Fosamprenavir (Lexiva) approved in US
1 December 2003. Related: Antiretrovirals.
On 20 October the US Food and Drug Administration approved the protease inhibitor fosamprenavir (Lexiva, GW908). Fosamprenavir is a pro-drug of amprenavir (Agenerase). This new formulation requires fewer pills than amprenavir (now usually four pills a day including the ritonavir, vs. 16 pills a day for Agenerase), and no food restrictions.
European approval is expected to follow in about six months and until then fosamprenavir remains available on an expanded access programme.
Information for doctors and patients is at:
http://www.lexiva.com
Other links:
Brief review by the FDA of the pivotal clinical trials:
http://www.thebody.com/fda/lexiva.html?m18
GSK review:
http://www.gsk.com/press_archive/press2003/press_10212003a.htm
An extensive review by the activist organisation TAG (Treatment Action Group), supporting approval – but only when Lexiva is “boosted” with a low dose of ritonavir to increase blood levels of Lexiva:
http://www.aidsinfonyc.org/tag/tx/fosamprenavir.html
Combinations, adverse events, dosing, interactions, resistance:
http://www.hivandhepatitis.com/hiv_and_aids/lexiva_1.html
Source: AIDS Treatment News
http://www.aidsnews.org