The US FDA has granted traditional approval status Gilead Sciences' once-daily antiretroviral Viread (tenofovir disoproxil fumarate) and its fixed-dose product Truvada (emtricitabine and tenofovir disoproxil fumarate), which combines the company's two antiretrovirals Emtriva (emtricitabine) and Viread in a single daily tablet. Traditional approval status was granted following FDA review of 48-week data from Study 934, the second confirmatory pivotal study for Viread. The FDA previously granted accelerated approval for Viread and Truvada in October 2001 and August 2004, respectively.
As part of traditional approval, the US prescribing information for Viread and Truvada now include 48-week data from Study 934, a Phase III open-label trial comparing a once-daily regimen of Viread, Emtriva and efavirenz to twice-daily Combivir (lamivudine/zidovudine) and once-daily efavirenz in treatment-naive patients. Eighty-four percent of patients in the Viread/Emtriva group compared to 73 percent of patients in the Combivir group achieved and maintained HIV RNA less than 400 copies/mL through week 48, according to the company release.
"In the United States, Truvada is now the most-prescribed antiretroviral of its class and its use is quickly growing in the European Union, where it was more recently made available," Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences said adding, "We look forward to continuing to generate and share important data from ongoing clinical studies to help further define the profile of our products for the medical community."
Guidelines issued by the US Department of Health and Human Services (DHHS) list emtricitabine and tenofovir disoproxil fumarate as preferred agents for use as part of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen in appropriate patients who have never taken anti-HIV medicines before.
Gilead and Bristol-Myers Squibb have established a US joint venture to produce a once-daily fixed-dose product containing Truvada and efavirenz and expect to file a new drug application with the FDA in the second quarter of this year. If approved by the FDA, the new product would be the first and only complete Highly Active Antiretroviral Therapy (HAART) regimen for HIV available in a single once-daily fixed-dose tablet. The US joint venture to develop and commercialize the fixed-dose regimen of Truvada and efavirenz is the first of its kind in the field of HIV treatment, stated the release.