Previous called “Quad,” it combines two previously approved HIV drugs and two new medications: elvitegravir, which interferes with one of the enzymes HIV needs to multiply, and cobicistat, which prolongs the effects of elvitegravir.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said the FDA’s Dr. Edward Cox. “New combination HIV drugs like Stribild help simplify treatment regimens.”
More than 1,400 adult patients not previously treated for HIV were evaluated in two double-blind clinical trials, with 88-90% of patients taking Stribild had an undetectable viral load, compared to the 87 % by those treated with Truvada plus atazanavir and ritonavir.
Like many HIV medications, Stribild still has several side effects, including the potential for in some patients nausea and diarrhea, kidney problems, and decreased bone-mineral density. Gilead says it will continue testing Stribild for its effects on women and children, drug resistance and drug interaction.
“Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen for the healthcare and patient communities,” said Gilead CEO John C. Martin.
However, be forewarned: Stribild is enormously expensive, close to one-third more than its competitors.