Study results show this new integrase inhibitor may be more advantageous over the current Isentress (raltegravir) and the experimental elvitegravir, including once daily dosing (Isentress is taken twice a day) and no need for a boosting drug (as with elvitegravir). Earlier study has shown that dolutegravir is effective against strains of HIV that are resistant to the other two integrase inhibitors.
This small study in 205 people who had never been on treatment compared three doses of dolutegravir to Sustiva. Average CD4 count was 324 and about 20% had viral loads above 100,000.
After 96 weeks, average CD4 count gains were similar between the dolutegravir arms (339) and Sustiva (301). Undetectable viral loads were seen at 88% on the 50mg dose, 78% on 25mg, 79% on 10mg and 72% on Sustiva. Fewer general side effects occurred on dolutegravir (11%) compared to Sustiva (24%). No resistance was seen in any of the participants.
Although these results come from the dose-ranging studies of dolutegravir, the drug is now in later-stage studies of treatment-experienced people and those going on treatment for the first time. It’s possible that we could see this drug approved by the FDA in 2013, and perhaps combined into a full-regimen pill.