FDA Approves Gilead's Stribild Pill for HIV

Megan Brooks


August 27, 2012

August 27, 2012 — The US Food and Drug Administration (FDA) today approved Gilead Sciences Inc's Stribild pill for patients with untreated HIV infection.

The approval follows a 13–1 endorsement of the drug by an FDA advisory committee back in May.

Formerly called "Quad," Stribild is a combination of the investigational integrase inhibitor elvitegravir and boosting agent cobicistat with Truvada, which consists of Gilead's nucleotide reverse transcriptase inhibitors emtricitabine (Emtriva) and tenofovir (Viread). It is the first once-daily single-tablet regimen containing an HIV integrase inhibitor.

"Exciting" Development

"This approval is an important and exciting development. Taking 1 pill once a day has a great charm to patients," John G. Bartlett, MD, chief of the Division of Infectious Diseases and professor of medicine at Johns Hopkins University Medical Center in Baltimore, Maryland, said in an interview with Medscape Medical News. Dr. Bartlett is a member of the Medscape HIV/AIDS editorial advisory board.

"This is the first new front-line drug we've had in a fairly long period of time," Dr. Bartlett noted, "and it's different in the sense that it not only has a new integrase inhibitor but it also has a new boosting agent cobicistat instead of ritonavir, which has been used in the past."

As previously reported by Medscape Medical News, in 2 large double-blind randomized phase 3 trials published in the Lancet in June, Stribild was as effective and as safe as 2 other recommended HIV drug regimens among treatment-naive adults. The other regimens were efavirenz/emtricitabine/tenofovir and a ritonavir-boosted regimen of atazanavir/efavirenz/tenofovir.

In recommending approval of Stribild, members of the FDA advisory panel said the drug has a generally acceptable safety profile, but there should be effective monitoring for potential kidney problems among patients taking it. In clinical trials, patients taking Stribild were more likely to experience adverse renal events.

Tenofovir, a component of Stribild, has been associated with new or worsening kidney problems in some patients. "Cobicistat is also a little bit tricky because it changes lab readings on kidney function in a way that doctors are going to have to learn to understand," Dr. Bartlett commented. Overall, Stribild has "a lot of advantages, but a disadvantage, of course, is that it's brand new," he added.

As with some other HIV drugs, Stribild's label will carry a boxed warning concerning the possibility of severe liver problems and lactic acid build-up in the blood, both of which can be fatal. According to an FDA news release, "The Boxed Warning also states that Stribild is not approved to treat chronic hepatitis B virus infection."

Switch to Stribild?

Although Stribild is approved for treatment-naive patients, some patients receiving an existing regimen may want to switch to Stribild, Dr. Bartlett noted, and that is a decision that should be made on a case-by-case basis.

"A lot of patients who are already in a regimen that they like probably won't change their regimen," he told Medscape Medical News.

"Most of us tell our patients that unless there is a reason to change and you've achieved success by getting no detectable virus, it's probably better to just continue with the regimen. If there is a problem due to a side effect, resistance, or convenience or pill burden, then this drug becomes a candidate," Dr. Bartlett said.

What will Stribild cost? "We don't know right now, but I believe it will be competitively priced — it's going to have to be in order to compete," Dr. Bartlett said.


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