Gilead Sciences Inc. - Special Call

Gilead Sciences, Inc. (GILD)

March 07, 2012 4:30 pm ET


Susan Hubbard - Vice President of Investor Relations

Norbert W. Bischofberger - Chief Scientific Officer and Executive Vice President of Research & Development

Paul Sax -

Andrew Cheng - Senior Vice President of Development Operations


Michael E. Ulz - JP Morgan Chase & Co, Research Division

Mark J. Schoenebaum - ISI Group Inc., Research Division

Matthew Roden - UBS Investment Bank, Research Division

Yaron Werber - Citigroup Inc, Research Division

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

Brian Abrahams - Wells Fargo Securities, LLC, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

M. Ian Somaiya - Piper Jaffray Companies, Research Division



Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Conference Call. My name is Stacey, and I will be your conference operator for today. [Operator Instructions] As a reminder, this conference call is being recorded today, March 7, 2012. I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations. Please go ahead.

Susan Hubbard

Thank you, Stacey. And good afternoon, everyone. Thank you for joining us today to discuss the 48-week results from Study 102, the pivotal Phase III study of our Quad drug head-to-head versus ATRIPLA. You can find the press release detailing the study results, as well as a link to the slides presented here today on our website at

We have Dr. Paul Sax with us today, the lead investigator from the study. Dr. Sax will recap the presentation he just gave here in Seattle at the Conference on Retroviruses and Opportunistic Infections. Dr. Sax's comments today will reflect his own conclusions, opinion and analysis and do not necessarily reflect Gilead's conclusions, opinions, and analyses. We're also joined today by our Executive Vice President of R&D, Norbert Bischofberger; and Andrew Cheng , our Senior Vice President of HIV Therapeutic and Development Operations. Dr. Sax, Norbert and Andrew will be available to take your questions following the presentation.

As a reminder, the purpose of this call today is to cover the details of the Study 102 results and answer any questions you have on the data from either Study 102 or 103. Because the Quad is still an investigational agent not yet approved by FDA, we're not in the position to comment on this call how the data may translate into prescribing information or uptake in the market.

We will also be making forward-looking statements regarding the Quad. These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statements. These risks include the possibility that the FDA, the European Medicines Agency and other regulatory agencies may not approve the Quad and risks related to the anticipated timelines or any regulatory review and approval.

In addition, even if approved, physicians may not see the advantages of the Quad over other therapies. Description of these and other risks can be found on our latest SEC disclosure documents and recent press releases. In addition, please note that we undertake no duty to update or revise them.

I will now turn the call over to Norbert for opening comments.

Norbert W. Bischofberger

Thank you, Susan. As Susan mentioned, we're very pleased to have Dr. Paul Sax joining us today to present the 48-week results of Study 102. By way of introduction, Dr. Sax is the Director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston. He is an Associate Professor at Harvard Medical School and has been on the faculty for more than 14 years. Dr. Sax received his M.D. from Harvard Medical School in 1987. He fulfilled his residency in Internal Medicine at Brigham and Women's Hospital by continuing his postdoctoral education with fellowships at Harvard and the Infectious Disease Unit of the Mass [Massachusetts] General Hospital. Dr. Sax is board certified in internal medicine and infectious disease. Apart from his clinical and teaching work, Dr. Sax is also involved in many professional societies, such as the Mass Medical Society; the Infectious Disease Society of America; and the Massachusetts Infectious Disease Society. He serves on editorial boards of AIDS Clinical Care; Infectious Disease Special Edition; UpToDate; and Medscape. He is on the core faculty of the International AIDS Society-USA and the New England AIDS Education and Training Center.

Gilead has worked with Paul for more than 10 years and he is an investigator in many of our clinical studies.

I will now turn over the call to Paul to present the study results. Paul?

Paul Sax

Thank you very much, Norbert. So I'm going to go through the slide presentation that I just presented at the Retrovirus Conference. Slide #2 provides a bit of background. We know that the standard of care treatment right now, HIV therapy is the co-formulated non-inferior FTC efavirenz tablet, one pill a day, also called ATRIPLA. And also there's an investigational single-tablet regimen that includes the integrase inhibitor elvitegravir, the PK booster cobicistat and the nucleoside analog tenofovir and FTC. This is the so-called Quad. Phase II data, published last year demonstrated that these 2 approaches were comparable, which led to the Phase III data that I'll be presenting now.

Next slide shows the study design. It's a randomized double-blind placebo-controlled trial. Treatment-naïve HIV infected patients with any CD4 cell count and HIV RNA greater than 5,000 were enrolled and then randomized to receive either the Quad once daily or the efavirenz-based regimen [Audio Gap] daily. They also received matching placebos. It was protocol-specified stratification by HIV RNA. The randomization was one-to-one and the study was conducted at sites in the United States and Puerto Rico.

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