Abacavir at Last
Glaxo Wellcome has finally announced the start of an expanded access program for its much heralded nucleoside analog abacavir. To qualify, they need only be "failing or intolerant to standard therapy and, in the judgment of the physician, unable to construct a viable treatment regimen without abacavir." There are no CD4 count or viral load ceilings. Enrollees must be over age 13 and not be pregnant or breastfeeding.
Glaxo recommends that patients initiate at least one other new anti-HIV drug along with abacavir. Abacavir, which now has the brand name Ziagen, appears to have exceptional potency in treatment-naïve persons but loses effect against HIV with multiple resistance mutations against nucleoside analogs. A former "open-label protocol," now being phased out enrolled 2,200 people who had CD4 counts below 100 and viral loads over 30,000. Enrollees were required to have failed at least two nucleoside analogs and one protease inhibitor or been intolerant to all marketed drugs. In this very advanced and heavily pretreated population, only about 25% achieved a modest 0.5 log (70%) or greater viral load reduction after starting abacavir. Community activists have worked for the past two years to get Glaxo to create a program with a better chance of success.
Since abacavir is expected to receive FDA marketing clearance by this fall, the new program will not last long. Physicians who wish to enroll patients may call 800/501-4672 for further information.
Anyone contemplating taking abacavir should bear in mind that about 3% of those starting the drug develop a severe hypersensitivity (allergic) reaction. The syndrome is aggravating enough to force interruption of treatment and can rapidly return in life-threatening proportions if abacavir is restarted after the initial symptoms subside. (See Treatment Issues, January 1998).
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.