Good news for many. The Food and Drug Administration has just approved antiretroviral that combines four medications to fight HIV/AIDS. Gilead Sciences' "Stribild" previously known as "Quad" will be a once-a-day treatment for adults who have not previously been treated for infection, reports Reuters.
Stribild contains two previously approved HIV medicines and two new drugs. The older medicines, emtricitabine and tenofovir, are currently sold by Gilead in its combination pill Truvada, which was approved in 2004, and are also part of Gilead's Atripla three-drug combination. The newer drugs are elvitegravir and cobicistat.
[Analysts] expect Gilead to aggressively market Stribild and deemphasize its Atripla and Complera combination therapies as Atripla contains a Bristol-Myers Squibb Co HIV drug and Complera contains a Johnson & Johnson drug. ... As a condition of approval, Gilead will be required to conduct additional studies to help further characterize the drug's safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs, the FDA said.
Clinical trials demonstrate the new therapy is more effective in some cases than Atripla, adds the New York Times.
Company studies showed that 88 to 90 percent of patients taking Stribild had an undetectable level of HIV in their blood after 48 weeks, compared with 87 percent for patients taking Atripla, another HIV drug that contains Truvada and one other drug.
Wall Street estimates the new combination pill will earn about $370 million in sales next year.
The announcement comes six weeks after the FDA approved Gilead's Truvada to reduce the risk of HIV infection in uninfected individuals. That prevention strategy is known as pre-exposure prophylaxis or PrEP. Truvada became the first medication ever to be approved for HIV prevention in adults, marking a major milestone in the 30-year global epidemic.
About 1.2 million people in the United States are living with HIV/AIDS, according to the U.S. Centers for Disease Control and Prevention. Blacks are the demographic that are hardest hit. Blacks comprise only 12 percent of the population but about 45 percent of all new infections.
The number of new HIV infections in the United States has remained "relatively stable" at about 50,000 per year between 2006 and 2009. But there have been a soaring number of seroconversions among Black men who have sex with men. The trend has been particularly “alarming” among Black MSM aged 13 to 19, according to the CDC. New infections have increased by 48 percent between 2006 and 2009. See EBONY: "New Data Show Black Gay Men Face "World's Highest" Risk of HIV"
"Black Gay Men Face "World's Highest" Risk" [EBONY]
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