August 14, 2013 | By Márcio Barra
GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.
Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.
In the SINGLE trial, 88% of study participants on the Tivicay regimen were virologically suppressed versus 81% taking Atripla (efavirenz/emtricitabine/tenofovir) after 48 weeks’ treatment.
Tivicay is an add-on to two standard HIV drugs, Ziagen (abacavir) and Zeffix (lamavidune), both available as generics. Tivicay’s wholesale price will be $1,175 per month, or $14,105 per year, a price that has come under fire from Médecins Sans Frontières (MSF).
“We are deeply concerned that ViiV’s business strategy will result in dolutegravir being priced out of reach in countries excluded from ViiV’s licensing deals,” MSF’s Rohit Malpani said in a statement regarding Tivicay’s cost.
A spokesperson for ViiV commented to PharmaTimes that the company is “committed to helping patients receive access to effective HIV treatment in the US and across the globe”.
Tivicay is owned by ViiV Healthcare, an HIV joint venture between GSK, Pfizer, and Shionogi & Co Ltd in which GSK is the largest shareholder, with a 76.5% stake.