Gilead's HIV Drug Stribild Approved by FDA

Stribild, previously known as the Quad, has been approved by the FDA to treat HIV-1 infection in adults who are starting HIV treatment for the first time.

Stribild, previously known as the Quad, has been approved by the FDA to treat HIV-1 infection in adults who are starting HIV treatment for the first time.

The FDA recently announced the approval of Gilead’s new once-a-day HIV treatment containing 4 different drugs in a single pill. The approval follows a 13-1 vote in May 2012 by the agency’s Antiviral Drugs Advisory Committee supporting the medication’s use in treatment-naïve patients. The pill, which contains elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate, was previously referred to as the Quad, but will be marketed under the name Stribild.

According to a report from The New York Times, Gilead plans to charge $28,500 per year for Stribild, somewhat more than the company charges for another popular HIV combination pill—Atripla—which costs approximately $21,000 per year.

Stribild’s efficacy in clinical trials covering 48 weeks of therapy was found to be comparable to that of Atripla (efavirenz plus emtricitabine and tenofovir) and Norvir (ritonavir)-boosted Reyataz (atazanavir) plus Truvada (tenofovir and emtrictabine). Stribild appears to lack some of the psychiatric side effects of Atripla, including incidences of insomnia, abnormal dreams, and dizziness.

A patient assistance program—Gilead’s U.S. Advancing Access initiative—will help HIV patients who lack insurance or who need financial assistance to pay for antiretrovirals, including Stribild. Gilead has also granted multiple Indian manufacturing partners and the Medicines Patent Pool the right to develop generic versions of Stribild and distribute them to developing countries.

The approval puts Gilead in a position to make significant financial gains, as the company owns all of Stribild’s ingredients. (For all of its previously approved single tablet HIV regimens, Gilead has had to share profits with other pharmaceuticals companies such as Bristol-Myers Squibb and Janssen.)

Supporters of Stribild’s approval argue that the new drug will help many newly diagnosed HIV patients avoid pill burden. “Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “New combination HIV drugs like Stribild help simplify treatment regimens.”