The HIV and Infectious Disease communities welcome the great news by the FDA, of the approval of Bristol-Myers Squibb and Gilead Scieces joint venture-Atripla Tablets. Atripla is a fixed dose combination of three widely used antiretroviral medications, in a single tablet, which is to be taken once a day or in combination with other antiretrovirals that treat HIV-1 infection in the adult population (FDA).
Atripla combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Sustiva, trademark of Bristol-Meyers Squibb and the first non-nucleoside reverse transcriptase inhibitor approved for once-daily use as part of combination therapy is considered to be the most crucial active ingredient in this combination drug.
When Sustiva was initially approved September 17, 1998 in capsule and tablet form in strengths of 50mg, 100mg, and 200mg Capsules, 300 mg and 600 mg Tablets (FDA). Most primary care physicians prescribed Sustiva at 600mg to be taken at bedtime, which utimately meant for patients to take (3) 200mg capsules. Moreover, the long term health effects of Sustiva are not known. But several patients have experienced some psychiatric adverse events. According to Bristol Meyers Squibb initial clinical trial (Stage IIA) information, serious psychiatric adverse experiences, have included severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%) and manic reactions (0.2%) have been reported in patients treated with Sustiva. Furthermore, clinical trial information revealed an “increase in psychiatric symptoms included history of injection drug use, psychiatric history, and use of psychiatric medication(Bristol Meyers Squibb). There have been occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if Sustiva was the cause (Bristol-Meyers Squibb).” These trials were at least a year in duration. As the infectious disease community awaits further instruction on dosage and administration; it would be very interesting when patients infected with HIV-1 should actually administer Atripla[day or night], considering the Sustiva effect.
“Today’s approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in the United States and abroad,” said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs. “Fixed dose combination products are an important tool in improving the quality of health care in developing nations. The approval of Atripla is a significant step forward in our commitment to providing medical care as effectively and efficiently as possible.”
Never before, has there been such cooperation among several “Big Pharma” stakeholders in one venture. Besides the Bristol and Gilead’s stake in Atripla, Merck holds the right to the active ingredient (efavirenz) of Sustiva, which makes this particular venture quite significant.
Atripla was approved in under three months under FDA’s fast track program. The manufacturer plans to make the drug available for purchase in the United States within 96 hours.
References
Food and Drug Administration. [Online].FDA Approves the First Once-a-Day Three-Drug Combination Tablet for Treatment of HIV-1
Atripla is a Landmark Achievement of Three Cooperating Retrieved July, 11, 2006 from http://www.fda.gov/cder/drug
Bristol Meyers Squibb. [Online]. Sustiva. Retrieved July 10, 2006 from http://www.sustiva.com/managehiv/sustiva/channels
News-Medical Net. [Online].FDA approves Atripla for the treatment of HIV-1 infection in adults. Retrieved July 11, 2006 from http://www.news-medical.net/?id=18854
Bristol Meyer Squibb. [Online]. U.S. Food And Drug Administration (FDA) Approves
ATRIPLA™ (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen For Adults With HIV-1 Infection. Retrieved July, 12, 2006 from http://www.bms.com/news/press/data/fg_press_release_6590.html