The combination of lamivudine/dolutegravir is effectiveness in the treatment of HIV-1
As follows from the results of a study recently published in the journal Lancet, lamivudine / doloutegravir combination therapy demonstrated satisfactory efficacy, safety, and tolerability in treating people with HIV-1.
The combination study consisted of 2 multicenter randomized double-blind studies (GEMINI-1 and GEMINI-2) and included 1,441 people with HIV-1.
All participants were randomly assigned either a daily regimen of 2 drugs (Dolutegravir 50 mg and lamivudine 300 mg; n = 719), or a daily regimen of 3 drugs (Dolutegravir 50 mg, tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg; n = 722) .
In the GEMINI-1 study, 90% of the group with 2 drugs and 93% of the group with 3 drugs (the adjusted treatment difference, -2.6%; 95% CI from -6.7% to 1.5%) reached the HH level HIV is less than 50 copies per ml.
In the GEMINI-2 study, 93% of the group with 2 drugs and 94% of the group with 3 drugs (the adjusted treatment difference, -0.7%; 95% CI, from -4.3% to 2.9%) reached these levels.
The most common side effects of both combinations were headache, nasopharyngitis, nausea, insomnia, upper respiratory tract infections, and diarrhea. At the same time, adverse events associated with treatment were more often registered among those who took the scheme of 3 drugs (24% versus 18%).
Only 2% stopped treatment due to adverse events in both groups.
In the GEMINI-2 study, there were 2 deaths, but both were not associated with treatment.
Both phase 3 studies were identical in design and were conducted from July 2016 to March 2017 in 21 countries. Participants were over 18 years old, all of them did not receive ARVT before the onset of CI and had HIV-1 RNA levels of ≤ 500,000 copies per ml.
According to the results of the work, the specialists came to the conclusion that “the dolutegravir / lamivudin regimen provides high antiviral activity with a high barrier to resistance and favorable safety and tolerability profiles. GEMINI's research provides convincing evidence that Dolutegravir / lamivudine is an effective, well-tolerated option for treating patients with HIV-1 infection. ”