Gilead’s 4-in-1 Stribild HIV Pill Wins U.S. FDA Approval

Gilead Sciences Inc., the world’s biggest maker of AIDS drugs, won U.S. approval to sell a pill for new HIV patients that combines four of the company’s drugs into one.

The therapy, called Stribild, was cleared as a medicine that will help simplify patients’ treatment regimens, the U.S. Food and Drug Administration said yesterday in a statement. Stribild contains two new drugs and two previously approved compounds that make up Foster City, California-based Gilead’s Truvada HIV medicine.

The new treatment, previously referred to as Quad, will help make up for a potential $5 billion in lost sales when Gilead’s other HIV drugs lose patent protection starting in 2018 and face generic competition, said Robyn Karnauskas, an analyst with Deutsche Bank Securities in New York. Stribild may generate $4.7 billion in peak annual sales, she said.

“It’s a big deal for Gilead,” Karnauskas said in a telephone interview before the FDA’s decision. “It offers convenience for patients that never had it before and a better side-effect profile.”

Gilead rose less than 1 percent to $57.63 at the close of New York trading. The shares have gained 49 percent in the past 12 months.

Karnauskas estimated that about 35 percent of new patients will use the drug at a cost of as much as $29,000 a year. About 1.2 million people in the U.S. have HIV, the virus that causes AIDS, according to the Centers for Disease Control and Prevention. About 50,000 people become infected each year.

Kidney Risks

The other drugs that make up Stribild are elvitegravir, which interferes with the enzymes HIV needs to multiply, and cobicistat, which inhibits an enzyme that metabolizes certain HIV drugs to prolong the effect of elvitegravir, the FDA said.

Gilead’s Atripla, approved in 2006, is the top-selling HIV treatment. The $3.2 billion medicine combines three drugs in one pill, two compounds that make up Gilead’s Truvada and Bristol-Myers Squibb Co.’s Sustiva. Atripla will lose patent protection in 2021, Karnauskas said.

Truvada also won expanded approval in July as the first preventative against HIV in healthy people who are at high risk of contracting the disease.

“For much of the company’s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” John C. Martin, the company’s chairman and chief executive officer, said yesterday in a statement. “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.”

Side Effects

A Gilead-sponsored study found Stribild worked as well as Atripla and patients experienced fewer abnormal dreams, anxiety and dizziness.

An FDA review of studies funded by Gilead found a higher number of kidney complications reported in people taking Stribild compared with other HIV treatments. Those side effects included four cases of kidney failure and one case of a rare syndrome in which substances aren’t absorbed into the blood stream by the kidneys.

The drug’s label gives advice to health-care providers on how to monitor patients for kidney effects. Gilead is required to conduct additional studies on the drug’s safety in women and children, how resistance develops to Stribild and the possibility of interactions between the treatment and other drugs, the FDA said.

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