On August 27, 2012, the U.S. Food and Drug Administration (FDA) approved the drug Stribild to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild (previously called “Quad”) is the first complete once-a-day drug that is formulated as a single tablet for initial HIV treatment.
“In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” says Debra Birnkrant, M.D. of the FDA.
However, the overall rate of HIV infection has not changed since 2004. There are currently 12,565 HIV-infected people living in Connecticut (~1.2 million in the U.S.) and approximately 400 new cases of HIV infection are diagnosed each year (~50,000 in the U.S.).
Stribild is a new once-a-day combination pill containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Stribild was approved largely based on the results of two Phase 3 clinical trials. These studies evaluated patients not previously treated for HIV (treatment-naïve) and compared Stribild to two popular HIV drug regimens (Atripla and Norvir). Both studies found Stribild to be comparable in terms of keeping viral load undetectable. This means that the percentage of patients who had an undetectable amount of HIV in their blood was comparable between the treatments. Specifically, between 87.6% and 89.5% of patients treated with Stribild had an undetectable amount of HIV in their blood as compared with 84.1% treated with Atripla and 86.8% treated with Norvir.
Additional studies are required to help further characterize the drug’s safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs.
Over the past decade, treatment for HIV patients has evolved from multi-pill regimens to single-pill regimens. These new combination drugs help simplify HIV treatment regimens.
“… co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Paul Sax, MD, principal investigator of one of the Stribild Phase 3 studies. “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.”
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