ACTG A5353: a pilot study of dolutegravir plus lamivudine

[Jim Allen]

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.

http://www.aidsmap.com/Dolutegravir-and-lamivudine-potent-and-safe-in-patients-starting-HIV-therapy-for-the-first-time/page/3201711/

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

[connor]

Just seen this article in the news.

Second two drug regime after Juluca will be available soon.

http://www.pharmatimes.com/news/viiv_submits_two-drug_regimen_for_hiv_in_europe_1252248

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

[life2]

https://www.viivhealthcare.com/media/press-releases/viiv-healthcare-submits-new-drug-application-to-us-fda-for-single-tablet-two-drug-regimen-of-dolutegravir-and-lamivudine-for-treatment-of-hiv.aspx