Amprenavir (Agenerase (tm)) Now Available in Expanded Access
On September 21 both Glaxo Wellcome and Vertex Pharmaceuticals Inc. announced an expanded-access program for the experimental protease inhibitor amprenavir (brand name Agenerase, formerly known as VX-478 or 141W94). This program will be open to patients failing treatment with currently approved protease inhibitors. Glaxo and Vertex are working together on the development of amprenavir; Vertex discovered the drug, and Glaxo is responsible for manufacture, clinical trials, and submission for FDA approval.Here is the rapidly-changing information on this program, as of September 30 when this issue went to press.
There are three different open-label protocols in the expanded-access program:
Protocol 30010 is for patients who either had viral rebound or were intolerant on a currently-approved protease inhibitor therapy. This protocol is open to both adults and children (ages 4 and above).
Protocol 30011 is for those who are intolerant to their current protease-inhibitor therapy; they can be changed to a specific amprenavir-plus-abacavir protocol, or the physician can choose a dual-protease-inhibitor arm. In order to qualify for this option, they must not have taken abacavir previously for longer than eight weeks. This protocol is open to adults and adolescents (age 13 and above).
Protocol 30012 is an open-label clinical trial to determine the effect of amprenavir on lipid metabolism (hyperlipidemia and lipodystrophy) in subjects experiencing these adverse effects and who are not failing current antiretroviral therapy. It is open to adults and adolescents.
Also, when physicians call, they may be referred to ACTG protocols (398 and 400) with amprenavir treatment arms, in case they could send their patient to a local ACTG site. Also, physicians with pediatric patients may be referred to a Glaxo Wellcome phase III pediatric trial (for patients not previously treated with protease inhibitors). This referral will be a suggestion, not a requirement.
"Regardless of which option physicians and patients opt for, patients need to have received prior treatment with at least one protease inhibitor in addition to fulfilling other standard criteria. Patients will also be strongly encouraged to start at least one other anti-HIV agent that they have not previously used." (Quoted from press statements issued jointly by the two companies).
Over 700 patients have received amprenavir so far through clinical trials.
Patients interested in entering this program should have their physician call the Agenerase/Amprenavir Early Access Program, 800-248-9757, 8 a.m. to 6 p.m. Eastern time, Monday through Friday.
