GSK’s ViiV Healthcare Seeks FDA Approval for Combination HIV Therapy

ViiV seeks priority review for its combination dolutegravir (DTG) and lamivudine (3TC) therapy.

UK-based ViiV Healthcare, owned by partners GlaxoSmithKline, Pfizer and Shionogi, has a portfolio of 13 antiretroviral HIV therapies that generated over $5.5 billion in 2017. ViiV’s greatest rival is US-based Gilead, which has the largest share of the market, with an anticipated value in 2025 of $22.5 billion.

ViiV is hoping to obtain approvals of two-drug therapies that can compete with the three-drug cocktails offered by Gilead. The belief is that with two rather than three drugs, the side effects, dosing frequency and cost may all be reduced; however, the counter-argument is that with only two drugs to combat, the virus could more easily develop resistance. 

ViiV and GSK’s latest two-drug therapy consists of dolutegravir (DTG) and lamivudine (3TC). ViiV has submitted a new drug application to the US Food and Drug Administration using a priority review voucher (PRV) from GSK, which was granted after the company secured approval for the malaria drug Krintafel earlier in 2018. The application for the two-drug HIV therapy is based on results from two phase III GEMINI trials that demonstrated DTG and 3TC together worked as effectively as standard three-drug therapy in treatment-naive patients with both low and high levels of the virus. In addition, none of the 1,400 patients enrolled across the trials, developed drug resistance.

HiiV previously submitted a market approval application for the single-tablet DTG and 3TG regimen to the European Medicines Agency in September, 2018.


Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications