Written by Rita Jenkins| 13 October, 2007 22:49 GMT
The US
Food and Drug Administration on Friday approved the
Merck drug Isentress (raltegravir), an integrase enzyme inhibitor. The new drug offers hope for AIDS patients who have become resistant to other forms of antiretroviral therapy.
Taken in tablet form twice a day, Isentress interferes with HIV replication by keeping it from inserting its DNA into human DNA.
Other drugs inhibit protease and reverse transcriptase, two other enzymes involved in HIV replication. However, until now, there has not been a drug available to suppress integrase, according to the pharmaceutical giant.
The FDA approval came after trials with human subjects, begun in 2005, showed that Isentress was particularly beneficial when used in combination with protease and reverse transcriptase inhibitors.
The patients involved in the tests had been infected with HIV for years, and had become resistant to many AIDS drugs.
For more than 80 percent of them, the combination of Isentress with other AIDS medications brought their disease under control, dropping the level of HIV in their blood to barely detectable levels.
Isentress will cost $27 per day, or about $10,000 for a year of treatment, according to Merck.
"The development of Isentress is a significant milestone in the history of HIV/AIDS therapy because we now have a drug that's potent against another key enzyme essential for viral replication," said Joseph J. Eron Jr., MD, professor of medicine, Division of Infectious Diseases, UNC Chapel Hill School of Medicine.
"It's important for physicians to know that Isentress should always be used in combination with other active agents," he stressed. |
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