Gilead Sciences, Inc. (Nasdaq: GILD) today announced full Phase 3 clinical trial results from pivotal Study 102 demonstrating that the Quad, a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection, is non-inferior to Atripla ® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) after 48 weeks of therapy in treatment-naïve adults. Atripla is currently the most-prescribed HIV treatment regimen in the United States. The Study 102 findings were presented today in an oral session (Abstract #101) at the 19 th Conference on Retroviruses and Opportunistic Infections (CROI 2012) taking place in Seattle.
“These data show that the Quad is as effective as a current standard of care in HIV therapy. The safety profile of Quad was also comparable to that of Atripla, and was better tolerated in terms of key neurological side effects,” said Paul Sax, MD, Clinical Director of the HIV Program and Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, and principal investigator of Study 102. “Based on these results, I believe the Quad could represent a potentially important new treatment regimen for a wide range of HIV patients initiating therapy.”
The study found that at 48 weeks of treatment, 88 percent of Quad patients compared to 84 percent of Atripla patients achieved HIV RNA (viral load) less than 50 copies/mL, based on the U.S. Food and Drug Administration (FDA) snapshot algorithm (95 percent CI for the difference: -1.6 percent to +8.8 percent; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -12 percent). While the frequency of grade 3-4 adverse events and laboratory abnormalities were comparable between study arms, the Quad demonstrated a lower incidence than Atripla with regard to central nervous system (CNS) side effects, lipids and rash. Discontinuation rates due to adverse events were comparable in both arms of the study.
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