Bristol-Myers Squibb Company and Gilead Sciences Inc. have obtained data supporting bioequivalence of a new formulation of the fixed-dose combination of Bristol-Myers Squibb's Sustiva (efavirenz) and Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate) with the components that make up the new combination. The new fixed-dose regimen is intended for the treatment of HIV-1 infection in adults.
The fixed-dose regimen was developed using a bi-layer technology to co-formulate Sustiva and Truvada as individually formulated layers combined in one tablet. In August of 2005, Gilead announced that the companies were proceeding with the evaluation of three new formulations in parallel, based on bi-layer technology, states the company release.
A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills. Gilead and Bristol-Myers Squibb anticipate filing a new drug application with the US FDA in the second quarter of 2006.
"Tremendous progress has been made in the fight against HIV/AIDS, yet there is still work that needs to be done. Together with our partner Gilead, Bristol-Myers Squibb will continue advancing the development of this potential innovative treatment option for HIV patients," said Anthony C. Hooper, president, US Pharmaceuticals, Bristol-Myers Squibb.
"The advancement of our fixed-dose regimen represents an important step forward in the further simplification of HIV treatment. Gilead and Bristol-Myers Squibb share a commitment to the treatment of HIV, a disease for which significant unmet medical need continues to exist, and we look forward to working with regulatory authorities," said John C. Martin, president and chief executive officer, Gilead Sciences.
In December 2004, Gilead and Bristol-Myers Squibb established a US joint venture to co-formulate the antiretrovirals Truvada and Sustiva in a fixed-dose regimen. If approved by the FDA, the new product would be the first complete Highly Active Antiretroviral Therapy (HAART) treatment regimen for HIV available in a fixed-dose combination tablet taken once daily. Fixed-dose combinations contain multiple medicines formulated together and may help simplify HIV therapy for patients and providers. The joint venture established by the two companies is the first of its kind in the field of HIV therapy.
Guidelines issued by the US Department of Health and Human Services (DHHS) list the combination of emtricitabine, tenofovir disoproxil fumarate and efavirenz as one of the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI)-based treatments for use in appropriate patients that have never taken anti-HIV medicines before. Efavirenz should not be used during the first trimester of pregnancy due to the potential harm to the fetus. Pregnancy should be avoided in women receiving efavirenz. It is important that patients be aware that individual HIV medications must be taken as part of combination regimens, and that they do not cure HIV infection or prevent passing HIV to others, added the release.
Sustiva is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1).
Truvada combines Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) in one tablet taken once a day in combination with other antiretroviral agents. In the United States, Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.