NDA Submitted to FDA for Single-Tablet, 2-Drug HIV Treatment Regimen


Dolutegravir plus lamivudine showed non-inferiority to a 3-drug, first-line regimen in treating HIV 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.

“We have now entered an exciting new era of treatments for people living with HIV,” Deborah Waterhouse, chief executive officer of ViiV Healthcare, said in the release. “ViiV Healthcare believes that a 2-drug regimen has the potential to be an important option for many who may spend their lifetime taking drugs to control their virus.”

If approved, the DTG plus 3TC regimen could potentially be an easier, alternative option for patients currently taking a 3-drug regimen to maintain virus control.

“This regulatory submission is the next step in the 2-drug regimen journey and reinforces our belief that many patients can control their disease with 2 drugs instead of 3 or more,” Waterhouse added.

A priority review voucher was submitted to the FDA along with the NDA, according to ViiV. The anticipated target action date for this NDA with a priority review voucher is 6 months after the FDA has received the application.


ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV [news release]. 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. Accessed October 22, 2018.

ViiV Healthcare presents phase III data showing two drug regimen has similar efficacy to a three drug regimen in treatment naïve HIV patients, with no resistance [news release]. ViiV’s website. https://www.viivhealthcare.com/media/press-releases/2018/july/viiv-healthcare-presents-phase-iii-data-showing-two-drug-regimen-has-similar-efficacy-to-a-three-drug-regimen-in-treatment-naïve-hiv-patients-with-no-resistance.aspx. Accessed October 22, 2018.

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