The Food and Drug Administration (FDA) announced August 12, 2013 that they approved a new integrase inhibitor against HIV, called dolutegravir (Tivicay). The drug works by keeping HIV from integrating into human DNA, which then prevents the virus from reproducing.
The FDA approval is based upon the results from four clinical studies (SINGLE, SPRING, SAILING, VIKING) that included a few more than 2,500 people. Dolutegravir is approved for adults who are both new to treatment or have taken HIV treatment before, including other integrase inhibitors. Children 12 years and older can also be prescribed this drug.
Generally speaking, these studies showed that dolutegravir controlled HIV as well as the other standalone integrase inhibitor raltegravir and Atripla, the full regimen pill that includes the NNRTI efavirenz (Sustiva).
As a class of HIV drugs, integrase inhibitors generally have few side effects and are well tolerated by most people. The studies showed this is no different for dolutegravir.
Dolutegravir is the third integrase inhibitor to reach the market after raltegravir (Isentress) and elvitegravir (only available in the full regimen pill Stribild). Where the new drug differs is that it’s taken once a day (unlike raltegravir) and doesn’t need a booster drug as does elvitegravir.
Read Project Inform’s earlier report on dolutegravir from the International AIDS Society Conference.