ViiV Submits NDA for Single-Tablet, 2-Drug HIV Therapy

ViiV Healthcare has submitted a New Drug Application (NDA) for its single-tablet, 2-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection.

ViiV Healthcare has submitted a New Drug Application (NDA) for its single-tablet, 2-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection, according to a company press release.

The NDA submission is based on data from the GEMINI 1 and 2 clinical studies, which evaluated the DTG plus 3TC regimen compared with a 3-drug, first-line regimen of DTG plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for the treatment of HIV infection. The study included 1400 antiretroviral therapy (ART)-naïve adults with baseline viral loads up to 500,000 c/mL.

The study results showed non-inferiority based on plasma HIV-1 RNA <50 c/mL at week 48. According to the data, 91% of patients taking DTG plus 3TC had HIV-1 RNA <50 copies/mL compared with 93% of patients taking DTG plus TDF/FTC.

The findings demonstrated broadly consistent results for viral suppression across individuals with higher viral load and lower viral load HIV-1 plasma RNA. Rates of virologic failure were ≤1% across all arms of the study. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance, according to the studies.

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