BASEL, Switzerland, December 15 /PRNewswire/ -- Today's positive opinion by the European Committee for Medicinal Products for Human Use (CHMP) of Tibotec's boosted protease inhibitor darunavir is good news for HIV treatment-experienced patients facing drug resistance. Studies have shown that darunavir, when used in combination with the fusion inhibitor FUZEON, can substantially increase the chances of reaching undetectable viral load - the new treatment goal in HIV.
Until recently, it was reluctantly considered acceptable for treatment-experienced patients to continue to have a detectable viral load (more than 50 copies of viral RNA per ml of blood) so long as their immune system was preserved. Unfortunately the consequences of remaining detectable while on therapy are that patients are likely to develop drug resistance, with a consequent loss of future antiretroviral treatment options and ultimately leading to a decrease in immune function and an increase in clinical disease progression.
However guidelines issued by major health associations such as the US Department of Health and Human Services (DHHS), the International AIDS Society (IAS-USA Panel), the French Ministry of Health and Solidarity and the British HIV Association have recommended that achieving maximum viral suppression should now be the treatment goal in treatment experienced patients. This far more ambitious goal for people living with drug-resistant HIV has been made possible through the emergence of new HIV medications such as FUZEON. The use of FUZEON with an active agent such as a boosted protease inhibitor is acknowledged in the guidelines as one of the best way to achieve undetectable viral load. Today's positive opinion by the CHMP means that patients will soon have access to a new potent anti-viral combination.
Notes to Editors:
Approved by the FDA in March 2003, FUZEON is the first and only fusion inhibitor for the treatment of HIV and works in a way that is different from other types of anti-HIV drugs. Darunavir, also known as TMC-114 and the trade name Prezista(TM), is a product of Tibotec Pharmaceuticals Ltd., a division of Janssen-Cilag. Darunavir is a member of the PI class and is reported to be active against virus that has developed resistance to other PIs.