Gilead Trials Challenge Merck Replication HIV Inhibitor, Shares Up

Gilead Trials Challenge Merck Replication HIV Inhibitor, Shares Up:

The battle against HIV rages on, and also does the competition fighting to produce the best drugs to treat it. Gilead has produced a new drug trucking through clinical trials, elvitegravir, which is as effective as its Merck counterpart, with only one dose daily compared to two.

Elvitegravir is also being studied as part of Gilead's investigational fixed-dose, single-tablet "Quad" regimen. The Quad contains four Gilead compounds in a fixed-dose, single-tablet: elvitegravir; cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines; and Truvada (emtricitabine/tenofovir disoproxil fumarate). The Quad is currently in Phase III testing. In addition, cobicistat is being evaluated as a stand-alone boosting agent for other antiretrovirals, in particular, protease inhibitors.

Gilead licensed elvitegravir from Japan Tobacco Inc in March 2005. Gilead has exclusive rights to develop and commercialize the drug everywhere except Japan. Gilead's shares rose 2.7% to $41.53 this week in light of the recent reports.

AIDS was first reported in the United States in 1981 and has since become a major worldwide epidemic. AIDS is caused by the human immunodeficiency virus, or HIV. By killing or damaging cells of the body's immune system, HIV progressively destroys the body's ability to fight infections and certain cancers. People diagnosed with AIDS may get life-threatening diseases called opportunistic infections. These infections are caused by microbes such as viruses or bacteria that usually do not make healthy people sick.

• Elvitegravir is designed to block the ability of the HIV virus to integrate into the genetic material of human cells which replicates the organisms' own DNA in the steps listed below:
• Fusion of the HIV cell to the host cell surface.
• HIV RNA, reverse transcriptase, integrase, and other viral proteins enter the host cell.
• Viral DNA is formed by reverse transcription.
• Viral DNA is transported across the nucleus and integrates into the host DNA.
• New viral RNA is used as genomic RNA and to make viral proteins.
• New viral RNA and proteins move to cell surface and a new, immature, HIV virus forms.

The virus matures by protease releasing individual HIV proteins.Click HERE for a full diagram illustration that shows how this process develops.

On January 10, 2011, Gilead announced an amendment to the design of this clinical trial, extending the blinded, randomized period of the study to up to 96 weeks to obtain longer term safety and efficacy data than originally planned. Based on the achievement of the non-inferiority endpoint, patients will continue to receive the regimen to which they were randomized in a blinded fashion.

Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences states:

"We are very pleased to have achieved the primary endpoint in this clinical trial, as data from this study will support regulatory filings for elvitegravir as well as Gilead's investigational Quad pill. By analyzing these data now we will be in a better position to advance filings as quickly as possible once data from subsequent Phase III clinical trials in our Quad development program become available later this year."

Since 1981, more than 980,000 cases of AIDS have been reported in the United States to the Centers for Disease Control and Prevention (CDC). According to CDC, more than 1,000,000 Americans may be infected with HIV, one-quarter of who are unaware of their infection. The epidemic is growing most rapidly among minority populations and is a leading killer of African-American males ages 25 to 44.

In addition, AIDS affects nearly seven times more African Americans and three times more Hispanics than whites. In recent years, an increasing number of African-American women and children are being affected by HIV/AIDS.