Gilead’s Experimental HIV Drug Shows Positive Results
Gilead Sciences Inc. recently announced at the Conference on Retroviruses and Opportunistic Infections that the company’s experimental the Quad HIV pill caused fewer side effects than their current three-drug pill, Atripla, Reuters reported.
In a statement the company said they revealed the "full results from the second pivotal Phase 3 clinical trial (Study 103) comparing the Quad single tablet regimen to a current standard of care in HIV therapy." Patients who took the Quad were studied for 48 weeks and 90 percent of them achieved target levels of the HIV virus, which is a three percent increase when compared to a protease-based regimen.
Those who took Atripla experienced much higher rates of dizziness, abnormal dreams, insomnia and rash than those who were on the Quad. The Quad did however show a higher rate of nausea, Reuters noted.
Atripla is a once-daily pill that combines Truvada with Bristol-Myers Squibb’s Sustiva. The Quad combines experimental integrase inhibitor elvitegravir and boosting agent cobicistat with Truvada, a pill that uses Gilead’s older HIV drugs Emtriva and Viread.
Dr. Paul Sax, the study’s lead investigator and the clinical director of the division of infectious diseases at Brigham and Women’s Hospital in Boston, said that 1.4 percent of patients in the Quad group quit because of kidney abnormalities, while 1.4 percent of the Atripla group left the study due to rash.
When asked if patients should switch from Atripla to the Quad Dr. Sax said, "It looks like a switch would be virologically safe and maybe associated with fewer central nervous system side effects."
U.S. regulators are currently reviewing the Quad and the Food and Drug Administration will decide by August 27 whether to approve the new pill.