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.