Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Stribild is a complete once-daily single tablet regimen for HIV-1 infection to treat na?ve adults.
Stribild is made up of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
Stribild pivotal studies principal investigator Paul Sax said co-formulated HIV medicines have simplified therapy for many patients and have become standard of care.
"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," Sax added.
FDA has approved Stribild on the basis of a 48-week data from two pivotal phase 3 studies, according to Gilead.
Gilead Sciences chairman and chief executive officer John Martin said Gilead has focused on the development of improved treatments and simplified regimens for HIV.
"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," Martin added.
Apart from Stribild, Gilead has also developed other two single tablet HIV regimens, Atripla and Complera.
