HIV Treatment Approved by the FDA
Gilead Sciences, a biotech research company, announced today that its new HIV treatment drug has been approved by the U.S. Food and Drug Administration. Dubbed Stribild, the once-daily tablet is made up of four different compounds and designed for those not currently taking medication for HIV.
“Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Dr. Paul Sax, professor of medicine at Harvard Medical School, and principal investigator on a Stribild study. “Today’s approval of Stribild will provide physicians and their patients an effective new single tablet treatment option for individuals starting HIV therapy for the first time.”
Stribild was approved following two studies that proved Stribild at least as effective as Atripla, another of Gilead’s single-tablet HIV regimin drugs which was approved by the FDA in 2006. Though Stribild does not cure HIV, it does block the ability for the HIV-1 virus to integrate into the genetic material of human cells. According to Gilead, the adverse side-effects of the medication, which include nausea, diarrhea, headache, fatigue, and abnormal dreams, were mild to moderate. The drug also includes box warnings for people with hepatitis B or those taking other antiretroviral drugs.
“For much of the company’s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” said John Martin, chairman and CEO of Gilead. “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 for the healthcare and patient communities.”
Full prescribing information for Stribild can be found on Gilead’s website.