dolutegravir monotherapy. Subsequently, four participants from the monotherapy group and three from the standard therapy group were excluded from the analysis.

Following the interim analysis at 48 weeks showing 100% viral suppression on monotherapy, the study team decided to extend the follow-up for another three years. 

None of the participants who completed the entire follow-up experienced virological failure.
These results were most likely also helped by the nearly 100% adherence the participants reported throughout the study.

Another analysis (intention-to-treat analysis) that included those participants who at some point failed to comply with study requirements also showed nearly identical results, however viral suppression on monotherapy dropped to 99%. This is because there was one participant who experienced virological failure and was excluded when it was realised that they had not met the enrolment criteria at study entry. It was found that the participant had started treatment after the phase of primary infection.

[Jim Allen]

I would agree with the below:

Criticism from other HIV experts also addressed the small sample size of the study group. This makes the possibility of error and chance results very real; a larger study may not be able to replicate the same results.

[daveR]

I would have to question the point of continually trying with the same drug, unmodified. The toxicity levels of the one or two other drugs DTG is commonly combined with are virtually zero. Generics are cheap so cost saving would not be great.

I can understand them trying a monotherapy with a new drug, that would be a different scenario.