UK patients with HIV will from this week have a new treatment option following the launch of ViiV Healthcare's once-daily pill Tivicay (dolutegravir), but in England the drug is only available via private prescription until a decision on NHS funding is reached.
The integrase inhibitor was given the green light in Europe last month for use in combination with other antiretroviral agents for the treatment of HIV-1 in a broad patient population of both treatment-naive and treatment-experienced adults and children aged 12 years and older (weighing at least 40kg).
The decision came on the back of data from four pivotal Phase III clinical trials in which 2,557 adults received treatment with Tivicay or a comparator.
In one such 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 is able to block 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.
Given that the drug comes with the added convenience of once-daily dosing and can be taken with or without food, as well as the fact that it is effective in both treatment-naive and treatment-experience patients, it is widely expected to become a key player in HIV treatment.
However, Tivicay, which costs £498.75 for 30 tablets, cannot be prescribed by the NHS in England until it has undergone a clinical and cost evaluation by the specialised commissioning arm of NHS England, a decision from which is expected between May and July this year.
The SMC will appraise the drug in Scotland and the AWMSG in Wales, with decisions exptected in May and June, respectively.