FOSTER CITY, Calif.—The U.S. Food and Drug Administration(FDA) has granted approval to Complera, a single-tablet regimen (STR) for thetreatment of HIV-1 infection in treatment-naïve adults. The treatment is acombination of three antiretroviral medications in one daily tablet: Truvadafrom Gilead Sciences, Inc., a fixed-dose combination of emtricitabine andtenofovir disoproxil fumarate, and rilpivirine, a non-nucleoside reversetranscriptase inhibitor from Tibotec Pharmaceuticals which is marketed asEdurant in the United States by Janssen Therapeutics. Truvada received FDAapproval in August 2004 and rilpivirine in May 2011, both for use as part ofHIV combination therapy.
"Complera is the second complete single-tablet regimen thatGilead has introduced, and it represents a collaboration between twoorganizations that share a vision of simplifying HIV therapy for patients,"said John C. Martin, Ph.D., Chairman and Chief Executive Officer at GileadSciences, in a press release. "Tremendous progress has been made in the fieldof HIV, but we recognize new therapies are still needed, and we continue towork to advance options that address the needs of patients."
Complera's approval is based on the results of two Phase IIIdouble-blind, active controlled, randomized studies, ECHO and THRIVE, conductedto evaluate rilpivirine's safety and efficacy when compared to efavirenz amongtreatment-naïve HIV-1 infected adults. The two studies were conducted byTibotec, while Gilead conducted a bioequivalence study which demonstrated thatthe combination STR could achieve the same levels of medication in the blood ofpatients as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.
Gilead and Tibotec first entered into a license andcollaboration agreement together in July 2009, for the development andcommercialization of Complera. Per the agreement, Gilead will have the leadrole in manufacturing, registering, distributing and commercializing Complerain the United States, Canada, Brazil, the European Union (EU), Australia andNew Zealand. For its part, Tibotec will oversee the commercialization ofrilpivirine as a stand-alone product and has the right to co-detail Complera inthose territories. The emtricitabine/rilpivirine/tenofovir disoproxil fumaratecombination STR currently has a marketing application pending in the EU.
Gilead will also be responsible for the registration,distribution and commercialization of the STR in Latin America and theCaribbean, while Tibotec will take charge of all countries outside of Gilead'sterritories, including Japan, the Middle East, Eastern Europe and all ofAfrica.
"In the 30 years since the first AIDS cases were reported,we've made incredible strides in the treatment of this disease," said TonyMills, M.D., Director of Medical Research, Anthony Mills MD, Inc. and aparticipating investigator in ongoing Complera studies. "The concept of asingle-tablet regimen has become a goal in HIV drug development, and thestandard of care in medical practice in the United States. However, no onetherapy is appropriate for all patients. Given its efficacy, safety andconvenience, the availability of Complera represents an exciting milestone inaddressing the individual needs of patients new to HIV therapy."
The most common adverse drug reactions to rilpivirine, seenin incidence greater than or equal to 2 percent, were insomnia and headache.The most common adverse drug reactions to emtricitabine and tenofovirdisoproxil fumarate, seen in incidence greater than or equal to 10 percent,were nausea, fatigue, diarrhea, dizziness, insomnia, abnormal dreams, headache,depression and rash.
SOURCE: Gilead Sciences, Inc. press release