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Author Topic: ACTG A5353: a pilot study of dolutegravir plus lamivudine  (Read 1823 times)

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Offline Jim Allen

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ACTG A5353: a pilot study of dolutegravir plus lamivudine
« on: December 28, 2017, 11:25:02 am »
Not a new combination to pilot, however interesting and good to see more results backing this combination. Hopefully it will lead to a treatment combination in the future.


Viral load was measured at regular intervals over 24 weeks. The main outcome was viral suppression (below 50 copies/ml) at week 24. Virological failure was defined as a viral load above 400 copies at weeks 16/20 or above 200 copies/ml at week 24. Patients experiencing virological failure underwent therapeutic drug level monitoring and resistance testing. Data were gathered on adherence and safety.

The patients had a median age of 30 years and 87% were male. Median baseline viral load and CD4 cell count were 40,000 copies/ml and 387 cell/mm3, respectively.

Seven patients were lost to follow-up or withdrew from the study before week 24.

Overall, 108 patients (90%) had an undetectable viral load at week 24. Rates of viral suppression were similar for patients with baseline viral loads above and below 100,000 copies/ml (90% vs. 89%).

Three patients experienced virological failure. Drug level monitoring showed undetectable levels of dolutegravir, therefore suggesting poor treatment adherence.

One patient with virological failure developed the M184V mutation, which confers resistance to lamivudine, and also the R263R/K mutation, potentially limiting the effectiveness of dolutegravir.

Other studies using dolutegravir & lamivudine:
https://forums.poz.com/index.php?topic=63655.0 The GEMINI trial in Phase 3 now also had great phase 2 results , dual therapy with dolutegravir plus lamivudine
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Offline connor

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Dolutegravir and Lamivudine dual threapy two drug regime.
« Reply #1 on: September 15, 2018, 01:44:30 pm »
Just seen this article in the news.

Second two drug regime after Juluca will be available soon.


I'm on the Gemini trial since March 2016 of just taking Dolutegravir and Lamivudine and the new single tablet two drug regime will be out soon which is good. I've had no side effects where I have had before on other meds as you can see in my signature below I've been on a few different meds because of side effects
04 Mar 2014 Negative test results
14 May 2014 CD4 530 VL 10,000 TDF+FTC+RAL+DRV+RTV (started meds during seroconversion. HIV-1 subtype B)
28 May 2014 CD4 630 VL 66,182
17 Jun 2014 CD4 704 VL UD TDF+FTC+RAL
26 Aug 2014 CD4 646 VL UD
28 Oct 2014 CD4 797 VL UD TDF+FTC+EVG/c
12 May 2015 CD4 730 VL UD
08 Sep 2015 CD4 787 VL UD
13 Nov 2015 CD4 658 VL UD DTG+3TC+ABC (hypersensitivity ABC)
20 Nov 2015 CD4 718 VL UD TDF+FTC+RAL
21 Mar 2016 CD4 889 VL UD DTG+3TC (Dual Therapy. Gemini Study)
13 Jun 2016 CD4 1006 VL UD
29 Aug 2016 CD4 1081 VL UD
02 Dec 2016 CD4   801  VL UD
13 MAR 2017 CD4 1070 35% UD
01 JUN  2017 CD4   994 42% UD
16 NOV 2017 CD4 1168 34% UD
20 APR 2018 CD4    982 38% UD
04 OCT 2018 CD4    681 33% UD
01 APR 2019 CD4    978 35% UD


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