August 29, 2012
Four-In-One HIV Drug Approved By FDA
Connie K. Ho for redOrbit.com — Your Universe Online
The Food and Drug Administration (FDA) recently approved the sale and distribution of Stribild, an HIV medication that includes four different drugs in one pill. The FDA believes that Stribild offers complete treatment for infections related to HIV.
The cost of the drug is about $28,500 for a year´s supply, which gives manufacturer Gilead Sciences Inc. unlimited pricing power as the company retains ownership of all the ingredients and the drug has the possibility of making $5 billion in possible sales.
“That´s shockingly irresponsible,” activist Michael Weinstein, president of the AIDS Healthcare Foundation, told The Guardian Express. “It´s just unsustainable at these levels.”
Gilead believes that the price for Stribild is similar to other drugs for treating HIV. Stribild is the third once-a-day bill for HIV produced by Gilead, following Atripla (produced in 2006) and Complera (produced in 2011).
“It´s a big deal for Gilead,” Robyn Karnauskas, an analyst for Deutsche Bank Securities, mentioned in a phone interview with Bloomberg News. “It offers convenience for patients that never had it before and a better side-effect profile.”
Clinical studies have showed Stribild to be equal in effectiveness to Atripla, but with fewer side effects than Atripla. After 48 weeks of taking Stribild, approximately 88 to 90 percent of participants in the clinical trials had almost untraceable amounts of HIV in their blood. The Wall Street Journal reported that the drug was previously called Quad and is made up of HIV drug Truvada along with new ingredients elvitegravir, which stops the enzymes needed by HIV to replicate, and covicistat, which stops an enzyme that metabolizes certain HIV drugs to continue the impact of elvitegravir.
According to the Centers for Disease Control and Prevention (CDC), approximately 1.2 million people in the U.S. currently suffer from HIV. Every year, almost 50,000 people become infected with the disease.
According to The Guardian Express, the product packaging of Stribild includes information on possible side effects of the drug, such as the buildup of lactic acid as well as the possibility of significant liver problems. Side effects seen in the clinical trials include lowered bone mineral density, differences in the immune system, fat redistribution, as well as the development of new or worsening kidney problems. The label advises health care providers on how to track the progress of kidney or bone side effects related to the drug.
Furthermore, the New York Times states that Gilead plans to offer discounts to state-affiliated AIDS Drugs Assistance program. These programs would help privately insured patients receive Stribild. For residents in poor countries, Gilead has given rights to specific companies in India to produce generic versions of the drug.
“For much of the company´s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” remarked John C. Martin, chairman and chief executive officer of Gilead, in a prepared statement that was mentioned in Bloomberg News. “Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen.”