Tibotec Pharmaceuticals, a division of Johnson & Johnson, manufactures the drugs which are called etravirine (TMC125) and darunavir (TMC114).
The studies examined the use of TMC125 in combination with other anti-retroviral medications in treatment-experienced adult HIV-1 patients with documented resistance to NNRTIs and PIs.
The results showed that after 24 weeks 18% more drug-resistant patients than those taking a standard drug regimen saw the virus in their blood drop to undetectable levels.
Tibotec plans to file these findings with the Food and Drug Administration as part of a new drug application.
“Adding only one active agent to a patient experiencing drug failure usually results in the rapid, predictable development of resistance to that agent. Very seldom do patients get the chance to receive two potent new investigational agents in one clinical trial,” said Dr. William Towner, one of the study authors and medical director for Kaiser Permanente’s HIV/AIDS Research Trials Program in Southern California.