Gilead Sciences (GILD) Reports non-Inferiority of Tablet Regimen to Atripla in Phase 3
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Gilead Sciences, Inc. (Nasdaq: GILD) 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 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012) taking place in Seattle.
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.
The Phase 3 clinical program for Quad includes two studies (Studies 102 and 103) that each evaluate the Quad regimen versus a standard of care among HIV-1 infected antiretroviral treatment-naïve adults. Gilead announced topline results for Studies 102 and 103 on August 15, 2011 and September 19, 2011, respectively. Gilead submitted a U.S. New Drug Application for Quad on October 27, 2011, and the FDA has set a target review date under the Prescription Drug User Fee Act of August 27, 2012. On November 24, 2011, the company submitted a Marketing Authorisation Application for the product to the European Medicines Agency, whose review may be complete by the end of 2012.
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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.
The Phase 3 clinical program for Quad includes two studies (Studies 102 and 103) that each evaluate the Quad regimen versus a standard of care among HIV-1 infected antiretroviral treatment-naïve adults. Gilead announced topline results for Studies 102 and 103 on August 15, 2011 and September 19, 2011, respectively. Gilead submitted a U.S. New Drug Application for Quad on October 27, 2011, and the FDA has set a target review date under the Prescription Drug User Fee Act of August 27, 2012. On November 24, 2011, the company submitted a Marketing Authorisation Application for the product to the European Medicines Agency, whose review may be complete by the end of 2012.
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