The Food and Drug Administration has approved a new HIV drug for those patients whose disease has not improved with standard treatments.
The drug, Prezista (darunavir), is approved for use when other antiretroviral drugs have failed. It may offer a new option for patients whose disease has not improved with other treatments.
"One of the greatest challenges in HIV care is finding therapies for treatment-experienced patients," said Dr. Michael S. Saag, director of the AIDS Outpatient Clinic and the University of Alabama Center for AIDS Research, in a press release published by Johnson and Johnson, the manufacturer of the drug.
Like other treatments, Prezista is a protease inhibitor, which works by preventing the virus HIV from replicating. However, because it works in a slightly different way from other protease inhibitors, this drug may be more successful in some patients whose disease proves resistant to other medication. Prezista is designed to be given in combination with another drug, ritonavir, which slows the breakdown of Prezista in the body.
In a clinical study of 131 patients with HIV whose disease failed to respond to other treatments, almost 70 percent showed a reduction in the number of HIV virus particles in the body after taking the Prezista/ritonavir combination for 24 weeks. Additionally, 45 percent of these patients had no detectable amount of the virus in the body. This does not mean they were cured of HIV, but the drug combination did reduce the amount of the virus to such a low level that it is undetectable with standard lab tests.
The results of this trial were so impressive that the FDA granted accelerated approval for the drug, which is a special category that allows early approval for drugs that may provide a significant difference or advantage over other available treatments.
"The approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," said Dr. Andrew C. von Eschenbach, acting commissioner of food and drugs for the FDA, "This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."
