Article

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.

Click to continue reading on Specialty Pharmacy Times.

Newsletter

Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.

Related Videos
HIV awareness
Image credit: Krakenimages.com | stock.adobe.com
Image credit: gamjai - stock.adobe.com