Further Results Using Dolutegravir Monotherapy: Urgent Need for Controlled Studies

January 12, 2016

A small case study using dolutegravir monotherapy in treatment naive patients1 has reported similar results to several other small studies presented at the EACS conference last year.2,3

Given the significance of this data in showing a lack of viral rebound, this highlights the the urgency of data from randomised controlled studies.

The current study was reported in a letter to JAIDS from Massimiliano Lanzafame from University Hospital Verona, and colleagues.1

It included retrospective results from nine HIV positive people (2 women, 7 men) who began initial therapy using dolutegravir after having "refused NRTIs". All participants were treatment-naive with baseline viral load <100,000 copies/mL (range 16,000 to 90,000) and no genotypic drug resistance (to NRTIs, NNRTIs, PIs or INSTIs). Mean age was 45 (range 36 to 76 years) and been time since diagnosis was about eight years.4

After four weeks, viral load was <50 copies/mL for all participants. This was reported as undetectable in three patients, <20 copies/mL in another three and at 31, 35 and 45 copies/mL in the remaining three.

Viral load at the last result, after a mean follow-up of 7.3 months (range 6 to 10 months) was <20 copies/mL for all participants. This was reported as undetectable in seven patients, and <20 copies/mL in the remaining two.

CD4 counts increased in all participants by a mean 152 cells/mm3 (range +94 to +284 cells/mm3).


The limited details in the JAIDS study mean that the results are laregly case reports.

Of note however, it shows than another research group independently initiated a study of dolutegravir monotherapy almost a year ago in early 2015.

At least half a dozen groups are now running small uncontrolled studies of monotherapy2 and dual therapy with 3TC.3

Given the potential savings in drug exposure and financial cost of treatment (if proved successful) it is a considerable missed opportunity for future research not to include a standard of care arm in a randomised design. Should this strategy not prove successful, there is an urgency to establish these concerns quickly, as off-label switching to reduced therapy in the absence of data is otherwise very likely.

The NIH-sponsored ACTG dual therapy study, is already enrolling but unfortunately also has no control group.5

This means that it might take several years until a sufficiently powered study establishes whether or not a significant risk exists for this strategy.


  1. Massimiliano L et al. Dolutegravir monotherapy in HIV-infected naive patients with <100,000 copies/mL HIV-RNA viral load. Letter to the editor. JAIDS, 08 January 2016, Publish Ahead of Print. doi: 10.1097/QAI.0000000000000931.
  2. Collins S. Remarkable results with dolutegravir monotherapy. HTB November/December 2015.
  3. Collins S. First-line ART with dolutegravir plus 3TC: 24-week early results. HTB November/December 2015.
  4. Personal communication.
  5. Dolutegravir plus lamivudine dual therapy in treatment naive HIV-1 patients. (not yet recruiting).

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.

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