HIV Drug Gets Approval from FDA

Gilead Sciences Stribild is four in one daily HIV drug

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) For more than a decade, HIV patients relied on a heavy “cocktail” of pills to keep the virus at bay. Now, there's the option of taking only one daily pill that combines four drugs.

Gilead Science's new four in one daily HIV drug has earned approval from the U.S. Food and Drug Administration.

Formerly known as Quad, the drug will be marketed under the brand name Stribild.

"Starting treatment? Ask your doctor if Stribild is right for you."

News of the approval came on August 27. An FDA panel had recommended the drug for approval earlier in the spring.

Stribild is intended for patients who have never been treated for HIV. It's estimated that 50,000 people are newly infected with HIV in the US each year.

The drug combines two drugs that were already on the market with two new drugs. The two previously approved drugs are emtricitabine and tenofovir disoproxil fumarate, and are marketed by Gilead Sciences as the combination pill Truvada.

These drugs work to block the work of an enzyme that allows HIV to replicate and spread through cells in the body.

The new drugs are elvitegravir and cobicistat. Elvitegravir acts on another enzyme that HIV requires to multiply. Cobicistat works to prolong elvitegravir's effect.

According to the FDA, the four drugs together create “a complete treatment regimen for HIV.” That means that a patient will only have to take this one pill, with food, to fight off HIV.

The convenience of taking just one pill could make a big difference for a patient. Anti-HIV drugs – also called antiretroviral therapy, or ART – has proved very effective in suppressing the virus, but it's not always easy for people to adhere to a complex drug regimen.

When patients miss pills, the drugs become less effective. The hope is that a single pill regimen will mean that more people are keeping the virus under control.

In clinical trials leading up to its approval, Stribild proved to be slightly more effective than drugs that are currently on the market.

Stribild comes with a warning on the box for patients and health care professionals. The drug, like other HIV drugs, can trigger a buildup of lactic acid in the blood, as well as severe liver problems. These health issues can be fatal.

Side effects include nausea and diarrhea, with more serious side effects being kidney problems, decreased bone mineral density, fat redistribution, and changes in the immune system.

Recently, a nonprofit and a group of California legislators have put pressure on Gilead to lower the price of the pill. Stribild will be more expensive than their other drugs on the market, for a wholesale price of $28,500 for a year of treatment.

Gilead has said that they will provide discounts to state assistance programs as well as a financial assistance program for patients.

Reviewed by: 
Review Date: 
August 28, 2012
Last Updated:
September 2, 2012