Gilead Sciences Inc. (GILD) said Wednesday that Phase 3 results from a pivotal study showed that the Quad regimen to treat HIV infection is non-inferior compared to standard care Atripla after 48 weeks of therapy in treatment-naive adults.
Quad is a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
Gilead's Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) is currently the most-prescribed HIV treatment regimen in the United States. In the company's fourth quarter, Atripla sales totaled $863.3 million, up 11 percent from last year.
Paul Sax, Clinical Director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital, Boston, and principal investigator of Study 102, said, "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 showed 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.
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 side effects, lipids and rash.
The Phase 3 clinical program for Quad includes two studies (Studies 102 and 103) with each evaluating the Quad regimen versus a standard of care.
Study 102 is a randomized, double-blind Phase 3 clinical trial. The primary endpoint of the study is the proportion of patients achieving HIV RNA levels less than 50 copies/mL at 48 weeks of treatment, per the FDA snapshot algorithm.
The most common adverse events occurring in greater than 10 percent of patients in either treatment arm included diarrhea, nausea, abnormal dreams, upper respiratory infections, headache, fatigue, insomnia, depression, dizziness and rash.
Gilead announced topline results for Studies 102 and 103 on August 15, 2011 and September 19, 2011, respectively.
Gilead had submitted a U.S. New Drug Application for Quad last October, for which the FDA has set a target review date under the Prescription Drug User Fee Act of August 27, 2012.
Last November, the company submitted a Marketing Authorization Application for the product with the European Medicines Agency, whose review may be complete by the end of 2012.
GILD is trading at $45.52, down $0.36 or 0.78%, on a volume of about 7 million shares on the Nasdaq.
by RTT Staff Writer
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