Phase III study for treatment for HIV-1 shows positive results
For the Phase III study, patients with HIV-1 were given 50mg doultegravir once a day and a once-daily dose of protease inhibitor. Another group was given a once-daily treatment of darunavir. At the 48-week time point, non-inferiority was demonstrated in the patients between dolutegravir and darunavir.
"These new clinical data are an important addition to our scientific understanding of dolutegravir," Dr. John Pottage, the chief medical officer at ViiV Healthcare, said. "This is the first study in our clinical program to compare dolutegravir to a boosted protease inhibitor in treatment-naive patients. PIs are often selected as part of a first-line regimen for treatment-naive patients, so these data provide important information regarding dolutegravir as a treatment choice for these patients."
At 48 weeks, a large proportion of the patients treated with dolutegravir, 90 percent, were virologically suppressed compared to the patients treated with darunavir, 83 percent. Non-response virologic rates were at 6 percent for dolutegravir and 7 percent for darunavir.
During the study, some patients experience side effects like diarrhea, nausea and headache. These side effects occurred in less than 10 percent of the patients.