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Author Topic: MONCAY study - Dolutegravir monotherapy  (Read 4234 times)

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Offline Jim Allen

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MONCAY study - Dolutegravir monotherapy
« on: August 31, 2018, 06:24:28 pm »
So previously the dutch "DOLUMONO" study that looked at dolutegravir monotherapy failed, with lower suppression rates & resistance:
https://forums.poz.com/index.php?topic=66233.0

Seems now a similar fate with a french dolutegravir monotherapy study

August 31, 2018
https://www.poz.com/article/switching-hiv-regimen-just-tivicay-neither-safe-ethical

Quote
Switching people with HIV from a three-drug antiretroviral (ARV) regimen to treatment with Tivicay (dolutegravir) alone raises the risk of viral rebound to an unacceptable extent, aidsmap reports. Consequently, researchers have argued that switching individuals to Tivicay monotherapy—treating the virus with just that ARV, instead of with standard combination therapy—is unethical because of safety concerns.

Presenting their findings at the International AIDS Conference in Amsterdam (AIDS 2018), French researchers from the MONCAY study enrolled 158 HIV-positive adults with a fully suppressed viral load thanks to Triumeq (dolutegravir/abacavir/lamivudine) treatment who had never had an AIDS-defining illness or a lowest-ever CD4 count below 100.

The participants were randomized to remain on triple-drug treatment with Triumeq or to receive Tivicay monotherapy—a respective 80 and 78 participants were put on each treatment.

The study looked primarily at the difference in viral suppression rates between the two groups after 24 weeks of treatment: 96 percent of those on Triumeq had a viral load below 50 at this point, compared with 94 percent of those on Tivicay monotherapy. By this point in the study, two of those on monotherapy had experienced virological rebound—meaning a viral load above 50—compared with no one in the triple-drug therapy group.

After an additional 24 weeks of treatment, another five members of the monotherapy group experienced virologic rebound; two of them developed new viral mutations associated with resistance to integrase inhibitors. (Tivicay belongs to that class of ARVs.) This led the study’s data and safety monitoring board to stop the study.
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Offline CaveyUK

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Re: MONCAY study - Dolutegravir monotherapy
« Reply #1 on: September 01, 2018, 07:35:17 am »
Fully understand why they would stop this study, but I suppose the interesting aspect of this is that for only 2% viral rebound after 6 months, and 10% after 12 months (so after a year on mono therapy 90% of people were still UD) there is scope to suggest that DTG isn't that far from being effective on it's own, which would suggest that it may not take a particularly powerful second agent - or a refinement to DTG to bridge that gap, which bodes well in terms of future drug development and the simplification of regimens ultimately.


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Offline Mindless

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Re: MONCAY study - Dolutegravir monotherapy
« Reply #2 on: September 01, 2018, 08:55:00 am »
which would suggest that it may not take a particularly powerful second agent

You mean something like Juluca? Or another kind of solution?
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