Triple regimen HIV pill gains approval
pharmafile | August 11, 2011 | News story | | Gilead, HIV, J&J, JJ, Truvada
A new three-in-one pill Complera has been approved in the US as a first line treatment for HIV.
Complera combines three antiretroviral drugs in a once-daily pill – Gilead’s emtricitabine and tenofovir disoproxil fumarate, and J&J’s similar rilpivirine.
Under its deal with J&J, Gilead will keep around 30% from what it makes from the Edurant component in Complera.
Gilead’s emtricitabine and tenofovir disoproxil fumarate are already on the market as a 2-in-1 called Truvada and J&J’s rilpivirine is known by the brand name Edurant.
The new combination Complera is expected to generate over $500 million in revenues in 2013, and will cost $1,705 a month per patient.
Tony Mills, director of medical research at Anthony Mills MD, Inc., and an investigator in ongoing Complera studies, said: “The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States.
“However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy.”
This will be the third HIV compound treatment launched by Tibotec Pharmaceuticals, a subsidiary of J&J.
The ECHO and THRIVE phase III studies evaluated the safety and efficacy of Edurant compared to Bristol Myers Squibb’s Sustiva (efavirenz) among treatment-naïve HIV-1 infected adults.
Both arms of the study were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada.
Gilead then conducted a bioequivalence study that demonstrated the single tablet achieved the same levels of medication in the blood as the three pills taken separately.
Complera is the second complete antiretroviral treatment regimen for HIV-1 available to treatment-naïve patients in a single once-daily pill.
The first, Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), is marketed by Gilead and Bristol-Myers Squibb, and made the companies $2.6 billion in sales from last year.
A marketing application for Complera was recently submitted for approval to the EMA.
Ben Adams
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