It's been a year of discovery about HIV, with news both good (death rates in the U.S. have fallen) and bad (one in five gay and bisexual men have HIV). Among the former, though, is the arrival of a new medication, Gilead's Stribild, a capsule that fuses four drugs into one pill, which may just revolutionize treatment routines for anyone who is just now testing positive.
Stribild (previously known as Quad) combines elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate into a single daily dose for people who have not previously been treated for HIV. There's a hefty market for that. Greater Than AIDS reported this year that of that one in five gay men who have HIV, a full half of them do not yet know it.
According to the Centers for Disease Control and Prevention, men who have sex with men (MSM) accounted for 61% of all new HIV infections in 2009, and young MSM accounted for 69% of new infections among persons age 13-29. That means that there are about 441,669 gay or bisexual men with HIV in the U.S., and close to a quarter million of those men have never been treated for the virus.
Paul Sax, MD, a physician at Brigham and Women's Hospital who was a principal investigator in one of the Stribild studies, says the approval of Stribild is crucial for those patients. Clinical trials, which took place over a 48-week period, indicated that Stribild was more effective than other drugs in keeping viral loads down.
"Through continued research and drug development, treatment for those infected with HIV has evolved from multipill regimens to single-pill regimens," adds Edward Cox, MD, of the Food and Drug Administration's Center for Drug Evaluation and Research. "New combination HIV drugs like Stribild help simplify treatment regimens." The prescription drug became available to patients in late August.
Since Stribild is a complete drug regimen, it should not be taken with any other HIV medication. The pill is slightly more effective than Atripla as well as Truvada combined with atazanavir and ritonavir. In one study, 88% of Stribild users had undetectable amounts of HIV in their blood (compared to 84% with Atripla). It's also being heralded as a good alternative because it mitigates certain side effects that patients have with Atripla.
Stribild is the third HIV combination medication developed by Gilead, following Atripla in 2006 and Complera in 2011. Gilead CEO John C. Martin, Ph.D., says his company has kept a solid focus on developing simplified yet effective HIV treatment regimens.
"Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success," he said in a statement following Gilead's FDA approval.
The pill's initial price of $28,500 per patient annually raised eyebrows, but after negotiations with state AIDS service directors, Gilead agreed to lower it for AIDS Drug Assistance Programs. The company's own patient assistance program will also help people with HIV handle the cost of treatment.
There are a few precautions that Stribild users need to know about: It must be taken with food and may interact badly with certain drugs. Like many HIV treatments, it may also cause side effects including kidney damage, fat redistribution, immune reconstitution syndrome, nausea, and headaches. Even with these issues, Gilead officials say the pill will carry fewer complications and be more effective in treating HIV than other medications on the market.