New HIV Drug Dolutegravir Could Soon Be Approved by FDA
Dolutegravir, an investigational integrase inhibitor, has been given priority review status by the U.S. Food and Drug Administration (FDA). In December, the drug was submitted for review for the treatment of HIV, in combination with other antiretroviral agents, in adults and adolescents.
The FDA grants priority review to drugs that, if approved, could offer significant improvement over current marketed drugs, or provide treatment where none exists. The decision on whether or not to approve dolutegravir is expected by Aug. 17, 2013, according to a press release from ViiV Healthcare, the company that is developing the drug.
ViiV Healthcare submitted the application for approval along with results from four phase-3 clinical studies. These studies followed 2,553 HIV-infected patients, including those who are treatment-naive, treatment-experienced or "salvage" patients (those who had exhausted all other treatment options).
As previously reported, one of the phase 3-studies, known as SPRING 2, found dolutegravir to be non-inferior to raltegravir (Isentress) in treatment-naive patients. Both drugs were well tolerated and likely to suppress viral load below 50 copies/mL (88% for dolutegravir and 85% for raltegravir).
A companion phase-3 study found a regimen consisting of abacavir/lamivudine (Epzicom, Kivexa) plus dolutegravir to be superior to tenofovir/emtricitabine (Truvada) plus efavirenz (Sustiva, Stocrin) in treatment-naive patients. After 48 weeks, 88% of those treated with the dolutegravir-based regimen achieved a viral load below 50 copies/mL, compared to 81% of those treated with the efavirenz-based regimen.