ViiV Healthcare, a joint venture launched by GlaxoSmithKline, Pfizer and Japanese partner Shionogi & Co Ltd to treat people living with HIV, has received approval from the US Food and Drug Administration for its once-daily 50mg tablet drug, Tivicay (dolutegravir).
Known as an integrase inhibitor, Tivicay prevents the HIV virus from inserting itself into host cells.
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The drug is recommended to be used in conjunction with other antiretroviral agents for adults who have HIV-1 and who have either been treated with other medications or have not had any treatment.
The treatment can also be used by children aged 12 and over with a weight of at least 40kg (88lbs), who have not taken a similar type of drug.
According to ViiV Healthcare chief executive officer Dr Dominique Limet, "Today’s approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV/AIDS global response."
ViiV chief medical officer Dr John Pottage commented: "In many regimens, the differentiating component is the third agent. Tivicay provides a new opportunity for healthcare professionals to choose the right regimen for their patients, providing a focal point around which to individualise therapy."
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By GlobalDataThe approval was contingent on data from Phase III trials, which involved 2,557 adults with HIV who were treated with at least one dose.
The trial also involved comparing Tivicay to other similar drugs such as Merck’s twice-daily Isentress (raltegravir) and Gilead Sciences‘ once-daily Atripla (emtricitabine/tenofovir/efavirenz).
Tivicay does not use a pharmacokinetic boosting agent, which allows the drug to be taken with or without food, day or night.
Some of the minor side effects caused by the drug included insomnia and headache, as well as major adverse events such as allergic reactions and abnormal liver function, particularly in patients who were also infected with hepatitis B or C.
Image: Dolutegravir has been found to suppress the HIV virus in patients with the disease. Credit: Wikipedia.
