ViiV’s HIV Drug, Tivicay, Launched in the UK
diagnosis Tivicay, Launched in the UK” src=”http://i57.tinypic.com/2re6t69.jpg” width=”164″ height=”147″ />HIV patients in the UK will from this week have another treatment option after ViiV Healthcare announced the launch of their once-daily drug, Tivicay (dolutegravir).
The integrase inhibitor was approved in Europe last month for HIV-1 in a broad patient population of treatment-naive and treatment-experienced adults and children aged 12 years and above (weighing at least 40kg) when used in combination with other antiretroviral agents.
The European regulatory approval was based on the results from four pivotal Phase III clinical trials where 2,557 adults received treatment with Tivicay or a comparator.
In one clinical study, called SINGLE, 88% of study participants on the Tivicay regimen were virologically suppressed versus 81% taking Atripla (efavirenz/emtricitabine/tenofovir) after 48 weeks’ treatment, and time to viral suppression was also reduced (28 days versus 84 days, respectively).
Tivicay blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells), an essential step in the HIV replication cycle.
As Tivicay comes with the added convenience of once-daily dosing, and can be taken with or without food, in addition to being effective in both treatment-naive and treatment-experience patients, it is widely expected to become a key future player in HIV treatment.
Analysts have noted that Tivicay could generate annual sales of up to $2.1 billion by 2022 in the USA, Japan and five major EU markets of France, Germany, Italy, Spain and the UK, equating to 12.6% of the overall combined value of these markets.
However, Tivicay is currently only available through private prescription in England while a decision on NHS funding is made. The decision regarding the access of Tivicay on the NHS in England is expected between May and July this year.
Similarly, the SMC will appraise the drug in Scotland and the AWMSG in Wales, with decisions anticipated in May and June, respectively.