A new investigational drug used in combination with a second newer agent has proven to be effective in fighting drug-resistant HIV, according to a Lancet article to be published in its July 7th special HIV/AIDS issue.
The multinational phase III clinical trial, which involved 18 nations and more than 30 centers in the United States, is the first trial to offer patients infected with resistant HIV the potential of receiving two investigational new drugs together to fight the disease. The two drugs, amongst the most powerful agents to fight the disease to date, are TMC125 (etravirine) and TMC114 (darunavir, also known as Prezista), both made by Tibotec (a Johnson & Johnson company), the sponsor of the ongoing trial. The data will be presented for the first time during the July 22nd-25th International AIDS Society conference in Sydney, Australia by the lead investigator in the trial, Dr. Adriano Lazzarin of Italy.
"This study is one of the most significant worldwide HIV/AIDS clinical trials in recent years. It showed that when the two drugs are used in combination, there is a good chance HIV can be very effectively controlled in patients who have advanced, multi-drug-resistant HIV," said William J. Towner, MD, Kaiser Permanente Southern California, a co-author of the Lancet article. Kaiser Permanente had the highest number of enrollees in the study from the United States.
Dr. Towner said that the ongoing 'DUET-2' trial -- large, randomized, and placebo controlled -- is the pivotal registration and efficacy trial for TMC125 (it is in a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors [NNRTI]). The Lancet study found that at the 24th week, patients who received TMC125 in combination with TMC114 achieved superior virological suppression than those who received TMC114 alone. The results from the phase III clinical trial will be submitted to regulatory authorities, which must grant their approval before the new drug can be publicly available.
For the DUET trial, Kaiser Permanente enrolled the most patients of all the participating centers in the United States and was the third largest enroller in the world. Nationally, Kaiser Permanente is the second largest provider of HIV care, caring for more than 17,000 HIV infected patients. More than one million Americans are currently living with HIV, and the HIV/AIDS virus has killed more than 524,000 Americans to date.
Dr. Towner added that the trial is most uniquely significant because it utilized another novel HIV medication, TMC114 (in a class of HIV drugs called protease inhibitors; TMC114 was still an investigational agent when the trial started).
According to Dr. Towner, "Treating a resistant virus with two active agents has been a mantra in HIV care for quite some time. 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. The DUET trials were one of the first to give the patients such a chance."
Dr. Towner is the Medical Director of Kaiser Permanente Southern California's HIV/AIDS Research Trials (HART) and the Kaiser Permanente Southern California Regional HIV/AIDS Physician Coordinator. The HART Program was founded in order to ensure that Kaiser Permanente HIV patients with advanced disease have access to the latest drugs.
Kaiser Permanente is America's leading integrated health plan. Founded in 1945, it is a not-for-profit, group practice program headquartered in Oakland, Calif. Kaiser Permanente serves more than 8.7 million members in nine states and the District of Columbia. Today it encompasses the not-for-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the for-profit Permanente Medical Groups. Nationwide, Kaiser Permanente includes approximately 156,000 technical, administrative and clerical employees and caregivers, and 13,000 physicians representing all specialties.